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September 7, 2022

Dispelling Myths About Packaging for Medical Devices

By: admin/Medical Packaging

Medical device packaging is not an easy task. Since the creation of the international standard ISO 11607 in 2006, in particular, qualitative packaging has been prioritized. However, most manufacturers still need to learn how to package medical devices properly. The following blog highlights some common myths regarding medical device packaging.

1 – One Size Fits Every Product

One type of medical packaging does not work for all sorts of medical devices. According to ISO 11607, medical device packaging should consist of two key aspects. One is the sterile barrier system that minimizes the item’s exposure to external pollutants; another is an additional layer of packaging that protects the sterile barrier system. However, most of the packaging for medical devices is inadequate.

Many packages reach customers with defects like holes. This can be extremely harmful to the quality of the device. It’s important to remember that every device is unique in terms of its design as well as its functional use. The packaging manufacturers should ensure that they are designing the packaging according to the device.

2 – Packaging Needs to be Validated Only Once

ISO 11607 for medical packaging strictly outlines that all the materials in the devices should be regularly tested for their sterile barrier systems and packaging systems as part of the validation process. However, many companies make the mistake of only testing the packaging once, even though it is recommended to recheck the packaging across the product life cycle.

3 – Medical Device Packaging Is Not Very Complicated

Another very common misconception of various manufacturers is that medical device packaging is not a highly complex process. Companies treat the process similar to that of normal items. However, they don’t realize that even packaging validation testing is a very complicated process. For instance, the validation testing procedure involves a test of integrity to prevent the growth of the microorganisms, validation of the microbial barrier, and identifying the strength required to open the package.

For each category, there are multiple tests that a manufacturer can do. For instance, integrity tests can be done through migration or dye immersion processes. Microbial barrier tests, on the other hand, can be completed through microbial ranking.

Accordingly, it is pretty apparent that medical device packaging is not as easy as it may seem, and a lot is involved in ensuring that the medical device is packaged safely and securely.


Manufacturers are required to follow strict standards when it comes to packaging medical devices. To get the best healthcare shipping solutions in the region, contact Coleman Containers Limited today. Coleman Containers can help with medical device packaging with high-quality and cost-effective solutions.

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