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 dye solution used in penetration testing will wick through penetratiob porous material over time, but normally not within the suggested maximum time.
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.
Overview of ASTM F1929 Dye Penetration Integrity Test
However, since these tests are designed to detect leaks, components that exhibit any indication of leakage are normally rejected. Leaks may also result from a pinhole in the packaging material. After contact with the dye penetrant for a specified time, the package is visually inspected for dye penetration.
Harmful biological or particulate contaminants may enter the device through leaks. Uncoated papers pehetration especially susceptible to leakage and must be evaluated carefully for use with each test method. Please keep this in mind when developing your studies and validations.
Because air escapes through the walls of a porous package during inflation, the flow rate atsm be increased to compensate for the lost air through the walls and create the back pressure in the porous package. Observe each seal for a recommended penetratlon of 5 to 20 seconds.
The package will penetrafion visually inspected for dye penetration after contact with the dye penetrant for a specified time. No indication of leak size can be inferred from these tests. 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. Either is to be regarded as standard. Leaks may dyee result from a microscopic pinhole in the packaging material that is invisible to the human eye.
ASTM-F – Medical Package Testing
Link to Active This link will always route to the current Active version of the standard. They are not quantitative.
The dye will have discolored the surface of the 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 20 seconds. Historical Version s – view previous versions of standard. Learn more about the different testing services penetratoon at each location.
If wicking does occur, it may be verified by observing the porous side of the subject seal area. In the Burst Testair is introduced into the package at a predetermined pressure and flow rate.
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 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.
Place a bead of solution tesg 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.
The porosity or lack thereof of the package material determines the inflation rate for the burst test. A dye penetrant solution is applied locally to the seal edge to be tested for leaks. Water already in the seal defects may render them undetectable with a dye penetrant. The Creep Test provides a test for slow shear of the adhesive bond similar to a dead weight hanging on the seal.
If ASTM F testing is used as the quality control method, the test specimen must consist of a complete packaged device. These leaks are frequently discovered at seals between package components of the same or dissimilar materials. ASTM F procedure requires that the dye penetrant have good contrast to the opaque packaging material. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.
These leaks are frequently found at seals between package components of the same or dissimilar materials. For more information visit www. However, since ASTM F testing is designed solely to detect leakage, components that illustrate any indication of leakage are usually rejected.
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. This pressure creates the force needed to rupture the seal.
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. Observe the package for any leaks originating from the inside edge of the package seal towards the outside edge of the package seal. Refer to Appendix X1 for details on wicking and guidance on the observance of false positives. A dye penetrant solution is applied locally to the seal edge to be tested for leaks.
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. If wicking does transpire, it may be verified by observing the porous side of the subject seal area.
The presence of a number of small leaks, tesf found in porous packaging material, which could be detected by other techniques, will not be indicated.