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 package is then removed and inspected for channels. The package is then rotated in order to expose the dye to the remaining sides of the package.
Below are descriptions of the methods that can be considered when choosing a ff1929 for evaluating a sealed package. However, since ASTM F testing is designed solely to detect leakage, components that illustrate any indication of leakage are usually rejected.
ASTM F1929 – 15
Please keep this in mind when developing your studies and validations. After contact with the dye penetrant for a specified time, the package is visually inspected for dye penetration. Learn more about the different testing services provided at each location. The method involves injecting dye into the package covering the longest edge with a depth of approximately 0.
A dye penetrant solution is applied locally to the seal edge to be tested for leaks.
The porosity or lack thereof of the package material determines the inflation rate for the burst test. Uncoated papers are especially susceptible to leakage and must be evaluated carefully for use with each test method.
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.
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. Here is a quick overview of the changes: 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.
They are not quantitative. Learn more about the different testing services provided at each location. Leaks may also result from a microscopic pinhole in the packaging material that is invisible to the human eye. Observe the package for any leaks originating from the inside edge of the package seal towards the outside edge of the package seal. These leaks are frequently found at seals between package components of the same or dissimilar materials.
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. Method C requires packages to have excess material along the outside of the seal to contain the dye. Method B — Edge Dip: The dye will have discolored the surface of the material.
The New ASTM F, Which Dye Leak Method is Right for you?
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. 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 r1929 walls and create the back pressure in the porous package. The Eyedropper method requires wstm packages to have an unsealed area that extends beyond the outer edge of the seal.
A dye penetrant solution is applied locally to the seal edge to be tested for leaks. The Creep Wstm provides a test for slow shear of the adhesive bond similar to a dead weight hanging on the seal. In the Burst Testair is introduced into the package at a predetermined pressure and flow rate. These leaks awtm frequently discovered at seals between package components of the same or dissimilar materials. The update results in three different dye application methods.
Most commonly, an eyedropper or pipette is used to apply the dye penetration solution between the transparent and porous materials of the unsealed area. 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.
Refer to Appendix X1 for details on wicking qstm guidance on the observance of false positives. As in method B, channels are detected from the exterior to the interior of the package. This method exposes the exterior of the package to the dye in order to detect channels. This method involves using an eye dropper to apply dye along the edge of the package seal between the transparent and porous materials.
The New ASTM F1929-12, Which Dye Leak Method is Right for you?
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 is allowed to contact the sealed edge for a maximum of five seconds and a channel would be detected within this time, if present.
For more information visit www. Along the extended unsealed area beyond outer seal edgethe transparent material is separated from r1929 porous astmm with use of a finger, paperclip, etc.
DDL actively works with customers to select the best test method for their package and situation as each dye method is subject to change depending on the packaging materials. The presence of a number of small leaks, as found in porous packaging material, which could be detected by other techniques, will not be indicated.
Method A — Injection: If wicking does occur, it may be verified by observing the porous side of the subject seal area.
No indication of leak size can be inferred from these tests. This pressure creates the force needed to rupture the seal. Leaks may also result from a pinhole in the packaging material. Method C — Eye Dropper: These two new methods give manufacturers a new opportunity to perform dye leak testing without exposing the g1929 to a significant amount of dye, causing less mess, and using less dye.