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Autoclaves Qualification & Validation

AutoclavesQualification & ValidationBy Holger Fabritz2 of 39 Autoclaves : Qualification & ValidationHolger Fabritz Expertentreff 14. September 2007 in BadenContents Types of Autoclaves Regulatory Aspects GMP Risk Analysis URS / FDS Design Qualification Installation Qualification / Operational Qualification Performance Qualification / Process Validation Responsibilities Summary3 of 39 Autoclaves : Qualification & ValidationHolger Fabritz Expertentreff 14. September 2007 in Baden Steam Autoclaves Sterilisation with Steam / Air Mixture Saturated Steam with possible initial vacuum sequence(s) Cooling with Air cooled down by heat exchanger Hot Water Spray Autoclaves Sterilisation with Spraying of Water (Flooding with water) Cooling with Water cooled down by heat exchanger Hot Air Sterilisers- Types of Autoclaves -4 of 39 Autoclaves : Qualification & ValidationHolger Fabritz Expertentreff 14.

7 of 39 Autoclaves: Qualification & Validation Holger Fabritz - Expertentreff 14. September 2007 in Baden - Regulatory Aspects - • GAMP • The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture,

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