Burst testing medical packages - the regulations - Industrial Physics Burst testing medical packages - the regulations - Industrial Physics

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Burst testing medical packages – the regulations

Burst testing medical packages – the regulations

Any manufacturer wants their product, of any product, wants their wares to arrive in perfect condition at their customer’s premises.

This is a given, whether you make food items or consumer goods. But when you’re involved in manufacturing medical devices, or making the packaging they’re sent out in, it’s vital that the highest level of protection is offered.

Not only must the product arrive functional and without defects, but typically they will need to be sterile too. Which is why packaging inspections like the burst pressure test are so important.

So, what is a burst test?

Simply put, the 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.

For what purpose? Well, burst testing is an accurate but simple way of simulating real world supply chain challenges. To ensure that your medical package will withstand the trials presented through sterilization, shipping, and storage. . AA burst strength tester is particularly helpful in demonstrating how the package will react at differing regional elevations, or even extreme altitudes when sent by air.

Regulating medical burst testing

The medical packaging burst test is one of a sequence of vital inspections and there are associated industry-wide, national and international burst pressure test standards to follow.

Depending on where you make and sell your products, there are different standards to conform to. When you can show that you have met the relevant international burst pressure standard it gives your customers confidence. Confidence that when your goods arrive, they are sterile, and have been properly protected during transportation.

Burst…in the USA

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 labelinglabelling 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. Plus 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).

A European Union of burst testing

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.

If you have questions about medical device burst testing or any aspect of the FDA and MDR testing stipulations then contact Industrial Physics today.

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