Implementation and validation of an in-house combined fluorescein/media-fill test to qualify radiopharmacy operators.

ABSTRACT:

Background

The purpose of this work was to design, validate and implement a media-fill test combined with fluorescein (MFT-F) for the specific qualification and training of radiopharmacy operators, in accordance with United States Pharmacopeia General Chapter 797 and European Good Manufacturing Practices. MFT-F was embedded in the quality management system of our radiopharmacy unit. Its validation involved fluorescein concentration choice, media growth promotion test and evaluation protocol controls (with or without intentional aseptic mistakes). Each operator was evaluated following a three-part evaluation form. Evaluation criteria related to garbing and hygiene, fluorescent contamination and bacteriological contamination (pre- and post-evaluation environment controls and MFT-F sa

SUBMITTER: Fersing C 

PROVIDER: S-EPMC7790972 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature