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Burst testing medical packages – the regulations

Everything you need to know about burst testing medical packaging

All manufacturers want their products to arrive with their customers in good condition, but it’s especially true for manufacturers of medical products and devices. The users and makers of medical packaging need to be able to rely on its strength, integrity and ability to keep its contents protected and sterile. That’s where burst testing comes in.  

Burst testing explained

A burst test involves applying increasing air pressure within your package until it bursts. It highlights the weakest seal of your medical package and tells you the burst pressure needed to compromise – or burst – that seal. 

It is an accurate yet simple way of simulating real world supply chain challenges. It allows you to determine whether your medical package will withstand the trials presented through sterilization, shipping, and storage. A burst strength tester is particularly helpful in demonstrating how the package will react at differing regional elevations, or even extreme altitudes, which is particularly useful for products that will be air shipped.  

Medical packaging and burst testing regulations

Medical packaging burst testing is an important job and as such, it’s subject to a variety of recognised standards and regulations. Depending on where you make and sell your products and medical packaging, the industry regulations you’ll be required to conform to will vary. For example:  

American medical packaging regulations 

In the United States medical burst pressure testing is regulated by the Food and Drug Administration (FDA). To be more precise – under Title 21 of the CFR, which offers guidelines for ‘safely manufacturing, packing, storing, and installation of medical devices.’ 

The burst test limit inspection requirements fall under part 820 on labelling and packaging control. This section calls upon the manufacturer to prove the safety and integrity of the packaging system. The burst limit test should form part of a comprehensive inspection process. This must include tests to verify the sterile barrier system. As well as tests that simulate real time – or accelerated – shelf life testing. One of the key statements to consider is: 

“Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution” (21CFR820.130). 

European medical packaging regulations

Medical burst testing in the European Union is regulated by the 2017 Medical Device Regulation (MDR). 

Within the guidance medical packaging manufacturers will find approaches to minimize patient risk from contaminants, pathogens, and residues. Like the FDA requirements, the MDR details burst testing specifics and describes how to keep medical devices sterile and undamaged during transport and storage. So that product integrity is maintained when it arrives in the hands of the end user. 

Burst testing medical packaging: everything you need 

At Industrial Physics, we understand the importance of testing the burst strength of your medical packaging and ensuring that all burst testing is in line with local regulations. If you have questions about medical device burst testing or any aspect of the FDA and MDR testing stipulations, then contact Industrial Physics today.