Do you have your own ETO sterilization Chamber or Do you plan to purchase any? Have you think of the validation requirement for the ETO sterilization process?
Validation of ETO sterilizer is deem mandatory and compulsory to ensure assurance of sterilization of good being evaluated and verified in accordance to the designated manual.
Some of the requirements for the validation are the pre validation requirements which cover the product condition, packaging specification, measuring tools and many more.
One need to ensure the component of the validation requirements being fulfilled.
a. Installation Qualification
b. Operational Qualification
c. Performance Qualification - Physical
d. Performance Qualification - Microbiological
During all of these stages, validation shall cover the requirements for machine (ETO) installation and operational conformance to the intended use. Evaluation of Bio Indicator to be use during the process need to be carry out to ensure accuracy, dependable, reliability and meeting the specification for ETO process. Identification of lethal cycle or Half cycle identification which will mark the final dwell time requirements for full cycle of successful sterilization process.
Need to know more information regarding the ISO 11135 (now 2014) Sterilization of health-care products - Ethylene
oxide - Requirements for the development, validation and routine
control of a sterilization process for medical devices
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