Teil 2: Luft: Anforderungen/Monitoring-Programm
Dr. Hanfried Seyfarth
Correspondence: Dr. Hanfried Seyfarth, Kirschenweg 12, 88400 Biberach (Germany)
Microbiological Monitoring / Part 2: Air: Requirements, monitoring programme
First, the possibility (probability) of contamination of container by airborne micro-organisms during filling is presented, using the formulas developed by Whyte. Then, the calculation of alert and action levels is described and guidance values are proposed.
Finally, a survey of the items of monitoring programme (level, methods, equipment, frequency, action to be taken, when limits are exceeded, allocation of responsibilities for sampling, allocation of responsibilities for testing,documentation and sampling points) is given.
Key words Anforderungen an die Luft • Aseptische Herstellung • Monitoring-Programm