EFHSS Questions and Answers - Question Q00435

While using peelpouch as wrappers should the expiry depend on method of sterilization? If an item is sterilized by steam, the wrapper is subjected to more physical stress as compared to during low temperature (ETO) sterilization is a fact or a myth?

Dear Neena,

The quick answer to your question is that the expiration date does not depend on the method used to sterilize the items.

There is indeed more physical stress on the peel pouch seals in a high vacuum steam sterilizer than in EtO sterilizers, but the peel pouches are designed by the manufacturers to be able to withstand the stress experienced while in the sterilizer. You are absolutely correct that the seal integrity needs to be inspected after sterilization because it is critical to sterility maintenance. Heavy items can cause the seal integrity on the peel pouches to fail. Placing items into pouches which are too small for the item can also put undue stress on seal, causing it to fail. Any time a seal on the pouch has bubbles, or small unsealed areas, or any other flaws, the item must be repackaged and resterilized.

You may be interested in some of the earlier discussions on expiration dates and event related sterility discussed in questions Q00417, Q00318, Q00196, Q00176, Q00117, and Q00110.

Warm Regards,
Pete Bobb