Vermeidung der Kreuzkontamination
GMP/Arbeitsschutz an Reinigungsanforderungen für nicht-produktberührende Oberflächen*)
GMP / GLP / GCP
Abstract
GMP product and operator protection and cleaning requirements of non-product-contact surfaces in aseptic isolators
Isolators are being used more and more frequently in the sterile manufacture of pharmaceuticals to protect the product from direct access by personnel in the critical manufacturing process. The use of isolators also makes it possible to reduce the size of the GMP-critical area for aseptic manufacture in cleanroom Class A/ISO Class 5 to an absolute minimum. Isolators are considered in general to be non-product-contact surfaces as, for the large part, their surfaces and fixtures do not come into direct contact with the product. However, product contact contamination at critical locations within an isolator can occur – e.g. in the filling area. In theory, contamination of the air due to released product particles can also create a risk. While this applies to all substances manufactured in an isolator, special attention should be paid to HPAPIs, for which the permitted daily exposures (PDEs) are particularly low. The EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities dated November 20, 2014 applies when it comes to setting these PDEs.
Zusammenfassung
Isolatoren werden in der sterilen Herstellung von Fertigarzneimitteln immer häufiger zum Schutz des Produktes vor dem direkten Zugriff des Personales in den kritischen Herstellprozess eingesetzt. Durch den Einsatz von Isolatoren wird auch der
