SPMC's FAQs provide guidance for your technical challenges.

Material and Sterile Barrier Systems

"Porous Area Needed for EtO Sterilization"

How much porous area do I need for EtO sterilization?

Last Updated On May 15, 2008

The amount of porous area required can only be determined through validation efforts utilizing your unique sterilization process, and your medical device. The density of the product to be sterilized, the pack out configuration, and the sterilization cycle are all unique factors that determine the amount of porous area required for a package.

For example, typically you start with some package that is known to go through the process successfully. Determine how different the package being designed is from that package and make a judgment on where to start sizing the porous area. Adjusting the porous area to larger and smaller sizes run them through the ETO cycle and determine if the package remains intact and the product gets adequate sterilization. This occurs in the design phase of the package, not in the validation stage of the package. Also make sure you are not masking the porous area of your package with a label or excessive shipping materials or dunnage.