Teil 1: Notwendigkeit von Umgebungskontrollen/Raumklassifizierung
Dr. Hanfried Seyfarth
Corresponding author: Dr. Hanfried Seyfarth, Kirschenweg 12, 88400 Biberach (Germany)
Microbiological Monitoring / Part 1: Necessity of environmental checking/clean room classification
The purpose of microbiological monitoring is the provision of an indicator that allows detection of any deviation from normal validated conditions. Thus, immediate action can be taken in order to re-establish validated conditions.
First, official requirements, recommendations resp. as to monitoring in general and especially for air, surfaces and personnel are presented.
Then room classification for each production step is described and discussed.
Key words Aseptische Herstellung • Mikrobiologische Umgebungskontrollen • Reine Räume