IV 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 IV bag manufacturers.
Jinan, China, February 20, 2009 --(PR.com)-- Intravenous injection containers include glass bottles, intravenous bottle (PP or PE), IV bags (PVC and non-PVC), but the trend is IV bag.
1 IV Bag Needs Material Barrier Test
New IV bag has many prominent advantages over traditional glass package, but IV 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 IV bag.
2 The Influence of Nitrogen Permeation Rate Test
Nitrogen transmission rate test through IV 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 IV bag manufacturers will choose the differential pressure test instrument when they are purchasing gas barrier property test instruments.
3 Perspectives on IV Bag Standards
Now, there was few national standard for container test, but whole IV 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 IV bag permeation rate is expected to be included in the next standard revision. Consequently some test institutes and IV bag manufacturers are ready to buy or buying the equal pressure principle instruments.
4 The Development of Test Technology
Generally speaking, the current IV bag film gas permeation test needs manometric principlel instrument. But if it is the oxygen permeation rate test of IV 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 IV bags and bottles. It is a better test equipment choice to medical packaging industry and IV 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
###
1 IV Bag Needs Material Barrier Test
New IV bag has many prominent advantages over traditional glass package, but IV 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 IV bag.
2 The Influence of Nitrogen Permeation Rate Test
Nitrogen transmission rate test through IV 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 IV bag manufacturers will choose the differential pressure test instrument when they are purchasing gas barrier property test instruments.
3 Perspectives on IV Bag Standards
Now, there was few national standard for container test, but whole IV 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 IV bag permeation rate is expected to be included in the next standard revision. Consequently some test institutes and IV bag manufacturers are ready to buy or buying the equal pressure principle instruments.
4 The Development of Test Technology
Generally speaking, the current IV bag film gas permeation test needs manometric principlel instrument. But if it is the oxygen permeation rate test of IV 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 IV bags and bottles. It is a better test equipment choice to medical packaging industry and IV 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
###
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Labthink Instruments Co.,Ltd.
Tracy Bao
86-531-85061153
www.labthink.cn
Tracy Bao
86-531-85061153
www.labthink.cn
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