Ambient air micro (APC, Y&M) limits
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.
Matthew
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.