ABSTRACT
A FTER successful completion of the sterilization validation, a pro-cess specification must be written that explains the proper procedures to be followed routinely. 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. All specified process parameter values must be met or product cannot be released as sterile. The process specification should include the following:
(1) Identity of radiation modality qualified for sterilization (2) List of the items approved for sterilization in the process covered
by the specification, i.e., the product listing (3) The maximum dose allowed and the sterilization dose (4) Written procedures for sterilization process operations or refer-
ence to specific operator manuals (5) Sterilizer tote loading configurations and dose mapping showing
the relationships between the reference point and the maximum and minimum dose positions
(6) Descriptions and diagrams of the placement of dosimeters and other test samples
(7) Specified minimum dose and minimum and maximum tolerances and reference to the dosimeter system used routinely
(8) Requirements for routine quality control tests and periodic audits related to sterilization
(9) Written criteria for sterile product acceptance, reprocessing, rejection, and release for distribution, including instructions for selection, handling, and testing of samples
102 ROUTINE MONITORING AND CONTROL
Failure to meet the physical specifications should result in quarantine of the sterilization load and in an investigation. The investigation should be documented. If the delivered dose is below the validated dose, the sterilization load should not be released; product should be either resterilized or scrapped. Because radiation effects on materials are cumulative, any decision to resterilize must be based on acceptable product aging test data after multiple sterilizations. Process interruptions or delays should be evaluated to determine the effect on the microbiological quality ofthe product and on the dosimetry systems.
