ABSTRACT
The process specification must describe the aspects of the sterilization process necessary to assure conformance with the validated dose and dose mapping and must be maintained with an established change control procedure. After successful completion of the sterilization validation, a process specification must be written that explains the proper procedures to be followed routinely. When a new or altered device is added to the product line, an evaluation must be conducted to ensure the device's compatibility with the sterilization process and to ascertain the challenge it presents to the current validated dose. Failure to meet the physical specifications should result in quarantine of the sterilization load and in an investigation. A checklist should be developed that lists all the device construction and package and load configuration issues that affect sterilizability.
