Teil 6*): Monitoring in Betrieben zur Herstellung nichtsteriler Arzneimittel
Dr. Hanfried Seyfarth
Korrespondenz: Dr. Hanfried Seyfarth, Kirschenweg 12, 88400 Biberach (Germany)
Microbiological Monitoring/Part 6: Monitoring of Manufacturers of Non-Sterile Pharmaceuticals
The microbiological contamination caused by environment has also to be controlled in case of production and filling of non-sterile preparations. The conditions which should be under control are air, surfaces and personnel. A monitoring programme has to be established which regulates level, methods, equipment, sampling points, frequency, action to be taken when limits are exceeded.
Keywords: Anforderungen an Luft und Oberflächen • Herstellung nichtsteriler Zubereitungen • Monitoring-Programm
pharmind 2010, Nr. 5, Seite 897