What are the sampling requirements for sterility testing when a finished product batch of a terminally sterilised medicinal product is made up of more than one steriliser load?

The sampling plan for sterility testing should take account of the definition of a batch as stated in the
glossary of the GMP guideline together with the recommendations of annex 1 section 93 . Each steriliser load is considered to be an independent sub-batch. Consequently, one sterility test should be performed per sub-batch. The number of samples per
steriliser load should conform to European Pharmacopoeia requirements, section 2.6.1.3.