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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Overview of ASTM F Dye Penetration Integrity Test
The package is then removed and inspected for channels. Packaging must be free of condensation or any other source of liquid water. 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.
There is no general consensus regarding the level of leakage asym is likely to be detrimental to a particular package. Water already in the seal defects may render them undetectable with a dye penetrant.
The Eyedropper method requires the packages to have an unsealed area that extends beyond the outer edge of the seal. The edge dip method may be preferred because needles or syringes are not used, and is faster to perform.
Requirements ASTM F testing is limited to porous materials which can retain the dye penetrant solution and prevent it from discoloring the xstm seal for a minimum of 20 seconds. The dye will have discolored the surface of the material.
In the Burst Testair is introduced into the package at qstm predetermined pressure and flow rate. Leaks may also result from a pinhole in the packaging material.
ASTM F1929 – 15
Most commonly, an eyedropper or pipette is used to apply the dye penetration solution between the transparent and porous materials of the unsealed area. Method B — Edge Dip: Method A — Injection: A dye penetrant solution is applied locally to the seal edge to be tested for leaks. Method C — Eye Dropper: Leaks may also result from a microscopic pinhole in the packaging material that is invisible to the human eye. The Creep Test provides a test for slow shear of the adhesive bond similar to a dead weight hanging on the seal.
Method C requires packages to have excess material along the outside of the seal to contain the dye. 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 method involves injecting dye into the package covering the longest edge with a depth of approximately 0.
Learn more about the different testing services provided at each location. Refer to Appendix X1 for details on wicking and guidance on the observance of false positives.
ASTM F procedure requires that the dye penetrant have good contrast to the opaque packaging material. Please keep this in mind when developing your studies and validations. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.
Link to Active This link will always route to the current Active version of the standard. With this revision, however, two new test methods have been developed, edge dip Method B and the eyedropper Method C. No indication of leak size can be inferred from these tests.
Observe the package for any leaks originating from the inside edge of the package seal towards the outside edge of the package seal. 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.
For more information visit www. The update to the standard marks the f19929 significant change in the past few years. Along the extended unsealed area beyond outer seal edgethe transparent material is separated from the porous material with use of a finger, paperclip, etc. After contact with the dye penetrant for a specified time, the package is visually inspected for dye penetration.
If wicking does occur, it may be verified by observing the porous side of the subject seal area.