What is Bubble Leak Package Testing?
Bubble leak testing detects gross leaks in packaging. Detecting gross leaks in packaging by internal pressurization is also called the bubble test. This packaging test type is primarily used for tray/pouch packaging. It can detect leaks as small as 250 microns. Bubble leak integrity testing is destructive. Therefore, it requires entry into the package to supply internal air pressure.
As a leader in package compliance testing, Keystone understands the importance of bubble leak integrity testing. Our knowledge of the distribution system and packaging compliance standards has allowed us to create a streamlined approach to package validation. From test plan to test report, Keystone Compliance walks customers through the entire process.
Why is Bubble Leak Compliance Testing Important?
Internal pressurization and bubble testing provide a practical way to examine packages for gross leaks. As mentioned above, bubble leak testing indicates the breach of a sterile barrier.
Sterile barriers are used when designing packaging for medical devices. From manufacturer to end-user, hospital, doctor’s office, etc., a medical device will undergo stress throughout the distribution process. The loss of sterility in a package can result in returns, expensive replacement costs, and loss of customer trust.
Bubble Leak Integrity Test Process
Before testing, several specimens are chosen to permit an adequate determination of representative performance. In most cases, conditioning is to be at equilibrium with normal room temperature.
First, the package is inflated underwater. The inflation is to a predetermined pressure. Next, the package is observed for leaks. Failure is indicated by a steady stream of air bubbles.
The differential pressure can be increased or decreased. It is important to have repeatable results. Therefore, establishing a test pressure for each package is important. The method of pressurization, size and material will also play a factor in attaining repeatable results.
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.
To complete bubble leak testing, three primary pieces of equipment are used.
- A pressure delivery system. This system includes a pressure monitoring gauge and bleed-off control valve. The system must be capable of delivering air at a pressure of 0-50 mbar.
- A needle. This package puncturing device allows the insertion of air from the pressure delivery system.
- A water container. The device being tested must be covered with at least one inch of water.
Upon completion of testing, a report is issued, providing the following information.
- The date, operator’s name, and package type
- Any identification numbers such as serial numbers
- The defect size used to establish the test sensitivity
- The test pressure and use of blocking agents, if any
- The total number of test packages
- The number of packages that passed
- The number of packages exhibiting leaks and the location of each leak
Keystone’s Bubble Leak Testing Equipment and Capabilities
Keystone Compliance 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 reach-in to large walk-in chambers up to 1,300 cu. ft.
Additionally, we own shakers up to 12 kips, and multiple compression/tensile testers. Keystone offers complete pack-out services and testing for all types of flexible and rigid packages.
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 testing is also used for packages with unique sizes and shapes.
ASTM F2096 is ideal for medical packaging. However, this test standard has not been evaluated for use with porous materials other than spun-bonded polyolefin or with nonporous packaging.
ASTM D3078 detects gross leaks in flexible packaging containing a headspace gas.
The test specimen is first submerged in a fluid contained in the vessel within the vacuum chamber. Next, a vacuum level is chosen to optimize the sensitivity of the test. The vacuum is then released. The unit is examined for the presence of test fluid in the specimen. If there are no bubbles observed and no test fluid is found in the specimen, the test unit has passed the test.
Expert Bubble Leak Package Integrity Testing
Keystone Compliance partners with customers to achieve package compliance. Our accurate test reports are delivered quickly. Our proven process helps avoid product launch delays. In addition to bubble leak and bubble emission testing, Keystone has a full scope of expertise including compression, drop, and accelerated aging.
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 17025 and ASTM certified.