Validation of all processes and the method of sterilization is essential, particularly as sterility testing is always a destructive test and can only be carried out on a sample of the batch. You should look very carefully at validation results for any methods that are not in accordance with national standards or pharmacopoeia, or for materials and products that are not solutions. If there are changes in the sterilization method, they must be validated.

The manufacturer must have data to support its decision for the sterilisation process. The suitability and efficacy in achieving the desired sterilising conditions in each part of load, and each type of load must have been validated. This validation is done initially and repeated at least annually and after change.