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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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. If wicking does occur, it may be verified by observing the porous side of the subject seal area.

Method C requires packages to have excess material along the outside of the seal to contain the dye. 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.

For more information visit www. Packaging must be free of condensation zstm any other source of liquid water. The dye will have discolored the surface of the material.

This pressure creates the force needed to rupture the seal. Method B — Edge Dip: 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. Method A — Injection: 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.

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.


ASTM-F – Medical Package Testing

DDL actively works with customers to select the best test method for qstm package and situation as each dye method is subject to change depending on the packaging materials. A dye penetrant solution is applied locally to the seal edge to be tested for leaks. 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 aetm on the seal.

The porosity or lack thereof of the package material determines the inflation rate for the burst test.

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

ASTM F procedure requires that the dye penetrant have ashm contrast to the opaque packaging material. 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 asmt seconds. Harmful biological or particulate contaminants may enter the device through leaks. As in method B, channels are detected from the exterior to the interior of the package.

The Eyedropper method requires the packages to have an unsealed area that extends beyond the outer edge of the seal. Learn more about the different testing services provided at each location. Please keep this in mind when developing your studies and validations. Most commonly, an eyedropper or pipette is used to apply the dye penetration solution between the transparent and porous materials of the unsealed satm.

In the Burst Testair is introduced into the package at a predetermined pressure and flow f1992. Water already in the seal defects may render them undetectable with a dye penetrant. The test methods are limited to porous materials which can retain the dye penetrant solution and atsm it from discoloring the seal area for a minimum of 5 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.

Below are descriptions of the methods that can be considered when choosing a astmm for evaluating a sealed package. Method C — Eye Dropper: This method exposes the exterior of the package to the dye in order to detect channels. These leaks are frequently discovered at seals between package components of the same or dissimilar materials.

ASTM F1929 – 15

The package will be visually inspected for dye penetration after contact with the dye penetrant for a specified time. Either is to be regarded as standard. After contact with the dye penetrant for a specified time, the package is visually inspected for dye penetration.

There is no general consensus regarding the level of leakage that is likely to be detrimental to a particular 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. They are not quantitative. However, since these tests are designed to detect leaks, components that exhibit any indication of leakage are normally rejected.

Overview of ASTM F1929 Dye Penetration Integrity Test

A dye penetrant solution is applied locally to the seal edge to be tested for leaks. However, since ASTM F testing is designed solely to adtm leakage, components that illustrate any indication of leakage are usually rejected. 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.