ASTM F2095 Leak Testing for Flexible Packages
ASTM F2095 leak testing helps determine the effectiveness of flexible medical packages or pouches. As an ISTA and ISO 17025 certified lab, we realize the importance of ASTM F2095 leak testing. Meeting the ASTM D2095 flexible package requirements can be difficult. We understand the challenges and guide companies through the process.
Keystone has a reputation of helping customers achieve their package certifications. We provide comprehensive reports shortly after completion of the testing. Keystone also partners with customers to achieve package compliance. We provide the peace of mind that all of your needs will be met.
Summary of Flexible Packages With and Without Restraining Plates
This ASTM F2095 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.
F2095 pouch leak validation testing detects leak rates in flexible packages. However, the leak rate is dependent on package volume as tested. Two test methods are explained below. The pouch gross leak methods are destructive in that they require entry into the package.
ASTM package integrity testing conditions are 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 Leak Testing
ASTM F2095 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 compliance standard requires the package to be at a stable volume configuration.
ASTM F2095 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 Leak Compliance Testing
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 ASTM F2095 flexible leak compliance report includes general information such as date, time, location, and test engineer. Other details of the include, but is not limited to:
- Method used
- Package type, size, materials, and lot numbers
- Whether the package was tested empty or filled with product
- The apparatus used and settings for test pressure
- Conditioning parameters and environmental conditions at the time of the test
Expert Pressure Decay Leak Package Laboratory Testing
In addition to ASTM F2095 testing, Keystone has a full scope of expertise including accelerated aging, high impact shock, and temperature validation. Our team strives to give our customers more time and energy on product development instead of testing. Keystone has a full lab of test equipment which permits us to provide short lead times on scheduling.
Contact us to learn first hand why so many companies partner with Keystone to achieve their ASTM F2095 leak package sustainability and certification needs.