N.84

USP 1116 for Microbial Air Monitoring – OOS (Out Of Specifications) and OOT (Out Of Trends)

GLOSSARY Bioburden, alert limit, action limit, corrective action, CFU, Environmental isolates, Environmental Monitoring, genus, microbial identification, OOS, OOT, species, trend. INTRODUCTION The USP Pharmacopea Inspectors request that the trend variation in a Cleanroom or RABS or Isolators in Pharma production should be seriously considered when "alert" and "action" levels are detected.

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