Abstract: Medical blister packaging is a common form of packaging in medicine. It has high barrier properties and good sealing performance. It can isolate the interference between drugs, and the oxygen barrier performance of medical blister packaging directly affects the quality of blister. An important factor in pros and cons. In this paper, Labthink OX2/230 oxygen transmission rate test system is used to test the barrier performance of capsule blister packaging to external oxygen. The basic process of the test, the applicable scope of the test equipment, equipment parameters, etc., related health products, The pharmaceutical industry can be used as a reference when selecting packaging materials and oxygen barrier devices.
Key words: medical blister, oxygen barrier, oxygen barrier performance, oxygen transmission rate, oxygen transmission rate test system
1, meaning
With the continuous updating of pharmaceutical packaging forms, blister packaging has become an important part of the current pharmaceutical packaging market with its advantages of good protection, convenient use and light weight. Blister packaging, also known as blister packaging, PTP packaging, is mainly composed of two parts, respectively, plastic blister with blister and 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.
If the blister package has poor oxygen barrier property, that is, the oxygen transmission rate is too large, it is easy to cause discoloration and deterioration of the drug, which not only affects the drug efficacy and shelf life of the drug, but also seriously affects the brand image of the pharmaceutical company, and the profit of the enterprise declines. Therefore, pharmaceutical companies should strengthen the key monitoring of the overall oxygen barrier of blister packaging.
Figure 1 Medical blister packaging
2, the implementation of standards
The domestic oxygen transmission rate test method for packaging parts is mainly the coulomb test method, GB/T 31354-2014 "Package and container oxygen permeability test method coulomb test method" This standard was implemented in 2015, stipulated Test method for the oxygen permeability of packages and containers by coulometric method under steady state conditions, and oxygen permeability for packaging materials such as plastics and composite packages and containers suitable for use in dry environments with a volume of less than 2L. Passive test.
3, test samples
Capsules supplied by a pharmaceutical company are packaged in blister packs.
4, test equipment
Jinan Languang Electromechanical Technology Co., Ltd. independently developed and designed the OX2/230 oxygen transmission rate test system.
Figure 2 OX2/230 oxygen transmission rate test system
4.1 Test principle
The OX2/230 uses the isostatic test principle to clamp a pre-treated sample between test chambers, with oxygen or air flowing on one side of the membrane and high purity nitrogen flowing on the other side of the membrane. Oxygen molecules diffuse through the membrane to the high purity nitrogen in the other side and are carried to the sensor by the flowing nitrogen. By analyzing the oxygen concentration measured by the sensor, parameters such as oxygen transmission rate are calculated. For packaging containers, high purity nitrogen flows within the container, and air or high purity oxygen surrounds the outside of the container.
4.2 Scope of application
(1) This equipment is suitable for oxygen transmission rate testing of containers, plastic film, sheet, paper, cardboard and composite materials.
Containers include oxygen transmission rate tests for bottles, bags, cans, boxes, and barrels made of plastic, rubber, paper, paper-plastic composite, glass, metal, etc., such as medical blister, cola bottle, peanut oil drum, Tetra Pak packaging, vacuum packaging bags, metal three-piece cans, plastic cosmetic packaging, toothpaste hoses, jelly cups, yogurt cups, etc.
The film-like materials include oxygen transmission rate tests of film materials such as various plastic films, paper-plastic composite films, aluminized films, aluminum foils, and aluminum foil composite films.
The sheet material includes oxygen transmission rate tests of various sheet materials such as engineering plastics, rubber, and building materials, such as PP sheets, PVC sheets, and PVDC sheets.
In addition, this equipment can be applied to special packaging oxygen transmission rate test such as pharmaceutical packaging, automobile fuel tank, battery plastic casing, plastic pipe, solar back panel, etc. after configuring special fixtures.
(2) This equipment can meet a number of national and international standards, such as GB/T 31354, ISO 15105-2, GB/T 19789, ASTM D3985, ASTM F2622, ASTM F1307, ASTM F1927, JIS K7126-2, YBB 00082003.
4.3 Equipment parameters
Test range: container test 0.0001 ~ 60 cm3 / pkg · d, film test 0.01 ~ 6500 cm3 / (m2 · d).
Number of samples: Three or three different samples can be tested simultaneously.
Resolution: container 0.00001 g/pkg·d, film 0.001 g/m2·24h.
Test temperature range: 15 ° C ~ 55 ° C, temperature control accuracy ± 0.1 ° C.
Test humidity range: 0% RH, 35% RH ~ 90% RH, temperature control accuracy ± 1% RH.
Test gas: O2, air (air source user-supplied).
The system can support up to 10 instruments in parallel connection, and establish an efficient system for simultaneous testing of 30 samples.
It can be combined with the water vapor transmission rate test system to form a hybrid test system, which is controlled by a computer to achieve an efficient and convenient test method for simultaneous oxygen and water vapor transmission rate testing.
Support LystemTM laboratory data sharing system to manage test results and test reports.
5, the test process
(1) Fix a separate blister package sample on a special fixture and fix it on the instrument-specific container test tray device. After the seal is completed, connect it to the instrument with a pipe, and then use a sealed bag to take the sample. And the tray device is sealed and wrapped.
(2) Set the sample name, test temperature, test humidity and other parameters.
(3) Click the "Start Test" option.
(4) Start the air supply, adjust the humidity and the carrier gas flow.
(5) After the test is over, the instrument automatically calculates and displays the test results.
6, test results
The oxygen permeability of the medical blister pack tested herein was 0.0368 cm3/pkg·d.
7. Conclusion
The OX2/230 Oxygen Transmission Rate Test System is an oxygen transmission rate tester for film and container testing. It is easy to operate, with high test accuracy and high repeatability. In addition to the oxygen barrier properties, medical blister packaging should also strengthen the overall sealing performance, heat seal strength and water vapor transmission rate and other key projects. As a leader in the development and manufacturing of packaging inspection equipment, Labthink provides professional, high-end packaging inspection equipment and testing services to customers around the world. Learn about its related testing equipment, you can log in to view. Jinan Languang Electromechanical Technology Co., Ltd. is willing to enhance technical exchanges and cooperation with enterprises and institutions in the industry.
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