Aseptic Area Validations STERILIZATION EQUIPMENTS ...

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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.

VALIDATION OF STERILIZATION EQUIPMENTS Aseptic Area Validations P h a r m a c e u t i c al & C h e m i c al I n d u s t r y Resea r c h a n d Devel o p m e n t Foundation – Slide: 1 /5

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