Documentos técnicos sobre monitoramento microbiológico

Presentation: Biological Air Sampling Product Line Overview (4.0 MB)

Explore microbial air sampling solutions to meet EC GMP, ISO 14698-1, USP 797, and FDA Sterile Guidelines (2004). This presentation covers validation requirements.

Microbial Monitoring of Compressed Gas Lines (168.4 KB)

There is a need to monitor for particulates and microbial contaminants in pharmaceutical gas lines, whether they are used as a process gas, control gas with open vent into the clean room, or as an aspiration point within a process. The regulations state that all processes shall meet either defined limits as set in the ruling or guidance document or follow appropriate ISO standard.