Aseptic medical device packaging internal pressure method for detecting gross leakage bubble method test method

Aseptic medical device packaging internal pressure method for detecting gross leakage bubble method test method

Sterile medical device packaging (final sterilized device packaging) is essential for sterile medical devices. It is the basic guarantee for the safety of sterile medical devices. It and the sterile device components themselves together build the product's safety and Effectiveness to ensure that sterile instruments can be used effectively in the hands of users. Sterile medical device packaging has been recognized as "part of the composition of medical devices". In many parts of the world, pre-formed sterile barrier systems that are sold to medical institutions and used for sterilization in institutions are treated as medical devices. Sterile medical device packaging has the following purposes: ① To protect the product from environmental pollution and maintain it in an acceptable small environment, in short: to protect the product. This is the most basic function of packaging. ②Allow and withstand the sterilization process, which is also a basic requirement. ③ Maintain the sterility and integrity of the device before use. ④Aseptically open to use the instrument. ⑤ Convenient for storage and transportation. ⑥ It is easy to identify products and is conducive to sales.

This article is based on "YY / T 0681.5-2010 Aseptic medical device packaging experimental methods Part 5: Internal pressure method to detect gross leakage (bubble method)" to detect gross leakage in medical packaging. The detection probability of the sensitivity of the method to the aperture above 250μm is 81%, and this method can be used for packaging of trays and combination bags.

The sensitivity of this test method depends on the pressure difference and pressure method. Determining the experimental pressure for each packaging material and specification is the key to repeatable results. Improper pressure on the packaging will significantly reduce the sensitivity of this test method. Increasing the pressure difference will increase the experimental sensitivity. However, the excessively high pressure will cause the seal to crack or eject bubbles from the breathable material and be confused with the defective bubbles, which may lead to a wrong conclusion about whether there is a defect.



experimental method

1. Experimental method A --- Procedure for non-breathable packaging

1. Use a piercer (such as a small slotted screwdriver or other suitable device) to wear an empty space on the package. In order to insert the air source and pressure monitor into the sample. The perforation is located in the center of the package as much as possible. The size of the hole should be able to be inserted into the air source and pressure monitor, and to minimize air leakage. If necessary, use tape and rubber pads as a plugging device to seal the insertion site.

2. Insert the air source and pressure monitor into the test sample. Immerse the package approximately 2.5 cm under water. Apply air to the package. (Using a stopper will help keep the entire package at an appropriate 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 a constant pressure.

4. Check the bubble flow in the damaged (passage, pinhole, rupture, tear, etc.) area on the entire package. The inspection time depends on the size of the package.

5. Remove the packaging from the water and mark all the damaged areas observed.



Second, the experimental method B --- breathable packaging procedures

1. Use a piercer (such as a small slotted screwdriver or other suitable device) to wear an empty space on the package. In order to insert the air source and pressure monitor into the sample. The perforation is located in the center of the package as much as possible. The size of the hole should be able to be inserted into the air source and pressure monitor, and to minimize air leakage. If necessary, use tape and rubber pads as a plugging device to seal the insertion site.

2. Insert the air source and pressure monitor into the test sample. Immerse the package about 2.5 cm under water and keep it for at least 5 s. Apply air to the package. (Using a stopper will help keep the entire package at an appropriate 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 a constant pressure.

4. Check the bubble flow in the damaged (passage, pinhole, rupture, tear, etc.) area on the entire package. The inspection time depends on the size of the package.

5. Remove the packaging from the water and mark all the damaged areas observed.









laboratory apparatus



Sterile medical device packaging experiment method Internal pressure method to detect gross leak bubble tester LSST-01A

According to "YY / T 0681.5-2010 Aseptic medical device packaging experimental methods Part 5: Internal pressure method for detecting gross leakage (bubble method)", it is professionally applicable to the testing of sterile medical device packaging.

Technical advantages of the internal pressure method for detecting gross leakage bubble method

PLC industrial control program to ensure accurate control of pressure and time

Automatically complete the experiment after setting the test pressure and time

Automatic constant pressure compensation during the experiment

7 inch TFT full touch screen is convenient for test parameter setting and test operation

Multiple sets of test parameters can be saved, saving time for repeated setting

Automatic statistical saving of time results

Technical parameters of internal pressure method for detecting gross leakage bubble tester

Test range: 0 -600 KPa; 0 -87.0 psi (standard)

Test error: ± 1%

Constant pressure time: 1-9999s

Air source interface: Φ6 mm polyurethane tube

Dimensions: 400 mm (L) × 270 mm (W) × 180 mm (H)

Standard configuration: host, puncture device, sealed tank

Optional devices: standard test rack, three-side seal test fixture, restraint plate test fixture, anti-theft bottle cap release fixture, non-standard device

Note: Theo has always been committed to the innovation and improvement of product performance and function. For this reason, the product technical specifications will also change accordingly. The above situation without prior notice, the company reserves the right to modify and interpret.

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