ASTM F2095 Leak Testing for Flexible Packages

ASTM F2095 leak testing helps determine the effectiveness of flexible medical packages. As an ISTA and ISO 17025 certified lab, we realize the importance of flexible package testing. Meeting the ASTM F2095 requirements can be difficult. We understand the challenges and guide companies through the process.

Keystone provides the peace of mind that all of your needs will be met. We have a reputation of helping customers achieve their package certifications. Keystone Package Testing creates an accurate test plan to eliminate expensive over-testing. We 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 Packages With and Without Restraining Plates Information

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

These F2095 test methods detect leak rates in flexible packages. However, the leak rate is dependent on package volume as tested. Two test methods are explained below. It should be noted that the methods are destructive in that they require entry into the package.

Conditions should be used to obtain the same temperatures that exist on the test apparatus. Samples are made to allow the operator to refer to the specific test samples, while recording test information and results.

Scope of ASTM 2095 Flexible Package Testing

Test Method A, pressure decay leak test allows the packages to be tested without restraint. Within test method A, the pouch, tray or other type package will contain a volume of air. This is  defined by its mechanical configuration and its ability to resist internal pressure applied. The ASTM F2095 test method requires the package to be at a stable volume configuration.

On the other hand, Method B allows the use of rigid restraining plates against the walls of the package. This helps limit the volume while stabilizing the package volume. The test 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.

Significance of ASTM F2095 Pressure Decay Testing

Observed changes in pressure indicate leakage paths in the package seals or pinholes in the surfaces. This leak may be found and displayed in decay pressure units or calculated leak rate units.

The use of calibrated hole sizes or orifices may be appropriate to determine leakage sensitivity or barrier integrity for these materials. Though theoretical leak rate sensitivity can be established, the measuring instruments and pressure units must be calibrated, certified and verified.

The report includes general information such as date, time, location, and test engineer. Details of the package include the type of material and other characteristics. The number of packages tested and the number of failures are recorded, as well as 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, conditioning parameters and environmental conditions at the time of the test.

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 accommodate flexible and rigid packages of all sizes, including large pallets. Keystone has a full lab of test equipment which permits us to provide short lead times on scheduling.

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