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Systèmes fermés
Machines ou équipements qui utilisent des solutions de confinement pour des processus critiques et empêchent les influences extérieures.
Table des matières
01
Définition
02
Mise en œuvre dans les processus de remplissage
03
Exigences OEB et réglementation
01
Définition
On entend par systèmes fermés des machines ou des équipements qui utilisent des solutions de confinement pour des processus critiques tels que le remplissage, le dosage ou encore le nettoyage, et empêchent ainsi toute influence extérieure. L’effet de tels systèmes fermés est décrit plus en détail sous le terme de confinement.
02
Mise en œuvre dans les processus de remplissage
Les solutions de confinement offrent un moyen efficace de mettre en œuvre un système fermé dans les processus de remplissage et d’empêcher ainsi la contamination des produits à conditionner. Les liners et sacs de transfert Rhein-Plast sont conçus comme une partie intégrante des solutions de systèmes fermés et sont entièrement validables.
03
Exigences OEB et réglementation
Pour les substances actives à partir de l’OEB 3, des systèmes fermés avec confinement primaire sont obligatoires. Rhein-Plast propose des solutions de confinement validées pour les classes OEB 2 à 5, conformes aux exigences réglementaires selon l’APCPPE et les GMP, et pouvant être intégrées dans des lignes de remplissage existantes.
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Parlez à nos experts de vos besoins spécifiques en
systèmes de confinement et emballages primaires.