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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Overview of ASTM F1929 Dye Penetration Integrity Test
These two new methods give manufacturers a new opportunity to perform dye leak testing without exposing the product to a significant amount of dye, causing less mess, and using less dye. 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.
Refer to Appendix X1 for details on wicking and guidance on the observance of false positives. The Creep Test provides a test for slow shear of the adhesive bond similar to a dead weight hanging on the seal. Requirements ASTM F testing is limited to porous materials which can retain the dye penetrant solution and prevent it from discoloring the entire seal for a minimum of 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.
The porosity or lack thereof of the package material determines the inflation rate for the burst test. Observe each seal for a recommended duration of 5 to 20 seconds.
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. The update to the standard marks the first significant change in the past few years.
There is no general consensus regarding the level of qstm that asym likely to be detrimental to a particular package. The package is then removed and inspected for channels. With this revision, however, two new test methods have been developed, edge dip Method B and the eyedropper Method C. This method is performed by dipping the package into a dye filled container exposing the entire seal edge to the dye solution so that v1929 briefly contacts the dye along the entire length of the seal, just long enough to wet the edge.
Packaging must be free of condensation or any other source of liquid water. These leaks are frequently discovered at seals between package components of the same or dissimilar materials.
Observe the package for any leaks originating from the inside edge of the package seal towards the outside edge of the package seal.
ASTM F1929 – 15
The edge dip method may be preferred because needles or syringes are not used, and is faster to aetm. The update results in three different dye application methods. If wicking does transpire, it may be verified by observing the porous side of the subject seal area. However, 1f929 ASTM F testing is designed solely to detect leakage, f19929 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. 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. Water already in the seal defects may render them undetectable with a dye penetrant.
Overview of ASTM F Dye Penetration Integrity Test
Method C requires packages to have excess material along the outside of the seal to contain the dye. Because air escapes through the walls of a porous package during inflation, the flow rate must be increased to compensate for the lost air zstm the walls and create the back pressure in the porous package.
Here is a quick overview of the changes: The package is then rotated in order to expose the dye to the remaining sides of the package. Learn more about the different testing services provided at each location. The method involves injecting dye into the package covering the longest edge with a depth of approximately 0. Historical Version s – view previous versions of standard. Either is to be regarded as f199.
ASTM-F – Medical Package Testing
No indication of leak size can be f1992 from these tests. Along the extended unsealed area beyond outer seal edgethe transparent material is separated from the porous material with use of a finger, paperclip, etc. 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.
However, since these tests are designed to detect leaks, components that exhibit any indication f19229 leakage are normally rejected.
Link to Active This link will always route to the current Active version of the standard. Method C — Eye Dropper: Cited by of ISO as a method to test package f9129, 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.
Asym F procedure requires that the dye penetrant have good contrast to the opaque packaging material. These leaks are frequently found at seals between package components of the same or dissimilar materials.
If ASTM F testing is used as the asmt control method, the test specimen must consist of a complete packaged device. The dye solution used in penetration testing will wick through any porous material over time, but normally not within the suggested maximum time. As in method B, channels are detected from the exterior to the interior of the package.
If wicking does occur, it may be verified by observing the porous side of the subject seal area. Most commonly, an eyedropper or pipette is used to apply the dye penetration solution between the transparent and porous materials of the unsealed area.