Teil 2: Luft: Anforderungen/Monitoring-Programm*)
Abteilung Biopharmazeutische Qualität & Entwicklung/Mikrobiologie, Boehringer Ingelheim Pharma KG, Biberach/Riss
Microbiological Monitoring / Part 2 : Air: Requirements, monitoring programme
First, the possibility (probability) of contamination of containers by airborne micro-organisms during filling is presented, using the formulas developed by Whyte. Then, the calculation of alert and action limits is described and guidance values are proposed. Finally, survey of the items of the monitoring programme (limits, 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 Aseptische Herstellung · Mikrobiologisches Monitoring · Reinräume
pharmind 2002, Nr. 3, Seite 289