Article Text

Download PDFPDF

Microbiological validation of a robot for the sterile compounding of injectable non-hazardous medications in a hospital environment
  1. Luigia Sabatini1,
  2. Demis Paolucci2,
  3. Francesco Marinelli3,
  4. Anna Pianetti1,
  5. Monica Sbaffo4,
  6. Celestino Bufarini4,
  7. Maurizio Sisti1
  1. 1 Department of Biomolecular Sciences, University of Urbino Carlo Bo, Urbino, Italy
  2. 2 Loccioni Humancare, Moie di Maiolati Spontini, Spontini, Italy
  3. 3 Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy
  4. 4 AOU Ospedali Riuniti, Clinical Pharmacy, Ancona, Italy
  1. Correspondence to Professor Maurizio Sisti, Department of Biomolecular Sciences, Sec Toxicological, Hygienistic and Environmental Sciences, Urbino, Italy; maurizio.sisti{at}


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.

  • drug manufacturing / preparation / compounding
  • aseptic preparation
  • compounding robots
  • sterile production
  • dispensing robots
  • good distribution practice (gdp)
View Full Text

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.