Keywords: blister packaging, blister packaging, PTP packaging, medicine, sealing performance, seal tester, gas leak, bubble
1, 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 because of its good protection, easy to use, and light weight. Blister packaging, also known as blister packaging, PTP packaging, is mainly composed of two parts, respectively, plastic blister with blister, medicinal aluminum foil. At the time of packaging, the medicine is placed in the blister of the hard sheet, and then heat-sealed with the medicinal aluminum foil to form a blister pack in which each blister is independent of each other. Since the damage of one of the blister packs in the blister pack does not affect or have a minor effect on the integrity of other blister eyes, the sealing integrity of each blister itself is particularly important. If the sealing performance of the blister package is poor, the water vapor, oxygen and other gases in the external environment will penetrate into the inside of the package along the poor seal, causing dehydration and discoloration of the drug.
Figure
2, standard
At present, the sealing performance test is mainly referred to GB/T 15171-1994 "Test Method for Sealing Performance of Flexible Packages", which is applicable to the sealing performance test of sealed flexible packages made of various materials.
3, test samples
A brand of granular drug packaging is packed in blister packs.
4, test equipment
In this paper, the Labthink MFY-01 seal tester was used to test the sealing performance of blister package samples.
Figure
4.1 Test principle
This equipment is developed using the differential pressure test principle. During the test, the sample is placed in the water of the sealed tank. By vacuuming the inside of the sealed tank, a pressure difference is generated inside and outside the sample immersed in the water. If the sample is poorly sealed, the gas inside the sample will be under the pressure difference. It leaks to the outside along the weak surface of the sample surface. In the water, there is continuous bubble generation on the surface of the sample, 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 Scope of application
l This equipment is suitable for sealing performance test of packaging bags, bottles, tubes, cans, boxes, etc. in food, pharmaceutical, medical equipment, daily chemicals, automobiles, electronic components, stationery, etc., including glass, plastic, metal materials. Classes, etc. It is suitable for testing the sealing performance of samples after drop, pressure and other tests.
l This equipment complies with a number of national and international standards, such as GB/T 15171, ASTM D3078 and so on.
4.3 Equipment parameters
l The degree of vacuum is 0 ~ -90 KPa.
l There are 3 effective sizes for the vacuum chamber, 270 mm (diameter) × 210 mm (height), 360 mm (diameter) × 585 mm (height), 460 mm (diameter) × 330 mm (height) .
l The system uses digital preset test vacuum and vacuum hold time to ensure the accuracy of test data.
l Automatic constant pressure air supply technology further ensures that the test can be carried out under preset vacuum conditions.
l Professional software supports automatic backflush unloading and automatic end of test functions to ensure the smooth progress of the test process.
5, the test steps
(1) Dip the blister pack sample in water in a sealed can.
(2) Close the sealing cover to ensure that there is no air leakage around the sealing cover and the sealed can is sealed well. The test parameters such as the vacuum degree required for the test and the dwell time in the vacuum tank are set by the microcomputer operation interface.
(3) Turn on the vacuum pump and click the test button on the operation panel to start the test.
(4) Observe the bubble on the surface of the sample during vacuuming and holding. If there are continuous bubbles on the surface of the sample, the pressure value at which the continuous bubble appears and the position at which the bubble is generated are recorded. If no continuous bubble is generated, it indicates that the sample has good sealing under the set pressure.
Figure
6, test results
In this test, a total of 5 blister package samples were tested, and all 5 samples showed air leakage. Among them, 4 samples showed air leakage at the heat sealing edge, and the pressure at the time of air leakage was -31.5 KPa, respectively. 70.0 KPa, -26.9 KPa, -43.1 KPa, another sample has no leaks at the maximum negative pressure of the instrument -90 KPa, and has good sealing.
7. Conclusion
Sealing performance is an important performance of blister packaging. MFY-01 Sealing Tester is a testing equipment specially used to test the sealing performance of blister packaging. It can quantitatively analyze the sealing performance of packaging and pass the position of air leakage. The qualitative analysis can also provide a basis for the improvement of the packaging process. In order to overcome the shortcomings of the traditional seal tester manual recording test results, the risk of transcription errors, data storage difficulties, difficult to access, poor traceability, Labthink is improved on the basis of the MFY-01 seal tester. Developed i-Process 6200 Seal Tester and Data Processing System, which is specially used for the detection of sealing performance of on-site products. It can automatically judge whether the test results are qualified or not. The test data can be automatically uploaded to the data management center for data. Management and storage, which is convenient for users to manage and control the sealing performance of product packaging on the production site.
Figure
In addition to sealing performance, the heat seal strength, water vapor transmission rate, oxygen transmission rate and other properties of the blister package will also have an important impact on the quality of the packaged drug. The corresponding testing equipment can be viewed at Or to consult. The more you understand, the more you trust! Labthink is looking forward to enhancing technical exchanges and cooperation with enterprises and institutions in the industry!
3 Mm /8 Mm Nano Tip,Electronic Board Marker Pen,Touch Board Marker Pens,Infared Smart Board Marker
Shenzhen Ruidian Technology CO., Ltd , https://www.szwisonen.com