Test of rubbing resistance of sterile medical device packaging bags

1. Significance


Sterile medical devices are produced through terminal sterilization methods or aseptic processing techniques to achieve the sterility of any viable microorganisms, that is, medical device manufacturers provide end users with medical devices that can be used directly without secondary sterilization. In addition to the production process, sterilization process and other factors related to the sterility of medical devices, the control of their circulation process is also crucial. Among them, the packaging bag is an effective barrier to isolate the medical device from the external environment, so maintaining the integrity of the packaging bag in the entire circulation process is an important measure to prevent secondary pollution of the medical device.


In the course of the circulation of medical devices, it is inevitable that external force will fold and squeeze the packaging bag, so the packaging material should have good resistance to rubbing, that is, the packaging structure can be kept intact under the rubbing of external force, and no leakage occurs. In this paper, the rubbing resistance of sterile medical device packaging bags was tested.

2. Test samples


This article uses a plastic composite film used for packaging sterile medical devices as a test sample.


3. Test basis


This test procedure is based on YY / T 0681.12-2014 "Test Methods for Packaging of Sterile Medical Devices Part 12 Anti-Kneadability of Flexible Barrier Film"


4. Test equipment


This article uses FDT-02 rubbing tester as the test equipment

4.1 Test principle


This equipment simulates the possible rubbing effect of the flexible plastic packaging material used in the actual circulation process after packaging medical devices. It rubs the sample horizontally and longitudinally by selecting different rubbing modes (different rubbing times and movement strokes) Control the rubbing strength of the sample. There are two main methods for evaluating the rubbing resistance of samples. One is the barrier verification method. That is, by comparing the barrier properties of the samples before and after rubbing, there is no significant difference in the barrier properties between the samples with better rubbing resistance before and after rubbing. For poor samples, the barrier properties after rubbing will be significantly different; the other is to use the turpentine method to analyze the rubbed samples. If there are pinholes throughout the sample, turpentine spots will be formed on the white paper. By comparing the number and size of spots, the rub resistance of the sample can be obtained. In this paper, the rubbing resistance of the sample was verified by the turpentine method.


4.2 Device parameters


Kneading frequency 45 times / min; pulling force 300 N; rotation torque 2 N·m; kneading angle 440 ° or 400 °; horizontal stroke 155 mm or 80 mm; five standard test modes, four sample stations Easily realize the combination test under different conditions; the rapid switching between long and short strokes greatly improves the test efficiency; the system is controlled by a microcomputer, with LCD screen, menu interface and PVC operation panel, which is convenient for users to carry out test operations quickly and conveniently .


4.3 Scope of application


This equipment meets the international standard ASTM F392, and can be applied to the testing of flexible films, composite films, coated films, and paper. For example, various aluminum-plastic composite films, composite films, aluminized films, nylon films, coated films, paper, etc. for food and drug packaging.


5. Test process


(1) Cut three 200 mm × 280 mm samples from the surface of the sample.


(2) Fix the three specimens with three pressure-sensitive double-sided tapes on three of the equipment and fix them with the fixing clips; close the protective door, select the test mode, start the test; the equipment starts to rub and reach the set After the number of kneading times, the equipment automatically stops; open the protective door and fixing clip, and remove the sample.


(3) Mark the test area of 150 mm × 200 mm in the middle of the three samples after rubbing.


(4) Take a piece of white paper and lay it flat on the test board, place one of the samples on the white paper, and repeatedly apply the prepared turpentine to the test area of the sample. After standing for 1 minute, remove the sample Observe whether there are red spots and the size and number of spots on the white paper.


(5) Repeat the operation of (4), and test the remaining two samples.


6. Test results


In this test, the sample was rubbed by using the C mode. The three pieces of rubbed samples showed 1, 1, and 3 pinholes with different sizes.


7. Conclusion


Maintaining the integrity and sealing of the packaging bag is an important guarantee to prevent secondary pollution of sterile medical devices, and the integrity of the packaging is closely related to the rubbing resistance of the packaging material. In this paper, the number of pinholes appearing on the surface of the sample after rubbing is used to characterize the rubbing resistance of the plastic composite film sample for sterile medical device packaging. The test process is simple, the equipment is easy to operate, and the test results are clear. Jinan Languang Electromechanical Technology Co., Ltd. is a high-tech (separator) technology enterprise specializing in the development and production of packaging testing equipment and packaging testing services. The existing equipment can also be used for the sealing performance, breathability, sealing strength and resistance of sterile medical device packaging Test of multiple performance indicators such as internal pressure failure, seal burst test, puncture resistance, etc., to understand the relevant equipment information, you can visit the Jinan Languang company website to view specific information or call for consultation. The more you understand, the more you trust! Labthink looks forward to enhancing technical communication and cooperation with enterprises and institutions in the industry.


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