ASTM F1929 Detecting Leaks in Medical Packaging
ASTM F1929 detects and locates leakage in package seals. As an ISTA and ISO 17025 certified lab, we realize the importance of dye penetration testing. Meeting the ASTM F1929 requirements can be difficult. We understand the challenges and guide companies through the process.
Keystone Package Testing creates an accurate test plan to eliminate expensive over-testing. We are in constant communication throughout the test process and quickly expedite our test reports. Additionally, when packages do not meet the requirements, our engineers assist with finding solutions.
Summary of ASTM F1929 Leak Testing Information
This ASTM F1929 standard test method defines materials and procedures for testing and locating package leaks. The leaks found are equal to or greater than a channel formed by a 50 μm wire. A wire is formed between a transparent material and porous sheet material.
ASTM F1929 is intended for use on packages with seals formed between a transparent and porous sheet material. The tests are limited to material that can retain the dye solution. Uncoated papers are especially prone to leakage and must be evaluated carefully for use with each test method.
Scope of ASTM F1929 Dye Penetration Leak Testing
Three dye procedures are covered in this transportation integrity test. Edge dip, injection, and eyedropper. Each test method requires that the dye penetrant solution have good contrast to the opaque packaging material.
Procedure A – Injection Method –
First, the dye penetrant solution is applied and injected into the package. The penetrant must be sufficient enough to cover the longest edge to a depth of 5mm.
When puncturing the package, care is taken not to damage other package surfaces. The device will provide a tenting effect that will separate the two sides of the package. This reduces the chances of an accidental puncture.
The package is then visually inspected for dye. The seal area and transparent side of the package must be observed. Channels in the seal will be readily detected. An optical device is recommended and may be used for detailed examination.
Lastly, the package is rotated and the test is repeated as necessary to expose each seal edge to the dye penetrant solution.
Procedure B – Edge Drip Method –
A container whose length is long enough to accommodate the longest sealed edge is selected. The dye is then poured into the container. The dye solution must cover the entire bottom surface. If the package being tested has excessive material beyond the seal, modifications must be made.
The package is removed from its dripped orientation. Observations are made to the package seal area. The testing procedure is then repeated for the remaining seals.
Procedure C – Eyedropper Method –
The dye solution is first poured into an open container. While using a finger or paperclip, the extended edge of the package is pushed back away from the transparent material. Next, an eyedropper is inserted into the dye solution.
With the transparent side of the package facing the operator, the dye solution is applied until the entire package seal is exposed to the solution. Smaller packages are slowly rotated to achieve this complete exposure to the solution. Otherwise, the solution is applied to one side at a time.
Significance of ASTM F1929 Porous Medical Package Testing
The objective of ASTM F1929 transportation compliance is to visually observe the presence of channel defects by the leakage of dye through the package. Harmful biological or particulate contaminants may enter medical packages through leaks. These leaks are commonly found at seals between package components and similar materials.
ASTM F1929 package integrity procedures are suitable to verify and locate leakage sites. However, the test is not quantitative. No indication of leak size can be inferred from this test. The methods are usually employed as a pass/fail test.
Lastly, a report is written and includes general and specific information on the test standard. General information consists of date, time, location, and test engineer. Specific information may include any conditioning, deviations from the standard, and evidence of dye penetration.
Expert ASTM F1929 Package Testing
Keystone Package Testing can accommodate flexible and rigid packages of all sizes, including large pallets. Our team strives to give our customers more time and energy on product development instead of testing. In addition to leak testing, Keystone has a full scope of expertise including accelerated aging, cold chain, and drop.
Contact us to learn first hand why so many companies partner with Keystone to achieve their medical packaging certification needs.
For more referenced ASTM standards and similar testing, please follow the links below:
- ASTM F17 Terminology Relating to Flexible Barrier Packaging
- ASTM Z1.4 Sampling Procedures and Tables for Inspection by Attributes