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The Importance of Filter Integrity Test to Ensure Sterility of Radiophamaceuticals for Using PET Image
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  • The Importance of Filter Integrity Test to Ensure Sterility of Radiophamaceuticals for Using PET Image
  • The Importance of Filter Integrity Test to Ensure Sterility of Radiophamaceuticals for Using PET Image
저자명
Cho. Yong-Hyun,Park. Jun-Hyung,Hwang. Ki-Young,Kim. Hyung-Woo,Lee. Hong-Jae,Kim. Hyun-Ju
간행물명
핵의학기술
권/호정보
2008년|12권 1호|pp.74-77 (4 pages)
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대한핵의학기술학회
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정기간행물|ENG|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

The radiopharmaceuticals are routinely injected to blood vessel for acquiring PET image. For this reason, It is imperative that they undergo strict quality control measures. Especially, Sterility test is more important than any other quality control procedures. According to the FDA guideline, It requires filter integrity test used in the processing of sterile solutions. Among several methods, we can decide to use bubble point test. We usually use vented GS-filters (Millipore co., USA) which are sterilizinggrade (0.22 um pore size) and are placed upper site on product vial. After the synthesis of $^{18}F$-FDG, solutions wet the membrane in filter and then go into the product vial. By all synthesis steps have finished, we can observe the presence of the bubbles in the product vial. Since we have started this study, we have never found any bubbles in the product vial. Because the maximum pressure intensity of the filter which has set by manufacturer is up to 5 bars, but helium gas pressure is up to 1 bar in our module system. So, we can make 5 bars pressure using helium gas bombe and increase pressure up to 5 bars step by step. However, it does not happen to anything in vial.