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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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. 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.
After contact with the dye penetrant for a specified time, the package is visually inspected for dye penehration. Link to Active This link will always route to the current Active version of the standard.
In the Burst Testair is introduced into the package at a predetermined pressure and flow rate. Water already in the seal defects may render them undetectable with a dye penetrant.
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Overview of ASTM F1929 Dye Penetration Integrity Test
Uncoated papers are especially susceptible to leakage and must be evaluated carefully for use with each test method. No indication of leak size can be inferred from these tests. Most commonly, an eyedropper or pipette is used to apply the dye penetration solution between the transparent and porous materials of the unsealed area. However, penetrafion ASTM F testing is designed solely to detect leakage, components that illustrate any indication of leakage are usually rejected. This pressure creates the force needed tesst rupture the seal.
Along the extended unsealed area beyond outer seal edgethe transparent material is separated from the porous material with use of a finger, paperclip, etc. They are not quantitative. Observe the package for any leaks originating from the inside edge of the package seal towards the outside edge of the package seal.
Observe each seal for a recommended duration of 5 to 20 seconds. Harmful biological or particulate contaminants may enter the device tesf leaks.
Overview of ASTM F Dye Penetration Integrity Test
Here is a quick overview of the changes: The package will be visually inspected for dye penetration after contact with the dye penetrant for a specified time.
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 f129 back pressure in the porous package. The dye will have discolored the surface of the material. Packaging must be free of condensation or any other source of liquid water.
Please contact us with any questions you may have tesh ASTM F, or if we can help you with any other testing questions or projects. Either is to be regarded as standard.
ASTM-F – Medical Package Testing
The porosity or lack thereof of the package material determines the inflation rate for the burst test. For more information visit www. 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. Historical Version s – view previous versions of standard. A dye penetrant solution is applied locally to the seal edge to be tested for leaks.
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.
ASTM F tdst requires that the dye penetrant have good contrast to the opaque packaging material. The Eyedropper method requires the packages to have an unsealed area that extends beyond the outer edge of the seal.
There is no general consensus regarding the level of leakage that is likely to be detrimental to a particular package. Please keep this in mind when developing your studies and validations.
These leaks are frequently found at seals between package components of the same or dissimilar materials. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.
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.