ASTM F2095 Leak Testing for Flexible Packages

ASTM F2095 leak testing determines how well flexible medical packages perform. As an ISTA and ISO 17025 certified lab, Keystone Package Testing knows the importance of flexible integrity package testing. Meeting the ASTM F2095 compliance requirements can be difficult. We understand the challenges and guide companies through the process.

As a result, Keystone provides the peace of mind that we will meet all of your needs. We have a reputation for helping customers achieve their package certifications. Keystone Package Testing creates an accurate test plan to eliminate expensive over-testing. Our experienced engineers are in constant communication throughout the test process.

Request a quote to see why so many companies partner with Keystone Package Testing. Contact us to receive more information on leak testing.

Summary of Flexible Package Integrity Testing With and Without Restraining Plates

ASTM F2095 standard testing covers the measurement of leaks in nonporous film, foil, or laminate flexible pouches. The enclosed material must not come into contact with water, oils, or other liquids.

F2095 flexible package integrity testing detects leak rates in flexible packages. However, the measured leak rate depends on the tested package volume. The ASTM F2095 standard explains two test methods below. It is important to note that both methods are destructive because they require entry into the package.

The laboratory uses conditions that match the temperatures present on the test apparatus. The laboratory prepares samples so the operator can refer to specific test samples while recording test information and results.

What types of packaging are tested using ASTM F2095?

ASTM F2095 deals with sealed packaging that contains a detectable headspace gas. It’s most commonly applied to:

Flexible packaging:

• Pouches
• Bags
• Sachets
• Blister packages with headspace

Semi-rigid packaging:

• Thermoformed trays with lids
• Trays sealed with flexible films

Medical device packaging:

• Sterile barrier systems (when headspace gas is present)
• Pharmaceutical and diagnostic packaging
• Food and modified-atmosphere packaging (MAP)

Key requirement:

The package must contain a known headspace gas (commonly oxygen or carbon dioxide). Solid-filled or vacuum-only packages without measurable headspace gas are not suitable for ASTM F2095.

Is ASTM F2095 destructive or non-destructive?

Industry professionals consider ASTM F2095 a destructive test method. The procedure measures the concentration of gases present in the package headspace by opening, puncturing, or otherwise damaging the package. Manufacturers typically do not release tested samples for commercial distribution and instead retain them for documentation, investigation, or validation records.

Is ASTM F2095 required by the FDA?

The FDA does not specifically require ASTM F2095. Also, the FDA does not mandate the use of any single ASTM test method for package integrity or leak detection. Instead, it requires manufacturers to demonstrate, through scientifically valid evidence, that their packaging systems maintain integrity and, where applicable, sterility throughout the product’s shelf life.

Industry regulators and manufacturers widely recognize ASTM F2095 as an effective method for meeting these expectations when it suits the package design and product type. Lastly, when manufacturers properly validate and justify its use, ASTM F2095 can support FDA submissions, package validation activities, and ongoing quality assurance programs.

Testing Procedures for ASTM 2095 Flexible Packaging

Sampling and Conditioning

First, technicians cut the samples to specified dimensions in accordance with the ASTM standard. Generally, the ASTM standard requires a minimum of five samples. Next, technicians condition the samples in a controlled environment.

Testing

Test Method A, the pressure decay leak test, allows operators to test packages without restraint.

Within Test Method A, the pouch, tray, or other package types contain a defined volume of air. The package’s mechanical design defines its ability to resist the applied internal pressure. The ASTM F2095 test method requires the package to be at a stable volume configuration.

On the other hand, Method B uses rigid restraining plates against the package walls.

The restraining plates help limit the volume while stabilizing the package volume. ASTM F2095 method B provides a standard to establish reports to find failures within the lab rather than within the field. It is used to detect small leaks rapidly in flexible seals or walls.

Report

The laboratory provides a report at the end of testing that includes general information such as date, time, location, and test engineer. Lastly, the test engineer records the number of packages tested, the number of failures, and any conditioning.

Specific information from this report consists of the package type, size, and materials. In addition, the report should include whether the package was tested empty or filled with product.

Significance of ASTM F2095 Pressure Decay Testing

The ASTM F2095 standard is important because it enables manufacturers to ensure the quality, performance, and safety of flexible barrier materials. By conducting standardized tests, packaging companies can meet regulatory requirements and evaluate material performance. This process also supports research and development and helps deliver reliable packaging solutions to consumers.

Performance Evaluation

Flexible packages are subjected to various stresses during transportation, storage, and handling. ASTM F2095 testing allows manufacturers and users to evaluate the performance of different materials under specific loading conditions.

Compliance to Industry Standards

Oftentimes, when flexible packaging is used for products such as food or pharmaceuticals, these packages must meet regulatory requirements. ASTM F2095 provides standardized testing to evaluate the properties of flexible packaging.

Consumer Safety and Satisfaction

Flexible packages are often in direct contact with consumer products, making it important to maintain the product’s quality and safety. ASTM F2095 testing helps identify potential weaknesses or flaws in flexible materials, allowing manufacturers to fix them before they reach the market.

This in turn, ensures that consumers receive products packaged with materials that were rigorously tested for their ability to withstand stresses.

Expert Pressure Decay Leak Package Testing

Keystone has a full scope of expertise including sterile barrier, temperature validation, and vibration in addition to flexible package testing. We can test flexible and rigid packages of all sizes, including large pallets. Lastly, Keystone operates a fully equipped lab that allows us to provide short scheduling lead times.

Ready to get your packaged product tested and analyzed? Request a quote and learn first hand why so many companies partner with Keystone to achieve their flexible package certifications.

Related ASTM and ISO Standards

• D4332 Practice for Conditioning Containers, Packages, or Packaging Components for Testing
• E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
• E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
• F17 Terminology Relating to Primary Barrier Packaging
• ANSI/AAMI/ISO 11607–1:2006 Packaging for Terminally Sterilized Medical Devices—Part 1: Requirements for Materials, Sterile Barrier Systems, and Packaging Systems

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