Media Fill Test for Validation of Non-Radioactive Kit for Radiopharmaceutical Preparations

Abstract

Introduction: The administration of improperly prepared intravenous fluids might determine healthcare-associated infections. Quality and sterility assurance in radiopharmaceutical manufacturing products must be evaluated by media fill tests that simulate the performance of the aseptic manufacturing procedure. The aim of this study is to show a methodological modification of a specific step of media fill tests, giving an overview of economic and organizational advantages that it might bring.

Materials and methods: Media fill tests were conducted to ensure that they reproduce as strictly as possible the routine aseptic production process with all the critical steps described in the internal Standard Operating Procedures. We introduced an innovative modification in step 1: instead of using a completely decayed ⁹⁹Mo/^99mTc generator, we used a⁹⁹Mo/^99mTc generator just before its disposal, eluting it with saline solution aspirated in an empty vacuum vial.

Results: A total of 47 production runs were performed, and a total of 799 vials were tested for sterility. Thirteen nuclear medicine technicians were assessed. We found contamination in 1% of the total number of vials analyzed.

Conclusions: The modification proposed shows several advantages: reduction of the costs of the media fill tests, the possibility to manage these without referring to external services, and decreased injuries for technicians who perform the tests.

Keywords: Mediafill tests; aseptic assurance; healthcare associated infections; microbial contamination; nonradioactive; sterile products.