Transcription of Autoclaves Qualification & Validation
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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 Exper
sterilisation methods) • Description of the sterilisation process (e.g. standard sterilisation, F0-sterilisation) on basis of the product properties • Definition of all (as possible) relevant GMP-critical points (e.g. sterility of cooling media, coldest spots) • Definition of the user needs for documentation and operation (e.g.
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