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Moisture Sensitive Components in EtO Sterilization

Q.

How should you go about packaging a moisture sensitive component for ETO sterilization?

A.

Two common package design approaches are double pouching and vented pouches. Double pouching with an inner breathable pouch and outer barrier pouch, such as foil, is a common option. The inner breathable pouch is ETO sterilized and then placed in outer foil pouch. In this case, only the inside of the primary sterile barrier system (the inner pouch) is sterile. Therefore, aseptic presentation can only be performed with the inner pouch. Package labeling should clarify this aspect to the user.

A vented foil pouch is a second option. The pouch is ETO sterilized and sealed, excluding the vent, which is removed by cutting. What remains is an all foil pouch. Since the package is designed with the extra vent area that is later removed, a larger pouch size is required. The benefits to this approach are single sterilization and less packaging material than double pouching.

In some moisture sensitive components of kit packs, a product can be packaged in a fully non-porous barrier material. These products are often radiation sterilized first and typically vacuum packaged in order to remove air. Trapped air within the package would expand under the pressure changes in EO cycles and potentially rupture seals or expand enough to open the kit pack closure thereby compromising the kit.

Last updated on 2014-05-02 12:40:56 UTC
Keywords: moisture sensitive, vented foil pouch, vacuum seal, double pouch

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