Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration

Importancia y uso:

4.1 Harmful biological or particulate contaminants may enter the medical package through leaks. These leaks are frequently found at seals between package components of the same or dissimilar materials. Leaks may also result from a pinhole in the packaging material.

4.2 It is the objective of this test method to visually observe the presence of channel defects by the leakage of dye through them.

4.3 This dye penetrant procedure is applicable only to individual leaks in a package seal. 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.

4.4 There is no general agreement concerning the level of leakage that is likely to be deleterious to a particular package. However, since these tests are designed to detect leaks, components that exhibit any indication of leakage are normally rejected.

4.5 These procedures are suitable to verify and locate leakage sites. They are not quantitative. No indication of leak size can be inferred from these tests. The methods are usually employed as a pass/fail test.

4.6 The dye solution will wick through any porous material over time, but usually not within the maximum time suggested. 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. Refer to Appendix X1 for details on wicking and guidance on the observance of false positives.

Subcomité:

F02.40

Referida por:

D7160-16R23, D7161-16R23, F2097-23, D5628-24, F2097-23

Volúmen:

15.10

Número ICS:

55.040 (Packaging materials and accessories)

Palabras clave:

dye penetrant; edge dip; eyedropper; flexible packaging; porous packaging; seal leaks;