Microbial Control and Monitoring in Aseptic Processing Cleanrooms
Aseptic processing cleanrooms and associated controlled environments provide the control of contamination (particle and microbial) to levels appropriate for accomplishing contamination-sensitive activities.
Microbial monitoring, including all Environmental Monitoring (EM), particularly in Pharmaceutical manufacturing facilities, includes both particle counters and microbiological test methods. It is a common assumption that if fewer total particles are present in a cleanroom, it is less likely that airborne microorganisms will be present. However, it is not possible to clearly distinguish between background total particulate contamination generated largely by mechanical operations and the total particulates contributed by personnel. Thus, it is routine for cleanroom environmental monitoring programs to consist of both particle counting and microbial monitoring components.
The data originated from these cleanroom monitoring components provide critical information on how well a stable and suitable environment for the aseptic preparation of medicinal products is maintained.
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