Sterile Barrier / Integrity
The integrity of medical device package seals can be tested by a dye penetration test conducted according to ASTM F1929, or a bubble emission test conducted on the entire pouch or tray according to ASTM F2096. Both of these procedures are qualitative tests and will result in a pass/fail determination and do not return a quantitative value.
To conduct the bubble emission test, the pouch or tray (Sterile Barrier System) is submerged 1 inch below a water bath surface and inflated with a pressure differential pre-determined by an induced controlled defect. Gross leaks in a non-breathable SBS are readily apparent. For breathable packages a steady stream of bubbles from a specific point will also indicate a possible path for microbial passage into the sterile interior.
The dye penetration test conducted according to ASTM F1929 consists of inserting a prescribed dye solution into the Sterile Barrier System and then rotating it causing fluid flow around the interior interface between two sealed surfaces of the package. Any defects in seals or "channel leaks" will be evident by the dye penetrating the narrow channel leak, which allows a graphic visual image of the potential problem.
Typical Sample Size
Typical sample sizes range from 30 to 60 samples.