The packaging solution from Trasis allows the preparation and the injection of single patient doses of PET and SPECT radiopharmaceuticals. It addresses in a global way the needs of the radiopharmaceutical industry for a more efficient, faster and safer preparation method of unit doses, the need to reduce drastically the weight of the shipping containers and the need for all hospitals to reduce the radiation exposure of the medical staff.
Cartridges replace syringes
The concept consists in a syringe-like unit dose Cartridge and a dedicated aseptic filling machine. Through the design of this specific container, single patient doses can now be prepared automatically, perfectly sealed, transported at half of the weight needed for syringes and delivered to hospitals in a form that reduces exposure and avoids any investment or change in medical procedures.
At the radiopharmacy, the filling machine prepares automatically an unlimited number of doses at a rate of 4 doses/minute.
At the hospital, the cartridges are delivered in Local Shields which replace syringe injection shields. The technician simply snaps an Injection Tool, assays the dose through the shield and plugs a Luer Adaptor into the Cartridge. The shielded dose is ready for injection! Refer to Dose Administration for more details.
The compact system includes a sliding tray to pull the dispenser
easily
out of the hotcell.
The 3 mL sealed Cartridge
replaces a syringe.
The Injection Tool and a Sample Luer Adapter convert the shielded Cartridge into a syringe ready for injection.
A fast aseptic Filling Machine for the industry
The filling machine allows the fast aseptic filling and capping of an unlimited number of doses. A very accurate filling is achieved by the combined measurements of activity and weight. The system allows different isotopes for PET and SPECT.
The filling machine includes a compounding area where the dilution is performed in a sterilized disposable Tubing Set, a Cartridge handling area where the Cartridges are aseptically filled and capped and an outlet area including an air-lock system where the Cartridges are assayed and dropped into their shields. Labels and manufacturing documents are issued on-line, displaying the actually measured volumes and activities. The system connects to the local Ethernet network and can be operated from any computer via a graphical user interface.
Main components
The filling machine includes two peristaltic pumps, actuators operating the Tubing Set, two dose calibrators, one for measuring the in-coming activity and the other for measuring each unit dose delivered, an RFID tag reader, a scale, an actuator to locate the Cartridge piston according to the amount of solution dispensed, a capping tool, a carrousel to move the Cartridges, an air-lock system to keep the system isolated from lower grade atmosphere as the filled Cartridges are dropped out of the machine and a label printer. The system is operated by 2 PLCs, controlled from a computer via a graphical user interface.
Automation from filling to final packing
A Shuttle located beneath the hotcell can automatically transfer the shielded cartridges from below the hotcell to the packing room. This option connects to the Ethernet network and is operated by the filling machine.
Control system
The software system allows the importing and creation of orders. It helps the operator to plan optimally the batches, taking into account the amount of activity available, the time of use of each dose, the transportation constrains and whatever new priorities may suddenly occur. It controls the filling machine and allows in-process follow up. It features operator logon, calibration traceability as well as remote control. Production reports are also issued and saved in a data base. The system allows the exchange of data with other applications.
The bulk is prepared on the left side and dispensed to Cartridges on the right side. The dispenser is waterproof and fully sanitizable.
Delivery end of the Shuttle: the shielded Cartridge visible in the black carriage is about to be dropped in a shipping container.
