The Importance of Filter Integrity Test to Ensure Sterility of Radiophamaceuticals for Using PET Image

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.