ASTM F2096 and its Practical Uses


Pharmaceutical Packaging

Leak testing can be performed to a variety of ASTM testing standards. When determining your leak testing procedures, it is important to understand different testing standards and determine which is most suitable for your product. ASTM F2096, Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) is a practical way to examine packages for gross leaks, which may render a product non-sterile. For more information on ASTM F2096 and its uses, continue reading. 

What is ASTM F2096

ASTM F2096 is most commonly used to evaluate the integrity of packages that have been designed to provide a sterile environment. The test is performed by submerging a package in water and observing for a steady stream of bubbles. During the test, internal pressure is increased until the package shows a constant stream of bubbles, indicating a specific defect or area of failure. If bubbles are present, this indicates a breach in the sterile barrier. 

As ASTM F2096 requires entry into the package to supply an internal air pressure, it is a destructive test. More sensitive than other bubble tests, ASTM F2096 can detect a breach in the sterile barrier down to 250 μm (0.010 in.), with 81% probability. The sensitivity of the test has not been evaluated for use with porous materials other than spun-bonded polyolefin or with nonporous packaging. 

ASTM F2096 Procedure

To conduct the ASTM F2096 testing standard, the package must first be submerged in water and inflated to increase its internal pressure. As the internal pressure is increased, the package should be observed. When a steady stream of air bubbles is present, this indicates a failure area. Test results should be recorded and repeated consistently to determine whether the packaging is reaching quality targets, and an internal pressurization target, or failure point, should be set, in order to maintain consistent package testing and track deterioration.

ASTM F2096 provides increased sensitivity, to 250 μm. The sensitivity of the test is dependent upon two factors: differential pressure, which can be increased or decreased, and the method of pressurization. To avoid discrepancies, it is important to establish a target test pressure allowing you to conduct repeatable testing. Establishing a testing standard can be done by setting a minimum acceptable performance, testing to failure point, and conducting repeatable testing. Appropriate internal pressure levels can also be determined by introducing a control defect in a known location, and observing at what point it is visually apparent.

ASTM F2096 Uses 

Due to its increased sensitivity, ASTM F2096 can be used to assess the integrity of sterile package materials, and therefore is often used to test medical and pharmaceutical products. Package integrity is extremely important for medical device and pharmaceutical packaging, as the product must be kept in a sterile environment. Not only could air permeation affect sterility, in some cases it could in fact cause the product itself to degrade, rendering it unfit for consumer use. 

The FlexPak Solution

If you would like to add ASTM F2096 to your leak testing regimen, FlexPak has the perfect solution for you. The FlexPak Internal Pressurization Assembly (FPIPA) can be combined with any standard FlexPak Leak Detector and used to perform ASTM F2096 to detect leaks, substrate holes, and channels, providing accurate and repeatable results. Due to its flexible testing capabilities, the FPIPA is useful in laboratory environments where there is no common package size or material across products. It can be used for heat-sealed, abnormally shaped, tray, and pouch packages. 

The FPIPA can detect micro leaks that would be undetectable by a standard Bubble Leak Test, due to ASTM F2096’s high sensitivity levels. FlexPak Leak Detectors’ transparent acrylic water chamber allows for further ease of use, giving the operator a 360 degree viewing of the package as the testing is underway. This eliminates the need for manual operator rotation of the package as clear sightlines are present at all angles. The FPIPA provides medical and pharmaceutical manufacturers with accurate and straightforward seal integrity testing, ensuring packaging remains sterile across its full lifespan. 

The ASTM F2096 testing standard can provide your leak testing procedures with additional sensitivity and accuracy. Whether you are testing sterile medical devices, or simply need to accommodate a large or unique product, ASTM F2096 and FlexPak’s Internal Pressurization Assembly (FPIPA) provides a solution. For more information on ASTM 2096 and the FPIPA, or other leak testing solutions, contact FlexPak at 1-416-399-5583. The most reliable solution for your leak testing needs, FlexPak can provide you with leak testing capabilities for your unique applications. 

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