(Editor's note: Part One of this series described how Asheville, NC-based Mission Health made use of two RIVA™ automated IV compounding systems from ARxIUM that sterile-fill liquids and lyophilized products into IV syringes and bags for administration to Mission Health patients. Part Two takes a detailed look at the syringe and IV bag filling process.)
The RIVA automated system prepares injectable doses in syringes and IV bags for Mission Health, performing all critical processing inside an ISO-Class 5 cleanroom enclosure with managed airflow to reduce the risk of contamination. The overall compounding process is both complex and variable.
Within the machine’s chamber are several automation stations, including a cleanroom version of the Staubli six-axis robot, which is positioned in the middle of the chamber and is the primary system for moving materials throughout the chamber.
Attached to the robot is a gripper with a special multi-tool design that allows it to handle various medication vials, syringes and IV bags. This robot was selected because of its flexibility, accuracy and the non-shedding cleanroom version necessary for aseptic dose processing.
The raw materials needed (medication vials, empty syringes, IV bags and syringe caps) are loaded externally via a flexible inventory carousel system. These materials enter the chamber through successive pass-through systems to minimize any risk of entry of outside air.
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The carousels are separated from the compounding area via walls and air barriers, and accessed by pass-through doors with air management that is designed to limit outside air from entering the inventory areas. During run-time, the carousels present items as needed to the robot, which loads, stages and supports the processing through all the other stations. This includes interacting with:
- Autonomous syringe manipulators that hold vials and syringes and perform all of the fluid transfers needed, under computer control. (These are called the SMU and SMD, for Syringe Manipulator needle Up and Down, reflecting the orientation of the syringe needle during operation). The robot interacts with these stations to place and remove syringes, vials and bags as needed.
- Vision-based identification stations (vial and bag ID stations) allow the system to identify and confirm that the materials (label, weight, item dimensions) are as expected.
- UV LED systems for disinfection of vial and bag ports (Port Disinfection System), where the robot presents, engages and holds items at a station and then flashes the port surfaces with UV light to kill bacteria and spores.
- Two different scales provide confirmation of fluid transfers by weight, where the robot places vials, bags and syringes on the scales and removes them once confirmed.
- Systems to automatically remove needle caps and needles from syringes (de-needler station) when the robot controller coordinates its move with the station’s hardware.
- Capping station that uses use a vision-based system to find the center of press-on caps within a cap tray, and then pass (X,Y) positioning data to the robot so it can align the syringe tip to the caps for engagement and attachment to the syringe tip.
- Two different printing stations use the robot to apply labels to syringes and IV bags and confirm labels are attached to syringes and bags prior to output.
- Interacts with a pass-through system to output prepared doses.