Microbiological validation of a robot for the sterile compounding of injectable non-hazardous medications in a hospital environment.

Purpose To design and execute a comprehensive microbiological validation protocol to assess an brand-new sterile compounding robot. Methods Qualification of the Class-A inner environment of the robot was performed through microbial air and surface quality assessment utilizing 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. To validate the aseptic processing the challenge Media Fill test was used. Results After 3 hours, no microorganisms retained viability. Monitoring inside the equipment evidenced complete absence of microorganisms. Media Fill test was always negative. Conclusions According to our results, 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 to conventional procedures of parenteral preparation production. The protocol has demonstrated to be a comprehensive and valuable tool to validate, from a microbial point of view, a sterile-compounding technology. This study might represent an important benchmark to develop a contamination control strategy, as required for instance in the Performance Qualification of the GMP in case of drug manufacturing.