Qualification of Dispensing Device for the Production of Iodine-131 Capsule

Full-text: Qualification is a process of assurance that a specific system, premises or equipment are able to function and operate consistently. The qualification process is performed before any product is issued or marketed. The first stage in the production of iodine-131 capsule is the qualification of the dispensing device where it is integrated into a hot cell. This device is a filling dispenser that delivers a specified amount of radioactive iodine-131 into the capsule. As such, the volume dispense will correspond to the amount of iodine-131 activity or dose given to patient. Consequently, the qualification process of the filling device is important to ensure the correct volume is dispense into each capsule every time. For the qualifying process, distilled water was used as a blank to replace the radioactive iodine-131. The entire qualification process is done in iodine clean room. The materials required for the qualification process are vials, rubber stopper, aluminum cap, pipette tips, distilled water and weighing balance. All vials, rubber stoppers and aluminum caps used were labeled and weighed before and after filling with distilled water. Data were recorded and reported to the Qualification Team. The qualification report fulfils one of the GMP licensing requirements for iodine-131capsule. (author)