As a leader in dye penetration package testing, Keystone Compliance understands the importance of detecting seal leaks in porous medical package testing. Our knowledge of packages has allowed us to create a streamlined approach to medical device package validation. We walk customers through the process from test plan to test report.
The remainder of this page speaks to the various components and considerations that exist with the dye penetration testing of packages. If you need medical package testing, request a quote. If you are unsure of where to start, contact us. We look forward to working with you to help you certify your packages through our perfected process.
The remainder of this document speaks to dye penetration testing, specifically to ASTM F1929.
The purpose of dye penetration testing is to detect gross leaks in packaging. ASTM F2096 is the standard test method for detecting seal leaks in medical device packaging. The test method defines materials and procedures that will detect and locate a leak equal to or greater than a channel formed by a 0.002-inch wire.
This channel is formed in package edge seals formed between a transparent material and a porous sheet material. A dye penetration solution is applied locally to the seal edge to be tested for leaks. After contact with the dye penetrant for a specific time, a visual inspection of the package is completed.
ASTM F1929 covers three different dye application methods. They are injection, eye dip and eyedropper. This test standard is limited to porous materials that can retain the dye penetrant solution and prevent it from discoloring the seal area for a minimum of five seconds.
The standard specifically points out the difficulty of uncoated papers. Uncoated papers are susceptible to leakage. These packages must be evaluated carefully for use with each of the three test methods.
Why Is Dye Penetration Testing Important?
Medical packaging must have sufficient seals. It is critical that contaminants not enter through leaks. These leaks are frequently found at seals between package components. This holds true whether the materials of the components are the same or different.
This test method is not used to observe leaks in porous material. The focus is only the channel seal. To determine the presence of other leaks, other testing methods should be used.
Test Equipment Needed
To complete dye penetrant testing, the package testing lab must have the following test equipment. For Method A, small knife or other apparatus to breach one of the packaging materials is required. A dye dispenser such as an eyedropper or syringe is also required for Method A. This is used to inject the dye penetrant solution.
Test Method B requires a pair of scissors or other cutting device as well as a dye solution container. For Test Method C, the test lab uses an eyedropper or one-millimeter pipette. A microscope or optical loop with magnification of 5x to 20x can be used to evaluate each of the methods.
The cutting and injection tools to be used must be appropriate. When puncturing the package to allow the dye to be injected, it is important to not damage other surfaces of the package. That is why selecting the correct tools to work with is important.
Important Sections of the ASTM-F-1929 Test Standard
The test standard includes guidance on the procedure, report, precision and bias. The test procedures are defined for each of the three individual test methods. There is also an appendix that speaks to the guidance on false positives. False positives can occur from wicking, oxidative sterilization and bending or folding.
ASTM F1929 Dye Penetration Leak Testing
As an industry leader in package testing, Keystone Compliance can meet all of your dye penetration package testing needs. Our team understands the medical packaging requirements. We streamline the process. Receiving ASTM F1929 certification can be challenging. Let us walk you through our proven process.
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 and ASTM certified. Our test experts are certified and our quality system in ISO 17025.To get started, request a quote to experience the Keystone Compliance difference. If you have questions, contact us. Rely on our expertise to guide you through package testing and medical device package testing.