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SMEPAC (Mesure standardisée des concentrations particulaires aéroportées des équipements)
Ancienne désignation du guide APCPPE actuellement en vigueur pour l’évaluation des systèmes de confinement.
Table des matières
01
Remarque : désignation obsolète
02
Pertinence pour les documentations existantes
03
Informations complémentaires
01
Remarque : désignation obsolète
SMEPAC est une désignation obsolète et a été remplacée par le guide APCPPE actuel (Assessing the Particulate Containment Performance of Pharmaceutical Equipment). Pour les validations actuelles et les dossiers réglementaires, seul le standard APCPPE de l’ISPE s’applique.
02
Pertinence pour les documentations existantes
Dans les anciens documents d’homologation et rapports d’audit, le terme SMEPAC est encore utilisé. Lors de la mise à jour de ces documents, il convient de faire référence à la norme APCPPE actuelle.
03
Informations complémentaires
Le guide APCPPE a été publié en 2004 par l’ISPE (International Society for Pharmaceutical Engineering) et est continuellement mis à jour. Il décrit des méthodes d’essai standardisées pour mesurer la concentration de particules dans l’air respiré lors du fonctionnement de systèmes de confinement. Voir aussi : APCPPE.
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