Theodorico 2 is an automatic shielded dispensing system for radiopharmaceuticals in open or closed vials. The productive requirements of the customer can be met thanks to the flexibility of system configuration. The dispensing chamber features a robot for the handling of the vials in all stages of dispensing. This significantly reduces the exposure of the operator to radiation.
Theodorico 2 has been designed to comply with GMP requirements; it features a Class B pre-chamber for the introduction of the materials, while the dispensed vials are extracted by means of an automatic and ventilated transfer system from the dispensing chamber (Class A) to the shielded container placed in the drawing system (Class B).
Theodorico 2 supports both aseptic dispensing and dispensing with final sterilization in an autoclave: the autoclave can be requested as an accessory at the moment of system configuration.
The dispenser receives the radiopharmaceutical in a bulk vial and it can calculate its concentration thanks to the integrated calibrator and the scale. The dispensing of the final vial is based on the measurement of the weight/volume with the verification of the activity dispensed in a second dose calibrator. The gas dispensing technology (patented) used is extremely accurate and highly reliable, and it is equipped with a consumable kit which is easy to install.
Theodorico 2 features functions such as the execution of the Bubble Point Test (BPT) for the dispensing filter, the leak test of the main chamber, the collection of bioburden samples and the filling speed test. Also, the device is set for the dynamic sampling of air, for the particle count and the VPHP sterilization cycle.
The critical parameters of the chambers are constantly monitored and displayed in real time on the operator panel on the front of the machine, and the history is recorded in the database of the integrated data logger. These parameters are the pressure of the pre-chamber, temperature, humidity and LAF speed in the main chamber.
Inside the main chamber, another series of sensors ensures a better usability of the machine, by checking the correct crimp and detecting the presence of the vial in the shielded container.
The shield for Theodorico 2 is available in two thicknesses, 75 or 100 mm of lead (present on all sides of the machine).