Aseptic Area Validations STERILIZATION …

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validation OF STERILIZATION EQUIPMENTSAseptic area Validations Ph armaceutic al & Chemic al Indu st ry Research an d Developmen t Foundation Slide: 1/51Content: Definition of STERILIZATION and Depyrogenation Microbiological aspects of STERILIZATION and Depyrogenation, Lethality calculation, D-Value, FH& F0Values Z-Value and use of microbiological indicators. Slide: 2/51Content:- Dry Heat Ovens- Dry Heat STERILIZATION Tunnels- Steam Sterilizator ( autoclaves ) 1. Design Qualification2. Installation Qualification3. Operational Qualification4. Performance aspects of Distribution and Heat Penetration studies. Slide: 3/51Definitions: 1. STERILIZATION : Validated process used to render a product free of living microorganisms including bacterial endospores. 2. Depyrogenation: Removal or inactivation of bacterial endotoxin. Slide: 4/51Sterilization Only: The cycle is designed to assure that the probability of survival of the native microflora is no greater than one cell in one million units of the commodity.

Content: - Dry Heat Ovens - Dry Heat Sterilization Tunnels - Steam Sterilizator (Autoclaves) 1. Design Qualification 2. Installation Qualification

  Area, Validation, Autoclaves, Aseptic, Sterilization, Aseptic area validations sterilization