ASTM F2096 Primary Packaging Bubble Emission

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:

Related Standards:

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Achieving ISO 17025 Accreditation is the pinnacle in third-party laboratory testing accreditation. It confirms that the facility has management, quality, and technical systems in place to ensure accurate and reliable analyses.
ISTA is revered as the certification standard for package testing for distribution. ISTA’s Testing Protocol remains a series of testing methodologies and standards well recognized within the packaging community.
A select few companies are authorized by PHMSA as an approved third-party packaging testing laboratory in accordance with Hazardous Materials Regulations, critical to ensuring safe transport of dangerous goods.

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The Technical Association of Pulp and Paper Industry’s peer-reviewed standards improve production through operational methods and industry recognized best practices.

 

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