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"Using Sterile Barrier Systems Produced in Validated Processes"

Any comments to using a supplier’s “process validated” product (pouches) and then having the device manufacturer use their worst case production process for performance validation?

Last Updated On May 15, 2008

This approach is by far the most common method for satisfying the requirement of ISO 11607-1 clause 6.3.4 and is the method that the authors of ISO 11607 had in mind when drafting the documents. Because it does not require specific and separate production runs by the sterile packaging manufacturer, it is economical while still creating packages that are known to represent the limits of the process (the closure seal).