ASTM-F describes the standard test method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration. 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. While the traditional ASTM F Dye. Penetration standard is Triton-X used in dye penetration testing is a non-ionic surfactant with both a hydrophilic.

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The dye will have discolored the surface of the material.

The package will be visually inspected for dye penetration after contact with the dye penetrant for a specified time. If wicking does transpire, it may be verified by observing the porous side of the subject seal area.

If ASTM F testing is used as the quality control method, the test specimen must consist of a complete packaged device. Learn more about the different testing services provided at each location. 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 penegration in the porous package.

There is no general consensus regarding the level of leakage that is likely to be detrimental to a particular package. However, since these tests are designed to detect leaks, components that exhibit any indication of leakage are normally rejected.


Along the extended unsealed area beyond outer seal edgethe transparent material is separated from the porous material with use of a finger, paperclip, etc.


This pressure creates the force needed to rupture the seal. The Eyedropper method requires the packages to have an unsealed area that extends beyond the outer edge of the seal. Packaging must be free of condensation or any other source of liquid water. In the Burst Testair is introduced into the package at a predetermined pressure and flow rate. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.

The dye will have discolored the surface of the material. Harmful biological or particulate contaminants may enter the device through leaks. ASTM 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. The dye solution used in penetration testing will wick through any porous material over time, but normally not within the suggested maximum time.

Observe each seal for a recommended duration of 5 to 20 seconds. They are not quantitative. Either is to be regarded as standard. A dye penetrant solution is applied locally to the seal edge to be tested for leaks.

A dye penetrant solution is applied locally to the seal edge to be tested for leaks. Observe the package for any leaks originating from the inside edge of the package seal towards the outside edge of the package seal. For more information visit www.

Overview of ASTM F Dye Penetration Integrity Test

The test methods are limited to porous materials which can retain the asm penetrant solution and prevent it from discoloring the seal area for a minimum of 5 seconds. After contact with the dye penetrant tet a specified time, the package is visually inspected for dye penetration. Due Creep Test provides a test for slow shear of the adhesive bond similar to a dead weight hanging on the seal. 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.


Refer to Appendix X1 for details on wicking and guidance on the observance of false positives. Historical Version s – view previous versions of standard. 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.

Overview of ASTM F1929 Dye Penetration Integrity Test

Leaks may also result from a pinhole in the packaging material. Most commonly, an eyedropper or pipette is used to apply the dye penetration solution between the transparent and porous materials of the unsealed area.

Place penteration bead of solution between the two psnetration along the outer edge of the package seal, ensuring the entire outer edge of the seal is wetted with the dye solution.

The porosity or lack thereof of the package material determines the inflation rate for the burst test. These leaks are frequently discovered at seals between package components of the same or dissimilar materials.