Cleanroom Facility Monitoring Systems (FMS) gather data from a variety of sensors, including particle monitors, microbial/viable monitors, and environmental sensors. Once all the data is gathered it must be correctly interpreted for actionable insights.
This paper by Particle Measuring Systems addresses how to set up the Facility Monitoring Systems FMS collection settings to support effective interpretation of the particle data to ensure effective cleanroom monitoring and particle management.
Introduction
ISO standards for cleanroom certification (ISO 14644-1:2015) and monitoring (ISO 14644-2:2015) are separate. In fact, ISO instructs that both certification and monitoring should be performed individually, and should not use identical values. General guidance in ISO 14644-2 Annex B states:
“Statistical process control principles can be used to set alert and action levels based on analysis of historical data.”
When performing a certification, there is a specific formula to determine where to take the sample, in addition to sampling time and volume. There are also pass/fail criteria for the certification. For monitoring, the values for alarm or alert should be based on historical information as well as what will affect the product quality.
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Particle Measuring Systems (PMS®) has complete cleanroom contamination control solutions for you including:
- Our Contamination Control Advisory Services 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. Contact us today for a quote.
