Sterilization Validation Program

Prudential’s sterilization validation applies to reusable polyester cleanroom garments and ancillary items (coveralls, boots, hoods, face masks, goggles, and mops), which are laundered and packaged at Prudential Cleanroom Services Plants in accordance with plant procedures, then gamma irradiated using a Cobalt 60 Radio nuclide source resulting in a 10-6 SAL (Sterility Assurance Level).

The validation activities contained in our validation manual and subsequent reports are based on ANSI/AAMI/ISO 11137:2006 (Sterilization of Health Care Products – Radiation – 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.