ABSTRACT
As noted in the introduction, procedures for validation of the sterilization process were developed and refined at an early point in time in the radia-
tion sterilization industry. Today, users of irradiators for sterilization purposes have all the necessary guidelines and standards for proper performance of a validation program. This program includes five basic steps:
(2) Product qualification, which entails setting of a maximum acceptable dose to ensure product quality, safety and performance throughout the lifetime of the product and setting of a minimum dose that ensures the product was processed to a predetermined sterility assurance level (SAL)
(3) Process qualification that establishes the loading configuration for each product type that is processed in the irradiator and dose mapping of each loading pattern to identify zones of minimum and maximum dose, which can be subsequently monitored on a routine basis
( 4) Maintenance activities that ensure the validation program adheres to predetermined product qualification criteria
(5) Formal program of documentation that serves to certify the process
Each of these steps is discussed in detail in an American National Standard and European Standard on sterilization of health care products [ 13,14]. Key elements of the validation program are discussed here.
