Viable Non Viable Particle Counters to Fully Meet Regulatory Requirements
Monitoring viable nonviable particle counts in a cleanroom is critical to meet regulatory requirements. A facility monitoring system effectively collects, manages and reports on data from both particle counters and microbial monitors.
Total particle contamination is a mixture of nonviable and viable particles. Historically, nonviable particles are monitored continuously while viable particles have been monitored on a less frequent basis. In modern aseptic manufacturing, both types should be monitored continuously to obtain an accurate indication of the cleanroom’s condition.
An ideal monitoring program provides the sampling data required and ensures data integrity through the use of an automated system to track any changes. The system used to track and record data must meet the requirements of 21 CFR Part 11 and should be incorporated into an automated Environmental Monitoring System.
What You Will Learn:
- Key regulations related to an Environmental Monitoring Systems.
- How to incorporate particle (non viable) and microbial (viable) sensors into an Environmental Monitoring Systems.
- The types of data and reports that should be expected from an Environmental Monitoring System.
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Particle Measuring Systems (PMS) has complete viable non viable cleanroom contamination control solutions for you including:
- Our Contamination Control Advisory Services who can conduct a Risk Assessment for your pharmaceutical processes
- PMS Cleanroom particle counters including portable/mobile and fixed/remote
- Microbial Monitors including portable/mobile, fixed/remote, and single use.
- Data management software from Particle Measuring Systems
Particle Measuring Systems is direct in every major market and able to ensure the same ongoing support no matter where you are located. Co
