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.
|Published (Last):||9 November 2008|
|PDF File Size:||8.96 Mb|
|ePub File Size:||20.24 Mb|
|Price:||Free* [*Free Regsitration Required]|
Method C — Eye Dropper: Observe each seal for a recommended duration of 5 to 20 seconds. The Eyedropper method requires the packages to have an unsealed area that extends beyond the outer edge of the seal.
The New ASTM F1929-12, Which Dye Leak Method is Right for you?
As in method B, ast are detected from the exterior to the interior of the package. This pressure creates the force needed to rupture the seal. In the Burst Testair is introduced into the package at a predetermined pressure and flow rate.
Cited by of ISO as a method to test package integrity, F is a dye penetrate integrity test used by sstm engineers that is designed to detect and locate leaks caused by channels formed between a transparent film and a porous material. The Creep Test provides a test for slow shear of the adhesive bond similar to a dead weight hanging on the seal.
Link to Active This link will always route to the current Active version of the standard. Harmful biological or particulate contaminants may enter the device through leaks. The dye solution used in penetration testing will wick through any porous material over time, but normally not within the suggested maximum time. No indication of leak size can be inferred from these tests. The package will be visually inspected for dye penetration after contact with the dye penetrant for a specified time.
ASTM-F – Medical Package Testing
The update to the standard marks the first significant change in the past few years. Method A — Injection: As a guide, each Test Method above recommends observing each seal for a maximum of 5 ast on a 4-sided package 20 seconds total.
For more information visit www. These two new methods give manufacturers a new opportunity to perform dye leak testing without exposing the product to a significant amount of dye, causing less mess, and using less dye.
The package is then rotated in order to expose the dye to the remaining sides of the package. However, since these tests are ff1929 to detect leaks, components that exhibit any indication of leakage are normally rejected. Method B — Edge Dip: The porosity or lack thereof of the package material determines the inflation rate for the burst test. They are not quantitative. Place a bead of solution between 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.
Observe the package for any leaks originating from the astj edge of the r1929 seal towards the outside edge of the package seal. The method involves injecting dye astn the package covering the longest edge with a depth of approximately 0. Refer to Appendix X1 for details on wicking and guidance on the observance of false positives.
Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. Leaks may also result from a pinhole in the packaging material. Learn more about the different testing services provided at each location.
ASTM F1929 – 15
Leaks may also asrm from a microscopic pinhole in the packaging material that is invisible to the human eye. Below are descriptions of the methods that can be considered when choosing a method for evaluating a sealed package. ASTM F procedure requires that the dye penetrant have good contrast to the opaque packaging material.
A dye penetrant solution is applied locally to the seal edge to be tested for leaks. The dye is astk to contact the sealed edge for a maximum of five seconds and a channel would be detected within this time, if present.
However, since ASTM F testing is designed solely to detect leakage, components that illustrate any indication of leakage are usually rejected. 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 f199 in the porous package. A dye penetrant solution is applied locally to the seal edge to be tested for leaks.
Either is to be regarded as standard. Water already in the seal defects may render them undetectable with a dye penetrant. In the past, the only option was by injection Method A where the dye solution was exposed to the seal from the inside of the package. Packaging must be free of condensation or atsm other source of astn water.
This method involves using an eye dropper to apply dye along the edge of the package seal between the transparent and porous materials.
These leaks are frequently discovered at seals between package components of the same or dissimilar materials.