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The Analysis on Infusion Bag Testing Requirements and Introduction to Relevant Testing Methods

The Analysis on Infusion Bag Testing Requirements and Introduction to Relevant Testing Methods
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The Analysis on Infusion Bag Testing Requirements and Introduction to Relevant Testing Methods - 1

The Analysis on Infusion Bag Testing Requirements and Introduction to Relevant Testing Methods Abstract: Infusion bag (or IV bag) is the future trend for the packaging of injection liquid. This article analyses the testing requirements for infusion bags, and introduces the testing methods for specific indexes based on the testing standards for pharmaceutical packaging material. Key Words: infusion bag, oxygen transmission rate (OTR), nitrogen transmission rate, suspension force, piercing force Compared with traditional glass packaging, infusion bag is more environmental-friendly, cost-saving, safe, healthy and convenient. In USA and many European countries, plastic infusion package/container has taken up a great market share. Though fierce competition exists between infusion bag and plastic infusion bottle, the trend of flexible plastic packaging for injection liquid is irresistible. Differing from the traditional glass infusion bottle testing, more specific and appropriate performance testing for infusion bags should be applied so as to guarantee the safety of injection liquid. 1. The Analysis on the Testing Requirements for Infusion Bag Infusion bag is inferior to the glass bottle in the barrier property, sealing property and transparency; among which, barrier property is greatly influenced by material change. Oxygen is the main cause for deterioration of injection liquid. In order to lower the oxygen content inside the infusion bag and postpone/stop the oxidization of the injection liquid, anti-oxidants, metal chelate agents or inert gases are adopted. As to inert gases for this purpose, the most commonly applied inert gas is nitrogen. Water vapor would transmit into the bag and result in concentration change of the injection liquid, whose medicinal safety would be endangered. Therefore, barrier property testing is very important for infusion bag. Besides, the mechanical indexes of film materials and glass materials are fundamentally different. The mechanical testing for infusion bag is, therefore, very important. Meanwhile, the combinational closure used in the infusion bag should also be tested so as to meet the standards and actual application. 2. Barrier Property Testing for Infusion Bag The testing requirements for water vapor transmission rate (WVTR), oxygen transmission rate (OTR) and nitrogen transmission rate are stated in YBB00102005, 3-layer Co-extrusion Films and Bags Used for Infusion, and YBB00112005, 5-layer Co-extrusion Film (I) and Bags Used for Infusion. At present, the technology for whole infusion bag barrier property testing has become mature. Since there is no support from the national standards, the above-stated YBB standards don’t mention barrier property testing. Actually, owing to the evenness of the material, sealing property of the mouth and other factors, the actual gas transmission rate of the whole infusion bag is higher than the calculated value of the film. Thus, gas transmission rate testing of the whole infusion bag is of great need. Oxygen transmission rate (OTR) testing is mainly used for oxygen transmission rate measurement of infusion bag film materials, infusion bags or the whole infusion bottles. Equal pressure method and differential pressure method, the two methods for oxygen transmission rate testing can both test the oxygen transmission rate of films and of the whole infusion bags and bottles. Those two methods have their respective advantages: differential pressure method has no requirements for testing gas, and can be used to test the transmission rate of any gas. Thus, this method can be used to test nitrogen transmission rate without further costs. However, this method is still at the www.labthinkinternational.com.cn

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The Analysis on Infusion Bag Testing Requirements and Introduction to Relevant Testing Methods - 2

initial stage in package testing. On the other hand, equal pressure method has become mature both for film testing and package testing. Yet, there exist limitations for testing gas. Water vapor transmission rate (WVTR) testing is used for water vapor transmission rate measurement of infusion bag film materials, infusion bags or the whole infusion bottles. At present, weighing method and sensor method (including moisture sensor method, IR sensor method and electrolytic sensor method) can both be used to test water vapor transmission rate for films as well as for whole infusion bags and...

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The Analysis on Infusion Bag Testing Requirements and Introduction to Relevant Testing Methods - 3

4.3 Pull Open Force Testing The open easiness of the pull open cap ring would directly influence the operational convenience of the infusion bag and the safety of the injection liquid. This force should be within a specific force range so as to avoid open difficulty, low tensile force and the corresponding leakage caused by decreased sealing performance of the infusion bag. The pull open force can be tested in the following way: sterilize the specimen with wet heating treatment. Then, fix the specimen onto the fixture of the auto tensile tester, and the pull open ring onto the other...

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