This article is provided by Jinan Crowdtest Electromechanical Equipment***
Sterile medical device packaging (terminal sterilized device packaging) is essential for sterile medical devices, it is the basic guarantee of the safety of sterile medical devices, it works with the sterile device components themselves to build the safety and effectiveness of the product, and ensure that the sterile device can be effectively used in the hands of users. Sterile medical device packaging has been recognized as "part of the medical device composition.""In many parts of the world, preformed sterile barrier systems sold to medical institutions and used for sterilization within the facility are treated as medical devices.
Sterile medical device packaging serves several purposes: to protect the product from environmental contamination and to maintain it in an acceptable small environment, in short: to protect the product. This is the most basic function of the package. It is also a basic requirement to allow and withstand the sterilization process. Maintain the sterility and integrity of the instrument prior to use. Aseptically open to allow for the use of instruments. It is convenient for storage and transportation. It is easy to identify the product, which is conducive to sales, etc.
This article is based on YY T 06815-2010 Experimental Methods for Sterile Medical Device Packaging Part 5: Internal Pressure Method for Detection of Coarse Leaks (Bubble Method) to detect coarse leaks in medical packaging. The sensitivity of the method has an 81% probability of detection for pore sizes above 250 m, and the method can be used for pallet and multi-bag packaging.
The sensitivity of this test method depends on the differential pressure and pressurization method. Determining the experimental pressure for each packaging material and specification is the key to reproducible results. Improper pressurization of the packaging will significantly reduce the sensitivity of this test method. Increasing the differential pressure will increase the sensitivity of the experiment. However, charging too much pressure can cause the seal to crack or to eject air bubbles from the breathable material that can be confused with defective bubbles, which can lead to incorrect conclusions about the existence of defects.
1. What kind of instrument is used for the packaging tightness test of sterile medical devices?
Sterile Medical Device Packaging Experimental Method: Internal Pressure Method Detection of Coarse Leakage Bubble Tester, LSST-02 Testing Instrument: According to YY T 06815-2010 Experimental Methods for Sterile Medical Device Packaging Part 5: Internal Pressure Method for Detecting Coarse Leakage (Bubble Method)" was developed and produced, which is professionally applicable to sterile medical device packaging testing.
2. Test method for detecting coarse leakage bubbles by internal pressure method for sterile medical device packaging
(1) Experimental method a--- procedure for non-breathable packaging
1. Use a perforator (such as a small slotted screwdriver or other suitable device) to wear an empty hole on the package. This allows the air source and pressure monitor to be inserted into the sample. The perforation is located as far as possible at the top of the package. The holes should be sized to allow insertion of an air source and pressure monitor with minimal air leakage. If necessary, seal the insertion site with tape and rubber pads as occluders at the piercing site.
2. Insert an air source and a pressure monitor into the test sample. Submerge the package under water for about 25cm。Apply air to the inside of the package. (Using a limiter 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 greater than or equal to the minimum experimental pressure determined in accordance with Appendix A. If necessary, adjust the pressure limiting valve and pressure regulator to maintain constant pressure.
4. Inspect the bubble flow in the area of broken (seal channel, pinhole, rupture, tear, etc.) on the whole package, and the inspection time depends on the size of the package.
5. Remove the package from the water and mark all observed damaged areas.
(2) Experimental method b--- procedure for breathable packaging
1. Use a perforator (such as a small slotted screwdriver or other suitable device) to wear an empty hole on the package. This allows the air source and pressure monitor to be inserted into the sample. The perforation is located as far as possible at the top of the package. The holes should be sized to allow insertion of an air source and pressure monitor with minimal air leakage. If necessary, seal the insertion site with tape and rubber pads as occluders at the piercing site.
2. Insert an air source and a pressure monitor into the test sample. Submerge the package under water for about 25cm and hold for at least 5s, apply air to the inside of the package. (Using a limiter 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 greater than or equal to the minimum experimental pressure determined in accordance with Appendix A. If necessary, adjust the pressure limiting valve and pressure regulator to maintain constant pressure.
4. Inspect the bubble flow in the area of broken (seal channel, pinhole, rupture, tear, etc.) on the whole package, and the inspection time depends on the size of the package.
5. Remove the package from the water and mark all observed damaged areas.