GMP compliant microbiological monitoring in hot cells for radiopharmaceuticals preparations

Abstract

Radiopharmaceuticals are produced inside specialized equipment named hot cell. The integration between cleanrooms and hot cells allows the radiopharmaceutical production to meet radiological protection and Good Manufacturing Practices (GMP) standards, as established by regulatory agencies. The installation of a hot cell in a pharmaceutical cleanroom is a complex activity that must be documented and validated through qualification protocols. This study aims to perform microbiological monitoring in a hot cell for aseptic radiopharmaceutical preparations at the IPEN radiopharmacy facilities, considering the active air, settle plates, contact plates, and indirect samples of gloves and clamps, as part of the equipment’s Operation Qualification (OQ) protocol. Microbiological monitoring was performed in five chambers of the hot cell (grade A and B). Four of the five chambers presented microbiological contamination within the limits established by the standard for all tests performed. The fifth chamber (Material Outlet) presented technical and construction limitations that prevented the active air sample test from being performed, so the hot cell partially met the regulatory requirements. Complementary tests, such as air cleaning by concentration of non-viable particles, detection of leaks in filtration systems, and air flow testing will contribute to justify the classification of the Material Outlet chamber.