WINNIPEG, Manitoba--(BUSINESS WIRE)--Intelligent Hospital Systems (IH Systems) today announced the Australian Therapeutic Goods Administration (TGA), that nation’s equivalent of the U.S. Food and Drug Administration, has approved a workflow process in which one of Australia’s largest pharmaceutical compounders will use RIVA technology to produce patient chemotherapy doses. This is the first time the TGA has approved a drug compounding process that includes a fully automated IV compounding system in a Current Good Manufacturing Practice (cGMP) facility.
“We are excited to demonstrate the benefits of integrating IV automation technology in compounding chemotherapy medications,” said Dr. Niels Erik Hansen, president and CEO of IH Systems. “This is an important recognition that the processes, safety features and airflow design of RIVA meet the strict requirements for sterile compounding in a cGMP environment.”
The TGA is part of the Australian government’s Department of Health and responsible for regulating therapeutic goods including prescription medicines and devices, among other things. IH Systems and the compounder worked together extensively on the necessary validation of the RIVA Chemotherapy system to demonstrate the technology and processes meet TGA’s stringent requirements. With TGA’s approval, the system is now in production manufacturing doses for Australia and New Zealand.
“This is a very important step forward in pharmaceutical compounding and represents the leading edge of integrating fully automated compounding into cGMP production processes,” said Dr. Hansen. “RIVA provides a technology platform that allows drug makers to maintain rigorous compounding standards while meeting customer and patient needs.”
The partnership is significant and may provide a model for future drug production in other highly regulated countries or compounding environments, Dr. Hansen added.
About Intelligent Hospital Systems
Founded in 2006, Intelligent Hospital Systems (IH Systems) is a medical device company focused on the design and development of automated solutions for the hospital environment. Based in Winnipeg, Manitoba, IH Systems manufactures RIVA, a fully automated IV compounding system that prepares medications for syringes and IV bags in an aseptic environment. Using RIVA, hospitals enhance patient safety, lower the cost-per-dose of medications, reduce their vulnerability to medication shortages and cut waste. For more information, visit http://www.intelligenthospitals.com/.
