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APCPPE (Évaluation des performances de confinement des particules des équipements pharmaceutiques)
Guide pour l’évaluation uniforme des systèmes de confinement, publié en 2004 par l’ISPE.
Table des matières
01
Qu'est-ce que l'APCPPE ?
02
Signification pour les lots de diapositives
03
Délimitation par rapport à SMEPAC
01
Qu'est-ce que l'APCPPE ?
L’APCPPE, anciennement SMEPAC, est un guide pour l’évaluation harmonisée des systèmes de confinement, publié en 2004 par l’ISPE (International Society for Pharmaceutical Engineering). Les lignes directrices qu’il contient sont évaluées en continu et, le cas échéant, adaptées. En particulier, les systèmes de confinement doivent être validés en ce qui concerne leur étanchéité et leur utilisation en exploitation.
02
Signification pour les lots de diapositives
Les lots de films proposés par Rhein-Plast sont un élément essentiel pour satisfaire aux directives APCPPE. Les exigences spécifiques du système porteur concerné peuvent être prises en compte et la solution de confinement la plus appropriée peut être déterminée.
03
Délimitation par rapport à SMEPAC
Le guide APCPPE a remplacé l’ancienne norme SMEPAC. Pour les validations actuelles, les qualifications des fournisseurs et les soumissions réglementaires, seul le guide APCPPE de l’ISPE fait foi. Les documents plus anciens qui font encore référence à SMEPAC devraient être mis à jour lors de la prochaine révision.
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Parlez à nos experts de vos besoins spécifiques en
systèmes de confinement et emballages primaires.