The validation activities contained in our validation manual and subsequent reports are based on ANSI/AAMI/ISO 11137:2015 (Sterilization of Health Care Products – Radiation – Part 1 Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices). Please note: these items are not health care products and the report does not imply that they should be considered as such. This validation of the sterilization process includes a qualification of materials, equipment, and processes, and the study of naturally-occurring bioburden on the product to be sterilized. The validation is performed to ensure that the products meet PCS sterility requirements. The selection of the dose to achieve 10-6 SAL was based on bioburden test results using an exhaustive recovery method, product weight and density. The sterility dose is confirmed quarterly by the performance of verification dose audits.
PRUDENTIAL’S STERILIZATION VALIDATION SAL10-6
Applies to reusable polyester cleanroom garments and ancillary items.
- Laundered and packaged at Prudential Cleanroom Services Plants
- Always in accordance with plant procedures
- Gamma irradiated using a Cobalt 60 Radio Nuclide source
- 10-6 SAL (Sterility Assurance Level)