Failure Modes

Each time you package a medical device for sale and delivery, your design – and its execution – get put to the test. Your products and procedures will be under the microscope, and failing these tests can seriously impact your business. Here are common test failure modes.

Seal Creep

Have you rightsized your package as well as selected the proper materials and sealant layer technology?
See an example of seal creep


Does your design allow ample room between the device and the end of the pouch to permit the chance of producing channels and wrinkling in the seal?
See an example of channels


Is your device too tightly packed? Are there any sharp edges that repeatedly push against the material during simulated or actual transportation?

Flex Cracking

Have you chosen a material with the malleability to stand up to the vibration cycle of simulated and actual distribution?
See an example of flex cracking


Often a result of undersized packaging, abrasion can lead to the formation of a pinhole. Does your package minimize material tenting to reduce abrasion?
See an example of abrasion

Device Damage

Device damage is one of the biggest risks that result from improperly-sized barrier systems and/or protective packaging. Is your package properly sized to ensure the product gets to market safely?
No matter what your healthcare packaging requirements or needs are, Oliver offers a wide variety of innovative and cost-effective solutions that provide high-value and superior performance to get you to market quickly.
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Oliver Stock Packaging Program

Whether you need pouches for testing and validation, are starting a new project, or simply require pouches to help cover inventory, we can help you meet your goals with our DuPont™ Tyvek® Pouches. Available in various sizes.

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Struggling to meet your compliance requirements?

Whether in our lab or in your facility, our healthcare packaging engineers tailor solutions that reduce costs, improve material performance, increase productivity, and can help troubleshoot packaging failures.
Learn how we can help you comply with ISO 11607.

Need help understanding testing methods?

Our industry standard test method videos demonstrate testing methods you can use to detect and avoid packaging failures.
View test method videos here.

What should your seal strength be?

Seal strength in medical device packaging is critical, and must stand up to the real world stress of sterilization, distribution and product load. For more than 40 years, industry professionals have been asking: What should my minimum value be, and how do I meet the 1.0 lb. seal strength standard?
Learn more about seal strength here.

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Frequently Asked Questions