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[Chinese Packaging Network News] blister packaging is a plastic hard film and medical aluminum foil formed by the heat sealing process of the packaging form, blister packaging sealing performance is an extremely important performance indicators, the quality of the packaging of drugs is important influences. This article uses the MFY-01 Sealing Tester independently developed by Jinan Languang Electromechanical Technology Co., Ltd. to test the sealing performance of the blister package, and introduces the testing principle of the equipment, and describes the basic process of the test, so as to seal the performance of the blister package for the enterprise. The monitoring provides a reference.
1, the meaning
With the survival of the fittest in the form of pharmaceutical packaging, blister packaging has become an important part of the current pharmaceutical packaging market with its advantages of good protection, ease of use, and light weight. Blister packaging, also known as blister packaging, PTP packaging, is mainly composed of two parts, namely plastic hard film with blister and medicinal aluminum foil. At the time of packaging, the medicine is put into the blisters of the hard sheet and then heat-sealed with the medicinal aluminum foil, thereby forming a blister package in which the blisters are independent of each other. Since the destruction of one of the blisters in the blister pack does not affect or have a minor effect on the integrity of other blisters, it is particularly important that the integrity of the seal of each blistering eye itself. If the blister packaging is poorly sealed, water vapor, oxygen, and other gases in the external environment will penetrate into the interior of the package along the poor seal and cause deliquescence and discoloration of the drug.
2, standard
At present, the sealing performance test is mainly based on GB/T “Test Method for Sealing Performance of Flexible Packagesâ€, which is applicable to the sealing performance test of sealed flexible packages made of various materials.
3, test sample
A brand of blister packaging for granular pharmaceutical packaging.
4, test equipment
This article uses Labthink blue MFY-01 sealing tester to test the sealing performance of blister packaging samples.
4.1 Test principle
This device is developed using the differential pressure test principle. During the test, the sample is placed in the water in the sealed tank. By drawing a vacuum inside the sealed tank, a pressure difference occurs between the inside and the outside of the sample immersed in water. If the sealing of the sample is poor, the gas inside the sample will be affected by the pressure difference. The outer surface of the sample is sealed and weak, and it overflows to the outside. The presence of continuous bubbles in the surface of the sample is observed in the water, or the sealing performance of the sample is judged by observing the expansion of the sample and the recovery of the shape after releasing the vacuum.
4.2 Application
l This equipment is suitable for the sealing performance testing of packaging bags, bottles, tubes, cans, boxes, etc. in the food, pharmaceutical, medical equipment, daily chemical, automotive, electronic components, stationery, etc., including glass, plastic, and metal materials. Classes and so on. It is suitable for the test of the sealing performance of the sample after dropping, pressure resistance and other tests.
l This equipment meets many national and international standards, such as GB/T 15171, ASTM D3078, etc.
4.3 Equipment Parameters
l The vacuum is 0 ~ -90 KPa.
l There are 3 available sizes for the vacuum chamber, 270 mm (diameter) × 210 mm (height), 360 mm (diameter) × 585 mm (height), and 460 mm (diameter) × 330 mm (height). .
l The system uses digital preset test vacuum and vacuum retention time to ensure the accuracy of test data.
l Automatic constant pressure air supplement technology further ensures that the test can be performed under preset vacuum conditions.
l The professional software supports automatic backflush unloading and automatic end of test functions to ensure the smooth progress of the test process.
5, test steps
(1) Immerse the blister pack sample in the water in the sealed tank.
(2) Close the sealing cap to ensure that the sealing cap is airtight and the sealing cans are well sealed. The test parameters such as the degree of vacuum required for the test and the pressure holding time in the vacuum tank are set through the microcomputer operation interface.
(3) Open the vacuum pump and click the test button on the operation panel to start the test.
(4) Observe the air bubbles on the sample surface during vacuum and pressure holding. If there is a continuous bubble on the surface of the sample, record the pressure value at the time of the continuous bubble and the position of the bubble. If there is no continuous bubble, it indicates that the sample has good sealing performance under the set pressure.
6, test results
A total of five blister packaging samples were tested in this test. There were leaks in all five samples. Among them, four samples all showed leakage at the heat sealing edge. The leakage pressure was -31.5 KPa, - 70.0 KPa, -26.9 KPa, -43.1 KPa, and the other sample has no leakage at the maximum negative pressure of -90 KPa, and has good sealing performance.
7. Conclusion
Sealing performance is an important performance of blister packaging, MFY-01 Sealing Tester is a professional testing equipment for testing the sealing performance of blister packaging, which can not only quantitatively analyze the sealing performance of packaging, but also through the position of leakage. The qualitative analysis can also provide a basis for the improvement of the packaging process. In order to overcome the shortcomings of traditional seal tester's manual recording of test results, such as large workload, the risk of transcripting errors, difficulty in data storage, difficulty in referencing, and poor traceability, Labthink developed and innovated on the basis of the MFY-01 seal tester. Developed i-Process 6200 sealing tester and data processing system. The system is professionally used to test the sealing performance of production products on site, and can automatically determine whether the test result is qualified or not. The test data can be automatically uploaded to the data management center for data. Management and storage make it easy for users to manage and control the sealing performance of product packaging at the production site.
In addition to sealing performance, blister packaging heat seal strength, water vapor transmission rate, oxygen permeability and other properties will also have an important impact on the quality of the packaged drugs, the corresponding testing equipment you can log in or consult. The more you understand, the more you trust! Labthink looks forward to working with companies and institutions in the industry to increase technical exchanges and cooperation!