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.

Author: Daibei Tut
Country: Mozambique
Language: English (Spanish)
Genre: Sex
Published (Last): 4 March 2005
Pages: 262
PDF File Size: 6.15 Mb
ePub File Size: 7.17 Mb
ISBN: 511-5-97188-490-6
Downloads: 80149
Price: Free* [*Free Regsitration Required]
Uploader: Balrajas

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. If ASTM F testing is used as the quality control method, the test specimen must consist of a complete packaged device.

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 dye solution used in penetration testing will wick through any porous material over time, but normally not within asgm suggested maximum time. f11929

A dye penetrant solution is applied locally to the seal edge to be tested for leaks. Satm porosity or lack thereof of the package material determines the inflation rate for the burst test.

For more information visit www. 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 will be visually inspected asfm dye penetration after contact with the dye penetrant for a specified time.

The presence of a number of small leaks, as found in porous packaging material, which could be detected by other techniques, will not be indicated. Learn more about the different testing services provided adtm each location.

ASTM-F – Medical Package Testing

Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. 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. There is no general consensus regarding the level of leakage that is likely to be detrimental to a particular package. The dye is allowed to contact the sealed edge for a maximum of five seconds and a channel would be detected within this time, if present.


The Eyedropper method requires the packages to have an unsealed area that extends beyond the outer edge of the seal. The Creep Test provides a test for slow shear of the adhesive bond similar to a dead weight hanging on the seal. Refer to Appendix X1 for details on wicking and guidance on the observance of false positives. They are not quantitative. Method A — Injection: Below are descriptions of the methods that can be considered when choosing a method for evaluating a sealed package.

Overview of ASTM F1929 Dye Penetration Integrity Test

Method C requires packages to have excess material along the outside of the seal to contain aztm dye. After contact with the dye penetrant for a specified time, the package is visually inspected for dye penetration. Method B — Edge Dip: Learn more about the different testing services provided at each location. The update to the standard marks the first significant change in the past few years.

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

However, since ASTM F testing is designed solely to detect leakage, components that illustrate any indication of leakage are usually rejected.

A dye penetrant solution is applied locally to the seal edge to be tested for leaks. Observe each seal for a recommended duration of 5 to 20 seconds. Leaks may also result from a microscopic pinhole in the packaging material that is invisible to the human eye. No indication of leak size can be inferred from these tests.

The dye will have discolored the surface of the material. Link to Active This link will always route to the current Active version of the standard. Leaks may also result from a pinhole in the packaging material. These leaks are frequently ff1929 at seals between package components of the same or dissimilar materials. Requirements ASTM F testing zstm 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.


asstm The package is then removed and inspected for channels. 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 package is then rotated in order to expose the dye to the remaining sides of the package. Along the extended unsealed area beyond outer seal edgethe transparent material is separated from the porous material with use of a finger, paperclip, etc. 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.


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. Most commonly, an eyedropper or pipette is used to apply the dye penetration solution between the transparent and porous materials of the unsealed area.

The update results in three different dye application methods. Harmful biological or particulate contaminants may enter the device through leaks. Zstm pressure creates the force needed to rupture the seal.

In the Burst Testair is introduced into the package at a predetermined pressure and flow rate. Observe the package for any leaks originating from the inside edge of the package seal towards the outside edge of the package seal. The method involves injecting dye into the package covering the longest edge with a depth of approximately 0.

If wicking does transpire, it may be verified by observing the porous side of the subject seal area. 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 edge dip method may be preferred because needles or syringes are not used, and is faster to perform.

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.

If wicking does occur, it may be verified by observing the porous side of the subject seal area. Water already in the seal defects may render them undetectable with a dye penetrant.