Sterilization Validation
Purpose of Sterilization Validation
The purpose is to standardize validation and ongoing monitoring of moist-heat sterilization processes and procedures performed by entities that sterilize medical devices.
Sterilization validation aims to demonstrate that sterilizers meet specified requirements.
Sterilization Validation Overview
Medical devices intended for sterilization should be manufactured under conditions that maintain consistently low bioburden. Validation must provide objective, documented evidence that sterilization process requirements are met consistently over time.
Scope of Application
Test Items
Sterilization Methods for Medical Devices
Select a method that considers individual device characteristics and does not adversely affect product quality.
Steam sterilization (autoclave)
Used for devices that are not damaged by heat; microorganisms are removed using saturated steam under pressure.
Radiation sterilization
Mainly used for heat-sensitive single-use devices; sterilization is achieved by destroying microbial DNA and cellular structures.
Ethylene oxide (EO) gas sterilization
Used for devices sensitive to heat and radiation; sterilization uses alkylation reactions that destroy microbial DNA and proteins.
Sterilizing filtration
Used when the above methods are not suitable; microorganisms are removed by filtration.