Testing Standard:
ASTM F2096 Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
Standard Number
ASTM F2096
Standard Title
Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
Overview for ASTM F2096:
ASTM F2096 is a test method that covers the detection of gross leaks in packaging where the method sensitivity is down to 250 μm. This test method is considered destructive due to the requirement of an entry into the package to supply internal air pressure. Purple Diamond Testing offers this testing as part of our packaging compliance and validation services.
ASTM F2096 is a standard test method for detecting and measuring the leak rate of sealable primary packaging systems for sterile medical devices using a bubble emission technique. The test is designed to identify and quantify any leaks or defects in the seal integrity of the packaging system that could compromise the sterility of the medical device.
The test involves submerging the package in a water-filled vacuum chamber and applying a vacuum to create a pressure differential. The package is then visually inspected for the presence of bubbles indicating the leakage points. The number and size of the bubbles are measured and used to calculate the leak rate of the package.
The test is typically performed on a sample of packages representative of the production lot to ensure consistency and reliability of the packaging system. The results of the test provide critical information for evaluating the integrity of the packaging system and identifying any potential sources of contamination or infection in the medical device.
Overall, the ASTM F2096 test is an essential tool for ensuring the safety and effectiveness of sterile medical devices by providing a reliable and accurate assessment of primary packaging seal integrity.
Rationale for ASTM F2096:
Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test). Is a practical way to examine packages for gross leaks and is extremely useful in a test laboratory environment where there is no common package material or size. ASTM F2096 is usually conducted during the manufacturing process and at various stages of the package’s life cycle. The test itself is considered an overly sensitive way to see the depth and size of a potential leak that may be in the packaging. Ultimately, this kind of practicality will save you thousands of dollars in the long run. If there is any kind of leak in any of your packaging, you want to get it taken care of before your whole product line is put out on the market. We recommend inquiring if you need your package checked for leaks.
The primary beneficiaries of ASTM F2096 – Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) are the manufacturers and users of primary packaging materials.
By using this test method, manufacturers can ensure that their primary packaging materials are leak-free before they are filled with the intended product. This helps to prevent product loss, contamination, and damage that could result from leaks in the packaging.
Similarly, users of primary packaging materials can benefit from this test method by verifying that the packaging material they have received is free from any defects that could compromise the quality and safety of their products.
Overall, ASTM F2096 helps to ensure the quality and safety of primary packaging materials, which ultimately benefits both manufacturers and users of these materials.
Key Points:
- Considered a destructive test that can determine leaks down to a sensitivity of 250 μm
- Evaluates the performance of seals in medical packaging
- Use ASTM F88 if actual package seal strength is needed
Related Standards:
- ASTM D4332 – Practice for Conditioning Containers, Packages, or Packaging Components for Testing
- ASTM E171 – Practice for Conditioning and Testing Flexible Barrier Packaging
- ASTM F88 – Test Method for Seal Strength of Flexible Barrier Materials
- ISO 11607-1 – Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems
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Related Testing Standards
- ASTM D642
- ASTM D685
- ASTM D880
- ASTM D951
- ASTM D999
- ASTM D3078
- ASTM D3103
- ASTM D3285
- ASTM D4169
- ASTM D4332
- ASTM D4728
- ASTM D5265
- ASTM D5276
- ASTM D5277
- ASTM D5487
- ASTM D6055
- ASTM D6179
- ASTM D6344
- ASTM D6653
- ASTM D7386
- ASTM F88
- ASTM F1140
- ASTM F1886
- ASTM F1929
- ASTM F1980
- ASTM F2096
- ASTM F2250
- ASTM F3039
- ASTM D1596
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The APASS program was designed by Amazon to help support vendors, sellers, and manufacturers in obtaining certification of their products as Frustration Free Packaging (FFP), Ships in Own Container (SIOC), or Prep-Free Packaging (PFP).
