Home » Science and Research Articles » Intravenous Bag Barrier Test Requirements and Prospect
Intravenous Bag Barrier Test Requirements and Prospect
Abstract:Labthink introduced PERME-DM2/330 tester with two methods gas permeation testing instrument, as a better option for medical packaging system and intravenous bag manufacturers.
SHANDONG, CHINA, February 19, 2009 /Science and Research PR News/ -- Intravenous injection containers include glass bottles, intravenous bottle (PP or PE), intravenous bags (PVC and non-PVC),but the trend is intravenous bag. Today, in developed countries such as European countries and the United States, intravenous injection containers account for about 96% of the total market.
1 Intravenous Bag Needs Material Barrier Tests
New intravenous bag has many prominent advantages over traditional glass package, such as environment friendly, cost, sanitary security and convenience. But intravenous bag also have disadvantages, such as barrier property, heat stability and transparency, among which barrier property is the most important one. Oxygen is the main factor which causes the deterioration of intravenous fluids. If the oxygen barrier property of intravenoous bag cannot perform well, it might cause the medicine to deteriorate before the guarantee date and the effect is unimaginable. As a result, antioxidant, metal-chelator and inert gases are often employed in order to reduce the oxygen in the packages, postpone and prevent the liquid from oxygenation. Nitrogen is stable and often used with little carbon-dioxide as ¡ inert gases¡¯ to replace the air inside bags. If the barrier property against nitrogen is not strong enough, the nitrogen would permeate through bags. It might reduce the protection effect of inert gases and increase the oxygen in the package. Vapor permeation affects the concentration of medicines especially solute liquid for injection. Such situation will increase the difficulty of medicine concentration and vital risks. As the good barrier property of glass is well known, it can be considered that gases and vapor cannot permeate through glasses. Soft plastic does not have such barrier property thus it is necessary to test the barrier property of intravenous bag.
2 The Influence of Nitrogen Permeation Rate Test
Nitrogen transmission rate test through intravenous bag film has always been noticeable. How to test the film? Currently only manometric principle instrument can test the permeation property of many gases (H2¡ N2¡ Air¡ O2¡ CO2 and so on). If the user can put the gas source under control and deal with the end gas (sometimes flammable, explosive or toxic), the instrument could be used to test the permeation property of some special gases (pay special attention to safety issue). The test process is the same with the test to ordinary oxygen. But equal pressure principle instrument cannot be used for the common-use gases permeation test. Because the test principle is not allowed. Though it is ok to use the method to test the carbon dioxide permeation rate of films, but equal pressure principle cannot test the nitrogen permeation rate of films (nitrogen is the carrier gas). Thus regarding to nitrogen permeation test, many institute and intravenous bag manufacturers will choose the differential pressure test instrument when they are purchasing gas barrier property test instruments.
However, some people argue that nitrogen and oxygen are both common inorganic gases. There is ¡ inner relationship¡¯ between the permeation rates of same kind of intravenous bag film. Estimates can be used to calculate the nitrogen permeation rate by a ratio relationship with oxygen permeation rate. This is not a normal method, thus the ratios are often the estimates of users, who read some literatures. The correctness is fairly low. A huge amount of test data also proved that estimates were often with low accuracy. As a matter of fact, there are many factors influencing the gas permeation rate of film. Furthermore, the property of materials and gases are complicated and interactive, not to mention the environmental factors and so on. Thus ratio relationship estimate is a wrong measure. Estimates often cause a wrong decision on material choice. Even it is a right decision there will still be potential risks.
3 Perspectives on Intravenous Bag Standards
The development of standards is often based on resolving current problems of products or methods. The significant problem of intravenous bag is that, because of the evenness of bag thickness and the sealing tightness, the gas permeation rate of whole bags is higher (sometimes one time higher) than the gas permeation rate deducted from film data. I think there are several factors causing the problem: first of all, the unevenness of material is a fairly common situation to intravenous bags and bottles. The unevenness can be the influence of manufacture or be the needs of design. Thus calculations based on thickness average values is often far different from actual tested data. Secondly, the sealing tightness is a key issue. The sealing tightness between intravenous bags and intravenous tubes has always been a focus. If the tightness is not strong enough, the barrier property of bags will be poor even the barrier property of the film is fairly good. Thirdly, the film area of bags is much larger than test film, which means defects appear more on bags. Now, there was few national standard for container test, but whole intravenous bag¡¯s gas permeation test is the development trend of international barrier property test. However the test can only be performed by equal pressure method. The intravenous bag permeation rate is expected to be included in the next standard revision. Consequently some test institutes and intravenous bag manufacturers are ready to buy or buying the equal pressure principle instruments.
4 The Development of Test Technology
Generally speaking, the current intravenous bag film gas permeation test needs manometric principlel instrument. But if it is the oxygen permeation rate test of intravenous bags, it needs equal pressure principle instruments. Two investments to two instruments, it raised the maintenance fee and investment of equipments as well as lower the utilization of all equipments. PERME-DM2/330, double method gas permeation rate test instrument has been introduced by Labthink Instruments Co.,Ltd. It is able to conduct differential pressure and equal pressure tests. Furthermore it can test the oxygen permeation rate of intravenous bags and bottles. It is a better test equipment choice to medical packaging industry and intravenous bag manufacturers. It can optimize the equipment cost, data accuracy and equipment utilization.
Labthink Instruments Co., Ltd.
No. 144 Wuyingshan Road, Jinan 250031, China
Jessica Xu trade@labthink.cn
Tel: 0086 531 85811021
About Labthink Instruments Co.,Ltd.
Labthink is the leading manufacture of packaging testing instruments in China. We offer good quality and permanent service.
Our products include Gas Permeability Tester. Water Vapor Permeability Tester . Tensile Tester. Heat-sealing Tester. Coefficient of Friction Tester. Friction/peel Tester. Thickness Tester. Tearing Tester. Falling Dart Impact Tester. Film Shrink Tester. Airproof Tester. Digital Torque Tester. Box Compression Tester. Primary/lasting Adhesive Tester. Rub Tester.
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