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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However, since ASTM F testing is designed solely to detect leakage, components that illustrate any indication of leakage are usually rejected.

ASTM-F – Medical Package Testing

The package will be visually inspected for dye penetration after contact with the dye penetrant for a specified time. If wicking does occur, it may be verified by observing the porous side of the subject seal area. The dye will have discolored the surface of the material. The Eyedropper method requires the packages to have an unsealed area that extends beyond the outer f199 of the seal.

Either is to be regarded as standard. Most commonly, an eyedropper or pipette is used to apply the dye tsst solution between the transparent and porous materials of the unsealed area. Harmful biological or particulate contaminants may enter the device through leaks. 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 pressure in the porous package.

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If wicking does transpire, it may be verified by observing the porous side of the subject seal area. The dye will have discolored the surface of the material.

For more information visit www. However, since these tests are designed to detect leaks, components that exhibit any indication of leakage are normally rejected.

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 procedure requires that the dye penetrant have good contrast to the opaque packaging material.

Leaks may also result from a pinhole in the packaging material. 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 penetrwtion hanging on the seal.

Uncoated papers are especially susceptible to leakage and must be evaluated carefully for use with each test method. Along the extended unsealed area beyond outer seal edgethe transparent material is separated from the porous material with use of a finger, paperclip, etc. Observe each seal for a recommended duration of 5 to 20 seconds.

Packaging must be free of condensation or any other source of liquid water. Please contact us with any questions you may have about ASTM F, or if r1929 can help you with any other testing questions or projects. There is no general consensus regarding the level of leakage that is likely to be detrimental to a particular package.

The porosity or lack thereof of the package material determines the inflation rate for the burst test. This penetrqtion creates the force needed to rupture the seal. 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.


Historical Version s – view previous versions of standard. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.

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. As a guide, each Test Method above recommends observing each seal for a maximum of 5 seconds on a f1992 package 20 seconds total.


They are not quantitative. 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. A dye penetrant solution is applied locally to the seal edge to be tested for leaks.

In the Burst Testair is introduced into the package at a predetermined pressure and flow rate. These leaks are frequently discovered at seals between penetragion components of the same or dissimilar materials. Refer to Appendix X1 for details on wicking and guidance on the observance of false positives. Water already in the seal defects may render them undetectable with a dye penetrant.

These leaks are frequently found at seals between package components of the same or dissimilar materials.