Vital signs of a sterile test and inspection operation - Industrial Physics Vital signs of a sterile test and inspection operation - Industrial Physics

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Vital signs of a sterile test and inspection operation

Vital signs of a sterile test and inspection operation

Manufacturers of medical packaging play a key role in patient safety.

Both the medical device and the packaging that protects it must remain sterile – from manufacturer to user. It’s vital that leak testing methods and a comprehensive process of integrity checks are performed. If they aren’t, it’s possible a patient could be exposed to dangerous pathogenic organisms, bacteria, fungal spores, and disease.

Healthcare packaging providers must decontaminate their products using a range of sophisticated sterilization techniques. Then ensure this is maintained throughout the supply chain, so that medical devices arrive safely into the hands of medical professionals.

An effective test and inspection process – with leak testing and preparation for real world conditions and challenges – is key to success. Medical professionals need assurance that the products they buy are protected from moisture or contamination. And that any knocks, drops, or abrasion incurred while in storage or transit won’t hamper seal integrity.

But it’s not easy to find a sterile leak test solution and ensure the integrity of medical devices. In fact, it’s one of the main challenges facing the healthcare industry.

Quality standards equals quality healthcare products

Fortunately, there are international quality standards that define proper leak testing and additional checks. Laying out clearly what is expected and how it can be achieved.

Take ISO (the International Organization for Standardization) 11607-2, for example. It introduced the concept of the ‘sterile barrier system.’ This describes the minimum functionality that a medical package must offer in order to guarantee sterilization and provide an acceptable microbial barrier. It covers leak testing and lays out the rules for achieving ‘aseptic presentation’ – the process of transferring sterile contents from a package to a sterile field.

Once you combine the sterile barrier system with the right design of ‘protective packaging,’ you create a fit-for-purpose medical device. Which can then be sent out with confidence.

Companies need to provide a sterile barrier system. It’s actually considered an accessory and component of a medical device. So much so that preformed sterile barrier systems – including pouches, header bags, or hospital packaging reels – are themselves sold as medical devices in many countries.

ISO 11607 package integrity and validation testing

So how do you go about leak testing and deliver additional checks and balances to ensure your medical device packaging meets stringent ISO 11607 standards?

A healthy test and inspection process depends on the type of device and packaging you make. Here are three of the most common types of tests, all of which Industrial Physics supports.

Package integrity and seal strength inspection

Make sure the packaging you make or buy in is sturdy enough to offer the sterile barrier protection you need to satisfy the ISO regulators.

Our quality leak testing machines deliver medical packaging and medical device burst and leak testing or pressure decay leak testing. Call on us for all your blister leak test apparatus or help with a bubble leak test..

The importance of seal strength is paramount. And our pouch leak testers and vacuum seal leak testing machines are just what the doctor ordered!

Shelf life studies, leak testing, and accelerated aging

With the best intentions and fastest distribution connections in the world, there’s always a delay in getting your products to the end user. Whether in transit, sitting in storage or waiting at a hospital to be used, your products and packaging will deteriorate with age.

As well as the best in leak testing equipment we can support your accelerated aging studies, packaging shelf life studies that will help you to understand the integrity of your sterile barrier system over time and prepare solutions for unforeseen challenges. For example, we make highly accurate machines for both water vapor permeation testing and gas permeation tests.

Distribution testing

The challenges of the supply chain will test the strength and integrity of your medical packaging. If your products are damaged on the road or during shipping, then this can result in sterile integrity breaches.

As well as leak testing of medical devices and packaging to ensure sterility, we can help you to simulate every knock, bump, squash, or scratch that your packages may encounter to get a true picture of how well your products will stand the test of time.

Check our industry-leading range of burst testing, deformation testing or coefficient of friction (CoF) testing devices. Or take a look at our cyclic corrosion test chambers – designed to deliver the precise environmental test conditions demanded by modern industry.

For life-saving medical leak testing and all aspects of package integrity support…get in touch today!

Contact us – Industrial Physics