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117 | Airborne Bacteria, Viruses and Spores in poultry premises by High Efficiency Electrostatic Bacterial Air Sampler |
96 | Subdivision of hospital operating department in different areas depending on the biological risk for staff and patients |
95 | Muestreador microbiológico de aire TRIO.BAS TRIO para la detección de contaminación microbiana en salas limpias y entornos controlados. |
76 | SOP – Standard Operating Procedure for use, maintenance, calibration of “TRIO.BAS” microbiological air samplers |
51 | Training of personnel in Cleanroom, Isolator, RABS according USP 38 – The United States Pharmacopeial – Document (1116) Aseptic Processing Environments – Page 1195 |
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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