RT Journal Article SR Electronic T1 Microbiological validation of a robot for the sterile compounding of injectable non-hazardous medications in a hospital environment JF European Journal of Hospital Pharmacy JO Eur J Hosp Pharm FD British Medical Journal Publishing Group SP e63 OP e68 DO 10.1136/ejhpharm-2018-001757 VO 27 IS e1 A1 Luigia Sabatini A1 Demis Paolucci A1 Francesco Marinelli A1 Anna Pianetti A1 Monica Sbaffo A1 Celestino Bufarini A1 Maurizio Sisti YR 2020 UL http://ejhp.bmj.com/content/27/e1/e63.abstract AB Objectives To design and execute a comprehensive microbiological validation protocol to assess a brand-new sterile compounding robot in a hospital pharmacy environment, according to ISO and EU GMP standards.Methods Qualification of the Class-A inner environment of the robot was performed through microbial air and surface quality assessment utilising contact plates, swabs and particulate matter monitoring. To evaluate the effectiveness of the microbial decontamination process (UV rays) challenge test against Pseudomonas aeruginosa, Staphylococcus aureus, Bacillus subtilis spores and Candida albicans was used. The challenge Media Fill test was used to validate the aseptic processing.Results After 3 hours, no microorganisms retained viability. Monitoring inside the equipment evidenced complete absence of microorganisms. The Media Fill test was always negative.Conclusions According to our results, the APOTECAunit meets the requirements for advanced aseptic processing in the hospital pharmacies and the pharmaceutical industry in general, providing advantages in terms of safety for patients compared with conventional procedures of parenteral preparation production. The protocol has demonstrated to be a comprehensive and valuable tool in validating, from a microbial point of view, a sterile-compounding technology. This study might represent an important benchmark in developing a contamination control strategy, as required, for example, in the Performance Qualification of the GMP in the case of drug manufacturing.