Abstract: Biological preparations are various forms of preparations for the prevention (health care), treatment and diagnosis of various physiological symptoms of human body. The packaging should have high barrier properties to ensure the performance of biological preparations. This paper uses Labthink OX2/230 oxygen transmission rate test system to test the barrier performance of APS bottle to external oxygen, and introduces the basic process of the test and the scope of application of the test equipment, equipment parameters, etc. The relevant biopharmaceutical industry can choose Refer to the packaging materials and oxygen barrier equipment.
Keywords: biological agents, APS bottles, oxygen barrier, oxygen barrier properties, oxygen transmission rate, oxygen transmission rate test system
1, meaning
In the pharmaceutical industry, biological agents are specifically referred to as immunological biological preparations, which are processed by microorganisms (bacteria, rickettsia, viruses, etc.) and their metabolites, effective antigen components, animal toxins, human or animal blood or tissues. , treatment, diagnosis of infectious diseases or other related biological products. According to its own characteristics, its packaging should have protective isolation functions, such as high barrier properties and sealing performance. If the oxygen barrier property is low, that is, the oxygen transmission rate is high, some components in the biological preparation are easily generated by oxygen. Oxidation causes discoloration of biological agents, reduction of efficacy, and even microbial contamination. Therefore, production companies should strengthen the key monitoring of the oxygen barrier of APS bottle packaging.
Figure 1 APS bottle for biological preparations
2, the implementation of standards
The domestic oxygen transmission rate test method for plastic packaging is mainly the coulomb test method, GB/T 31354 "Package and container oxygen permeability test method coulomb test method" stipulates that the coulomb method is used under steady state conditions. Test methods for oxygen permeability of packages and containers, and oxygen permeability tests for packaging materials such as plastics and composite packages and containers having a volume of 2 L or less in a dry environment.
3, test samples
APS bottle provided by a company.
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: including oxygen permeability test for bottles, bags, cans, boxes, and barrels made of plastic, rubber, paper, paper-plastic composite, glass, metal, etc., such as biologics APS bottles, cola bottles, peanut oil Barrel, Tetra Pak packaging, vacuum packaging bags, metal three-piece cans, plastic cosmetic packaging, toothpaste hoses, jelly cups, yogurt cups, etc.
Film type: oxygen transmission rate test of film materials such as various plastic film, plastic composite film, paper-plastic composite film, co-extruded film, aluminized film, aluminum foil, aluminum foil composite film, etc.
Sheet class: including oxygen permeability test of various engineering plastics, rubber, building materials and other sheet materials, such as PP sheet, PVC sheet, PVDC sheet.
In addition, the special configuration fixture of this equipment can also be applied to oxygen transmission rate test of special packaging such as medical packaging, automobile fuel tank, battery plastic casing, plastic pipe and solar backing.
(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 identical 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) Apply the quick-solid glue to the APS bottle mouth and fix it on the instrument-specific container test tray device. After the seal is completed, connect it to the instrument with the pipeline, and then use the sealed bag to carry the sample and the tray device. Seal the dressing.
(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 APS plastic bottle for biologics tested herein was 0.27453 cm3/pkg·d.
7. Conclusion
OX2/230 Oxygen Permeability Tester is a oxygen barrier test equipment for professional testing packaging containers. It has the advantages of high test efficiency, high precision of test results, good accuracy and repeatability, and can be used in addition to packaging containers. Oxygen transmission rate of samples such as packaging films and sheets. Labthink has been committed to providing professional testing services and equipment to customers around the world. Over the years, it has provided tens of thousands of oxygen permeability testing services to customers around the world, including different types of containers and film products from many companies at home and abroad. Provide reliable data support. For related testing equipment and testing services, you can log in to view. The more you understand, the more trust! 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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