Utilization of Clean Room for Radiopharmaceutical Kits Production

Abstract

The radiopharmaceutical kit production facilities usually use a clean room with an aseptic process. Therefore, it is very important to conduct research on clean room utilization for the production of radiopharmaceutical kits. The data was taken from radiopharmaceutical product that produced at Center for Radioisotope and Radiopharmaceutical Technology (PTRR), National Nuclear Energy Agency (BATAN) from 2015 to 2018. The results indicate the use of clean room depends on the drying duration of the radiopharmaceutical kit. Almost all radiopharmaceutical kits are dried for two days such as MIBI, MDP, Ethambutol, MAA, and Tetrofosmin kits. There are only two kits that are dried for one day, DTPA and EDTMP kits. The ratio of monitoring of drying temperatures during the drying process of DTPA kit (one day) and MDP kit (two days) shows that in 2015 the freeze dryer still showed maximum performance compared to the next three years. The optimal utilization of clean room is in 2015 as much as 100% while in 2016, 2017 and 2018 the average utilization of clean room is around 66%. The production process frequency is the lowest in June, followed by January and December due to the maintenance schedule. The longer the process of drying radiopharmaceutical kits, the longer the clean room facilities operate. The production process of radiopharmaceutical kits in 2015 is the most optimal.