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What is Flexible Package Integrity Testing?

A flexible package is defined as a package consisting of non-rigid materials. Generally, these packages are made up of paper, foil, or plastics, to create malleable pouches or bags. Flexible packaging is also known as a peel pouch.

Flexible package integrity testing evaluates flexible packaging materials during simulated environmental hazards. This test type is not limited to one standard; it is recommended that flexible peel pouches be subjected to multiple test methods that can be found and explained below, in the Equipment and capabilities section of this page.

Flexible package compliance testing also helps discover harmful contaminants that may enter the flexible package through leaks. These leaks are frequently found at seals between package components of the same or dissimilar materials. 

As an ISTA and ISO 17025 certified lab, Keystone Compliance realizes the importance of flexible package integrity testing. Meeting the flexible peel pouch 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. Our accurate test reports are delivered quickly.

Contact us to receive more information about regulatory peel pouch compliance testing.

Why is Flexible Compliance Testing Important?

Flexible package compliance testing is used to evaluate a flexible package in terms of different testing procedures. More specifically, this test type utilizes the testing of bubble emission, seal strength, burst strength, etc. to assess the integrity and sterilization of a flexible packaging system.

Peel pouches provide great benefits to industries such as the Food & Beverage, Personal Care, Medical Device, and Pharmaceutical industries. Flexible packaging used within these industries may include single-use medications, resealable candy bags, and household cleaning products. The benefits of using flexible packaging include:

  • Lower material and packaging costs
  • Customization of package design
  • User-friendly packaging
  • Light-weight packaging for easy transport
  • Extended shelf life

On the other hand, a poorly packaged product can be expensive and lead to a decline in sales, lost customer loyalty, and constant interruptions and delays.  

When dealing with pharmaceutical and medical devices, flexible pouches must remain sterile throughout the entire transportation cycle. If a packaged product unintentionally bursts or opens, the contents within the package can be subjected to damages and product loss. 

No matter the hazard, packaging costs can be substantially reduced or eliminated with the proper testing and certification.

Keystone’s Flexible Package Testing Equipment and Capabilities

Keystone utilizes numerous pressure delivery systems, vacuum chambers, and open/closed package test fixtures to provide expert package integrity testing. Our dozens of thermal chambers range from small reach-in to large walk-in chambers up to 1,300 cu. Ft. that can accommodate equipment such as large vehicles and machinery.

Keystone Compliance also owns multiple shakers and dynamic shock machines to provide the peace of mind that all your package integrity needs are met under one roof.

Below are two flexible package test standards that we most commonly perform.

ASTM F1929 Detecting Leaks in Medical Packaging

ASTM F1929 evaluates materials and procedures that detect and locate leak channels greater than 50 microns. These channels are formed between a transparent material and a porous sheet material. Lastly, ASTM F1929 is not quantitative, meaning no indication of leak size can be inferred from these tests. Generally, these tests are used on a pass or fail basis.

ASTM F1929 can be performed with two different approaches. Method A is the injection method. This is carried out by injecting a dye penetrant into the package to cover the longest edge. Method B is the edge drip method. A container is selected whose length is long enough to accommodate the longest sealed edge. Then, dye is poured into the container to cover the bottom surface.

ASTM F2096 Detecting Gross Leaks by Internal Pressurization (Bubble Test)

ASTM F2096 detects gross leaks in packaging down to 250 microns with an 81% probability. This standard is used for tray and pouch packages. However, the sensitivity of this test does not include porous materials other than spun-bonded polyolefin or with nonporous packaging.

To perform this test, the package is inflated underwater to a predetermined pressure. The packaging is then observed for a steady stream of air bubbles indicating a failure area.

For more information on flexible package compliance testing, please refer to the following standards.

ASTM D3078 Leaks in Flexible Packaging by Bubble Emission

This standard evaluates gross leaks of flexible packaging containing a headspace gas. Small leaks may not be detected by this procedure.

ASTM F88 Seal Strength Testing of Flexible Barrier Materials

ASTM F88 covers the measurement of the strength of seals in flexible barrier material. ASTM F88 can also be tested between a flexible material and rigid material.

ASTM F1886 Integrity of Seals for Flexible Packaging

ASTM F1886 evaluates channels in the package seal down to a width of 75 microns with a 60-100% probability.

ASTM F2054 Burst Testing of Flexible Seals Using Internal Air Pressurization

This standard determines the procedures for the minimum burst strength of a seal placed around the perimeter of a flexible package as it is internally pressurized and enclosed within restraining plates.

ASTM F2095 Leak Testing for Flexible Packages

ASTM F2095 measures leaks in nonporous film, foil, or laminate flexible pouches and foil-sealed trays. The standard is broken down into two methods, with or without restraining plates.

Don’t see a standard you are looking for? Contact us and we will determine the best course of action.

Expert Regulatory Package Compliance Test Laboratory

Keystone has a full lab of test equipment which permits us to provide short lead times on scheduling. In addition to flexible package integrity testing, Keystone Compliance has a full scope of expertise including bubble leak, compression, and vibration. Our team strives to give our customers more time and energy on product development instead of testing. 

Contact us to learn why so many companies partner with Keystone to achieve their package compliance and certification needs. Request a quote and find out first hand about our competitive pricing, timely process, and outstanding reputation.