scope:

This Technical Specification describes a method of substantiating the suitability of 25 kGy as a sterilization dose for radiation sterilization of products with an average bioburden of less than 1 000 colony-forming units (cfu) that are manufactured in small quantities (less than 1 000 product units). This method may be used to substantiate a sterilization dose of 25 kGy for any of the following situations: a) a single batch of product units; b) initial production of a new product while the sterilization dose is being established by another method; c) routine production of small batches. Information collected in applying the method of dose substantiation described in this Technical Specification may be applicable in meeting the product qualification requirements for sterilization dose selection of ISO 11137:1995 (see 6.2.2).