IH Systems has conducted a study which demonstrated that RIVA System (Robotic Intravenous Automation), a self-contained unit for aseptic compounding from Intelligent Hospital Systems (IH Systems), is an effective tool in automatically compounding IV doses in syringes and bags with minimal drug contamination.
The company said that 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 proved that RIVA was effective in meeting requirements for compounding sterile doses (pre-publication data).
Reportedly, 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 an improvement over similar studies of hazardous drug handling, claims the company.
Niels Erik Hansen, CEO of IH Systems, said: “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.
“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. This overall reduction of drug residue lessens the adverse exposure of staff while processing hazardous drugs.”
Jane Arnot, VP of customer sales and service at IH Systems, said: “The scrupulous research, development and commissioning program of the RIVA System has been integral in building confidence and support from directors of pharmacies worldwide. USP 797 and other regulatory guidelines set very strict parameters when it comes to sterility, accuracy and reduction of compounding risk, and meeting these requires a relentless commitment to excellence.”