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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Place a astn of solution between the two materials along the outer edge of the package seal, ensuring the entire outer edge of the seal is atsm with f11929 dye solution. 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. Packaging must be free of condensation or any other source of liquid water. 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.

In the Burst Testair is introduced into the package at a predetermined pressure and flow rate. The test methods are limited to porous materials which aetm retain the dye penetrant solution and prevent it from discoloring the seal area for a minimum of 5 seconds. Harmful biological or particulate contaminants may enter the device through leaks. Most commonly, an eyedropper or pipette is used to apply the dye penetration solution between the transparent and porous materials of the unsealed area.

ASTM-F – Medical Package Testing

Leaks may also result from a pinhole in the packaging material. Either is to be regarded as 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. Learn more about the different testing services provided at each location.

The update to the standard marks the first significant change in the past few years. This method is performed by dipping the package into a dye filled container exposing the entire seal edge to the dye solution so that it briefly contacts the dye along the entire length of the seal, just long enough to wet the edge.


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. 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.

A dye penetrant solution is applied locally to the seal edge to be tested for leaks. The edge dip method may be preferred because needles f9129 syringes are not used, and is faster to perform.

The package is then removed and inspected for channels. This method exposes the exterior of the package to the dye in order to detect channels. As f19299 method B, channels are detected from the exterior to the interior of the package. Method B — Edge Dip: This pressure creates the force needed to rupture the seal.

ASTM F1929 – 15

For more information visit www. After contact with the dye penetrant for a specified time, the package is visually inspected for dye penetration. The Creep Test provides a test for slow shear of the adhesive bond similar to a dead weight hanging on the seal. The dye will have discolored the surface of the material. Please keep this in mind when developing your studies and validations.

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

Here is a quick overview of the changes: If ASTM F testing is used as the quality control method, the test specimen must consist of a complete packaged device.

Below are descriptions of the methods that can be considered when choosing a method for evaluating a sealed package. Water already in the seal defects may render them undetectable with a dye penetrant. Historical Version s – view previous versions of standard. This method involves using an eye dropper to apply dye along the edge of the package seal between the transparent and porous materials.



Refer to Appendix X1 for details on wicking and guidance on the observance of false positives. There is no general consensus regarding the level of leakage that is likely to be detrimental to a particular package. 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.

The update results in three different dye application methods. Method C — Eye Dropper: No indication of leak size can be inferred from these tests.

They are not quantitative. These leaks are frequently discovered at seals between package components of the same or dissimilar materials. Method C requires packages to have excess material along the outside of the seal to contain the dye. Observe each seal for a recommended duration of 5 to 20 seconds. If wicking does transpire, 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.

Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. ASTM F procedure requires that the dye penetrant have good contrast to the opaque packaging material. The porosity or lack thereof aatm the package material determines the inflation rate for the burst test.

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 f11929 porous material.