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.
|Published (Last):||10 January 2004|
|PDF File Size:||9.38 Mb|
|ePub File Size:||10.76 Mb|
|Price:||Free* [*Free Regsitration Required]|
A dye penetrant solution is applied locally to the seal edge to be tested for leaks. The package will be visually inspected for dye penetration after contact with the dye penetrant for a specified time.
Harmful biological or particulate contaminants may enter the device through leaks. These leaks are frequently discovered at seals between package components of the same or dissimilar materials.
Leaks may also result from a microscopic pinhole in the packaging material that is invisible to the human eye.
Overview of ASTM F Dye Penetration Integrity Test
The dye solution used in penetration testing will wick through any porous material over time, but normally not within the suggested maximum time. If wicking does transpire, it may be verified by observing the porous side of the subject seal area. The dye will have discolored the surface of the material. There is penetrstion general consensus regarding the level of leakage that is likely to be detrimental to a particular package. However, since ASTM F testing is designed solely to detect leakage, components that illustrate any indication of leakage are usually rejected.
In the Burst Testair is introduced into the package at a predetermined pressure and flow rate. The porosity or lack thereof of the package material determines the inflation rate for the burst test.
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. This pressure creates the force needed to rupture the seal.
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.
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. Water already in the seal defects may render them undetectable with a dye penetrant. ASTM F procedure requires that the dye penetrant have good contrast to the opaque packaging material. For more information visit www.