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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This pressure creates the force needed to rupture the seal. 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. In the Burst Testair is introduced into the package at a predetermined pressure and flow rate. Below are descriptions of the methods that can be considered when choosing a method for evaluating a sealed package.
The New ASTM F1929-12, Which Dye Leak Method is Right for you?
The edge dip method may be preferred because needles or syringes are not used, and is faster to perform. These leaks are frequently found at seals between package components of the same or dissimilar materials.
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. 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 dye solution used in penetration testing will wick through any porous material over time, but normally not within the suggested maximum time.
Either is to be regarded as standard. Along the extended unsealed area beyond outer satm edgethe transparent material is separated from the porous material with use of a finger, paperclip, etc.
Learn more about the different testing services provided at each location. Water already in the seal defects may render them undetectable with a dye penetrant. Harmful biological or particulate contaminants may enter the device through leaks. However, since ASTM F testing is designed solely to detect leakage, components that illustrate any indication of leakage are usually rejected. A dye penetrant solution is applied locally to the seal edge to be tested for leaks.
The method involves injecting dye into the package covering the longest edge with a depth of approximately 0. The package will be visually inspected for dye penetration after contact with the dye penetrant for a specified time.
Overview of ASTM F1929 Dye Penetration Integrity Test
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 asym. However, since these tests are designed to detect leaks, components that exhibit any indication of leakage are normally rejected. 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.
The porosity or lack thereof of the package material determines the inflation rate for the burst test. Method A — Injection: The update results in three different dye application methods. The dye will have discolored the surface of the material. If wicking does transpire, it may be verified by observing the porous side of the subject seal area.
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. A dye penetrant solution is applied locally to the seal edge aztm be tested for leaks.
Method B — Edge Dip: With this revision, however, two new test methods have been developed, edge dip Method B and the eyedropper Method C. The package is then rotated in order to expose the dye to the remaining sides of the package. They are not quantitative.
The New ASTM F, Which Dye Leak Method is Right for you?
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 presence of a number of small leaks, as found in porous packaging material, which could be detected by other techniques, will not be indicated.
Learn more about the different testing services provided at each location. Packaging must be free of condensation or any other source of liquid water.
This method exposes the exterior of the package to the dye in order to detect channels. ASTM F procedure requires that the dye penetrant have good contrast to the opaque packaging material.
After contact with the dye penetrant for a specified time, the package is visually inspected for dye penetration.
The Eyedropper method requires the packages to have an unsealed area that extends beyond the outer edge of the seal. If wicking does occur, it may be verified by observing the porous side of the subject seal area. Uncoated papers are especially susceptible to leakage and must be evaluated carefully for use with each test method.
If ASTM F testing is used as the quality control method, the test specimen must consist of a complete packaged device.
ASTM-F – Medical Package Testing
The dye will have discolored the surface of the material. Here is a quick overview of the changes: Please keep this axtm mind when developing your studies and validations.
Historical Version s – view previous versions of standard. Method C requires packages to have excess material along the outside of the seal to contain the dye. As in method B, channels are detected from the exterior to the interior of the package. Observe each seal for a recommended duration of 5 to 20 seconds.
This method involves using an eye dropper to apply dye along the edge of the package seal between the transparent and porous materials. No indication of leak size can be inferred from these tests.
The update to the standard marks the first significant change in the past few years.