Effective and reliable microbial cleanroom testing is part of our comprehensive cleanroom certification services .
Particle Measuring Systems offers best-in-class microbial testing and consulting services to meet ISO 14644 microbial limits for your cleanroom operations and clean areas. Microbial contamination can impact clean manufacturing and operational areas in a similar way to particulate matter. While non-viable particles can be cleaned by filtration, even minor microbial contamination can replicate and spread. Monitoring microbial contamination levels in your cleanroom provides a cost-effective way to understand the sterility of the area and provides actionable data to implement corrective procedures. In addition, PMS’s microbial monitoring services help you effectively comply with regulations such as ISO 14644, ISO 14698 and (c) GMP such as EU GMP Annex 1 .
How can you increase your confidence in the sterility of your clean area?
The most basic approach to cleanroom microbial testing and monitoring is surface testing. Sedimentation plates are placed at static locations throughout the facility to manually measure contamination levels at that location. This is a viable and compliant solution for small operations and cleanroom certifications.
Another fully compliant approach is remote microbial monitoring (active air). This method uses a stationary instrument that continuously draws ambient air through the unit, monitors that air for germs, and regularly reports environmental data to a central computer to provide a real-time view of your operating facility.
As with any system, the more samples are taken, the greater the confidence in the data. To increase the confidence that the area being monitored is under control, PMS uses the industry-leading MiniCapt® mobile microbial air sampler and BioCapt® Single-Use microbial air monitor . These instruments are fully calibrated by our in-house SCS 0118 certified laboratory. Audit-ready calibration certificates are provided with your final report.
