TY - JOUR 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 SP - e63 LP - e68 DO - 10.1136/ejhpharm-2018-001757 VL - 27 IS - e1 AU - Luigia Sabatini AU - Demis Paolucci AU - Francesco Marinelli AU - Anna Pianetti AU - Monica Sbaffo AU - Celestino Bufarini AU - Maurizio Sisti Y1 - 2020/03/01 UR - http://ejhp.bmj.com/content/27/e1/e63.abstract N2 - 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. ER -