FAQ Guide to medical burst testing
The Industrial Physics FAQ guide to medical burst testing
Patient safety should be the priority for anyone who makes medical devices and the packaging systems that protect them. The burst test is an essential way to make sure that manufacturers can stick to this guiding principle.
Whether you make IV catheters, blood bags, or medical device packages, your products must be able to withstand certain pressure requirements – either while being used for purpose in a healthcare setting, or while traveling through the stages of the supply chain to get there.
So, what is burst testing and how can it help you to keep patients safe while protecting your reputation? Industrial Physics is a designer and manufacturer of the best burst testing equipment available. In this handy guide we delve into some burst test basics and explore some frequently asked questions.
FAQ1: What is a burst test?
Burst testing is a key component of a healthy test and inspection process for medical products and packaging.
In basic terms, the burst test involves pressurizing your product with air until it bursts. It highlights the weakest seal of your medical product or package. And it tells you the burst pressure needed to compromise – or burst – that seal.
What type of medical products can be put through a burst test? The list includes blood bags, catheters, medical balloons, medical device pouches and packages, medical device trays and foil pouches.
The resulting burst pressure reading gives insight into how medical products that are designed to contain air or liquid – like IV catheters or medical balloons – perform under pressure.
FAQ2: Why is burst testing important?
When medical products and packages will be subject to pressure during their lifetimes, burst testing is not just important. It’s essential.
Burst testing is needed for quality assurance. It shows manufacturers exactly how much pressure their products and packages can withstand. Burst testing gives suppliers the confidence that their packaging systems will maintain a sterile barrier through typical supply chain challenges. Without the information derived from a burst test, their goods are worth little in a healthcare setting.
The use of reliable burst testing equipment will support healthy safety design margins. It gives healthcare customers the complete confidence they need in their suppliers, when lives are at stake.
FAQ3: What is rated burst pressure (RBP)
When you manufacture certain medical devices – such as medical balloons or catheters – you must know how much pressure they can withstand before bursting. It’s also a figure you need to present to meet international and industry-specific medical standards.
Which is where the burst limit test and rated burst pressure (RBP) comes in handy!
For example, balloon rated burst pressure testing is the pressure at which 99.9% of balloons can survive. The pressure at which a manufacturer can say – with 95% confidence – that these balloons will not burst in conditions equal to, or below, this figure.
If the balloons you manufacture fail to maintain integrity at the RBP you have marketed, this could result in device failure or vessel damage. Which could compromise patient safety, lead to product recalls and financial damage, while harming your reputation.
FAQ4: How is medical burst testing regulated?
It stands to reason that the manufacture of medical devices and packaging systems are heavily regulated, all over the world.
When companies undertake burst testing they must adhere to stringent industry regulations and work to international testing standards.
A number of integrity inspections – including the burst test – gives the buyer confidence that the products they have ordered will arrive in first-rate condition.
International regulations and burst pressure
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.’
Medical burst testing in the European Union is regulated by the 2017 Medical Device Regulation (MDR).
The wide ranging rules of both the FDA and the MDT explain how companies should operate in order to eradicate as much patient risk from pathogens and contaminants as possible.
They also set the expectations on the supplier to make sure the medical device remains sterile during transport and storage. So that when it arrives – the end user can have total confidence that it is safe to use.
FAQ5: What is the best burst testing equipment?
Industrial Physics makes the best burst pressure test equipment in the business. Check out two of our most popular burst testing machines. They are loved by our customers across the healthcare sector.
BT Integra-Pack burst test machine
Our intelligent package burst test system is a bench-top, high-resolution (0.001 psig) test instrument. It has a conveniently small footprint and it’s easy to use.
The electronic pressure and flow controls provide precise and repeatable burst test conditions, while its automatic, high-flow output allows testing of large porous packages. It’s ideal for burst testing a range of flexible or rigid, porous and non-porous, open or sealed packages.
13-56 Burst Tester
This digital mullen-style burst tester from TMI uses advanced technology making
burst testing of your medical devices and packaging both easy and accurate.
The 13-56 allows you to measure the burst pressure strength of sheet materials by testing for real life failures such as punctures and rupture. The burst test function uses hydraulic pressure to deliver multi-directional stress to your sample to failure.
Burst testing expert help
We hope our FAQ guide has broadened your burst testing knowledge. But we’re bursting to answer any less frequently asked questions you may have! So get in touch today!