Sterilization Validation Program
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.
PRUDENTIAL’S STERILIZATION VALIDATION SAL10-6
Applies to reusable polyester cleanroom garments and ancillary items (coveralls, frocks, innerwear, sleeves, boots, hoods, face masks, goggles, and mops)
- 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)