The tolerance of medical packaging bags to internal pressure is an important factor that affects whether they are prone to breakage, and is one of the performance indicators that medical packaging should focus on. This paper uses the LSSD-01 leak and seal strength tester to test the bursting pressure of flexible plastic packaging bags for medical packaging. Through the introduction of the test principle, equipment parameters and scope of application, the test process, etc. Performance provides a reference.
1. Significance
There are many types of medical packaging and different packaging forms, such as packaging bags, bottles, tubes, inflatable packaging, aseptic packaging, strip packaging, child safety packaging, etc., among which flexible plastic packaging materials are the main components of pharmaceutical packaging materials. Most medical packaging contains a certain amount of gas, such as some liquid medicines, powder injections and other medicines used to ensure the effectiveness of the inflatable form of packaging, granular medicines used in ordinary packaging, etc. In the process of sterilization or transportation, the gas in the package is thermally expanded or squeezed by external force, which will have a greater impact on the bag body and the heat sealing edge. If the packaging material has poor resistance to internal pressure, it will be Under the impact of the gas, tensile deformation occurs, and even bag breakage occurs. Therefore, the monitoring of the internal pressure tolerance of medical packaging bags can effectively reduce the broken rate of medical packaging bags.
Figure 1 Common types of medical packaging
2. Testing basis
This article tests the internal pressure tolerance of the sample according to the standard YY / T 0681.3-2010 "Test Methods for Packaging of Sterile Medical Devices Part 3: Unconstrained Packaging Resistance to Internal Pressure Destruction".
3. Test samples
The test sample used in this test is an infusion bag provided by an enterprise.
4. Test equipment
The test equipment used in this article is the LSSD-01 leak and seal strength tester, which is independently developed and produced by Jinan Languang Electromechanical Technology.
Figure 2 LSSD-01 leak and seal strength tester
4.1 Test principle
There are three main evaluation methods for the resistance of the packaging to its internal gas pressure, namely burst test, creep test, and creep to failure:
The burst test is to continuously fill the inside of the package with gas until the packaging bag is destroyed, and record the pressure value when the packaging bag is destroyed, that is, the burst pressure to evaluate the resistance to internal pressure.
The creep test is to fill the inside of the package with a certain pressure of gas and maintain the pressure for a certain period of time, and evaluate the internal pressure resistance according to whether the package is damaged during the pressure holding process.
Creep to failure is to evaluate the internal pressure resistance of the package by testing the time when the package fails under a certain pressure.
4.2 Device parameters
The test range is 0 ~ 600 KPa (0 ~ 87.0 psi), and can be expanded to 0 ~ 1.6 MPa (0 ~ 232.1 psi) through special customization; the dual test methods of expansion inhibition and non-inhibition expansion can be completed, and the user can test according to different The purpose is to choose freely; it is divided into a variety of test modes: burst test, creep test, creep to failure test, which can meet different test needs of customers; support LystemTM laboratory data sharing system, unified management of test results and test reports
4.3 Scope of application
(1) It is suitable for the test of pressure rupture, creep performance, creep to rupture performance of various plastic films, aluminum films, paper-plastic composites, aluminum-plastic composites and other packaging bags.
(2) Applicable to the testing of pressure rupture, creep performance, creep to rupture performance of various plastic washing hose packaging hoses and other field article packaging hoses, such as toothpaste tubes and facial milk packaging hoses , Various medical ointment tubes, food packaging hoses, etc.
(3) It can also be applied to the pressure resistance test of blister packaging, the sealing performance test of aerosol valves of various pesticides, mousse, gel water, medicinal sprays, self-spray paint, and high-pressure tests, etc. .
5. Test process
Place the sample in an environment of 23 ° C and 50% RH for more than 48 h.
5.1 Burst test
(1) Paste the sealant pad in the middle of the sample surface, insert the probe through the sealant pad and carefully insert it into the sample to ensure that the probe will not damage other parts of the sample.
(2) Select the burst test mode, press the test button, the test starts, the device fills the sample with gas to expand it, and continues to inflate until the sample ruptures, and records the pressure value and location of the rupture.
5.2 Creep test
Insert the probe into the sample according to the operation in 5.1 (1), select the creep test mode, set the test pressure, holding time and other parameters, press the test button, the device will inflate into the package, when the gas in the package reaches the setting When the value is reached, the timer starts. Record whether the sample is damaged and the damaged position after the test.
5.3 Creep to destruction
Insert the probe into the sample according to the operation in 5.1 (1), select creep to failure mode, set the test pressure, press the test button, the sample will inflate and expand, and when the set pressure is reached, the device will start automatic timing. Record the time of failure of the sample.
6. Test results
The burst pressure of the tested sample was 80.4 KPa this time, and the lower edge of the sample ruptured; in the creep test, the set pressure was 65 KPa, the sample was not damaged after holding the pressure for 30 s; In the failure test, the sample was destroyed at 75 KPa for 12 s, and the lower edge was deformed.
7. Conclusion
The tolerance of the medical packaging bag to internal pressure is an important factor that affects whether it is easy to break the bag in sterilization and transportation. The level of this performance is related to the heat sealing situation of the heat sealing edge and the flexibility of the packaging material. This article uses three methods: burst test, creep test, and creep-to-destruction test to test the destructiveness of the infusion bag sample caused by the resistance to internal pressure. The test process is simple, the equipment is easy to operate, and the test results are true and reliable. Jinan Languang Electromechanical Technology Co., Ltd. is a high-tech enterprise specializing in the production, R & D and packaging inspection services of packaging inspection equipment. The existing equipment can test the oxygen permeability, water vapor permeability, nitrogen permeability of pharmaceutical packaging, Heat seal strength, tensile performance, sealing performance, solvent residue, non-volatile content, stickiness, peel strength and many other performance indicators, to understand related equipment and testing service information, you can log in to view. 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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