Automatic Dispenser μDDS-A medical device class 1m – CE 0476
Engineered to fulfill all GMP guidelines for PET and SPECT radiopharmaceutical dispensing and specially developed for syringe dispensing, it can be used also for vials: nothing has to be changed except the disposable set.
The dispenser can be connected to a radiopharmaceutical bulk vial or directly to the (F18-FDG) synthesis module. The μDDS-A Software is GAMP5 and FDA 21 CFR part.11 compliant.
The dispenser works connected to the up/down elevator for dose calibrator and to a commercial dose calibrator. Most commercial dose calibrators are already compatible. Empty tubes dispensing philosophy: it grants the absence of radioactive liquid along the tubes while the operator approaches his hand to connect-disconnect the syringe. “DFC – Dual Fiber Calibration” technology, patented by Tema Sinergie, makes the system fit dynamically on the specific characteristic of each mounted disposable set.
This allows the operator to solve potential disposable troubles before starting the radioactive dispensing.
A single interface for operations handling, system control, data saving and display. No additional device is required for the control of the hot cell. This unique feature makes the system store-save-trace any event and alarm concerning the hot cell work.
Among others:
– GM for door interlock (n.2 thresholds), alarm set up and visualization.
– Time saving solution: automatic on/off programming for ventilation and U.V. Iamp.
– N. 3 safety passwords (programmable): user, maintenance and RSO password.
