Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)

ASTM F2096

Leak Testing Standard: Bubble Leak Test

Test Theory and Process Overview

The ASTM F2096 test is designed to detect gross leaks by using pressurized air and water immersion. Flexible packages are internally pressurized, and the entire system is submerged in water. The fundamental principle behind the test is simple: when the package is pressurized, any defects or gross leaks will allow air to escape, producing visible bubbles in the water. This visual confirmation of a leak is highly reliable for gross leaks, ensuring packages meet required integrity standards.

Sensitivity, Application and Nature

The method can detect leaks as small as 250 microns, making it effective for ensuring that packaging retains its necessary airtight properties. Importantly, ASTM F2096 is applicable to a wide range of flexible packaging materials, including porous and non-porous materials. 

The sensitivity of this test method is dependent on the differential pressure and method of pressurization. 

ASTM F2096 Test Apparatus
ASTM F2096 Test Apparatus

Detailed Description of the Test Process

The package is inflated underwater to a predetermined pressure. The package is then observed for a steady stream of air bubbles indicating a failure area.

ASTM F2096 Test Method A—Procedure for Nonporous Packaging

  • 1. Preparation: Create a hole in the package using a puncturing device for inserting the air source and pressure monitor link into the control sample. Use tape or a rubber disk as a septum over the puncture site to seal the insertion site if necessary.
  • 2. Inflation: Submerge the package approximately 1 in. under water. Start airflow into the package. Adjust the airflow to slowly inflate the package to a value equal to or greater than the minimum test pressure and then maintain it as constant pressure.
  • 3. Inspection: Thoroughly inspect one side of the package facing upwards for a constant stream of bubbles indicating a specific area of failure (seal channels, pinholes, cracks, tears, and so forth). Then repeat the process by rotating the package 180º so the opposite side of the package is facing upwards. Inspection time will vary depending on package size.
  • 4. Mark: Remove the package from water and mark any observed area(s) of failure.

ASTM F2096 Test Method B—Procedure for Porous Packaging

Method B is basically the same process as Method A, except it has one more step for treating the porous packaging sample. As porous material may begin to breathe prior to observing the defect, apply a blocking agent 5 to the porous material and repeat above test step.  

The intent of the blocking agent is to reduce the porosity of the porous material, therefore, increasing the internal test pressure. However, the blocking agent may have a profound effect on both the physical and chemical nature of the porous packaging material and may therefore give a wide range of breathing point pressures. It is recommended to use the minimal quantity of blocking agent necessary to detect the known defect.

Significance of ASTM F2096

In industries such as pharmaceuticals, medical devices, and food packaging, even a small packaging defect can have significant consequences. The ability to ensure package integrity is therefore crucial, and ASTM F2096 offers a reliable, cost-effective solution for detecting gross leaks. This method helps manufacturers maintain quality control standards and ensures that the packaging can protect the product from environmental contaminants, spoilage, and sterility breaches.

The test is particularly useful for verifying the sterility of medical devices and the preservation of pharmaceutical products, where the smallest contamination could lead to catastrophic results.

GLT-01 Gross Leak Tester
ASTM F2096 Bubble Leak Tester

Advantages of ASTM F2096

Practical Testing

The ASTM F2096 internal pressurization test method provides a practical way to examine packages for gross leaks.

Large and Long Sample Applicable

ASTM F2096 test method applies to very large or long packages, which do not fit into any other package integrity test method apparatus.

Package Integrity Evaluation

Package integrity is crucial to consumer safety since heat sealed packages are designed to provide a contamination free and sterile environment to the product.

Equipment and Technology for ASTM F2096 Compliance

To effectively perform ASTM F2096 Bubble Leak Testing, specialized equipment is essential. High-precision tools that can maintain and control pressure increments, as well as large water-filled chambers, are required. A complete leak testing setup typically includes:

  1. Pressure Delivery System: A controlled air supply system capable of delivering air pressure to the package accurately.
  2. Water Immersion Tank: A chamber large enough to accommodate the full package, filled with water for submersion.
  3. Pressure Gauge or pressure transducer: A highly accurate gauge or transducer to monitor and control the air pressure applied to the package.
  4. Sealing and Puncture Devices: To introduce air into the package without compromising the seal.
MLT-01 Gross Leak Tester
MLT-01 Gross Leak Tester

The Cell Instruments GLT-01 Gross Leak Tester is an example of a sophisticated bubble leak tester that meets these requirements. It features a high-resolution display, real-time pressure monitoring, and user-friendly control settings. This equipment is designed for efficiency and accuracy, making it an excellent choice for companies that regularly conduct ASTM F2096 tests. By investing in GLT-01 Gross Leak Tester, manufacturers can streamline their testing procedures while ensuring they adhere to international standards.

Applications of ASTM F2096 Bubble Leak Testing

The ASTM F2096 Bubble Leak Test is highly applicable to a wide range of industries. Each of these industries faces strict regulations regarding product safety and quality, and adherence to ASTM F2096 helps meet those regulatory requirements. It is commonly used in:

Pharmaceutical packaging

Ensures sterility and prevents contamination.

Medical device packaging

Verifies the integrity of critical healthcare products.

Food packaging

Confirms that airtight seals preserve product freshness and quality.

Collaboration

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Test Under ASTM F2096
Test Under ASTM F2096

Importance of Testing Materials and Methodology

Using the right materials for packaging is just as important as ensuring they meet integrity standards. Flexible packaging, including both porous and non-porous materials, is often subjected to intense environmental stress, making testing a necessity.

By adhering to ASTM F2096, companies can detect weak points in their materials and improve manufacturing processes. This proactive approach reduces the risk of defective products entering the market, enhancing the company’s reputation for quality.

The ASTM F2096 Bubble Leak Test plays a critical role in ensuring the integrity of flexible packaging across various industries. Its effectiveness in detecting gross leaks helps manufacturers maintain the high standards required to ensure product safety, sterility, and quality. By using advanced equipment such as the Cell Instruments GLT-01 Gross Leak Tester, manufacturers can streamline their testing processes and ensure they are fully compliant with ASTM F2096.

This method is an essential component of a comprehensive quality assurance program, providing a simple yet effective way to detect packaging defects and ensure that products are delivered in optimal condition. For companies that prioritize packaging integrity, investing in high-quality leak testing equipment and adhering to standards like ASTM F2096 is a must.

FAQ about ASTM F2096

Flexible packages, including porous and non-porous materials, are ideal for this test.

Pharmaceuticals, medical devices, and food industries commonly use this test to verify packaging integrity.

The water bath allows for the visualization of air bubbles escaping from the package, indicating a leak.

Breathing point pressure means the pressure at which permeation of air through the porous material begins.

No, the method is designed for detecting gross leaks of approximately 250 microns or larger.

The ASTM F2096 test is typically destructive, because it requires entry into the package to supply an internal air pressure.

ASTM F2096 focuses on gross leaks using internal pressurization and water immersion, while methods like dye penetration or helium leak testing can detect smaller defects.

Yes. Establishment of a test pressure for each package material/size is critical for obtaining repeatable results. 

Inadequate pressurization can reduce the sensitivity and higher differential pressures will increase sensitivity. Excessive pressurization will rupture seals or cause misinterpretation of test result.

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Related Information

GLT-01 Gross Leak Tester

The GLT-01 Gross Leak Tester is a highly efficient and reliable solution designed to detect gross leaks in packaging using the internal pressurization method. In addition, it is also known as the bubble test, underwater immersion test, or dunking test. Specifically, this device is primarily utilized for pouches and sterile packaging.Furthermore, compliant with ASTM F2096, the GLT-01 offers a proven procedure to identify leaks in both porous and non-permeable materials through bubble leak testing.

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