Environment monitoring

I want suggestions about number of sampling point in manufacturing area.
First we have to do HVAC qualifications . Supposed At that time we decided location at return riser , near door near machine,etc… and HVAC was qualified.
But now on routine practice of EM required same to same number of sampling point as at time of qualifications.?
Or I can reduced some point? Please suggest me.

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Hello!

A risk assessment should be done to define which sampling points or locations are the most critical to consider for routine monitoring. Some ideas to consider:

  • Room clasification
  • Personnel intervention/interaction
  • Moving equipment
  • Ease of cleaning
  • Product exposure

A good approach could be to use the information from the HVAC qualification to aid in the determination of sampling points for routine monitoring. Also, once sufficient data is available through routine monitoring and HVAC verification, analysis can be done to conclude if total qtty of samples can be reduced (low risk sampling points) or if some of them would required a higher frequency due to higher risk, also useful to define/redefine alert and action levels.

Should always comply with specific regulatory requirements if applicable.

You can look for guidelines established by:

ISO 14644-2 Cleanrooms and associated controlled environments
Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration.

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