Best practices to reduce microbial contamination during media-fill testing process in hospital pharmacies: a scoping...

The Media-Fill Test is a crucial procedure in the pharmaceutical industry, especially for the production of sterile drugs that do not undergo terminal sterilization (meaning they are prepared directly under aseptic conditions).The primary goal of the Media-Fill Test is to evaluate the overall effectiveness of the aseptic process in preventing microbial contamination. It doesn't serve to test the sterility of an individual production batch, but rather to: Validate the aseptic process, Qualify personnel, Identify critical points and Verify the environment. The aim of this scoping review is To evaluate the enabling factors for successful media-fill tests to prevent microbial contamination of sterile preparations in hospital pharmacies.

A scoping review was conducted following Arksey and O'Malley's 5-stage methodological framework and the PRISMA-ScR checklist. A systematic search was performed on PubMed, Web of Science, and Scopus electronic databases for articles published between January 1990 and December 2024, using relevant search terms. Peer-reviewed articles in English reporting tools and strategies to reduce contamination risk in ISO Class 5 environments were included. Two independent researchers screened titles and abstracts, and a third resolved conflicts. Data were extracted using a tailored electronic sheet and synthesized through an iterative thematic analysis approach.

Thirteen documents were retrieved and two main thematic areas were identified: training and automation. Continuous and diversified training, emphasizing practical learning and the use of innovative tools like simulation and virtual reality, emerged as crucial. Studies highlighted the importance of practical training before entering the profession and the effectiveness of simulation-based training approaches. Regarding automation, automated processes, including robotics, showed a positive impact on reducing contamination and standardization, with lower failure rates compared to manual methods, although with variability in preparation times.

The findings underscore the need for targeted training programs that standardize aseptic techniques and integrate automation technologies. This multifaceted approach requires commitment at all organizational levels: management must recognize patient safety as a fundamental pillar, middle management must lead implementation and foster engagement, and professionals must adopt a culture of continuous training and collective responsibility. While the review is limited by the geographic scope and methodological heterogeneity of the included studies, it identifies relevant trends and thematic areas for improving sterile preparation practices.

Multidisciplinary training programs that integrate simulations and automation are essential for enhancing patient safety in daily practice, strengthening healthcare professionals' skills and confidence, and optimizing the interdependence between personnel and technology.