The process simulation test was conducted over two days in October 2009, under the direction of a third party industrial hygienist, to examine the drug handling capacity of RIVA and its effect on environmental and worker contamination.
Previous validation tests conducted in 2008 found that RIVA was effective in meeting requirements for compounding sterile doses.
"The positive results of this study are very rewarding for the IH Systems team as the acceptance of advanced, robotic technology is dependent on its performance," said Niels Erik Hansen, ceo of IH Systems. “These studies prove RIVA not only eliminates potential microbial contamination in the direct compounding area introduced by human contact but also reduces drug residue in the compounding environment and on surfaces of prepared doses.”
The study examined drug handling in the RIVA ISO 5 cell including the potential for drug cross contamination in final doses; drug contamination on surfaces in the cell; contamination on surfaces of final doses; and air contamination with drug both in the cell and in personal air samplers of workers who interact with the robot. Results demonstrated marked improvement over similar studies of hazardous drug handling.
RIVA allows hospital pharmacies to compound sterile preparations in a United States Pharmacopeia (USP) 797 environment while outputting doses in either syringes or bags. The automation of repetitive and complex tasks reduces errors and contamination, the company says.
The University of California Medical Centre in San Francisco, US has bought three RIVA systems, two antibiotic systems and one for preparing chemotherapy doses for its pharmacy. It will allow UCSF to compound ready to use sterile doses that are currently manually handled or purchased from outside vendors, improving production control and patient safety.
Contact www.rivasystem.com