The batch release method is a rapid and cost-effective approach to sterilizing single or small batches of product needed for clinical or animal trials with minimal sample requirements. The overkill concept using Ethylene Oxide (EO) sterilization is used to demonstrate a sterility assurance level to safely release product.
For most products, the batch release method can be performed in small laboratory vessels as well as at contract sterilization facilities and provides the much needed flexibility to get product to trials or to market without the time and expense of waiting for the completion of a full sterilization validation.
The requirements for an EO Sterilization Validation are outlined in ANSI/AAMI/ISO 11135 Part 1 & 2. Various AAMI TIRs also offer guidance in meeting the requirements of the sterilization standard. Nelson Labs specializes in Ethylene Oxide Sterilization Validations, and we can partner with you as well as many contract sterilizers through the entire process from protocol generation to final report completion. See below for more details.
- ANSI/AAMI/ISO 11135
- AAMI TIR 16