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Ambient air micro (APC, Y&M) limits

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matthewcc

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Posted 18 April 2024 - 11:01 PM

Hello all,

 

What is a good resource for setting micro limits for ambient air for aerobic plate count and yeast and mold?  I have seen only micro limits for compressed air (ISO 8573), and it appears ambient air is not included.  This would be for manufacturing areas where product and product-contact surfaces are exposed.

 

NSF GMP section 4.5.81 includes, "4.5.81 Environmental Monitoring Program shall be risk based to include controls to evaluate and
mitigate the presence of nonpathogenic microorganisms in production areas and equipment."  However, there is no limit here.
 
We are NSF GMP and SQF certified in the United States for manufacturing of dietary supplements.
 
Thank you,
Matthew


MMiller

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Posted 19 April 2024 - 01:30 PM

Levels for EMP monitoring should be set for each facility and process through risk assessment, the 'risk-based'.  Look at any historical data you have for those surfaces/products paired with air data from same time, if you don't have any that is your starting point.  Set an initial limit and start your program, then after a few rounds of samples evaluate your results and adjust limits if needed.  Document the process for your risk assessment and validation.  

 

As long as the limits work for your process/facility to mitigate contamination, they are the correct limits no 2 facilities are the same.



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