This test method covers the determination of channels in the package seal down to a width of 75 μm with a 60 to 100 % probability (see Annex B).
This test method is applicable to flexible and rigid packages with at least one transparent side so that the seal area may be clearly viewed.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ASTM F 17 Standard terminology relating to flexible barrier packaging
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
channel
any unimpaired pathway across the entire width of the intended seal
3.2
sterile package integrity
property of the package seal and material, which ensures that it presents a microbial barrier (see also ASTM F 17, Microbiological package integrity)
4 Summary of test method
This test method provides a qualitative visual inspection method to evaluate the appearance characteristics of unopened, intact seals in order to determine the presence of defects that may affect the integrity of the package.
Note: Annex A gives the appearance defects of the seal and their causes, and Annex B gives the precision and bias of the test methods specified in this standard.
