The environment of the medical device industry is fast-paced. It continuously shows the challenges faced in the industry and how best to adapt. One such challenge is the revision of the requirements of packaging medical devices. Packaging of a medical device or in the pharmaceutical industry is subject to special requirements, and just as well, the strictest of standards. That’s because product validation is important. So, look at the various standards put in place to ensure proper medical device sterile packaging. But first, understand how the packaging process of medical devices works.
What happens during medical device packaging?
It all begins in the offices of packaging solution providers. Recommended packaging options such as large boxes, films, foils, and sheets are essential in creating safe packaging for medical devices.
• The planning process.
The client comes in with the design or concept of the medical device. Then, sketches can be made to initiate the design concept around the product itself. That way, the client can see the development of their packaging idea and develop it.
• The development process.
Some healthcare packaging companies offer to validate the packaging themselves, thus saving their customers time and money. In addition, they can test the products during their development period.
So, the packages are put in a validation laboratory. There, the packaging solution company can simulate transport. That way, at a very early phase, the developmental phase, they can observe the behaviour of the packaging. Then, in the end, notes can be made about tweaking some things, or the packaging can be certified to have passed validation.
The packaging is put through various tough tests. These environmental stresses include going through pressure chambers and checking the durability of materials and the ageing of packages. Also, closures are exhaustively tested as well as submerged in water. That is done to check the strength of the seals at the edges. So yes, the packaging doesn’t go into production unless it passes all those tests with no damage.
The production process. Once the client checks out factors like design, costs, recycling, and such, the packaging can now go into production. They are labelled individually, sterilized, packed, and the completed packaging solutions are ready for delivery and storage.
Regulatory agencies and Standard Organizations and their medical device packaging standards
There are plenty of standard organizations as well as medical regulatory agencies available. They come together to put in place the accepted medical standards for medical devices. The list is quite big, but here are a few mentions:
1. International Organization for Standardization (IS0)
• ISO 10993- Biological evaluation standard.
• ISO 11607- Packaging standard.
• ISO 13485- Quality management standard.
• ISO 14971- Risk management standard.

2. International Electrotechnical Commission (IEC)
• IEC 60601- Medical electrical equipment standard.
• IEC 62304- Medical device software standard.
• IEC 62366- Usability standard.
3. American Society for Testing and Materials (ASTM), and many more.
• ASTM 2097- Design and evaluation of packaging standard.
• ASTM F2475-11- Biocompatibility of evaluation standard.
• ASTM F2914-12- Shelf-life test standard.
• ASTM F1089-18- Test method for corrosion of surgical equipment standard.
4. Food and Drug Administration (FDA). They deal with medical device labelling, installing, storing, and servicing.
5. Clinical Laboratory Improvement Amendments (CLIA).
6. Joint Commission on Accreditation of Healthcare Organizations (JCAHO).
A medical device is a device intended for the treatment, prevention, and diagnosis of disease. There are nearly a thousand medical devices out there; that’s why the level of regulatory control constantly increases. But, unfortunately, without these medical device packaging standards, the effectiveness and safety of these medical devices cannot be evaluated and could be rendered useless.