Medicinal infusion bag heat seal strength monitoring program
Abstract: The heat-sealing strength of the infusion bag is related to whether the product is easy to leak or break the bag. It is related to the safety and convenience of the use of the liquid. This paper takes the test method of the heat seal strength of a brand infusion bag as an example, and introduces the test process of using the Labthink MED-01 medical packaging performance tester to detect the heat seal strength, and passes the test principle, equipment parameters and scope of application. The introduction provides a reference for companies to monitor the heat seal strength of pharmaceutical infusion bags.
Key words: heat seal strength, heat seal strength, pharmaceutical packaging performance tester, infusion bag, soft plastic packaging, medical packaging
1, meaning
With the increasing variety of soft plastic packaging and continuous improvement of performance, traditional infusion glass bottles are being replaced by soft plastic infusion bags. Most of the common soft plastic infusion bags are made of polypropylene, polyethylene, polyamide and a variety of elastic materials through co-extrusion process. Compared with traditional glass bottles, soft plastic infusion bags are environmentally friendly, hygienic and not brittle. The advantages of use and transportation are convenient, and in order to ensure that the liquid does not leak during transportation and storage, the quality is intact, and the heat seal strength of the infusion bag seal is a property that has to be considered during use.
Heat sealing is a barrier that separates the liquid medicine in the infusion bag from the external environment. If the heat sealing strength is poor, the liquid is easy to leak, and the gas in the environment easily penetrates into the infusion bag, causing the oxidation of the liquid component to be invalid. Harmful substances are generated. In addition, if it is squeezed or dropped by external force during transportation or storage, it may break the bag at a poor heat seal. During the filling process of the liquid medicine, the liquid droplets are likely to be contaminated at the heat sealing mouth, which affects the heat sealing strength of the sealing, so it is necessary to strengthen the monitoring of the heat sealing strength of the medical infusion bag.
Figure 1 Infusion bag
2, test samples
In this paper, a brand of infusion bag is used as a test sample to test its heat seal strength.
3. Testing basis
The test process is based on the standard YBB00122003-2015 "Heat Strength Test Method". This standard is applicable to the heat sealing strength of plastic heat sealing on plastic or other substrates and the heat sealing strength of plastic composite bags.
4, test equipment
In this paper, the heat sealing strength of the sample is tested by MED-01 medical packaging performance tester. The equipment is independently developed and produced by Jinan Languang Electromechanical Technology Co., Ltd.
Figure 2 MED-01 medical packaging performance tester
4.1 Principle of the test
The heat seal strength refers to the force value required to break the heat seal. The device is equipped with two upper and lower clamps for clamping the two ends of the sample, and the heat seal of the sample is opened by the movement of the upper clamp. Destruction, the upper clamp is equipped with a force value sensor, which can monitor the change of the force value generated during the process of breaking the heat seal edge in real time, and display the force value of the test on the force value curve, thereby obtaining the heat seal strength of the sample.
4.2 Equipment parameters
The test range of the device is 250 N, and 50 N, 100 N, and 500 N can be selectively configured. The test accuracy is better than 0.5, which effectively ensures the accuracy of the test results.
The device has a stroke of 600 mm.
The equipment supports two-way test mode of tension and compression. The progress of the fixture and the return speed are available in 6 steps, which are 10 mm/min, 50 mm/min, 100 mm/min, 150 mm/min, 200 mm/ Min, 300 mm/min.
Intelligent configuration such as limit protection, overload protection and automatic return to ensure the user's operation safety.
A test machine integrates 16 independent test procedures such as medical instruments, heat seal strength, peeling, compression and stretching of foam, providing users with a variety of test items.
Labthink's newly developed embedded computer system platform, with the latest operating software, supports the LystemTM laboratory data sharing system, unified management of test results and test reports.
4.3 Scope of application
(1) This equipment is suitable for testing the heat-sealing strength, 90-degree peeling, 180-degree peeling, tensile properties and tear resistance of medical packaging bags.
(2) This equipment is suitable for rubber plug penetration force, ampule breaking force, syringe sliding performance, syringe body tightness, needle penetration force, needle needle tube connection firmness, needle needle seat and sheath combining force , plastic blood bag pressure emptying test and other indicators tested.
(3) After special modification or special accessories, the equipment can also be used for testing various performance indexes such as rubber plug pull-out force, tape unwinding force, protective film separation force, combined cover opening force and release paper separation force.
(4) This equipment complies with a number of national and international standards, such as GB 8808, GB/T 1040.1 ~ GB/T 1040.5, GB/T 4850, GB/T 12914, GB/T 2790 ~ GB/T 2792, ISO 37, More than 30 items such as ASTM E4, ASTM D882, ASTM D1938, QB/T 2358, JIS P8113, YY 0613-2007, and YBB 00042002.
5, the test process
(1) At the four heat seal edges of the sample, a width of 15 mm is cut in a direction perpendicular to the heat seal edge, and a total of 10 samples having a length of at least 100 mm are unfolded.
(2) Set parameter information such as sample name, test speed 300 mm/min, and sample width 15 mm.
(3) Take one of the samples and open it with the heat sealing edge as the center. The two ends of the sample are clamped in the upper and lower fixtures of the equipment, so that the axis of the sample coincides with the center line of the upper and lower fixtures, and the heat sealing edge Try to be equal to the distance between the two fixtures.
(4) Click the Start option and the test begins. The upper clamp moves upward according to the set test speed, and drives the heat seal to break, and displays the force value change in real time.
(5) At the end of the test, the device displays the heat seal strength of the test sample.
(6) Repeat (3) ~ (5) until all 10 samples have been tested.
6, test results
The test results of 10 samples were 35.625 N/15mm, 33.649 N/15mm, 34.056 N/15mm, 36.790 N/15mm, 32.483 N/15mm, 36.020 N/15mm, 34.631 N/15mm, 33.549 N/15mm, 34.156. N/15mm, 36.048 N/15mm, the heat seal strength of the tested infusion bag samples was taken as the average value of the test results of 10 samples, which was 34.701 N/15 mm.
7. Conclusion
Good heat-sealing strength is one of the necessary conditions for maintaining the integrity of the pharmaceutical infusion bag and ensuring the efficacy of the drug. It is of great significance to strengthen the monitoring of the heat-sealing strength of the infusion bag. The MED-01 medical packaging performance tester can accurately test the heat seal strength of the infusion bag, and the device is easy to operate, and the repeatability of the test data is good, which can well reflect the heat sealing condition of the heat sealing edge of the infusion bag. In addition to testing the heat seal strength, the device can also be used to test the tensile properties, tear properties, composite fastness of medical bags, the adhesiveness of medical tapes, the puncture resistance of rubber stoppers, and the use of infusion bags. Applicability, performance of injections, etc., is a cost-effective testing equipment. Learn about the MED-01 Medical Packaging Performance Tester and Labthink's other types of testing equipment and services, which you can view. The more you understand, the more trust! Jinan Languang Electromechanical Technology Co., Ltd. is looking forward to enhancing technical exchanges and cooperation with enterprises and institutions in the industry!
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