Microbial Monitoring Solutions for 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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Looking for a an environmental monitoring solution? Only Particle Measuring Systems (PMS) has a wide range of solutions to meet all your needs:
- Particle counters, portable and remote
- MiniCapt Active Air Samplers available in a variety of portable or remote models
- BioCapt Impactors available as a single use solution or stainless steel
- Environmental motoring software
- Data management solutions
- Advisory services
Particle Measuring Systems is direct in every major market and able to ensure the same ongoing support no matter where you are located. Contact us today for a quote.
RELEVANT CONTENT
The Antibacterial MiniCapt® Mobile – For Best-in-Class Microbial Contamination Monitoring
Compressed Gas Microbial Contamination Monitoring & Contamination Control Strategy
Microbial Environmental Monitoring: Managing Auditor Expectations
Electronic Data in Pharmaceutical Manufacturing: Real-Time Microbial Monitoring (Series Part 6 of 6)
USP and Its Implications for Measuring Microbial Recovery Rates
Statistical Corrections Microbial Monitoring in Grade C/D Cleanrooms
