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
Paul Hartigan is the Global Product Line Manager for Software and Systems with Particle Measuring Systems. He has held various product management responsibilities over the last 10 years with Particle Measuring Systems including responsibility for Liquids, Aerosol and Microbial based products, with his latest role being involved in the Environmental Monitoring Systems. Responsibilities have included developing the latest technologies into products for use in Life Science cleanroom operations. Paul holds a B.S. in Electrical Engineering and a Master’s degree in Business. He has written numerous papers related to the application of products in the Life Sciences industry and presented at organizations throughout the world, including instruction at various trade organizations.