Mikrobiologisches MonitoringTeil 4: Oberflächen/Personal: Anforderungen/Monitoring-Programm*) Hanfried Seyfarth Abteilung Biopharmazeutische Qualität und Entwicklung/Mikrobiologie, Boehringer Ingelheim Pharma KG, Biberach/Riss Microbiological Monitoring / Part 4 : Surfaces/personnel: requirements, monitoring programme First, the contamination risk caused by surfaces and personnel during production of pharmaceutical preparations is presented. The legal problems regarding hygiene tests of staff are discussed. Further, proposals for limits for microbiological quality of surfaces and personnel are presented. Finally, the contents of a monitoring programme is described - Methods/equipment- Frequencies - Investigations in case of deviations - Sampling (responsibilities) - Laboratory testing (responsibilities) - Sampling points - Documentation
Key Words Aseptische Herstellung · Mikrobiologisches Monitoring · Aseptische Herstellung · Reinräume *)Teil 1, 2 und 3 siehe Pharm. Ind. 64, Nr. 1 , S. 75, Nr. 3, S . 289, und Nr. 10, S. 1096 (2002).
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pharmind 2002, Nr. 11, Seite 1186
