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Bubble Leak Package Integrity Testing

As a leader in package testing, Keystone Compliance understands the importance of bubble leak testing. Our knowledge of packages has allowed us to create a streamlined approach to package validation. We walk customers through the process from test plan to test report.

The remainder of this page speaks to the various components and considerations that exist with bubble leak testing of packages. If you need bubble leak package testing, request a quote. If you are unsure of where to start, contact us. We look forward to working with you to help you certify your packages through our process.

The remainder of this document speaks to bubble leak testing, specifically to ASTM F2096.

The purpose of bubble leak testing is to detect gross leaks in packaging. ASTM F2096 is the standard test method for detecting gross leaks in packaging by internal pressurization. This is also called the bubble test. This packaging test is primarily used for pouch and packaging. This testing is destructive. It requires entry into the package to supply internal air pressure. ASTM-F-2096 has not been evaluated for use with porous materials other than spun-bonded polyolefin or with nonporous packaging.

Bubble Leak Testing Process

The test method of ASTM F2096 involves several steps. First, the package is inflated underwater. The inflation is to a predetermined pressure. The package is then observed. Failure is indicated by a steady stream of air bubbles. This indicates a failure area.

The sensitivity of this test is dependent on two primary factors. The differential pressure can be increased or decreased. The method of pressurization can also play a role. It is important to have repeatable results. Therefore, establishing a test pressure for each package is important. The size and material will play a factor.

Higher pressure increases sensitivity. Likewise, lower pressure reduces sensitivity. The use of a bleed-off control valve with a pressure monitoring device will aid in stabilizing the test pressure. This assists in reducing excessive pressurization.

Applying the Testing

Bubble leak testing to ASTM F2096 can be applied to many different packages. Large and long packages that do not fit other package integrity test methods can be tested to this standard. Bubble leak is also a good fit for packages with unique sizes and shapes.

ASTM F-2096 is ideal for medical packaging. Package integrity is important to medical device packaging. This is true since heat-sealed packages are designed to provide a contamination-free or sterile environment.

There are two bubble leak testing methods. Method A is for nonporous packaging. Test Method B is for porous packaging.

Test Equipment Required for Bubble Leak Testing

There are three primary pieces of equipment necessary to complete bubble leak testing. The first is a pressure delivery system. This system includes a pressure monitoring gage and bleed-off control valve. The system must be capable of delivering air at a pressure of 0-50 mbar.

The second piece of equipment is the needle. This package puncturing device allows the insertion of air from the pressure delivery system.

A water container is the last piece of equipment. The device being tested must be covered with at least one inch of water.

Bubble Leak Testing Report

Upon completion of testing, a report is issued. This report provides the following information. The date, operator’s name, and package type are included. Any identification numbers such as serial numbers are included. The defect size used to establish the test sensitivity is recorded. So is the test pressure and use of blocking agents, if any.

The total number of test packages is included. The number of packages that passed, the number of packages exhibiting leaks, and the location of each leak are included in the report. Lastly, the instrument used to create the opening of the package is described and included in the final test report.

ASTM F2096 Bubble Leak Testing

As an industry leader in package testing, Keystone Compliance can meet all of your bubble leak package testing needs. Our team understands the requirements. We streamline the process. Receiving ASTM F2096 certification can be challenging. Let us walk you through our proven process.

As experts in medical package testing, we know the appropriate test pressure to use. We also understand and can explain which packages meet the requirements and which ones do not. Our lab is ISTA and ASTM certified. To get started, request a quote to experience the Keystone Compliance difference. If you have questions, contact us. Rely on our expertise to guide you through package testing and medical device package testing.