Medical Packaging and the Pressure Decay Test - Industrial Physics Medical Packaging and the Pressure Decay Test - Industrial Physics

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Medical Packaging and the Pressure Decay Test

Medical Packaging and the Pressure Decay Test

The pressure decay test is a great way of demonstrating how effective your flexible medical packages and pouches are.

It will show you if there are any potential leak problems, allowing you to understand if they could jeopardize the sterile nature of the contents, risking the safety of patients when they reach a healthcare setting.

What is pressure decay testing?

Leak testing using the pressure decay method provides a physical measure of package integrity.

Decay describes the difference in pressure from a starting state of complete pressurization to the pressure at the end of a leak decay test cycle. The pressure decay leak test is a fast, accurate process.

You simply fill your package or product with air, remove the supply pressure and measure the pressure release. If the decay (loss) of the pressure is different to what you expect this indicates a leak.

ASTM F2095-07 and the pressure decay test

ASTM International F2095-07 is a pressure decay test standard used to measure leaks in nonporous film, foil, or laminate flexible packaging, pouches and foil-sealed trays.

Its test methods are used to detect leaks at a rate of 1 × 10−4 sccs (standard cubic centimeters per second) or greater. And the limitation of leak rate depends on the volume of the package under test.

The ASTM F2095-07 pressure decay approach can be used on empty packages – or those that contain a solid product. If there’s an item already contained, the package seals or surfaces must not come into contact with water, oils, or any other liquid due to their ability to mask leaks

Depending on the results you are seeking, ASTM allows you to test on either restrained or unrestrained packages. Some companies prefer to secure their medical package samples – this ensures proper loading on the seal areas leading to more consistent results.

But it’s your call! If you decide against restraints, then ASTM F2095-07 test method A is the method to follow. But if you’d prefer pressure decay results while your medical package is restrained, then opt for method B.

Whatever you decide both tests are destructive in nature. To carry out F2095-07 testing you will need to supply an internal pressure of a gas – such as air or nitrogen through our one of a kind package port system.

What does ASTM F2095-07 leak testing show?

If you note a loss of pressure after an ASTM F2095-07 testing then this suggests that there are leaks to the package seals, or even small holes in the surfaces. Pressure decay test equipment will find these leaks and typically present the problem in decay pressure, or calculated leak rate units.

At Industrial Physics we know a thing or two about testing packaging for medical devices. Over the last few decades, we’ve been designing and building pressure decay test equipment to help our customers to dispatch sterile and safe products.

For specialist advice in choosing, integrating, or implementing a new testing solution for your medical packaging and devices, get in touch.