L'enregistrement est destiné aux professionnels qui travaillent avec des technologies de confinement et d'isolation et il autorise un accès total à nos fiches de données et catalogues de produits
Solution personnalisée pour votre fabrication stérile en vrac
ENTIÈREMENT-AUTOMATISÉ
PROTECTION PERSONNELLE
PROCÉDÉ ASEPTIQUE
Défis liés à la poudre stérile en vrac
Plusieurs types de conteneurs
Les solutions Comecer pour la manipulation et le remplissage aseptiques de poudres API en vrac dans l’industrie pharmaceutique sont compatibles avec tous les types de conteneurs.
Sac RTP
sac en forme de bouteille
baril en PE
baril en aluminium
Isolateur ou RABS ?
Un ISOLATEUR est un système de barrière bien défini (physique) qui peut être validé pour réduire considérablement le risque de contamination biologique. Un isolateur assure une isolation sans compromis, continue et de classe A de son intérieur par rapport à l’environnement extérieur.
Un RABS est une combinaison de barrières physiques et aérodynamiques au-dessus de la zone de traitement aseptique. Le RABS est une méthode alternative de contrôle de la contamination conçue pour être utilisée dans des salles blanches de classification supérieure (classe B de l’UE – ISO 7 minimum) et basée sur des systèmes moins complexes sur le plan technique.
Pourquoi Comecer préfère-t-elle l’isolateur ?
Compte tenu de la séparation totale entre les opérateurs et la zone aseptique, la solution d’isolateur est plus susceptible d’être mise en œuvre avec un certain niveau d’automatisation lorsque les tailles des lots sont importantes. De même, lorsque l’API présente un certain degré de confinement, la solution avec isolateur est indispensable. D’autre part, les RAB peuvent être adoptés lorsqu’une opération extrêmement manuelle est effectuée et qu’il n’y a pas de problème de confinement.
Conception ad hoc du processus
Tous les processus de stérilisation en vrac ont de nombreux aspects communs, mais chaque application a ses propres exigences et contraintes spécifiques.
C’est pourquoi Comecer repense la configuration du système de manière ad hoc en intégrant des solutions nouvellement conçues aux modules fonctionnels déjà adoptés.
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