Gallium hot cell
NMC Ga-68 hot cell has been conceived to accomplish the latest GMP guidelines for the Ga-68 complete preparation cycle:
NMC Ga-68 is a GMP grade A hot cell with 2 GMP grade B pre-chambers, 2 gloves, a tray for the synthesis module, a dose calibrator area and a waste container.
The hot cell can also be equipped with the µ DDS-A automatic dispenser.
NMC Ga-68 is suitable for the preparation of doses and radiopharmaceuticals for PET diagnostic and for Nuclear Medicine isotopes too.More details
Synthesis modules hot cell
SYNT cell has been designed to host automatic radiopharmaceutical synthesis modules, offering a controlled and safe environment in compliance with the latest GMP guidelines.
Its inflatable seals are granting an ISO 10648:2 air tightness while the ventilation system provides a GMP class B clean air environment.
The AISI 316L stainless steel inner finishing, the complete extraction of the tray module, the air-tight pass-through system for radio fluids and gases make SYNT the ideal equipment for any synthesis process.
As an option, each box of the SYNT 1 and SYNT 2 may be equipped with a specific shielded waste drawer with automatic door (SYNT WASTE DRAWER) that allows the positioning of max n.3 IBA Synthera® modules and, when the synthesis is over, grants the automatic dropping and storing for decaying of the spent cassettes inside the shielded drawer.
GMP flexible Vials and Syringe dispensing system
FLEX is a multi-purpose GMP grade A shielded isolator, with vertical laminar flow all over the working area. The cell is shielded with 75 mm of Lead in all sides.
Its wide inner space and specific equipment make FLEX a flexible working instrument for many different applications.
The manual dispensing can be carried out through the FLEX standard configuration.
The automatic dispensing can be carried out through:
µ DDS-A automatic dose drawing system for dispensing closed vials (septum piercing), open vials (closing through crimping station) and shielded syringes at the same time
CRP vial dispenser
The cell can be also equipped with an autoclave for the final sterilization of the processed vials mod. AUT 1500.
The laminar flow shielded isolator Mod. NMC DSI has been specifically designed for both manual and automatic pharmaceutical preparation of FDG doses for PET diagnostics and conventional Nuclear Medicine isotope doses, according to the GMP standard procedures.
The combination of NMC DSI manipulation hot cell and the µ DDS-A dose fractioning system forms the laminar flow automatic fractioning system Mod. NMC-µ, a great and affordable GMP compliant choice for PET and SPECT radiopharmaceuticals dispensing with the highest safety level for both the operator and the product.
GMP compliant dispensing line
The unit, which has been designed for class C laboratories, is the state-of-the-art GMP compliant dispensing line that enables the dispensing of registered radiopharmaceutical by managing materials insertion, vials extraction, sterilisation of the most critical environment according to the strictest pharmaceutical standards.
This dispensing line is composed by:
DTC: dispensing cell; it can be equipped with the automatic dispensing system mod. CRP
SAS: shielded or unshielded prechamber for materials introduction/extraction
Dispensing Hot cell
DHC is a GMP grade A shielded isolator, with vertical laminar flow all over the working area, dedicated to radiopharmaceuticals dispensing processes in a controlled and safe environment.
DHC was first conceived to provide the most relevant radiopharmaceutical companies a total laminar flow dispensing shielded isolator compliant with the latest GMP, USP and FDA regulations.
Automatic Synthesis and Dispensing Hot Cell
The Flexa-Flexall hot cell is a turnkey system composed of a GMP grade B shielded isolator for synthesis and a GMP grade A shielded isolator for dispensing, in one single hot cell.
It is designed for the automatic and manual preparation of PET & Nuclear Medicine radiopharmaceuticals injectable doses.
n.1 total laminar air flow area in the upper part
n.1 synthesis module area in the lower part
n.1 air-tight and vented pre-chamber (double door drawer)
vial extraction system (double door tunnel)
integrated dose calibrator area
optional vial crimping station Mod. CRP
Manual dispensing can be carried out with the FLEXA-FLEXALL standard configuration.
Automatic dispensing can be carried out with the CRP automatic dispenser for vials.
The Flexa-Flexall hot cells are equipped with inflatable seals to provide air tightness Class II (ISO 10648:2).More details