Testing Standard:
ASTM F1929 Test Method for Detecting Seal Leaks in Porous Medical Packaging (Dye Penetration)
Standard Number
ASTM F1929
Standard Title
Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
Overview for ASTM F1929:
ASTM F1929 is a test method that will detect and find leaks equal to or greater than a channel formed by a 50 μm wire in package edge seals formed between a porous sheet material and a transparent material. There are three dye application methods that consist of injection, edge dip, and eyedropper. This test method is limited to porous materials, which can keep the dye solution and prevent it from discoloring the seal area for a minimum of 5 seconds. Purple Diamond Testing offers ASTM F1929 Testing as part of our packaging compliance and validation services.
ASTM F1929 is a test method that evaluates the dye penetration of primary packaging materials. The test is used to determine the ability of packaging materials to prevent the penetration of liquids and gases into or out of the package. It is particularly useful in evaluating the barrier properties of sterile medical packaging materials.
The term “primary packaging” refers to the packaging material that is in direct contact with the product. For example, in the case of a medical device, the primary packaging would be the packaging material that directly surrounds the device.
During the ASTM F1929 test, a dye solution is applied to the package and allowed to dwell for a specified period of time. The package is then rinsed with a specified solution and examined for any penetration of the dye. The results of the test are used to evaluate the effectiveness of the packaging material in preventing the penetration of liquids and gases.
The ASTM F1929 test is an important quality control measure for manufacturers of sterile medical products and other products that require a high level of packaging protection. By evaluating the barrier properties of primary packaging materials, companies can ensure that their products are properly protected during storage and transport, reducing the risk of contamination or deterioration.
Rationale for ASTM F1929:
Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration. Its intended use is to see the presence of channel defects that may allow harmful biological or particulate contaminants to enter. Leaks are often found in seals between package components of the same or dissimilar materials. ASTM F1929 is usually conducted during the manufacturing process and at various stages of the package’s life cycle.
The primary beneficiaries of ASTM F1929 dye penetration testing for primary packaging are manufacturers and consumers. Manufacturers benefit from the testing as it ensures that their primary packaging is correctly sealed and will protect the product from contamination during distribution and storage. Consumers also benefit from the testing as it provides them with assurance that the product they are purchasing has not been contaminated during the packaging process. Ultimately, this testing helps to ensure that products are safe for consumption and use.
Steps to ASTM F1929 Dye Penetration Testing
1. Clean the surface of the primary package to remove any debris or contaminants.
2. Prep the dye solution according to the specifications in the ASTM F1929 standard.
3. Apply the dye solution onto the surface of the primary package, covering the area to be tested.
4. Let the dye solution sit on the surface for the required amount of time specified in the ASTM F1929 standard.
5. Remove the excess dye solution from the surface of the primary package, being careful not to smear or wipe away any dye that may have penetrated the surface.
6. Inspect the treated area with a UV light, looking for any indications of dye penetration.
7. Record the results of the dye penetration test, reporting any areas where dye has penetrated the surface of the primary package.
Key Points:
- Comprised of three applications including injection, edge dip, and eyedropper
- Detects seal defects in medical packaging greater than or equal to 50 μm
- Use ISO 11607-1 with this test standard to set validation standards
Related Standards:
- ASTM D4332 – Practice for Conditioning Containers, Packages, or Packaging Components for Testing
- ASTM F2096 – Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
- ISO 11607-1 – Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems
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ASTM is an acronym for the American Society for Testing and Materials. It is a globally recognized organization that develops and publishes technical standards for a wide range of materials, products, systems, and services. These standards are used by manufacturers, regulators, and consumers to ensure the quality, safety, and performance of products and materials. The standards developed by ASTM are voluntary and are intended to help companies improve their processes and products.
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- ASTM F1929
- ASTM F1980
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- ASTM F2250
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