This presentation is designed to acquaint those in the medical device community with the appropriate way to sterilize small or infrequent loads of product using the batch release method. This process allows the manufacturer to sterilize a single lot of product for use in clinical trials or animal studies where large numbers of samples are not available. This provides a rapid and cost effective way to provide sterile product without undergoing the full validation process. The batch release method, when properly used, can also be used to help satisfy the requirements of a full sterilization validation.
The validation methods used are outlined in AAMI TIR 16:2009 and are based on sterilization principles from ANSI/AAMI/ISO 11135-1:2007. Some of the related testing discussed includes comparative resistance, bioburden resistance, bioburden enumeration, sterility testing, sterilant gas residues, and temperature/humidity distribution studies.