IngenesTM offers product Ethylene Oxide (EO) and radiation sterilization validations across a broad range of technologies. IngenesTM understanding of material compatibility, sterilization science, validation approaches and cycle optimization ensures customers have a reliable, and defensible validation strategy.IngenesTM offers complete package of testing and sterilization validation services in compliance with global regulatory requirements.
All types of products, whether sterilized in-house or by a contract sterilizer, must be validated to ensure compliance with national and international standards.An EO Sterilization Validation is designed to assist the manufacturer in the development of a sterilization process that delivers the appropriate sterility assurance level and ensures repeatability for each product type developed.
The EO Sterilization Validation requirements are outlined in ANSI/AAMI/ISO 11135. Various AAMI TIRs offer guidance in meeting the requirements of the sterilization standard. IngenesTMspecializes in Ethylene Oxide Sterilization Validations. We can partner with your companyor your contract sterilization facilities through the entire process from protocol generation to final report completion.
Radiation sterilization validation determines the appropriate radiation sterilization dose for a product that requires a sterile label claim. It incorporates bioburden testing, a bioburden recovery efficiency test, a sublethal radiation dose (verification dose), test of sterility and bacteriostasis and fungistasis testing.
If a sterile label claim is required and the sterilization method will be radiation, a validation is required to determine the appropriate sterilization dose. The radiation sterilization validation testing complies with the standard ANSI/AAMI/ISO 11137 and technical specification ANSI/AAMI/ISO 13004.
Please contact us for further information about our sterilization validation services.
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