ASTM F “Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration” is a dye penetration integrity. ASTM recently announced a significant update to ASTM F The update to the dye leak standard marks the first significant change in the. The current test method is ASTM F dye penetration. • It has been used for many years for testing seal integrity of sterile barrier systems. • Round robin.

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Requirements ASTM F testing is limited to porous materials which can retain the dye penetrant solution sstm prevent it from discoloring the entire seal for a minimum of 20 seconds.

The method involves f19299 dye into the package covering the longest edge with a depth of approximately 0. Observe each seal for a recommended duration of 5 to 20 seconds. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Place a bead of solution between the two materials along the outer edge of the package seal, ensuring the entire outer edge of the seal is wetted with the dye solution. The update to the standard marks aastm first significant change in the past few years. This pressure creates the force needed to rupture the seal.

Below are descriptions of the methods that can be considered when choosing a method for evaluating a sealed package. Cited by of ISO as a method to test package integrity, F is a dye penetrate integrity test used by package engineers that is designed to detect and locate leaks caused by channels formed between a transparent film and a porous material. They are not quantitative.

Please contact us with any questions you may have about ASTM F, or if we can help you with any other testing questions or projects. The dye will have discolored the surface of the material.

Either is to be regarded as f1992. Link to Active This link will always route f1992 the current Active version of the standard.

These leaks are frequently discovered at seals between package components of the same or dissimilar materials. DDL actively works with customers to select the best test method for their package and situation as each dye method is subject to change depending on the packaging materials.


Because air escapes through the walls of a porous package during inflation, the flow rate must be increased to compensate for the lost air through the walls and create the back pressure in the porous package. DDL has conducted package integrity testsfor over 20 years and recommends the use of Method A due to its consistency and applicability to more package designs. The package is then removed and inspected for channels.

Here is a quick overview of the changes: Method C — Eye Dropper: The dye solution used in penetration testing will wick through any porous material over time, but normally not within the suggested maximum time. In the past, the only option was by injection Method A where the dye solution was exposed to the seal from the inside of the package.

These leaks are frequently found at seals between package components of the same or dissimilar materials. Learn more about the different testing services provided at each location. Along the extended unsealed area beyond outer seal edgethe transparent material is separated from the porous material with use of a finger, paperclip, etc.

Method C requires packages to have excess material along the outside of the seal to contain the dye. This method is performed by dipping the package into a dye filled container exposing the entire seal edge to the dye solution so that it briefly contacts the dye along the entire length of the seal, just long enough to wet the edge. The test methods are limited to porous materials which can retain the dye penetrant solution and prevent it from discoloring the seal area for a minimum of 5 seconds.

The New ASTM F, Which Dye Leak Method is Right for you?

Water already in the seal defects may render them undetectable with a dye penetrant. Method A — Injection: However, since ASTM F testing is designed solely to detect leakage, components that illustrate any indication of leakage are usually rejected. This method involves using an eye dropper to apply dye along the edge of the package seal between the transparent and porous materials.

Refer to Appendix X1 for details on wicking and guidance on the observance of false positives. Historical Version s – view previous versions of standard. A dye penetrant solution is applied locally to the seal edge to be tested for leaks.


If wicking does occur, it may be verified by observing the porous side of the subject seal area. As a guide, each Test Method above recommends observing each seal for a maximum of 5 seconds on a 4-sided package 20 seconds total. Harmful biological or particulate contaminants may enter the device through leaks. The porosity or lack thereof of the package material determines the inflation rate for the burst test.

The Eyedropper method requires the packages to have an unsealed area that extends beyond the outer d1929 of the seal. The dye will have discolored the surface of the material.

If ASTM F testing is used as the quality control method, the test specimen must consist of a complete packaged device. Packaging must be free of condensation or any other source of liquid water. With this revision, asttm, two new test methods have been developed, edge dip Method B and the eyedropper Method C. The edge dip method may be preferred because needles or syringes are not used, and is faster to perform. Learn more about the different testing services provided at each location.

Uncoated papers are especially susceptible to leakage and must be evaluated carefully for use with each test method. A dye penetrant solution is applied locally to the astmm edge to be tested for leaks. In the Burst Testair is introduced into the package at a predetermined pressure and flow rate.

These two new methods give manufacturers a new opportunity to perform dye leak testing without exposing the product to a satm amount of dye, causing less mess, and using less dye.

Overview of ASTM F1929 Dye Penetration Integrity Test

Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. Most commonly, an eyedropper or pipette is used to apply the dye penetration solution between the transparent and porous materials of the unsealed area.

ASTM F procedure requires that the dye penetrant have good contrast to the opaque packaging material.

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