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KMID : 1142220230180010071
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Regulatory Research on Food, Drug & Cosmetic
2023 Volume.18 No. 1 p.71 ~ p.79
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A Study on the Evaluation Method of the Pore Size of Filter for Infusion Instruments
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Lee Won-Hoi
Lee Seung-Won
You Sung-Min
Choi Jeong-Yeol
Kim Eun-Song
Jung Kyu-Jin
Chun Youn-Wook
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Abstract
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Infusion instruments used for the purpose of injecting medicine into patients are used by combining filters of various pore sizes for the purpose of removing microorganisms, particulates, and air. Filter of appropriate pore size shall be used depending on the purpose of use and the injection used. However, there is no standardized test method that can check the pore size, and it is difficult to identify defects in the manufacturing process because there is no test method in the form of medical devices. Here, we applied the evaluation of 0.2 μm and 1.2 μm pore sizes, which are mainly used in infusion instruments filters, to infusion instruments by approaching them as non-destructive testing methods and microbial testing methods. The maximum pore size and mean flow pore size of the through pores can be calculated from the pressure relationship with the amount of gas passing through the filter. This test method can be performed to measure the pore size non-destructively. In addition, the pore size of the filter was confirmed through the reduction rate of the removed microorganisms by passing the selected microorganisms by pore size through the filter. Through these evaluation methods, the integrity of the filter can be confirmed by checking the pore size of various filters, and the safety of the infusion instruments can be confirmed.
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KEYWORD
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Infusion instruments, Filter, Pore size, Removal of microorganisms
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