How Are You Testing the Integrity of Your Sterile Medical Packaging?

From visual inspection to bubble emission to tracer gas methods, you've got a lot at your disposal. What are you using, and what challenges are you facing?

Packaging engineers, quality engineers, and other medtech professionals involved in packaging development for sterile medical devices rely on a number of whole-package test methods. A few years ago our sister publication Pharmaceutical & Medical Packaging News, now a channel of Packaging Digest, put together an overview of then-available package integrity test methods--and it is now time for an update, with your help.

To help PMP News better understand the current state of the art, we invite you, the users of these methods, to complete a short survey on package integrity test methods. We’d like to know what the most popular test methods are, what challenges you are facing, and how you might be addressing those challenges.

The survey is anonymous, and results and anonymous comments will be shared in an upcoming article. Survey results and other details will be shared in an upcoming presentation at EastPack/MD&M East in New York City on June 12. This presentation will offer a comprehensive overview of available package integrity test methods, detailing their operation, sensitivity, and alignment with industry and FDA consensus standards.

Please help by clicking here.

And be sure to join us at at EastPack/MD&M East in New York City on June 12-14. In addition to hearing the results of this survey, you'll have the opportunity for 3 days of free education on packaging, medical device issues, and smart manufacturing at three on-floor theaters.


We have received the following comment from Tim Galekop, Director / Owner of TIGAMED:

"I read the Qmed MD+Di Daily Europe from 18-4-2018 and was particularly interested in the topic 'How are you testing the integrity of your sterile medical packaging?'

Personally, I find that the title already has a mistake, having been under others for more than 25 years the convener of CEN TC 102 WG 4 Packaging for terminally sterilized medical Devices ( EN 868 Series 2 - 10) and expert in ISO TC 198 WG 7 Packaging for terminally sterilized medical devices ISO 11607-1 / ISO 11607-2 and TS ISO 16775 — Guidance on the application of ISO 11607 part1 and 2.

Today, we do not want to talk any longer about medical packaging and have changed the following definitions in ISO 11607:

  • Sterile Barrier Systems: The minimum packaging configuration that maintains sterility of the package contents until aseptic presentation at the point of use.
  • Protective Packaging: The packaging configuration designed to prevent damage to the sterile barrier system and its contents from the time of their assembly until the point
  • of use.
  • Packaging System: The combination of the Sterile Barrier System and the protective packaging.

So according to me, your topic should have been called, 'How are you testing the integrity of your Sterile Barrier System or Packaging System?'

Also, you published two pictures with the article that are not the way to do it. One with a kidney tray in a peal pouch, which will never become sterile and which is not in line for patient safety.

Another picture [on Packaging Digest] shows a self-seal pouch, which is discouraged to be used due to sterility problems (even mentioned in ISO 16775). Why are they closing the pouch with sterile gloves?

For Qmed MD+DI Daily Europe, it is imperative that the information is correct and professional."

Our response:

We sincerely thank Mr. Galekop for his response. We use “medical packaging” as a general term, but moving forward for our overview article we would very much like to be precise and in-line with ISO 11607. We have also removed the images in question.

Daphne Allen

Daphne Allen is editor-in-chief of MD+DI. She previously served as executive editor of Pharmaceutical & Medical Packaging News, which serves as the pharmaceutical and medical device channel of Packaging Digest. Daphne has covered medical device manufacturing, packaging, labeling, and regulatory issues as well as pharmaceutical packaging and labeling for more than 20 years. She is also a member of the Institute of Packaging Professionals's Medical Device Packaging Technical Committee. Follow her on Twitter at @daphneallen.


Shutterstock/Vereshchagin Dmitry
Filed Under
500 characters remaining