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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 |
The TRIO.BAS air samplers: fulfil the requirements of: · ISO Standard 14698-1 – 2004 Guidance for Industry on Sterile Drug Products by Aseptic Processing – Current Good Manufacturing Practice · FDA – 1987 Guideline on Sterile Drug Products by Aseptic Processing · ACGIH – Guideline for Assessment of Bio-aerosol in the Indoor Environment · ASTM – Draft Protocol – Committee D22.05.06 · USP Chapter <1116> Microbiological Evaluation of Clean Rooms and Controlled Environments · EU Guide for GMP – Manufacture of Sterile Medicinal Products Control Medicines and Inspection
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