N.35

Certificate of conformity

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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