TY - JOUR T1 - Assessment of <sup>99m</sup>Tc-bicisate (Neurolite®) sterility when used for ictal studies. JF - Journal of Nuclear Medicine JO - J Nucl Med SP - 164 LP - 164 VL - 62 IS - supplement 1 AU - Jenna Allen AU - Tim Houston AU - Gabrielle Humphrey AU - Steven Kowalczyk AU - Michelle Gruchot AU - Gary Dillehay Y1 - 2021/05/01 UR - http://jnm.snmjournals.org/content/62/supplement_1/164.abstract N2 - 164Objectives: According to USP General Chapter &lt;825&gt;, a radiopharmaceutical may no longer be sterile one hour after it has been exposed to ambient air during preparation. At Northwestern Memorial Hospital, 99mTc-bicisate is prepared under aseptic conditions within an ISO Class 5 certified hood. After product purity is confirmed via thin layer chromatography testing, a unit dose is dispensed. For ictal studies, the administration setup is assembled in ambient air. This setup allows for immediate administration in the event the patient experiences a seizure. The setup may be in place for up to five hours before being replaced with a new dose administration set if needed. Although USP &lt;825&gt; does not apply to the administration of radiopharmaceuticals to patients, the purpose of this research is to determine whether or not the current setup used at Northwestern Memorial Hospital remains sterile throughout the maximum assembled time period. Methods: 99mTc-bicisate was prepared per approved protocol using fresh sodium pertechnetate within a certified ISO Class 5 primary engineering control. Five separate 99mTc-bicisate unit doses were dispensed each calibrated at 25 mCi with a final volume of 2.0 mL. The five doses were then each assembled in ambient air into the normal administrative setup used which includes a unit dose, a sterile 10 mL 0.9% sodium chloride syringe, and one sterile IV line all connected by a three-way stopcock. The line was primed with sterile 0.9% sodium chloride before being connected to the three-way. Five hours later, the doses were each administered into a sterile collection vial. Tryptic Soy Broth (TSB) was added to each vial to support the growth of microorganisms. Both positive and negative control vials were included. The vials were then stored for 7 days at 20 to 25° C followed by an additional seven days at 30 to 35° C with daily documentation of temperature and either negative or positive growth. Results: The five 99mTc-bicisate administration sets were evaluated daily with temperature and findings documented. The final results are summarized in Table 1. Conclusions: The results revealed that there was no microbial growth among all five administrative setups through a period of five hours. The results of this research study support the ictal study protocol used at Northwestern Memorial Hospital. ER -