《YYT 0681.5-2010 Test Methods for Aseptic Medical Device Packaging Part 5: Internal Pressure Method for Detecting Coarse Leakage (Bubble Method) "is a professional standard for testing the sealing performance of product packaging in the medical industry. It is applicable to the detection of coarse leakage in paper plastic packaging bags, blister boxes, and other packaging of various medical device products.

Aseptic medical device packaging sealing performance tester, based on the principle of positive pressure methodThe "Leakage and Sealing Strength Tester" is a specialized instrument used to evaluate the sealing performance of sterile medical device packaging. The sealing performance of packaging is crucial in the manufacturing and quality control process of medical devices, as it directly affects the safety and effectiveness of the product. This tester can comprehensively and objectively evaluate the sealing performance of packaging through scientific and accurate methods, providing strong support for the quality assurance of medical devices.

The working principle of the coarse bubble sealing leak tester is to use a perforating device to pierce a hole in the packaging, so that the air source and pressure monitor can be inserted into the sample. Tape and rubber pads are used as a sealing device at the perforation site to seal the insertion siteInsert an air source and pressure monitor into the test sample and immerse the packaging approximately 2.5cm underwater. Apply air inside the packaging; Adjust the gas and pressure limiting valve, slowly inflate the packaging to a pressure greater than or equal to the specified minimum test pressure. If necessary, adjust the pressure limiting valve and pressure regulator to maintain constant pressure; Inspect the bubble flow in areas showing damage (sealed passages, pinholes, ruptures, tears, etc.) on the entire packaging, and the inspection time depends on the size of the packaging; Remove the packaging from the water and mark all observed damaged areas.