Detection of Gross Leak by Internal Pressure Method

Sterile medical device packaging (terminal sterilized device packaging) is very important for sterile medical devices. It is the basic guarantee for the safety of sterile medical devices. Effectiveness, to ensure that sterile instruments can be used effectively in the hands of users. Sterile medical device packaging has been recognized as "a part of medical devices", and many parts of the world regard preformed sterile barrier systems sold to medical institutions and used for sterilization in institutions as medical devices for management. Sterile medical device packaging has the following purposes: ① Protect the product from environmental pollution and maintain it in an acceptable small environment, in short: protect the product. This is the most basic function of packaging. ② It is also a basic requirement to allow and withstand the sterilization process. ③Maintain the sterility and integrity of the device before use. ④ Aseptically open the instrument for use. ⑤ Convenient storage and transportation. ⑥It is easy to identify products and facilitate sales.

This article is based on "YY/T 0681.5-2010 Experimental Methods for Sterile Medical Device Packaging Part 5: Detection of Gross Leaks by Internal Pressure Method (Bubble Method)" to detect gross leaks in medical packaging. The sensitivity of the method is 81% for the detection probability of the pore size above 250 μm, and the method can be used for tray and combination bag packaging.

The sensitivity of this test method depends on the differential pressure and the method of pressurization. Determining the test pressure for each packaging material and size is the key to reproducible results. Improper pressurization of the package will significantly reduce the sensitivity of the test method. Increasing the differential pressure increases the sensitivity of the experiment. But inflating to too high a pressure can cause seals to crack or air bubbles to be ejected from the breathable material to be confused with defective air bubbles, which can lead to false conclusions as to whether a defect exists.

Experimental method B --- the procedure of air-permeable packaging

1. Use a perforator (such as a small slotted screwdriver or other suitable device) to punch a hole in the package. to insert the air source and pressure monitor into the sample. The perforation should be placed in the center of the package as much as possible. The holes should be sized to allow insertion of the air source and pressure monitor with a minimum of air leakage. If necessary, seal the insertion site with tape and a rubber pad as a puncture site occluder.

2. Insert the air source and pressure monitor into the test sample. Submerge the package approximately 2.5 cm under water and hold for at least 5 s, applying air to the package. (Using a stopper will help keep the entire package at the proper depth)

3. If necessary, adjust the gas and pressure limiting valve, and slowly inflate the package to a pressure greater than or equal to the minimum test pressure determined in Appendix A. If necessary, adjust the pressure limiting valve and pressure regulator to maintain constant pressure.

4. Inspect the entire package for air bubble flow in areas showing damage (channels in the seal, pinholes, ruptures, tears, etc.), and the inspection time depends on the size of the package.

5. Remove the package from the water and mark any areas of damage observed.
Sterile medical device packaging test method Internal pressure method to detect coarse leakage bubble method tester LSST-01A

According to "YY/T 0681.5-2010 Experimental Method for Sterile Medical Device Packaging Part 5: Internal Pressure Method for Detection of Gross Leakage (Bubble Method)", it is professionally applicable to the test of sterile medical device packaging.



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