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"Whole Package Sterilization Qualification"

Medical device companies use double barrier packaging for aseptic presentation of the primary package into the sterile field of an operating room. Is it sufficient to perform the sterilization qualification on the inner package only, or should that qualification be performed on the entire package (device, inner, and outer package)?

Last Updated On August 18, 2014

The medical device and the double barrier packaging consisting of the inner package (e.g. primary package), and the outer package does need to be sterilized as a whole system. The inner package is intended to be presented in an aseptic field. A breach of the outer package sterility would result in a non-sterile inner package. We recommend referencing ISO 11607 Packaging for Terminally Sterilized Medical Devices, and ISO 13485 Medical Devices-Quality Management Systems-Requirements for Regulatory Purposes, specifically pertaining to sections on medical device packaging; and ASTM 2097 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products.

As a note, when you are considering whole package testing for maintenance of sterility, the ASTM F1608 microbial challenge method had been studied closely and has been shown to result in false positives. The published results triggered the FDA to look closely at the acceptance of physical package and integrity testing and determine this was acceptance for submission rather than the whole package test approach.


“Toward a New Consensus on Sterile Device Packaging,” MD&DI, January 1993. Parisi et al.

“Microbial Challenge of Whole Packages,” ASTM’s Standardization News, March 1993. Hansen et al.

“How Effective Is Microbial Challenge Testing for Intact Sterile Packaging?” MD&DI, August 1993. John Spitzley.

“In Quest of Sterile Packaging, Part 1: Approaches to Package Testing,” MD&DI, August 1995. Hansen et al.

“In Quest of Sterile Packaging, Part 2: Physical Package Integrity Test Methods,” MD&DI, September 1995. Jones et al.