ARxIUM Introduces cGMP IV Compounding System for 503B Facilities
Posted on November 28, 2018
Company to host demonstrations of new RIVA system at ASHP Midyear Clinical Meeting and Exhibition December 3-5
(WINNIPEG, Manitoba – November 28, 2018) – ARxIUM, a global provider of industry-leading pharmacy automation, workflow and consulting solutions, today announced the launch of its cGMP RIVA IV compounding system for 503B central-fill, hospital and outsourcing pharmacies. As the only fully automated cGMP system on the market, it prepares syringes and IV bags in an aseptic ISO Class 5 environment and provides the highest level of medication safety, quality and monitoring.
The cGMP configuration allows pharmacies to implement RIVA’s proven safe and efficient compounding process to manufacture a wide range of medications. It also offers environmental monitoring and logging functions to meet regulatory requirements for 503B pharmacies. In fact, three systems are in late phase implementation (final operational and process qualification) for production at Florida-based 503B facilities.
At the 2018 American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting and Exhibition in Anaheim, Calif. December 3-5, ARxIUM will demonstrate the system’s unmatched compounding capabilities and other features at booth 901.
“As North America IV compounding regulations continue shifting to cGMP requirements, our new RIVA system will help meet customers’ safety and compliance needs,” said Dr. Niels Erik Hansen, president and CEO of ARxIUM. “For years, we have been closely working with customers on the installation, process and operational qualifications for cGMP in accordance with 503B regulations. As a result, we applied our expertise – with valuable customer feedback – to create the most advanced, regulatory-compliant IV compounding system available.”
The system integrates with clean room environmental monitoring systems to stop compounding
if adverse conditions occur and provide consolidated reporting. It also offers direct input to the
monitoring system about its current operational status. For example, the system automatically
records if RIVA is in production or if its doors are open. It also logs when RIVA is being cleaned,
which eliminates the need for users to manually record the activity.
Also at ASHP, ARxIUM’s leadership team will be available to discuss the industry-first
Pharmacy 4.0 initiative and observe demonstrations of its RxWorks Pro inventory management
software, MedSelect Flex automated dispensing cabinet, and FastPak Elite oral solid
medication pouch packager.
Based in Winnipeg, Manitoba and Buffalo Grove, Illinois, ARxIUM is an industry-leading developer of
pharmacy automation, workflow and consulting solutions that improve safety, productivity and workflow. The company provides solutions to shared service centers and health system, hospital, long-term care, retail and government pharmacies. ARxIUM is the developer of the only fully automated IV compounding system in the market today, and offers automated packaging, dispensing, vial filling and high volume systems. In addition, the company provides inventory management, scheduling and workflow software, technical consulting, and system implementation assistance, among other services. ARxIUM is also the creator of the Pharmacy 4.0 approach, which seamlessly converges clinical pharmacy, central production and automation advancements into fully automated, interactive data processes. The approach allows pharmacies to better monitor and react in real-time to address patient care and medication delivery demands. For more information, visit www.arxium.com.
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