<table style="min-width: 25px"><colgroup><col style="min-width: 25px"></colgroup><tbody><tr><td colspan="1" rowspan="1"><h1 style="text-align: left"></h1></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><table style="min-width: 150px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"></p></th><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Rédaction/redaction</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Vérification/verification</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Approbation/approval</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Nom/name</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left">Feriel</p><p style="text-align: left">MRABET</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Hichem BEN AMOR</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Salha GARBAYA</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Mahmoud ALSWISSI</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Mohamed Amine</p><p style="text-align: left">BOUJBEL</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Signature /Signature</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Date /date</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><p style="text-align: left"><strong>REGISTRE DE REVISION /MODIFICATION SUMMMARY</strong></p><table style="min-width: 125px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Numéro de l'ancienne version /last version number</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Les modifications apportées sont/section modifiée (§)/modification description</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Date de modification/modification date</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Modifiée par /modified by</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Numéro de la nouvelle version/new version number</strong></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><h1 style="text-align: left"></h1><h1 style="text-align: left"></h1><table style="min-width: 25px"><colgroup><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><h1 style="text-align: left"></h1><h1 style="text-align: left">sommaire /SUMMARY</h1><h1 style="text-align: left"></h1></th></tr><tr><td colspan="1" rowspan="1"><ol><li><p style="text-align: left"></p></li></ol><h1 style="text-align: left">Présentation du produit /product presentation</h1><ul><li><p style="text-align: left"></p></li></ul><h1 style="text-align: left">Formule de fabrication /manufacturing formula</h1><ul><li><p style="text-align: left"></p></li></ul><h1 style="text-align: left">Précautions pour la fabrication /manufacturing precaution</h1><ul><li><p style="text-align: left"></p></li></ul><h1 style="text-align: left">flow chart de fabrication du produit/product manufacturing flow chart</h1><ul><li><p style="text-align: left"></p></li></ul><h1 style="text-align: left">Vérification des articles de conditionnement primaire et des consommables de production /primary packaging material check and production consumables verification</h1><ul><li><p style="text-align: left"><strong>Lavage dépyrogenisation des flacons /vial washing and depyrogenation</strong></p></li><li><p style="text-align: left"></p></li></ul><h1 style="text-align: left">Désinfection du sac stérile et des boites de pétri /sterile bag and settle plate disinfection</h1><ul><li><p style="text-align: left"></p></li></ul><h1 style="text-align: left">Stérilisation des bouchons + système de filtration et répartition/stopper filtration and filling system sterilization</h1><ul><li><p style="text-align: left"></p></li></ul><h1 style="text-align: left">Pesée des matières premières : excipients /raw material weighing excipient</h1><ul><li><p style="text-align: left"></p></li></ul><h1 style="text-align: left">Pesée des matières premières : matière active / raw material weighing : active ingredient</h1><ul><li><p style="text-align: left"></p></li></ul><h1 style="text-align: left">Fabrication /manufacturing</h1><ul><li><p style="text-align: left"></p></li></ul><h1 style="text-align: left">Filtration stérilisante /sterilizing filtration</h1><ul><li><p style="text-align: left"></p></li></ul><h1 style="text-align: left">Répartition +prébouchage/filling + half stoppering</h1><ul><li><p style="text-align: left"></p></li></ul><h1 style="text-align: left">Lyophilisation /lyophilization</h1><ul><li><p style="text-align: left"></p></li></ul><h1 style="text-align: left">Stérilisation des capsules/caps sterilization</h1><ul><li><p style="text-align: left"></p></li></ul><h1 style="text-align: left">Capsulage/capping</h1><ul><li><p style="text-align: left"></p></li></ul><h1 style="text-align: left">Lavage externe /external washing</h1><ul><li><p style="text-align: left"></p></li></ul><h1 style="text-align: left">Réconciliation /yield calculation</h1><ul><li><p style="text-align: left"></p></li></ul><h1 style="text-align: left">Rapport détaillé de reconciliation</h1><ul><li><p style="text-align: left"></p></li></ul><h1 style="text-align: left">Gestion des déchets /waste management</h1><ul><li><p style="text-align: left"></p></li></ul><h1 style="text-align: left">Déviation et décisions du PCP/deviation and production pharmacist decison</h1><h1 style="text-align: left"></h1></td></tr></tbody></table><ol><li><p style="text-align: left"><strong>1. </strong><span data-section="1"><strong>PRESENTATION DU PRODUIT : /PRODUCT PRESENTATION</strong></span></p><p style="text-align: left"><span data-question="1">PRESENTATION DU PRODUIT : /PRODUCT PRESENTATION</span></p></li></ol><table data-table-form-id="7014" data-question-id="9408" data-header-orientation="horizontal" data-table-form-status="created" style="min-width: 50px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Désignation /designation</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"><strong>PEMETREXED NEAPOLIS 100 MG</strong></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>DCI / INN</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>PEMETREXED</strong></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Durée de vie /shelf life</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>24 MOIS / 24 months</strong></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Modèle /Model</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>LOCAL/HOSPITALIER /LOCAL /HOSPITAL</strong></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Forme pharmaceutique /pharmaceutical form</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>FLACON LYOPHILISAT /lyophilised vial</strong></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Dosage /strength</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>100 MG</strong></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Taille de lot en litres /batch size liter</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>15 LITRES/liters</strong></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Taille de lot en unité de production /batch size in production unit</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>3750 FLACONS /vials</strong></p></td></tr><tr><td colspan="1" rowspan="1"><h1 style="text-align: left">Conditionnement primaire/primary packaging material</h1></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Flacon transparent type 1 format 10 R /</strong></p><p style="text-align: left"><strong>clear vial type 1 size 10 R</strong></p></td></tr><tr><td colspan="1" rowspan="1"><h1 style="text-align: left">Taille de lot pratique /practical batch size</h1></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>15 litres/liters pour/for 3750 flacons /vials</strong></p></td></tr></tbody></table><ol start="2"><li><p style="text-align: left"><span data-section="2"><strong>FORMULE DE FABRICATION/MANUFACTURING FORMULA</strong></span></p></li></ol><p style="text-align: left"><span data-question="1">FORMULE DE FABRICATION/MANUFACTURING FORMULA</span></p><table data-table-form-id="7015" data-question-id="9409" data-header-orientation="horizontal" data-table-form-status="created" style="min-width: 100px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Code article/material code</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Désignation</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Quantité</strong></p><p style="text-align: left"><strong>par flacon /quantity per vial</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Quantité par lot /quantity per batch</strong></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>MAN00021</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>PEMETREXED DISSODIUM HEPTAYDRATE quantité correspondante en pemetrexed à&nbsp;/ corresponding amount in pemetrexed to</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>139.8 mg</strong></p><p style="text-align: left"><strong>100 mg</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>524.25 g</strong></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>MEN00019</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>MANNITOL</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>100 mg</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>375 g</strong></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>MEN00044</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>HCL 1N</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>QS PH 7.0- 7.4</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>QS PH 7.0- 7.4</strong></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>MEN00042</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>NAOH 1N</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>QS PH7.0- 7.4</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>QS PH7.0- 7.4</strong></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>MEN00040</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>EPPI /WFI</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>QSP 4 ml</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>SQF 15 litres /liters</strong></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>FVN00003</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>FLACON VERRE ETRIE BLANC 10R /GLASS vial ETRIE WHITE 10R</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>1</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>3750 unités /unit</strong></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>BON00001</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>BOUCHON IGLOO BROMOBUTYL GRIS / IGLOO BROMOBUTYL grey stopper</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>1</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>3750 unités/unit</strong></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>CSN00002</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>CAPSULE FLIP OFF DIAMETRE 20 BLEUE /flip off caps 20 diameter blue</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>1</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>3750 unités/unit</strong></p></td></tr></tbody></table><p style="text-align: left">Joindre l'OF à cette page/ Attach manufacturing order to this page</p><ol start="3"><li><p style="text-align: left"><span data-section="3"><strong>PRECAUTIONS POUR LA FABRICATION /MANUFACTURING PRECAUTION</strong></span></p></li></ol><p style="text-align: left"><span data-question="1"><strong><em>Précautions vis à vis du personnel /personnal precaution</em></strong></span></p><table data-table-form-id="7016" data-question-id="9410" data-header-orientation="horizontal" data-table-form-status="created" style="min-width: 25px"><colgroup><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left">Précautions vis à vis du personnel /personnal precaution</p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Toutes les opérations de fabrication : de la pesée au capsulage doivent être réalisées à l'intérieur d'un système ferméou d’un isolateur ./all the operations from the API weighing to capping must be done in closed system or under isolator</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Protection des mains/ hand protection : Porter des doubles gants /wear double gloves</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Protection des yeux :Porter des lunettes de sécurité ou un masque complet / eye protectionwear safety glassor full face protection mask</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">En cas de déversement accidentel ou un risque de dégagement incontrôlé.</p><p style="text-align: left">appliquer instruction en vigueur ./ In case of accidental spill or risk of uncontrolled release apply the instruction .</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">En cas de contact avec les yeux : Rincer immédiatement les yeux avec de l'eau pendant au moins 15 minutes. Si une irritation se produit ou persiste, notifier votre superviseur hiérarchique./ in case of eye contact immediately flush eyes with water for at least 15 minutes. If irritation occurs or persists, notify your supervisor</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">En cas de contact avec la peau Laver la zone exposée avec du savon et de l'eau et enlever les vêtements / chaussures contaminés, si une irritation se produit ou persiste, avertir le personnel médical et le superviseur. /In case of skin contact Wash exposed area with soap and water and remove contaminated clothes / shoes, if irritation occurs or persists, notify medical personnel and supervisor</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">En cas d'inhalation Amener immédiatement le sujet exposé à l'air frais. Si il ne respire pas, procéder à la respiration artificielle . Si la respiration est difficile, administrer de l'oxygène. Aviser immédiatement le personnel médical et le superviseur./In case of inhalation Immediately move the exposed person to fresh air. If she is not breathing, give artificial respiration. If breathing is difficult, administer oxygen. Immediately notify the medical staff and supervisor.</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">En cas d'ingestion Ne pas faire vomir à moins d'indication contraire du personnel médical, ne donner rien à boire à moins d'avis contraire du personnel médical, avertir le personnel médical et le superviseur/ If swallowed Do not induce vomiting unless directed to do so by medical personnel, give nothing to drink unless directed by medical personnel, notify medical personnel and supervisor</p></td></tr></tbody></table><table style="min-width: 25px"><colgroup><col style="min-width: 25px"></colgroup><tbody><tr><td colspan="1" rowspan="1"><ul><li><p style="text-align: left">Toutes les opérations de fabrication : de la pesée au capsulage doivent être réalisées à l'intérieur d'un système ferméou d’un isolateur ./all the operations from the API weighing to capping must be done in closed system or under isolator</p></li></ul><ul><li><p style="text-align: left">Protection des mains/ hand protection : Porter des doubles gants /wear double gloves</p></li><li><p style="text-align: left">Protection des yeux :Porter des lunettes de sécurité ou un masque complet / eye protectionwear safety glassor full face protection mask</p></li><li><p style="text-align: left">En cas de déversement accidentel ou un risque de dégagement incontrôlé.</p></li></ul><p style="text-align: left">appliquer instruction en vigueur ./ In case of accidental spill or risk of uncontrolled release apply the instruction .</p><ul><li><p style="text-align: left">En cas de contact avec les yeux : Rincer immédiatement les yeux avec de l'eau pendant au moins 15 minutes. Si une irritation se produit ou persiste, notifier votre superviseur hiérarchique./ in case of eye contact immediately flush eyes with water for at least 15 minutes. If irritation occurs or persists, notify your supervisor</p></li><li><p style="text-align: left">En cas de contact avec la peau Laver la zone exposée avec du savon et de l'eau et enlever les vêtements / chaussures contaminés, si une irritation se produit ou persiste, avertir le personnel médical et le superviseur. /In case of skin contact Wash exposed area with soap and water and remove contaminated clothes / shoes, if irritation occurs or persists, notify medical personnel and supervisor</p></li><li><p style="text-align: left">En cas d'inhalation Amener immédiatement le sujet exposé à l'air frais. Si il ne respire pas, procéder à la respiration artificielle . Si la respiration est difficile, administrer de l'oxygène. Aviser immédiatement le personnel médical et le superviseur./In case of inhalation Immediately move the exposed person to fresh air. If she is not breathing, give artificial respiration. If breathing is difficult, administer oxygen. Immediately notify the medical staff and supervisor.</p></li><li><p style="text-align: left">En cas d'ingestion Ne pas faire vomir à moins d'indication contraire du personnel médical, ne donner rien à boire à moins d'avis contraire du personnel médical, avertir le personnel médical et le superviseur/ If swallowed Do not induce vomiting unless directed to do so by medical personnel, give nothing to drink unless directed by medical personnel, notify medical personnel and supervisor</p></li></ul></td></tr></tbody></table><p style="text-align: left"><strong><em>3.2.</em></strong><span data-question="2"><strong><em>Précautions vis à vis du produit: / product precautions</em></strong></span></p><p style="text-align: left"></p><table data-table-form-id="7017" data-question-id="9411" data-header-orientation="horizontal" data-table-form-status="created" style="min-width: 25px"><colgroup><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left">Précautions vis à vis du produit: / product precautions</p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Matière première : Conserver dans des récipients étanches et résistants à la lumière à21±3° C /Raw material: Keep in tight, light-resistant containers at 21±3° C</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">le produit intermédiaire durant toutes les étapes de la mise en solution à la congélation doit être conservé à 20±5°C° /the intermediate product during all stages of freeze-solution must be stored at 20±5°C°</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">La filtration et le remplissage doivent se faire sous azote/ Filtration and filling must be done under nitrogen</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">les flacons capsulés doivent être conservés à une température de 21±3° C / capped vials must be stored at a temperature of 21±3° C</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">La matière première doit être pesée le même jour de la fabrication / The raw material must be</p><p style="text-align: left">weighed the same day of manufacture</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">la durée entre la fin de la filtration et le début du remplissage ne doit pas dépasser 48h / the time between the end of filtration and the start of filling must not exceed 48 hours</p></td></tr></tbody></table><table style="min-width: 25px"><colgroup><col style="min-width: 25px"></colgroup><tbody><tr><td colspan="1" rowspan="1"><ul><li><p style="text-align: left">Matière première : Conserver dans des récipients étanches et résistants à la lumière à21±3° C /Raw material: Keep in tight, light-resistant containers at 21±3° C</p></li><li><p style="text-align: left">le produit intermédiaire durant toutes les étapes de la mise en solution à la congélation doit être conservé à 20±5°C° /the intermediate product during all stages of freeze-solution must be stored at 20±5°C°</p></li><li><p style="text-align: left">La filtration et le remplissage doivent se faire sous azote/ Filtration and filling must be done under nitrogen</p></li><li><p style="text-align: left">les flacons capsulés doivent être conservés à une température de 21±3° C / capped vials must be stored at a temperature of 21±3° C</p></li><li><p style="text-align: left">La matière première doit être pesée le même jour de la fabrication / The raw material must be</p></li></ul><p style="text-align: left">weighed the same day of manufacture</p><ul><li><p style="text-align: left">la durée entre la fin de la filtration et le début du remplissage ne doit pas dépasser 48h / the time between the end of filtration and the start of filling must not exceed 48 hours</p></li></ul></td></tr></tbody></table><ol start="4"><li><p style="text-align: left"><span data-section="4"><strong>FLOW CHART DE FABRICATION DU PRODUIT/PRODUCT MANUFACTURING FLOW CHART</strong></span></p></li></ol><p style="text-align: left"></p><p style="text-align: left"><span data-section="5"><strong>VERIFICATION DES ARTICLES DE CONDITIONNEMENT PRIMAIRE ET DES CONSOMMABLES DE PRODUCTION /PRIMARY PACKAGING MATERIAL CHECK AND PRODUCTION CONSUMABLES VERIFICATION</strong></span></p><p style="text-align: left"></p><p style="text-align: left"><span data-question="1">Date et heure début/date and hour of starting</span></p><table data-table-form-id="7018" data-question-id="9412" data-header-orientation="horizontal" data-table-form-status="created" style="min-width: 25px"><colgroup><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left">Date et heure début/date and hour of starting</p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><table style="min-width: 492px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="width: 442px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>7Date et heure début/date and hour of starting /......./...../...... .. .....h.......</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th><th colspan="1" rowspan="1" colwidth="442"><p style="text-align: left"></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Etape de fabrication/manufacturing phase</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Fait par /done by</strong></p></td><td colspan="1" rowspan="1" colwidth="442"><p style="text-align: left"><strong>Vérifié par /checked by</strong></p></td></tr><tr><td colspan="1" rowspan="1"><ol><li><p style="text-align: left"><span data-question="2">Vérifier la disponibilité des flacons /check the vials availability FVN00003</span></p></li></ol><table data-table-form-id="7042" data-question-id="9442" data-header-orientation="vertical" data-table-form-status="created" style="min-width: 50px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left">Quantité /quantity</p></th><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><th colspan="1" rowspan="1"><p style="text-align: left">Numéro de lot / batch number</p></th><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><th colspan="1" rowspan="1"><p style="text-align: left">Nombre de barquettes / container number</p></th><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1" colwidth="442"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="2"><li><p style="text-align: left"><span data-question="3">Vérifier la disponibilité des sacs de bouchons&nbsp; /check the stopper bags availability <strong>BON00001</strong></span></p></li></ol><table data-table-form-id="7036" data-question-id="9436" data-header-orientation="horizontal" data-table-form-status="created" style="min-width: 50px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left">Quantité /quantity</p></th><th colspan="1" rowspan="1"><p style="text-align: left">...........................</p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Numéro de lot / batch number</p></td><td colspan="1" rowspan="1"><p style="text-align: left">...........................</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Nombre de sacs / bags number</p></td><td colspan="1" rowspan="1"><p style="text-align: left">...........................</p></td></tr></tbody></table></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1" colwidth="442"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="3"><li><p style="text-align: left"><span data-question="4">Vérifier la disponibilité des sacs de capsules /check the caps availability <strong>CSN00002</strong></span></p></li></ol><table data-table-form-id="7037" data-question-id="9437" data-header-orientation="horizontal" data-table-form-status="created" style="min-width: 50px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left">Quantité / quantity</p></th><th colspan="1" rowspan="1"><p style="text-align: left">...........................</p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Numéro de lot / batch number</p></td><td colspan="1" rowspan="1"><p style="text-align: left">...........................</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Nombre de sacs / bags number</p></td><td colspan="1" rowspan="1"><p style="text-align: left">...........................</p></td></tr></tbody></table></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1" colwidth="442"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="4"><li><p style="text-align: left"><span data-question="5">Vérifier la disponibilité des filtres /check the filter availability <strong>CPN00219</strong></span></p></li></ol><table data-table-form-id="7038" data-question-id="9438" data-header-orientation="horizontal" data-table-form-status="created" style="min-width: 50px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left">Quantité / quantity</p></th><th colspan="1" rowspan="1"><p style="text-align: left">...........................</p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Numéro de lot / batch number</p></td><td colspan="1" rowspan="1"><p style="text-align: left">...........................</p></td></tr></tbody></table></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1" colwidth="442"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="5"><li><p style="text-align: left"><span data-question="6">Vérifier la disponibilité du sac de filtration /check the filtration bag availability <strong>CPN00203</strong></span></p></li></ol><table data-table-form-id="7039" data-question-id="9439" data-header-orientation="horizontal" data-table-form-status="created" style="min-width: 50px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left">Quantité / quantity</p></th><th colspan="1" rowspan="1"><p style="text-align: left">...........................</p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Numéro de lot / batch number</p></td><td colspan="1" rowspan="1"><p style="text-align: left">...........................</p></td></tr></tbody></table></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1" colwidth="442"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Date et heure fin/ ending hour and date ......./...../...... .. .....h.......</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1" colwidth="442"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Visa et date superviseur: signature and date supervisor : ...........................................................................</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1" colwidth="442"><p style="text-align: left"></p></td></tr></tbody></table><p style="text-align: left"><span data-question="7">Date et heure fin/ ending hour and date</span></p><table data-table-form-id="7040" data-question-id="9440" data-header-orientation="horizontal" data-table-form-status="created" style="min-width: 25px"><colgroup><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left">Date et heure fin/ ending hour and date</p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><p style="text-align: left"><span data-question="8">Visa et date superviseur: signature and date supervisor</span></p><table data-table-form-id="7041" data-question-id="9441" data-header-orientation="horizontal" data-table-form-status="created" style="min-width: 25px"><colgroup><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left">Visa et date superviseur: signature and date supervisor</p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><ol start="6"><li><p style="text-align: left"><span data-section="6"><strong>LAVAGE ET DEPYROGENISATION DES FLACONS/ VIAL WASHING AND DEPYROGENATION</strong></span></p></li></ol><p style="text-align: left"><span data-question="1">Equipement</span></p><table data-table-form-id="7043" data-question-id="9443" data-header-orientation="vertical" data-table-form-status="created" style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Désignation équipement /equipment code</strong></p></th><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Code /code</strong></p></th><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Dernière date de qualification/étalonnage last calibration and qualification date</strong></p></th><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><table style="min-width: 1197px"><colgroup><col style="width: 1147px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1" colwidth="1147"><p style="text-align: left"><strong>Date et heure début/date and hour of starting /......./...../...... .. .....h.......</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th></tr><tr><td colspan="1" rowspan="1" colwidth="1147"><p style="text-align: left"><strong>Etape de fabrication /manufacturing phase</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Fait par date et signature /done by date and signature</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Vérifié par date et visa /checked by date and signature</strong></p></td></tr><tr><td colspan="1" rowspan="1" colwidth="1147"><ol><li><p style="text-align: left"><span data-question="3">vérifier&nbsp; le vide de ligne du local et des 2équipements/check the2 equip mentsand the room line clearance</span></p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1" colwidth="1147"><ol start="2"><li><p style="text-align: left"><span data-question="4">démarrer la laveuse des flacons selon l'instruction en vigueur/start the washing line according SOP</span></p></li><li><p style="text-align: left">Démarrer le tunnel de dépyrogénisation selon l'instruction en vigueur./start the sterilizing tunnel according SOP</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1" colwidth="1147"><ol start="4"><li><p style="text-align: left"><span data-question="6">Remplir lesdonnées suivantes :/ indicate the following informations</span></p></li></ol><table data-table-form-id="7046" data-question-id="9449" data-header-orientation="vertical" data-table-form-status="created" style="min-width: 721px"><colgroup><col style="width: 696px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1" colwidth="696"><p style="text-align: left">N° de lot des flacons /vial batch number</p></th><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><th colspan="1" rowspan="1" colwidth="696"><p style="text-align: left">Quantité/quantity</p></th><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><th colspan="1" rowspan="1" colwidth="696"><p style="text-align: left">Température de lavage/ washing temperature :75±15°C</p></th><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><th colspan="1" rowspan="1" colwidth="696"><p style="text-align: left">Heure début lavage /starting hour washing</p></th><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><th colspan="1" rowspan="1" colwidth="696"><p style="text-align: left">Heure fin lavage /ending hour washing</p></th><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><th colspan="1" rowspan="1" colwidth="696"><p style="text-align: left">Nombre de flacons &nbsp; /vials number</p></th><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><th colspan="1" rowspan="1" colwidth="696"><p style="text-align: left">Heure début de chauffage du tunnel&nbsp;/starting hour of tunnel heating</p></th><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><th colspan="1" rowspan="1" colwidth="696"><p style="text-align: left">Température de dépyrogénisation/depyrogenation temperature : 295 °C(+10-5°C)</p></th><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><th colspan="1" rowspan="1" colwidth="696"><p style="text-align: left">Température de refroidissement /cooling temperature : 20°C</p></th><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><th colspan="1" rowspan="1" colwidth="696"><p style="text-align: left">Heure fin depyrogenisation /ending hour depyrogenisation</p></th><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1" colwidth="1147"><ol start="5"><li><p style="text-align: left"><span data-question="7">Procéder au vide de ligne des 2 machines selon la documentation en vigueur./start the line clearance of the 2 equipments and the room according SOP.</span></p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1" colwidth="1147"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1" colwidth="1147"><p style="text-align: left"><strong>Date et heure fin / ending date and hour ......./...../...... .. .....h......</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1" colwidth="1147"><p style="text-align: left"><strong>Visa et date superviseur/signature and date supervisor :...............................................................................</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><p style="text-align: left">Joindre le vide de ligne de ou des équipements et l'étiquette statut local/attach the line clearance and the cleaning label of the room and the equipment</p><ol start="7"><li><p style="text-align: left"><span data-section="7"><strong>DESINFECTION DU SAC STERILE ET DES BOITES DE PETRI/ SETLLE PLATE, STERILE BAG DISINFECTION </strong></span></p></li></ol><table style="min-width: 50px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Désignation équipement /equipment designation</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Pass box steridry</strong></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Code /code</strong></p></td><td colspan="1" rowspan="1"><h1 style="text-align: left"><em>eqhpece 14</em></h1></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Dernière date de qualification/étalonnage /last calibration and qualification date</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left">........./......./...........</p></td></tr></tbody></table><table style="min-width: 1150px"><colgroup><col style="width: 1100px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1" colwidth="1100"><p style="text-align: left"><strong>Date et heure début /starting date and hour /......./...../...... .. .....h.......</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th></tr><tr><td colspan="1" rowspan="1" colwidth="1100"><p style="text-align: left"><strong>Etape de fabrication/manufacturing phase</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Fait par /done by</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Vérifié par /checked by</strong></p></td></tr><tr><td colspan="1" rowspan="1" colwidth="1100"><ol><li><p style="text-align: left"><span data-question="3">Vérifier le vide de ligne et le nettoyage du pass box /check the cleaning and the line clearance of pass box</span></p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1" colwidth="1100"><ol start="2"><li><p style="text-align: left"><span data-question="4">Appliquerl'instruction de passage par le Pass-Box en vigueur et enregistrer les données /apply the SOP of the pass box and record the information in the table</span></p></li></ol><table data-table-form-id="7052" data-question-id="9457" data-header-orientation="vertical" data-table-form-status="created" style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left">Paramètre/parameter</p></th><td colspan="1" rowspan="1"><p style="text-align: left">Consigne/set</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Valeur/value</p></td></tr><tr><th colspan="1" rowspan="1"><p style="text-align: left">Temps de contact/<em>contact time</em></p></th><td colspan="1" rowspan="1"><p style="text-align: left">15 min</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><th colspan="1" rowspan="1"><p style="text-align: left">Temps d’aération/<em>blowing time</em></p></th><td colspan="1" rowspan="1"><p style="text-align: left">45 min</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><th colspan="1" rowspan="1"><p style="text-align: left">désinfectant/<em>disinfectant</em></p></th><td colspan="1" rowspan="1"><p style="text-align: left">Phasospray</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1" colwidth="1100"><p style="text-align: left"><span data-question="5">Numéro du cycle /<em>cycle number</em></span></p><table data-table-form-id="7053" data-question-id="9458" data-header-orientation="horizontal" data-table-form-status="created" style="min-width: 25px"><colgroup><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left">Numéro du cycle /cycle number</p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><p style="text-align: left"><span data-question="6">Date de péremption du sac:/bag expiry date</span> </p><table data-table-form-id="7054" data-question-id="9459" data-header-orientation="horizontal" data-table-form-status="created" style="min-width: 25px"><colgroup><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left">Date de péremption du sac:/bag expiry date </p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><ol start="3"><li><p style="text-align: left"><span data-question="7">Enregistrer au niveau du cahier de route du pass box /record in the pass box log book</span></p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1" colwidth="1100"><p style="text-align: left"><strong>Date et heure fin / ending date and hour ......./...../...... .. .....h......</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1" colwidth="1100"><p style="text-align: left"><strong>Visa et date superviseur/signature and date supervisor :...............................................................................</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><p style="text-align: left">joindre le vide de ligne de ou des équipements et l'étiquette statut local/attach theequipment and room cleaning and the line clearance label</p><ol start="8"><li><p style="text-align: left"><strong>STERILISATION DES BOUCHONS ET DU SYSTEME DE FILTRATION ET DE REPARTITION/STOPPER FILTRATION AND FILLING SYSTEM STERILIZATION</strong></p></li></ol><table style="min-width: 50px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Désignationéquipement/equipment designation</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"><strong><em>AUTOCLAVE FEDEGARI</em></strong></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Code /code</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong><em>EQHPECE 15</em></strong></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Dernière date de qualification/étalonnage / last calibration and qualification date</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left">........./......./...........</p></td></tr></tbody></table><table style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Date et heure début/date and hour of starting /......./...../...... .. .....h.......</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Etape de fabrication/manufacturing phase</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Fait par /done by</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Vérifié par /checked by</p></td></tr><tr><td colspan="1" rowspan="1"><ol><li><p style="text-align: left">Vérifier la présence de /check the presence of</p></li></ol><ul><li><p style="text-align: left">la quantité correspondante à la taille du lot en bouchons emballés dans les sacs autoclavables./corresponding quantity to batch size of stopper in ready to autoclave bag</p></li><li><p style="text-align: left">Des sacs de tissus de nettoyages et le dossier de fabrication /cleaning wipe bags and manufacturing batch record</p></li><li><p style="text-align: left">la crible du bioimpacteur , du vibreur bouchon et raille /sampling head of air sampler , stopper bowl</p></li><li><p style="text-align: left">Les filtres et le circuit de répartition /filter and filling system</p></li></ul></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="2"><li><p style="text-align: left">Effectuer la stérilisation de la charge selon l'instruction de sterilisation en vigueur en sélectionnant le programme code 6 /start the load sterilization according the sterilization SOP select the program code 6</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="3"><li><p style="text-align: left">Indiquer les paramètres de stérilisation mentionnés dans le tableau suivant /indicate the sterilization parameters in the following table</p></li></ol><table style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Paramètre/parameter</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Consigne/set</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Valeur /value</strong></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Température min de stérilisation/</p><p style="text-align: left">Sterilization min temperature</p></td><td colspan="1" rowspan="1"><p style="text-align: left">121 °C</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Température max de stérilisation/ Sterilization max temperature</p></td><td colspan="1" rowspan="1"><p style="text-align: left">122°C</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Valeur/ value F(T,z)</p></td><td colspan="1" rowspan="1"><p style="text-align: left">≥30 min</p></td><td colspan="1" rowspan="1"><p style="text-align: left">F0 min=</p><p style="text-align: left">F0 max=</p></td></tr></tbody></table></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><table style="min-width: 50px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><td colspan="1" rowspan="1"><p style="text-align: left">Numéro cycle de stérilisation /sterilization cycle number</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><p style="text-align: left">Conformité du cycle/cycle conformity</p><p style="text-align: left">Conforme/complies Non-conforme /not complies</p><ol start="4"><li><p style="text-align: left">enregistrer l'opération au niveau du cahier de route de l’autoclave/record in the autoclave log book</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Date et heure fin ending date and hour ......./...../...... .......h.......</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Visa et date superviseur/signature and date supervisor :..........................................................................................</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><p style="text-align: left">joindre le vide de ligne de ou des équipements et l'étiquette statut local/attach the cleaning and the line clearance label</p><ol start="9"><li><p style="text-align: left"><strong>pesée des matières premières : excipients/raw material weighing excipients</strong></p></li></ol><table style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Désignation équipement/equipment designation</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Centrale de pesée /weighing booth</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Balance de pesée /weighing scale</strong></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Code /code</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>EQ HP ECE 03</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>EQ HP DSM 01</strong></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Dernière date de qualification/étalonnage / last calibration and qualification date</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left">........./......./...........</p></td><td colspan="1" rowspan="1"><p style="text-align: left">........./......./...........</p></td></tr></tbody></table><table style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Date et heure début/starting date and hour /......./...../...... .. .....h.......</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Etape de fabrication/manufacturing phase</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Fait par /done by</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Vérifié par /checked by</p></td></tr><tr><td colspan="1" rowspan="1"><ol><li><p style="text-align: left">Vérifier le vide de ligne&nbsp; et le nettoyage de la balance et de la centrale de pesée /check the line clearance of the weighing booth and scale</p></li><li><p style="text-align: left">Indiquer le produit précédemment fabriqué ainsi que son n° de lot /indicate the previous product manufactured and the corresponding batch number</p></li><li><p style="text-align: left">Désignation /designation ..................numéro de lot/batch number ...............</p></li><li><p style="text-align: left">Vérifier le nettoyage&nbsp; des accessoires de pesée/check the cleaning of weighing tool</p></li><li><p style="text-align: left">Vérifier l’étalonnage de la balance /check the scale calibration</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="6"><li><p style="text-align: left">Effectuer les pesées selon l'instruction en vigueur./start the weighing according SOP</p></li></ol><p style="text-align: left">La quantité de matière à peser est calculée selon l’équation suivante&nbsp;: /the quantity of material to weightaccording the equation</p><ul><li><p style="text-align: left">Pesée à partir d’un seul lot de titre T&nbsp;:/weighing from only one batch with assay :T</p></li></ul><p style="text-align: left">avec&nbsp;:</p><p style="text-align: left">Q : Quantité de matière à peser./ Quantity of material to be weighed</p><p style="text-align: left">Qn : Quantité theorique /theoritical quantity</p><p style="text-align: left">T : titre du produit ./assay</p><p style="text-align: left">Calcul/calculation :</p><p style="text-align: left">..........................................................................................................</p><ul><li><p style="text-align: left">Pesée à partir de deux lots de titres respectifs T1 et T2:/ weighing from 2 different batches with assay T1 and T2</p></li></ul><p style="text-align: left">Soit Q1 la quantité de matière qui reste du lot N°1 de titre T1/ Q1 the quantity of material that remains from batch N ° 1 with assay T1</p><p style="text-align: left">Soit Q2 la quantité de matière qui doit être pesée du lot numéro 2 de titre T2</p><p style="text-align: left">The quantity Q2 of material that must be weighed from batch N ° 2 with assay T2</p><p style="text-align: left">Lot N°1</p><p style="text-align: left">T1 = ....................... Lot N°2 T2 = .......................</p><p style="text-align: left">Q1 =.................. Q2 = ……………</p><p style="text-align: left">AN :</p><p style="text-align: left">..........................................................................................................</p><p style="text-align: left">.........................................................................................................</p><p style="text-align: left">.........................................................................................................</p><p style="text-align: left">.........................................................................................................</p><ol start="7"><li><p style="text-align: left">A la fin de la pesée effectuer un nettoyage de la centrale et du local /at the end of weighing start the cleaning of dispensing booth and scale</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Date et heure fin ending date and hour ......./...../...... .......h.......</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Visa et date superviseur/signature and date supervisor :..........................................................................................</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><p style="text-align: left">joindre le vide de ligne de l'equipement et l'étiquette statut local/attach the equipment line clearance label and cleaning label of room</p><ol start="10"><li><p style="text-align: left"><strong>pesée des matières premières : matière active /weighing raw material : active pharmaceutical ingredient</strong></p></li></ol><table style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Désignation équipement/equipment designation</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Isolateur de pesée /weighing isolator</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Balance de pesée /weighing scale</strong></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Code /code</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>EQ HP ECE 04</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>EQ HP DSM 02</strong></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Dernière date de qualification/étalonnage / last calibration and qualification date</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left">........./......./...........</p></td><td colspan="1" rowspan="1"><p style="text-align: left">........./......./...........</p></td></tr></tbody></table><table style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Date et heure début/starting date and hour /......./...../...... .. .....h.......</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Etape de fabrication/manufacturing phase</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Fait par /done by</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Vérifié par /checked by</p></td></tr><tr><td colspan="1" rowspan="1"><ol><li><p style="text-align: left">Vérifier le vide de ligne&nbsp; et le nettoyage de la balance et de l'isolateur de pesée /check the line clearance of the weighing isolator and scale</p></li><li><p style="text-align: left">Indiquer le produit précédemment fabriqué ainsi que son n° de lot /indicate the previous product manufactured and the corresponding batch number</p></li><li><p style="text-align: left">Désignation /designation ..................numéro de lot/batch number ...............</p></li><li><p style="text-align: left">Vérifier la disponibilité &nbsp; des accessoires de pesée/check the availability of weighing tool</p></li><li><p style="text-align: left">Vérifier l’étalonnage de la balance /check the scale calibration</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="6"><li><p style="text-align: left">Entamer le test d'étanchéité automatique de l'isolateur /start the isolator leak test</p></li></ol><p style="text-align: left">Chambre/chamber 1: résultat/result conforme/pass /non conforme/fail</p><p style="text-align: left">Chambre/chamber 2: résultat/result conforme /pass non conforme /fail</p><p style="text-align: left">si non conforme refaire le test , si la non conformité persiste informer votre supérieur hiérarchique./ if the test is non-compliant repeat the test, if non conformity persists inform your supervisor</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="7"><li><p style="text-align: left">Indiquer les paramètres suivants/indicate the following :</p></li></ol><table style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"></p></th><th colspan="1" rowspan="1"><p style="text-align: left">Consigne /set</p></th><th colspan="1" rowspan="1"><p style="text-align: left">Valeur/value</p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Pression préchambre /prechamber pressure</p></td><td colspan="1" rowspan="1"><p style="text-align: left">- 75PA</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Pression chambre principale / Main chamber pressure</p></td><td colspan="1" rowspan="1"><p style="text-align: left">-100PA</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="8"><li><p style="text-align: left">Introduire respectivement au niveau de la première chambre de l'isolateur les accessoires de pesée à usage unique , le conteneur de la matière première après essuyage à l'alcool , tissu de nettoyage, sac de pesée /in the isolator prechamber , introduce the weighing accessories, the container of the raw material after wiping with alcohol, cleaning wipes, weighing bag,</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="9"><li><p style="text-align: left">Ouvrir le conteneur de la matière première ; récupérer le sac interne , le poser sur le plateau et le faire entrer au niveau de la chambre de pesée./ Open the container of the raw material; take the inner bag, put it on the tray and bring it into the weighing chamber.</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="10"><li><p style="text-align: left">Effectuer les pesées selon l'instruction en vigueur./start the weighing according SOP</p></li></ol><p style="text-align: left">La quantité de matière à peser est calculée selon l’équation suivante&nbsp;: /the quantity of material to weigh is calculated according the equation</p><ul><li><p style="text-align: left">Pesée à partir d’un seul lot de titre T&nbsp;:/weighing from only one batch with assay /T</p></li></ul><p style="text-align: left">avec&nbsp;:</p><p style="text-align: left">Q : Quantité de matière à peser./ Quantity of material to be weighed</p><p style="text-align: left">Qn : Quantité theorique /theoritical quantity</p><p style="text-align: left">T : titre du produit ./assay</p><p style="text-align: left">Calcul/calculation :</p><p style="text-align: left">..........................................................................................................</p><ul><li><p style="text-align: left">Pesée à partir de deux lots de titres respectifs T1 et T2:/ weighing from 2 different batches with assay T1 and T2</p></li></ul><p style="text-align: left">Soit Q1 la quantité de matière qui reste du lot N°1 de titre T1/ Q1 the quantity of material that remains from the batch N ° 1 with assay T1</p><p style="text-align: left">Soit Q2 la quantité de matière qui doit être pesée du lot numéro 2 de titre T2/The quantity Q2 of material that must be weighed from batch N ° 2 with assay T2</p><p style="text-align: left">Lot N°1</p><p style="text-align: left">T1 = ....................... Lot N°2 T2 = .......................</p><p style="text-align: left">Q1 =.................. Q2 = ……………</p><p style="text-align: left">AN :</p><p style="text-align: left">..........................................................................................................</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><table style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><ol start="14"><li><p style="text-align: left">A la fin de la pesée fermer le sac de matière pesée , essuyer la surface externe de ce dernier avec de l'alcool et le faire sortir à travers le liner/ At the end of the weighing, close the bag of weighed material, wipe the outer surface with alcohol and let it out through the liner</p></li></ol></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th></tr><tr><td colspan="1" rowspan="1"><ol start="11"><li><p style="text-align: left">Fermer le sac de matière à retourner à l'aide d'un sert câble, essuyer la surface externe de ce dernier avec de l'alcool et le faire sortir à travers le liner / Close the bag of material to be returned, wipe the outer surface of the bag with alcohol and let it out through the liner</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="12"><li><p style="text-align: left">A la fin récupérer le déchet et les accessoires de pesée à usage unique et le faire sortir à travers le liner /At the end collect the waste and single use weighing accessories and take them out through the liner</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="13"><li><p style="text-align: left">effectuer le nettoyage de l'isolateur et la balance selon la procédure en vigueur /clean the isolator and scale according to the SOP.</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Date et heure fin ending date and hour ......./...../...... .......h.......</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Visa et date superviseur/signature and date supervisor :..........................................................................................</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><p style="text-align: left">joindre le vide de ligne de l'equipement et l'étiquette statut local/attach the equipment line clearance label and cleaning label of room</p><table style="min-width: 250px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>FICHE DE PESEE/WEIGHING SHEET</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>CODE/code</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>DESIGNATION /designation</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>N° DE LOT/batch number</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>TITRE /assay</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>QUANTITE NOMENCLATURE/theoritical quantity</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>QUANTITEE</strong></p><p style="text-align: left"><strong>A PESER/quantity to weigh</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>QUANTITEE</strong></p><p style="text-align: left"><strong>PESEE/quantity weighed</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>CODE BALANCE/scale code</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>FAIT PAR /done by</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>VERIFIE PAR /checked by</strong></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>MAN00021</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Pemetrexed dissodium heptahydraté</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>524.25 G</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>EQ HP DSM 02</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>MAN00021</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Pemetrexed dissodium heptahydraté**</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>EQ HP DSM 02</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>MEN00019</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Mannitol</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>375 G</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>EQ HP DSM 01</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>men00044</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>hcl 1n</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>QS PH 7.0-7.4</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>men00042</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>naoh 1n</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>QS PH 7.0-7.4</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>MEN00040</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>EPPI/wfi</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Qsp 15 litres/Liter</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>IN HP EFH 07 07</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><p style="text-align: left"><strong>*si la matière à disposition appartient à 2 lots de titres différents /if we have 2 batches with 2 differents assay</strong></p><p style="text-align: left"><strong>nombre de contenants/number of container :</strong></p><p style="text-align: left">Joindre les étiquettes de pesée à cette page/attach the weighing label to this page</p><ol start="11"><li><p style="text-align: left"><strong>fabrication /manufacturing</strong></p></li></ol><table style="min-width: 100px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Désignation équipement/equipment designation</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Isolateur de préparation /preparation isolator</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Balance double pesée/weighing check scale</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Dissoluteur de préparation/preparation tank</strong></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Code /code</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>EQ HP ECE 08</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>EQ HP DSM 05</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>EQ HP EFH 07</strong></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Dernière date de qualification/étalonnage /last calibration and qualification date</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left">........./......./...........</p></td><td colspan="1" rowspan="1"><p style="text-align: left">........./......./...........</p></td><td colspan="1" rowspan="1"><p style="text-align: left">......../......./...........</p></td></tr></tbody></table><table style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Date et heure début/starting date and hour /......./...../...... ........h.......</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Etape de fabrication/manufacturing phase</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Fait par /done by</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Vérifié par /checked by</p></td></tr><tr><td colspan="1" rowspan="1"><ol><li><p style="text-align: left">Vérifier le vide de ligne et le nettoyage de l'isolateur du dissoluteur de préparation et de la balance double pesée /check the line clearance and the cleaning of praparation tank , preparation isolator , weighing scale</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="2"><li><p style="text-align: left">Entamer le test d'étanchéité de l'isolateur /start leak test isolator</p></li></ol><p style="text-align: left"><strong>: résultat /result conforme /pass non conforme /fail</strong></p><p style="text-align: left">si non conforme refaire le test , si la non conformité persiste informer votre supérieur hiérarchique / if the test is non-compliant repeat the test, if non conformity persists inform your supervisor</p><ol start="3"><li><p style="text-align: left">entamer le test d'étanchéité des gants de l'isolateur /start the gloves leak test</p></li></ol><p style="text-align: left"><strong>: résultat /result conforme /pass non conforme /fail</strong></p><p style="text-align: left">si non conforme refaire le test , si la non conformité persiste informer votre supérieur hiérarchique / if the test is non-compliant repeat the test, if non conformity persists inform your supervisor</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="4"><li><p style="text-align: left">indiquer les paramètres suivants /indicate the parameter</p></li></ol><table style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"></p></th><th colspan="1" rowspan="1"><p style="text-align: left">Consigne /set</p></th><th colspan="1" rowspan="1"><p style="text-align: left">Valeur /value</p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Pression chambre principale /main chamber pressure</p></td><td colspan="1" rowspan="1"><p style="text-align: left">-100 PA</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><ol start="5"><li><p style="text-align: left">Faire introduire au niveau de l'isolateur la matière pesée selon l'instruction en vigueur. /introduce in the isolator the weighed raw material according the SOP</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="6"><li><p style="text-align: left">introduire sous agitation et barbotage d'azote/introduce under mixing and nitrogen 12 KG EPPI /WFI</p></li><li><p style="text-align: left">faire refroidir à une température de20 ±5°C /cool to the temperature de 20 ±5°C</p></li><li><p style="text-align: left">faire dissoudre sous agitation et barbotage d'azote /introduce under mixing and nitrogen</p></li></ol><ul><li><p style="text-align: left"><strong>mannitol ………………..g</strong></p></li></ul><ol start="9"><li><p style="text-align: left">faire fonctionner l'agitation jusqu'à dissolution totale /start mixing until complete dissolution</p></li></ol><table style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left">Paramètre/parameter</p></th><th colspan="1" rowspan="1"><p style="text-align: left">Consigne /set</p></th><th colspan="1" rowspan="1"><p style="text-align: left">Valeur lue /value</p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Vitesse Agitation /mixing speed</p></td><td colspan="1" rowspan="1"><p style="text-align: left">300 rpm</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Heure début agitation /mixing starting hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left">13-15 min</p></td><td colspan="1" rowspan="1"><p style="text-align: left">.......h.......</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Heure fin agitation / mixing ending hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left">.......h.......</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Température/temperature</p></td><td colspan="1" rowspan="1"><p style="text-align: left">20 -25°C</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Aspect /appearance</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Limpide /clear</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="10"><li><p style="text-align: left">Faire dissoudre sous agitation et barbotage d'azote /introduce under mixing and nitrogen</p></li></ol><ul><li><p style="text-align: left"><strong>Pemetrexed dissodium heptahydrate ………………..g</strong></p></li></ul><ol start="11"><li><p style="text-align: left">maintenir l'agitation jusqu'à dissolution totale /start the mixing until complete dissolution</p></li></ol><table style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left">Paramètre/parameter</p></th><th colspan="1" rowspan="1"><p style="text-align: left">Consigne /set</p></th><th colspan="1" rowspan="1"><p style="text-align: left">Valeur lue/value</p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Vitesse Agitation /mixing speed</p></td><td colspan="1" rowspan="1"><p style="text-align: left">300 rpm</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Heure début agitation /mixing starting hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left">15-20 min</p></td><td colspan="1" rowspan="1"><p style="text-align: left">.......h.......</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Heure fin agitation / mixing ending hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left">.......h.......</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Température/temperature</p></td><td colspan="1" rowspan="1"><p style="text-align: left">20 -25°C</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Oxygen dissous/dissolved oxygen</p></td><td colspan="1" rowspan="1"><p style="text-align: left">0.2%-0.4%</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Aspect /appearance</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Clair et de couleur incolore à jaune ou vert-jaune /Clear and ranges in colour from colourless to yellow or green-yellown</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="12"><li><p style="text-align: left">Vérifier le ph spontané de la solution /check the ph of the solution</p></li></ol><p style="text-align: left">ph=......................................norme 7.0-7.4</p><ol start="13"><li><p style="text-align: left">Ajuster si nécessaire la solution avec HCL 1N ou NAOH 1N sous agitation /adjust if necessary the ph with HCL 1N or NAOH 1N under mixing</p></li></ol><table style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left">Paramètre/parameter</p></th><th colspan="1" rowspan="1"><p style="text-align: left">Consigne /set</p></th><th colspan="1" rowspan="1"><p style="text-align: left">Valeur lue/value</p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Vitesse Agitation /mixing speed</p></td><td colspan="1" rowspan="1"><p style="text-align: left">300 rpm</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Heure début agitation /mixing starting hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Jusqu’à atteindre la valeur du ph /until reaching the ph value</p></td><td colspan="1" rowspan="1"><p style="text-align: left">.......h.......</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Heure fin agitation / mixing ending hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left">.......h.......</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Oxygen dissous/dissolved oxygen</p></td><td colspan="1" rowspan="1"><p style="text-align: left">0.2%-0.4%</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Température/temperature</p></td><td colspan="1" rowspan="1"><p style="text-align: left">20 ±5°C</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Aspect /appearance</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Clair et de couleur incolore à jaune ou vert-jaune /Clear and ranges in colour from colourless to yellow or green-yellown</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><ol start="14"><li><p style="text-align: left">relever le volume ajouté /indicate the volume added</p></li></ol><table style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left">Désignation</p></th><th colspan="1" rowspan="1"><p style="text-align: left">HCL 1N</p></th><th colspan="1" rowspan="1"><p style="text-align: left">NAOH 1N</p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Numéro de lot /batch number</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Volume ajouté /added volume</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><ol start="15"><li><p style="text-align: left">Vérifier le ph après ajustement /check the ph after adjustement</p></li></ol><p style="text-align: left">ph=......................................norme 7.0-7.4</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="16"><li><p style="text-align: left">compléter QSP 15 litres/complete QS to 15 litres</p></li><li><p style="text-align: left">vérifier le ph final de la solution /check the final ph of the solution</p></li></ol><p style="text-align: left">ph=......................................norme 7.0-7.4</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="18"><li><p style="text-align: left">Procéder à un prélèvement d’un échantillon de 20ml destiné au laboratoire CQ physico-chimique et 20 ml dans un flacon stérile pour bio charge selon la documentation en vigueur./take a sample of 20 ml for physicochemical tests and 20 ml in a sterile vial for bioburden according SOP</p></li><li><p style="text-align: left">Indiquer l’heure de prélèvement (biocharge juste avant la filtration ) Indicate the time of sampling (bioburden just before filtration )</p></li><li><p style="text-align: left">Heure prélèvement physico-chimique/hour sampling physicochemical tests …..h…….</p></li><li><p style="text-align: left">Heure prélèvement biocharge /hour sampling bioburden …..h…….</p></li><li><p style="text-align: left">Remplir la DPA et l’expédier au CQ avec l’échantillon./record the request analysis and send it with the sample to QC lab</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="23"><li><p style="text-align: left">à la fin de fabrication, faire sortir les déchets à travers le liner /at the end of manufacturing take out the waste through the liner</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>date et heure fin ending hour and date ......./...../...... .......h.......</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Visa et date superviseur signature and date supervisor :.....................................................................................</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><p style="text-align: left">joindre le vide de ligne et l'étiquette de nettoyage du dissoluteur ,isolateur , balance double pesée et l'étiquette statut local/attach cleaning label of isolator, preparation tank , weighing scale and cleaning label of the room</p><ol start="12"><li><p style="text-align: left"><strong>FILTRATION STERILISANTE /sterilizing filtration</strong></p></li></ol><table style="min-width: 50px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Désignation équipement/equipment designation</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Testeur d'intégrité des filtres /filter integrity tester</strong></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Code /code</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>EQ HP ELQ 05</strong></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Dernière date de qualification/étalonnage / last calibration and qualification date</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left">........./......./...........</p></td></tr></tbody></table><table style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Date et heure début starting date and hour ......./...../...... .......h.......</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Etape de fabrication/manufacturing phase</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Fait par /done by</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Vérifié par /checked by</p></td></tr><tr><td colspan="1" rowspan="1"><ol><li><p style="text-align: left">Procéder, à la connexion du système de filtration, à travers l'orifice séparant les deux classes selon l'instruction de filtration stérilisante./Proceed, at the connection of the filtration system, through the hole separating the two classes according to the sterilizing filtration instruction</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="2"><li><p style="text-align: left">Effectuer aussi les connexions nécessaires à l’accomplissement du test d’intégrité des filtres selon l'instruction en vigueur du test d’intégrité des filtres./Also make the necessary connections to complete the filter integrity test according to the current filter integrity test statement.</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>AVANT FILTRATION /before filtration</strong></p><table style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left">Type de filtre /filter type</p></th><th colspan="1" rowspan="1"><p style="text-align: left">Filtre hydrophile /hydrophilic filter 0.22μ</p></th><th colspan="1" rowspan="1"><p style="text-align: left">Filtre hydrophile/hydrophilic filter0.22μ</p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Référence /reference</p></td><td colspan="1" rowspan="1"><p style="text-align: left">KA2NPF1</p></td><td colspan="1" rowspan="1"><p style="text-align: left">KA2NPF1</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Numéro de série /serial number</p></td><td colspan="1" rowspan="1"><p style="text-align: left">...................................</p></td><td colspan="1" rowspan="1"><p style="text-align: left">...................................</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Type de test /test type</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Diffusion</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Diffusion</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Norme débit /flow max</p></td><td colspan="1" rowspan="1"><p style="text-align: left">3.2 ml/min</p></td><td colspan="1" rowspan="1"><p style="text-align: left">3.2 ml/min</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Mesure /value</p></td><td colspan="1" rowspan="1"><p style="text-align: left">.....................</p></td><td colspan="1" rowspan="1"><p style="text-align: left">.....................</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Conformité /conformity</p></td><td colspan="1" rowspan="1"><p style="text-align: left">........................</p></td><td colspan="1" rowspan="1"><p style="text-align: left">........................</p></td></tr></tbody></table><p style="text-align: left">En cas de non conformité ne pas entamer la filtration et informer votre supérieur hiérarchique /if the test is non-compliant do not start the filtration and inform your supervisor</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="3"><li><p style="text-align: left">Entamer la filtration stérilisante selon l'instuction en vigueur /start the sterilizing filtration according SOP</p></li><li><p style="text-align: left">indiquer les données suivantes /indicate the parameter</p></li></ol><table style="min-width: 100px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left">Durée filtration /filtration time&nbsp;: 50±10 min</p></th><th colspan="1" rowspan="1"><p style="text-align: left">Pression /pressure</p><p style="text-align: left">0.8 bar</p></th><th colspan="1" rowspan="1"><p style="text-align: left">Température /temperature</p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Heure début /starting hour filtration</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Heure fin /ending hour filtration</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>APRES FILTRATION /after filtration</strong></p><table style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left">Type de filtre /filter type</p></th><th colspan="1" rowspan="1"><p style="text-align: left">Filtre hydrophile /hydrophilic filter 0.22</p></th><th colspan="1" rowspan="1"><p style="text-align: left">Filtre hydrophile/ hydrophilic filter 0.22</p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Référence /reference</p></td><td colspan="1" rowspan="1"><p style="text-align: left">KA2NPF1</p></td><td colspan="1" rowspan="1"><p style="text-align: left">KA2NPF1</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Numéro de série /serial number</p></td><td colspan="1" rowspan="1"><p style="text-align: left">...................................</p></td><td colspan="1" rowspan="1"><p style="text-align: left">...................................</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Type de test /test type</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Diffusion</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Diffusion</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Norme débit /flow max</p></td><td colspan="1" rowspan="1"><p style="text-align: left">3.2 ml/min</p></td><td colspan="1" rowspan="1"><p style="text-align: left">3.2 ml/min</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Mesure /value</p></td><td colspan="1" rowspan="1"><p style="text-align: left">.....................</p></td><td colspan="1" rowspan="1"><p style="text-align: left">.....................</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Conformité /conformity</p></td><td colspan="1" rowspan="1"><p style="text-align: left">........................</p></td><td colspan="1" rowspan="1"><p style="text-align: left">........................</p></td></tr></tbody></table><ol start="5"><li><p style="text-align: left">En cas de non conformité ne pas entamer le remplissage et informer votre supérieur hiérarchique /if the test is non-compliant do not start the filling and inform your supervisor</p></li><li><p style="text-align: left">Effectuer le nettoyage du dissoluteur et du local préparation immédiatement après filtration /Clean the preparation tank and the preparation room immediately after filtration</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>date et heure fin ending hour and date ......./...../...... .......h.......</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Visa et date superviseur signature and date supervisor :.....................................................................................</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><h1 style="text-align: left"></h1><p style="text-align: left">Fixer les enregistrements des tests d’intégrités des filtres à cette page /attach the filter integrity test report to this page</p><h1 style="text-align: left"></h1><ol start="13"><li><p style="text-align: left"><strong>REPARTITION +pre-bouchage/filling anf half stoppering</strong></p></li></ol><table style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Désignation équipement/equipment designation</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Ligne de remplissage/filling line steriline</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Balance/scale In process control</strong></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Code /code</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>EQ HP EFH 10 03</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>EQ HP DSM 07</strong></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Dernière date de qualification/étalonnage /last calibration and qualification date</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left">........./......./...........</p></td><td colspan="1" rowspan="1"><p style="text-align: left">........./......./...........</p></td></tr></tbody></table><table style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Date et heure début/starting date and hour /......./...../...... ........h.......</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Etape de fabrication/manufacturing phase</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Fait par /done by</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Vérifié par /checked by</p></td></tr><tr><td colspan="1" rowspan="1"><ol><li><p style="text-align: left">vérifier le vide de ligne et le nettoyage du local, du C rabs et de la machine /check the line clearance and the cleaning of the machine</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="6"><li><p style="text-align: left">Entamer le test d'étanchéité de la C RABS (joindre le graphique du test) /start leak test of C RAB</p></li></ol><p style="text-align: left"><strong>: résultat /result conforme /pass non conforme /fail</strong></p><p style="text-align: left">si non conforme refaire le test , si la non conformité persiste informer votre supérieur hiérarchique / if the test is non-compliant repeat the test, if non conformity persists inform your supervisor</p><p style="text-align: left">entamer le test d'étanchéité des gants de l'isolateur /start the gloves leak test</p><p style="text-align: left"><strong>: résultat /result conforme /pass non conforme /fail</strong></p><p style="text-align: left">si non conforme refaire le test , si la non conformité persiste informer votre supérieur hiérarchique / if the test is non-compliant repeat the test, if non conformity persists inform your supervisor.</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="7"><li><p style="text-align: left">Introduire les sacs contenant les accessoires stérilisés de la remplisseuse au niveau de la C RABS de la machine et procéder à leur montage sous flux laminaire / introduce the bags containing the sterilized accessories of the filling machine under the machine's C RABS and install them under laminar flow</p></li><li><p style="text-align: left">connecter le sac de bouchons via laconnexion alpha /beta of the C RABS /connect the stopper bag through the connection alpha /beta of the C RABS</p></li><li><p style="text-align: left">Remplir le vibreur par des bouchons igloo./fill the vibration bowl with igloo stopper</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="10"><li><p style="text-align: left">Procéder au montage du circuit de répartition/ install the filling system</p></li><li><p style="text-align: left">Connecter le système de remplissage avec le sac stérile sous flux laminaire/connect the filling system with the sterile bag under laminar flow</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="12"><li><p style="text-align: left">Démarrer la machine selon l'instruction en vigueur en faisant toutes les vérifications nécessaires (centrage des aiguilles )/ Start the machine according to the instructions by doing all the necessary checks (centering needles)</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="13"><li><p style="text-align: left">Vérifier l'étalonnage de la balance /check the calibration of the scale .</p></li><li><p style="text-align: left">A l'aide de la balance vérifier la masse des premiers flacons remplies et reporter les résultats sur la fiche de contrôle de l'IPC/Using the scale, check the mass of the first filled vials and report the results on the IPC checklist</p><p style="text-align: left"></p><img class="editor-image" src="media/image5.png"></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="15"><li><p style="text-align: left">Rejeter les premiers flacons remplies/reject the first filled vials :.................flacons/vials</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="16"><li><p style="text-align: left">Si les résultats sont hors normes , procéder au réglage de la pompe hors norme /if the result are out of range proceed to the adjustment of the pump out of norm.</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="17"><li><p style="text-align: left">Prélever 2 flacons chaque 15 min pour le contrôle en cours de remplissage et qualité de pré bouchage et assurer l'enregistrement au niveau de la fiche IPC./take a sample of 2 vials every 15 min for in process control of filling and half stoppering and record the result</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="18"><li><p style="text-align: left">Assurer le chargement des flacons directement au niveau du lyophilsateur en ligne avec le remplissage /start the vial loading of the freez dryer on line with filling</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="19"><li><p style="text-align: left">relever le nombre de flacon remplis /indicate the number of filling vials .......................flacons/vials</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="20"><li><p style="text-align: left">procéder au vide de ligne de la machine /start the line clearance of the machine</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="21"><li><p style="text-align: left">faire sortir les déchets à travers les BETA BAG /take out the waste throught BETA BAG</p></li><li><p style="text-align: left">démonter le circuit de répartition et faire son nettoyage sans ouvrir la C RABS / dismantle the distribution circuit and clean it without opening the C RABS</p></li><li><p style="text-align: left">effectuer le nettoyage de la machine et de la C rabs et du local immédiatement après répartition et sans ouvrir les chambres / clean the machine and C rabs and the room immediately after distribution and without opening the chambers</p></li><li><p style="text-align: left">Si un événement risquant de porter atteinte à la stérilité du produit survient au cours du remplissage, porter sur la fiche D’IPC la nature de l’évènement et le numéro de la caissette remplie juste après sa survenue / If an event that may affect the product sterility occurs during filling, refer to the IPC document the nature of the event and the number of the box filled immediately after its occurrence</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>date et heure fin ending hour and date ......./...../...... .......h.......</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Visa et date superviseur signature and date supervisor :.....................................................................................</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><p style="text-align: left">joindre à cette page étiquette de vide de ligne et de nettoyage machine , étiquette statut local /attach to this page the line clearance and the cleaning label of the machine</p><p style="text-align: left"><strong>FICHE DE CONTROLE EN COURS REMPLISSAGE -PREBOUCHAGE</strong></p><p style="text-align: left"><strong>/CHECK LIST IPC FILLING AND HALF STOPPERING</strong></p><p style="text-align: left">Date et heure début de remplissage /date and hour starting filling …../……./……. . ….h…….</p><table style="min-width: 200px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><td colspan="1" rowspan="1"><p style="text-align: left">Heure/hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Masse répartie /filling weight</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Qualité pré bouchage**/half stoppering quality</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Boite sédimentation/settle plate</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Intervention</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Fait par/done by</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Vérifié par /checked by</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left">H. ouverture./opening hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left">H. fermeture/closing hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Visa et date superviseur:.................................................................................................................</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><p style="text-align: left">** MB&nbsp;: Mauvais pré-bouchage/bad half stoppering ; BB&nbsp;: Bon pré bouchage/good half stoppering</p><p style="text-align: left"><strong>FICHE DE CONTROLE EN COURS REMPLISSAGE -PREBOUCHAGE</strong></p><p style="text-align: left"><strong>/CHECK LIST IPC FILLING AND HALF STOPPERING</strong></p><table style="min-width: 200px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><td colspan="1" rowspan="1"><p style="text-align: left">Heure/hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Masse répartie /filling weight</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Qualité pré bouchage**/half stoppering quality</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Boite sédimentation/settle plate</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Intervention</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Fait par/done by</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Vérifié par /checked by</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left">H. ouverture./opening hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left">H. fermeture/closing hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Visa et date superviseur:.................................................................................................................</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><p style="text-align: left">** MB&nbsp;: Mauvais pré-bouchage/bad half stoppering ; BB&nbsp;: Bon pré bouchage/good half stoppering</p><p style="text-align: left"><strong>FICHE DE CONTROLE EN COURS REMPLISSAGE -PREBOUCHAGE</strong></p><p style="text-align: left"><strong>/CHECK LIST IPC FILLING AND HALF STOPPERING</strong></p><table style="min-width: 200px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><td colspan="1" rowspan="1"><p style="text-align: left">Heure/hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Masse répartie /filling weight</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Qualité pré bouchage**/half stoppering quality</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Boite sédimentation/settle plate</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Intervention</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Fait par/done by</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Vérifié par /checked by</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left">H. ouverture./opening hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left">H. fermeture/closing hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Visa et date superviseur:.................................................................................................................</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><p style="text-align: left">** MB&nbsp;: Mauvais pré-bouchage/bad half stoppering ; BB&nbsp;: Bon pré bouchage/good half stoppering</p><p style="text-align: left"><strong>FICHE DE CONTROLE EN COURS REMPLISSAGE -PREBOUCHAGE</strong></p><p style="text-align: left"><strong>/CHECK LIST IPC FILLING AND HALF STOPPERING</strong></p><p style="text-align: left">Date et heure début de remplissage /date and hour starting filling …../……./……. . ….h…….</p><table style="min-width: 200px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><td colspan="1" rowspan="1"><p style="text-align: left">Heure/hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Masse répartie /filling weight</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Qualité pré bouchage**/half stoppering quality</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Boite sédimentation/settle plate</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Intervention</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Fait par/done by</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Vérifié par /checked by</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left">H. ouverture./opening hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left">H. fermeture/closing hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Visa et date superviseur:.................................................................................................................</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><p style="text-align: left">** MB&nbsp;: Mauvais pré-bouchage/bad half stoppering ; BB&nbsp;: Bon pré bouchage/good half stoppering</p><p style="text-align: left"><strong>FICHE DE CONTROLE EN COURS REMPLISSAGE -PREBOUCHAGE</strong></p><p style="text-align: left"><strong>/CHECK LIST IPC FILLING AND HALF STOPPERING</strong></p><p style="text-align: left">Date et heure début de remplissage /date and hour starting filling …../……./……. . ….h…….</p><table style="min-width: 200px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><td colspan="1" rowspan="1"><p style="text-align: left">Heure/hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Masse répartie /filling weight</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Qualité pré bouchage**/half stoppering quality</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Boite sédimentation/settle plate</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Intervention</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Fait par/done by</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Vérifié par /checked by</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left">H. ouverture./opening hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left">H. fermeture/closing hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Visa et date superviseur:.................................................................................................................</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><p style="text-align: left">** MB&nbsp;: Mauvais pré-bouchage/bad half stoppering ; BB&nbsp;: Bon pré bouchage/good half stoppering</p><p style="text-align: left"><strong>FICHE DE CONTROLE EN COURS REMPLISSAGE -PREBOUCHAGE</strong></p><p style="text-align: left"><strong>/CHECK LIST IPC FILLING AND HALF STOPPERING</strong></p><p style="text-align: left">Date et heure début de remplissage /date and hour starting filling …../……./……. . ….h…….</p><table style="min-width: 200px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><td colspan="1" rowspan="1"><p style="text-align: left">Heure/hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Masse répartie /filling weight</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Qualité pré bouchage**/half stoppering quality</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Boite sédimentation/settle plate</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Intervention</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Fait par/done by</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Vérifié par /checked by</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left">H. ouverture./opening hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left">H. fermeture/closing hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Visa et date superviseur:.................................................................................................................</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><p style="text-align: left">** MB&nbsp;: Mauvais pré-bouchage/bad half stoppering ; BB&nbsp;: Bon pré bouchage/good half stoppering</p><ol start="14"><li><p style="text-align: left"><strong>LYOPHILISATION /lyophilization</strong></p></li></ol><table style="min-width: 50px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Désignation équipement/equipment designation</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Lyophilisateur telestar</strong></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Code /code</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>EQ HP EFH 11</strong></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Dernière date de qualification/étalonnage / last calibration and qualification date</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left">........./......./...........</p></td></tr></tbody></table><table style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Date et heure début/starting date and hour /......./...../...... ........h.......</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Etape de fabrication/manufacturing phase</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Fait par /done by</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Vérifié par /checked by</p></td></tr><tr><td colspan="1" rowspan="1"><ol><li><p style="text-align: left">Vérifier le vide de ligne et le nettoyage de l'équipement /check the line clearance and the cleaning of the equipment</p></li><li><p style="text-align: left">Introduire la recette suivante/load following recipe</p></li></ol><table style="min-width: 150px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><td colspan="1" rowspan="1"><p style="text-align: left">Opération /operation</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Consignes /set</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Réalisées /made</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left">Temps /time</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Température/temperature</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Temps /time</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Température/temperature</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Congélation /freezing</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Chargement plateaux/ shelfes loading</p></td><td colspan="1" rowspan="1"><p style="text-align: left">-</p></td><td colspan="1" rowspan="1"><p style="text-align: left">20°C</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left">Descente 1/ramp 1</p></td><td colspan="1" rowspan="1"><p style="text-align: left">15 min</p></td><td colspan="1" rowspan="1"><p style="text-align: left">5°C</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left">Palier 1 de congélation /freezing hold 1</p></td><td colspan="1" rowspan="1"><p style="text-align: left">30 min</p></td><td colspan="1" rowspan="1"><p style="text-align: left">5°C</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left">Descente 2 /ramp 2</p></td><td colspan="1" rowspan="1"><p style="text-align: left">10 min</p></td><td colspan="1" rowspan="1"><p style="text-align: left">-5°C</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left">Palier 2 de congélation /freezing hold 2</p></td><td colspan="1" rowspan="1"><p style="text-align: left">30 min</p></td><td colspan="1" rowspan="1"><p style="text-align: left">-5°C</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left">Descente 3/ramp 3</p></td><td colspan="1" rowspan="1"><p style="text-align: left">35 min</p></td><td colspan="1" rowspan="1"><p style="text-align: left">-40°C</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left">Palier 3 de congélation /freezing hold 3</p></td><td colspan="1" rowspan="1"><p style="text-align: left">2h</p></td><td colspan="1" rowspan="1"><p style="text-align: left">-40°C</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Vide/vacuum</p></td><td colspan="1" rowspan="1"><p style="text-align: left">100 µbar</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Pression</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Préparationcondenseur/condenser preparation</p></td><td colspan="1" rowspan="1"><p style="text-align: left">T°≤-55°C</p></td><td colspan="1" rowspan="1"><p style="text-align: left">T°=</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Dessication primaire /primary drying</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Dessication primaire Réchauffement 1/primary drying ramp 1</p></td><td colspan="1" rowspan="1"><p style="text-align: left">24 min</p></td><td colspan="1" rowspan="1"><p style="text-align: left">-28°C</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left">Dessication primaire palier 1 /primary drying hold 1</p></td><td colspan="1" rowspan="1"><p style="text-align: left">3H</p></td><td colspan="1" rowspan="1"><p style="text-align: left">-28°C</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left">Dessication primaire Réchauffement 2/primary drying ramp2</p></td><td colspan="1" rowspan="1"><p style="text-align: left">1H</p></td><td colspan="1" rowspan="1"><p style="text-align: left">+5°C</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left">Dessication primaire Palier 2 /primary drying hold 2</p></td><td colspan="1" rowspan="1"><p style="text-align: left">22 H</p></td><td colspan="1" rowspan="1"><p style="text-align: left">+5°C</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Dessiccation secondaire /secondary drying</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Dessication secondaire Réchauffement 1/secondary drying ramp1</p></td><td colspan="1" rowspan="1"><p style="text-align: left">20 min</p></td><td colspan="1" rowspan="1"><p style="text-align: left">+25°C</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left">Dessication secondaire palier 1/secondary drying hold 1</p></td><td colspan="1" rowspan="1"><p style="text-align: left">2 h</p></td><td colspan="1" rowspan="1"><p style="text-align: left">+25°C</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left">Vide/vacuum</p></td><td colspan="1" rowspan="1"><p style="text-align: left">500 µbar</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left">Dessication secondaire palier 2 /secondary drying hold 2</p></td><td colspan="1" rowspan="1"><p style="text-align: left">6 H</p></td><td colspan="1" rowspan="1"><p style="text-align: left">+25°C</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Test de maintien de vide/leak test</p></td><td colspan="1" rowspan="1"><p style="text-align: left">AP &lt;= 4µbar pendant 1 mn</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Bouchage /Stoppering</p></td><td colspan="1" rowspan="1"><p style="text-align: left">sous vide /under vacuum</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Numéro cycle de lyophilisation / cycle number&nbsp;: …..............</p><p style="text-align: left">Conformité du cycle/ cycle conformity : conforme/ comply non conforme /not comply</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>date et heure fin ending hour and date …..../…../…... …....h…....</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Visa et date superviseur signature and date supervisor&nbsp;:…..................................................................................</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><p style="text-align: left">joindre à cette page étiquette de vide de ligne et de nettoyage machine , étiquette statut local /attach to this page the line clearance and the cleaning label of the machine</p><ol start="15"><li><p style="text-align: left"><strong>STERILISATION DES CAPSULES/CAPS STERILIZATION</strong></p></li></ol><table style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Désignation équipement/equipment designation</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"><strong><em>AUTOCLAVE FEDEGARI</em></strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Code /code</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong><em>EQHPECE 15</em></strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Dernière date de qualification/étalonnage / last calibration and qualification date</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left">…....../…..../…........</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Date et heure début/starting date and hour /…..../…../…... ….....h…....</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Etape de fabrication/manufacturing phase</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Fait par /done by</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Vérifié par /checked by</p></td></tr><tr><td colspan="1" rowspan="1"><ol><li><p style="text-align: left">Vérifier la présence de la quantité correspondante à la taille du lot en capsules filp off emballés dans les sacs autoclavables./Check the presence of corresponding quantity to batch size of stopper in ready to autoclave bag</p></li><li><p style="text-align: left">Des sacs de tissus de nettoyages et du dossier de fabrication pour le capsulage/cleaning wipe and manufacturing batch record bag la crible du bioimpacteur /sampling head of air sampler ,</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="5"><li><p style="text-align: left">Effectuer la stérilisation de la charge selon l’instruction de sterilisation en vigueur en sélectionnant le programme code 6 /start the load sterilization according the sterilization SOP select the program code 6</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="6"><li><p style="text-align: left">Indiquer les paramètres de stérilisation mentionnés dans le tableau suivant /indicate the sterilization parameter in the table below</p></li></ol><table style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Paramètre/parameter</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Consigne/set</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Valeur /value</strong></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Température min de stérilisation/</p><p style="text-align: left">Sterilization min temperature</p></td><td colspan="1" rowspan="1"><p style="text-align: left">121 °C</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Température max de stérilisation/ Sterilization max temperature</p></td><td colspan="1" rowspan="1"><p style="text-align: left">122°C</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Valeur/ value F(T,z)</p></td><td colspan="1" rowspan="1"><p style="text-align: left">≥30 min</p></td><td colspan="1" rowspan="1"><p style="text-align: left">F0 min=</p><p style="text-align: left">F0 max=</p></td></tr></tbody></table></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Numéro cycle de stérilisation</p><p style="text-align: left">/cycle number Conformité du cycle Conforme/complies Non-conforme /not complies</p><ol start="7"><li><p style="text-align: left">Enregistrer l'opération au niveau du cahier de route de l’autoclave/record in the autoclave log book/</p></li><li><p style="text-align: left">joindre le graphique de stérilisation /attach the sterilization graph</p></li><li><p style="text-align: left">Joindre l’indicateur de stérilité à cette page /attach the sterilization indicator to this page</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>date et heure fin ending hour and date ......./...../...... .......h.......</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Visa et date superviseur signature and date supervisor :.........................................................................</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><p style="text-align: left">joindre à cette page étiquette de vide de ligne et de nettoyage machine , étiquette statut local /attach to this page the line clearance and the cleaning label of the machine</p><ol start="16"><li><p style="text-align: left"><strong>CAPSULAGE DES FLACONS /VIAL CAPPING</strong></p></li></ol><table style="min-width: 50px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Désignation équipement/equipment designation</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Capsuleusesteriline</strong></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Code /code</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>EQ HP EFH 10 04</strong></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Dernière date de qualification/étalonnage / last calibration and qualification date</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left">........./......./...........</p></td></tr></tbody></table><table style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Date et heure début/starting date and hour /......./...../...... ........h.......</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Etape de fabrication/manufacturing phase</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Fait par /done by</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Vérifié par /checked by</p></td></tr><tr><td colspan="1" rowspan="1"><ol><li><p style="text-align: left">vérifier le vide de ligne et le nettoyage du local, du C rabs et de la machine /check the line clearance and the cleaning of the machine , the Crabs and the room.</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="25"><li><p style="text-align: left">Entamer le test d'étanchéité de la C RAB (joindre le graphique du test) /start leak test of C RAB (attach the test graph)</p></li><li><p style="text-align: left">résultat /result conforme /pass non conforme /fail</p></li></ol><p style="text-align: left">si non conforme refaire le test , si la non conformité persiste informer votre supérieur hiérarchique / if the test is non-compliant repeat the test, if non conformity persists inform your supervisor</p><ol start="27"><li><p style="text-align: left">entamer le test d'étanchéité des gants de l'isolateur /start the gloves leak test</p></li></ol><p style="text-align: left"><strong>: résultat /result conforme /pass non conforme /fail</strong></p><p style="text-align: left">si non conforme refaire le test , si la non conformité persiste informer votre supérieur hiérarchique / if the test is non-compliant repeat the test, if non conformity persists inform your supervisor.</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="28"><li><p style="text-align: left">connecter le sac de capsules via la connexion alpha /beta du C RABS /connect the caps bag through the connection alpha /beta of the C RABS</p></li><li><p style="text-align: left">Remplir le vibreur par des capsules ./fill the vibration bowl with caps</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="30"><li><p style="text-align: left">Ouvrir la chambre du lyophilisateur /open the freeze dryer chamber</p></li><li><p style="text-align: left">Décharger le lyophilisateur par caissette et commencer le capsulage /unload the freez dryer by frame and start the capping</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="32"><li><p style="text-align: left">Vérifier la qualité du capsulage chaque 15 min /check the capping quality every 15 min</p></li><li><p style="text-align: left">A la fin du capsulage relever le nombre de flacon capsulés /at the end of capping indicate the number of capped vials .................................</p></li><li><p style="text-align: left">effectuer le nettoyage de la machine et de la C rabs immédiatement après le capsulage et sans ouvrir les chambres /start the cleaning of the machine and the C rabs immediately after capping without opening the chamber</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>date et heure fin ending hour and date ......./...../...... .......h.......</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Visa et date superviseur/ signature and date supervisor :.........................................................................</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><p style="text-align: left">joindre à cette page étiquette de vide de ligne et de nettoyage machine , étiquette statut local /attach to this page the line clearance and the cleaning label of the machine</p><p style="text-align: left"><strong>FICHE DE CONTROLE EN COURS CAPSULAGE / IPC CAPPING CHECK LIST</strong></p><table style="min-width: 175px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><td colspan="1" rowspan="1"><p style="text-align: left">Heure/hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Qualité Capsulage**/capping quality **</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Boite sédimentation /settle plate</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Intervention/intervention</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Fait par/done by</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Vérifié par /cheked by</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left">H. ouverture./opening hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left">H. fermeture/closing hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Visa et date superviseur/ signature and date supervisor :.........................................................................</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><p style="text-align: left"><strong>** MC&nbsp;: Mauvais Capsulage/ bad capping ; BC&nbsp;: Bon Capsulage/good capping</strong></p><p style="text-align: left"><strong>FICHE DE CONTROLE EN COURS CAPSULAGE / IPC CAPPING CHECK LIST</strong></p><table style="min-width: 175px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><td colspan="1" rowspan="1"><p style="text-align: left">Heure/hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Qualité Capsulage**/capping quality **</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Boite sédimentation /settle plate</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Intervention/intervention</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Fait par/done by</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Vérifié par /cheked by</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left">H. ouverture./opening hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left">H. fermeture/closing hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Visa et date superviseur/ signature and date supervisor :.........................................................................</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><p style="text-align: left"><strong>** MC&nbsp;: Mauvais Capsulage/ bad capping ; BC&nbsp;: Bon Capsulage/good capping</strong></p><p style="text-align: left"><strong>FICHE DE CONTROLE EN COURS CAPSULAGE / IPC CAPPING CHECK LIST</strong></p><table style="min-width: 175px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><td colspan="1" rowspan="1"><p style="text-align: left">Heure/hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Qualité Capsulage**/capping quality **</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Boite sédimentation /settle plate</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Intervention/intervention</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Fait par/done by</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Vérifié par /cheked by</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left">H. ouverture./opening hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left">H. fermeture/closing hour</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Visa et date superviseur/ signature and date supervisor :.........................................................................</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><p style="text-align: left"><strong>** MC&nbsp;: Mauvais Capsulage/ bad capping ; BC&nbsp;: Bon Capsulage/good capping</strong></p><ol start="17"><li><p style="text-align: left"><strong>LAVAGE EXTERNE/EXTERNAL WASHING</strong></p></li></ol><table style="min-width: 50px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Désignation équipement/equipment designation</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Laveuse externe steriline</strong></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Code /code</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>EQ HP EFH 10 05</strong></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Dernière date de qualification/étalonnage / last calibration and qualification date</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left">........./......./...........</p></td></tr></tbody></table><table style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Date et heure début/starting date and hour /......./...../...... ........h.......</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Etape de fabrication/manufacturing phase</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Fait par /done by</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Vérifié par /checked by</p></td></tr><tr><td colspan="1" rowspan="1"><ol><li><p style="text-align: left">vérifier le vide de ligne et le nettoyage du local, du C rabs et de la machine /check the line clearance and the cleaning of the machine, the C rabs and the room</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="2"><li><p style="text-align: left">Faire fonctionner la laveuse externe en suivant la vitesse de la capsuleuse/start the external washing on line with the capping machine</p></li></ol><ol start="35"><li><p style="text-align: left">Indiquer les paramètres suivants : /indicate the following parameter</p></li></ol><table style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Parametre /parameter</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Consigne /set</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Valeur lue /value</strong></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Débit de pulvérisation des aiguilles de lavage /spraying flow washing needles</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>0.2 bar</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Débit de pulvérisation des aiguilles d'air comprimé/spraying compressed air washing needles</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>2 bar</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="36"><li><p style="text-align: left">Placer les flacons lavés dans des caissettes inox identifiés /put the washed vial in identifiedStainless steel boxes</p></li><li><p style="text-align: left">A la fin du lavage externe faire le vide de ligne et le nettoyage de la machine sans ouvrir la C rabs / at the end of operation start the line clearance and the machine cleaning without opening the C rabs</p></li><li><p style="text-align: left">relever le nombre de flacons lavés / indicate the number of vials washed .............................................</p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>date et heure fin ending hour and date ......./...../...... .......h.......</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Visa et date superviseur/ signature and date supervisor :.........................................................................</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><p style="text-align: left">joindre à cette page étiquette de vide de ligne et de nettoyage machine , étiquette statut local /attach to thispage the line clearance and the cleaning label of the machineand the room</p><ol start="18"><li><p style="text-align: left"><strong>RECONCILATION DE LA FABRICATION /YIELD CALCULATION</strong></p></li></ol><table style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Date et heure début/starting date and hour /......./...../...... ........h.......</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Etape de fabrication/manufacturing phase</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Fait par /done by</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Vérifié par /checked by</p></td></tr><tr><td colspan="1" rowspan="1"><ol><li><p style="text-align: left"><strong>MATIERES &nbsp;: joindre une copie du bon de retour et de la fiche consommation des matières à la page suivante/ Attach a copy of return sheet and theconsumption sheetof material to this page</strong></p></li></ol></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="2"><li><p style="text-align: left"><strong>VRAC /bulk</strong></p></li></ol><table style="min-width: 125px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Quantité fabriquée/manufacturing quantity VQSP</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Qtité Remplie/filled quantity A × V moy 10-3</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Reste/remain</strong></p><p style="text-align: left"><strong>B</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Perte totale/total loss</strong></p><p style="text-align: left"><strong>C</strong></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Vrac/bulk</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>&nbsp;…………….. litres</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>……x……=………..litres</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>………..litres</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>……….. litres</strong></p></td></tr></tbody></table><p style="text-align: left"><strong>A= nombres de flacons remplis/number of filled vial</strong></p><p style="text-align: left"><strong>V moy = la masse moyenne des flacons répartis /densité = average weight filled vial / density</strong></p><p style="text-align: left"><strong>B= Quantité de vrac non remplie= bulk quantity not filled</strong></p><p style="text-align: left"><strong>C= Perte totale en solution /total waste of the solution = VQSP – (A × V moy 10-3)</strong></p><p style="text-align: left"><strong>Calculer le rendement&nbsp;de la fabrication : calculate the yield of manufacturing</strong></p><p style="text-align: left">R fabrication = {quantité remplie /quantité fabriquée -reste }</p><p style="text-align: left">×100</p><p style="text-align: left">R manufacturing = { filled quantity / manufactured quantity - remain } ×100</p><p style="text-align: left"><strong>A.N.=</strong></p><p style="text-align: left"><strong>R fabrication /manufacturing yield = {……litre /……..litre - …….litre } ×100=…… %</strong></p><p style="text-align: left"><strong>L e reste vrac doit etre évacué au niveau du point de drainage des produits dangereux /the remained bulk must be rejected in drain point of hazardous product</strong></p><p style="text-align: left"><strong>Si le rendement est &lt; 99% faire une déviation / if the yield is &lt; 99% record a deviation</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><ol start="3"><li><p style="text-align: left"><strong>ARTICLES / material</strong></p></li></ol><table style="min-width: 125px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Qtité admise/quantity received</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Qtité utilisée / quantity used (nombre de flacons remplis</strong></p><p style="text-align: left"><strong>et capsulés capped and filled vial number )</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Reste / remain</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Perte totale/ total loss</strong></p></td></tr><tr><td colspan="1" rowspan="1"><h1 style="text-align: left"><strong>Flacons vials :</strong></h1></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Bouchons.stopper</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Capsule / caps</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Calculer le rendement&nbsp;de la répartition et du capsulage /calculate the filling and capping yield</strong></p><p style="text-align: left">R répartitions +capsulage = {quantité capsulée /quantité admise - reste }×100</p><p style="text-align: left">Filling and capping yield = { capped quantity /received quantity - remain} ×100</p><p style="text-align: left"><strong>A.N.=</strong></p><p style="text-align: left"><strong>R répartitions +capsulage Filling and capping yield</strong></p><p style="text-align: left"><strong>= {………… /……… - …….. }×100 = %</strong></p><p style="text-align: left"><strong>Si le rendement est &lt; 97% faire une déviation / if the yield is &lt; 97% record a deviation</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>date et heure fin ending date and hour ......./...../...... .......h.......</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Visa et date superviseur/ signature and date supervisor :.........................................................................</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><ol start="19"><li><p style="text-align: left"><strong>RAPPORT DETAILLE DE RECONCILIATION</strong></p></li></ol><table style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Date et heure début/starting date and hour /......./...../...... ........h.......</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Etape de fabrication/manufacturing phase</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Fait par /done by</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Vérifié par /checked by</p></td></tr><tr><td colspan="1" rowspan="1"><table style="min-width: 50px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left">Quantité fabriquée en litres / Quantity produced in liters</p></th><th colspan="1" rowspan="1"><p style="text-align: left">20 litres /liters</p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Quantité prélevée en ml avant filtration / Quantity taken in ml before filtration</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Quantité prélevée en ml après filtration /Quantity taken in ml after filtration</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Perte filtration en ml /filtration loss in ml</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Quantité remplie en litres /filled quantity in liter</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Perte flacon remplissage /vial loss filling</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Réglage/setting :</p><p style="text-align: left">IPC :</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Reste solution en ml fin remplissage /solution remain end of filling</p></td><td colspan="1" rowspan="1"><p style="text-align: left">0</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Quantité capsulée en flacon /capped quanity in vial</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Perte flacon capsulage /vial loss capping</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Réglage/setting :</p><p style="text-align: left">IPC :</p></td></tr></tbody></table></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>date et heure fin ending date and hour ......./...../...... .......h.......</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Visa et date superviseur/ signature and date supervisor :.........................................................................</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><ol start="20"><li><p style="text-align: left"><strong>GESTION DES DECHETS PHARMACEUTIQUES/ PHARMACEUTICAL WASTE MANAGMENT</strong></p></li></ol><table style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left"><strong>Date et heure début/starting date and hour /......./...../...... ........h.......</strong></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th><th colspan="1" rowspan="1"><p style="text-align: left"></p></th></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Etape de fabrication/manufacturing phase</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Fait par /done by</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Vérifié par /checked by</p></td></tr><tr><td colspan="1" rowspan="1"><table style="min-width: 75px"><colgroup><col style="min-width: 25px"><col style="min-width: 25px"><col style="min-width: 25px"></colgroup><tbody><tr><td colspan="1" rowspan="1"><p style="text-align: left">Produits/ product</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Quantité/quantity</p></td><td colspan="1" rowspan="1"><p style="text-align: left">Remarques/ remark</p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Vrac: bulk = B</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Déchets remplissage filling waste PSF =P&nbsp; lot&nbsp;:</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Flacons vides :/Empty vials</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Flacons IPC/IPC vials</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Bouchons/ stopper</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left">Capsules/Caps</p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><h1 style="text-align: left">Appliquer l'instruction de gestion de déchet en vigueur / apply the waste management SOP</h1></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>date et heure fin ending date and hour ......./...../...... .......h.......</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><strong>Visa et date superviseur/ signature and date supervisor :.........................................................................</strong></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><ol start="21"><li><p style="text-align: left"><strong>DEVIATIONS, INCIDENTS ET DECISON DU PCP/ deviation incident and production pharmacist decision</strong></p></li></ol><table style="min-width: 25px"><colgroup><col style="min-width: 25px"></colgroup><tbody><tr><th colspan="1" rowspan="1"><p style="text-align: left">Déviation / deviation</p><p style="text-align: left">.......................................................................................................................................................</p><p style="text-align: left">.......................................................................................................................................................</p><p style="text-align: left">.......................................................................................................................................................</p><p style="text-align: left">.......................................................................................................................................................</p><p style="text-align: left">N° déviation / deviation number</p><p style="text-align: left">.......................................................................................................................................................</p><p style="text-align: left">.......................................................................................................................................................</p><p style="text-align: left">.......................................................................................................................................................</p><p style="text-align: left">.......................................................................................................................................................</p></th></tr><tr><td colspan="1" rowspan="1"><table style="min-width: 25px"><colgroup><col style="min-width: 25px"></colgroup><tbody><tr><td colspan="1" rowspan="1"><p style="text-align: left"></p></td></tr></tbody></table><p style="text-align: left"><em>Ce lot a été fabriqué selon le process approuvé et la documentation en vigueur. Tous les documents ont été vérifiés pour conformité. Les éventuelles déviations sont notées et commentées sur le formulaire ci haut. /Thisbatch has been manufactured according to the approved process documentation. All documents have been verified for compliance. Any deviations are noted and commented on the document above</em></p></td></tr><tr><td colspan="1" rowspan="1"><p style="text-align: left"><em>Ingénieur responsable production/ Production engineer Pharmacien chargé de production/ Production pharmacist</em></p><p style="text-align: left"></p><p style="text-align: left"><em>Date et signature&nbsp;/date and signature Date et signature&nbsp;/date and signature</em></p><p style="text-align: left"></p><p style="text-align: left"></p></td></tr></tbody></table>