Environmental and Process Monitoring- Annex 1, Section 9.4

In Part 3 of our 5 part blog series, we look at Viable Non Viable (V/NV ) Particle counts regarding Environmental and Process Monitoring as found in Annex 1, Section 9.4:

• RA should be done to develop a comprehensive environmental monitoring program
  • Sampling locations of cleanroom particle counters and microbial monitors
  • Frequency of monitoring
  • Monitoring method used
  • Incubation conditions

That is: time, temperature, or aerobic / anaerobic conditions need to be established.

• A Risk assessment must be based on detailed knowledge of
  • the process inputs and final product,
  • the facility, equipment, specific processes, the operations involved,
  • historical monitoring data, monitoring data obtained during qualification
  • knowledge of typical microbial flora isolated from the environment.

Another approach to consider is air visualization studies.

The RA for Viable Non Viable Particle Counts needs to be regularly reviewed to confirm the effectiveness of the environmental monitoring process.

EMPQ and Monitoring

Process Understanding- What’s it for?

• It serves to correlate the process with the monitoring data
• It allows identifying areas and operations critical for the production

What data is needed for Viable Non Viable Particle Counts?

Gather detailed information about your process to define all critical operations and locations.

In the next blog in this series we will continue to examine Annex 1 and QRM principles and areas where those are discussed.

Find the right particle counters, microbial monitors, and data management solutions for your cleanroom monitoring needs.

Want to read more? Jump to other released posts in this series:

• Part 1 of 5, April 23: Quality Risk Management- Principle Section 2
• Part 2 of 5, April 24 Quality Risk Management- Annex 1 section 6.1
• Part 3 of 5,  V/NV Environmental and Process Monitoring- Annex 1, Section 9.4  (you are here!)
• Part 4 of ,5 publishing April 30 Definition of potential sampling points
• Part 5 of 5, publishing May 1; Blog 5 Process Risk Assessment

Learn more… Get the full paper here. 

Learn how our Advisory Services Team can help you conduct a Risk Assessment.