Note 1 - Magnification devices, such as eyeloops, can be used as analytical tools to characterize seal defect identification.
Note 2-Different package sizes and shapes may require varying lengths of time to fully inspect the entire printed border. Any time required with a visual inspection should allow for a complete seal inspection without too much time to focus intensely on any particular area.
This test method is under the jurisdiction of ASTM Committee F02 Flexible Barriers, which has direct responsibility for approval of the current, June 1, 2004 version of Subcommittee F02.60 for Medical Device Packaging. Published in June 2004. Originally in 1998. The last version was approved in 1998 as 1886-98.2 F. For reference ASTM standards, visit the ASTM website, www.astm.org, or contact customer service at service@astm.org for ASTM standards. For more information, see the Standards Document Summary page on the ASTM website. )
Note 3-Some packaging materials and adhesives may be damaged by UV rays. Observing the sealed area under a UV lamp will improve the contrast between the sealed-to-unsealed areas and provide greater defect identification.
7.3 Identify and record any portion of the seal that occurs in the channel across the entire width of the seal. Positioning channels.
Note 4 - All other evaluation defects (see Appendix X1) should be classified according to user-defined acceptance or rejection criteria. Define the behavior when a defect is discovered during a normal active production run.
Note 5-If confirmation of the peelable package in the channel or incomplete sealing area is necessary, such that the suspect package hand-skin completely separates the two material components and checks the transfer of sealant for the same integrity The avoidance encapsulation property. Care should be taken to ensure a smooth continuous peeling action so as not to cause any additional properties. High temperature seals should be cooled to the surrounding environment so that peeling of the adhesive bond to the opposite substrate occurs in some cases after a channel or area has been peeled apart. The packaging can be observed being peeled off. The adhesive transfers qualitative evidence of the substance's ability to release paint, rather than conclusive evidence that the seal does not have bees. It may be continuous to seal integrity, but it cannot be given to complete a transfer. This is because the paint can have a stronger affinity to the substrate on its surface rather than it being blocked. In this case, an additional physical seal integrity test may be required to confirm that it has been broken open.