Class A
EU GMP
NMC Ga-68
NMC Ga-68 is designed to comply with the latest GMP guidelines regarding the preparation of the complete Ga-68 cycle: elution, synthesis, and dispensing.
Used in contexts of:
Designed and Manufactured by Tema Sinergie
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Settings and Customization
NMC Ga-68 can also be used to prepare doses and radiopharmaceuticals for PET diagnostics and nuclear medicine isotopes.
Additional Features
Anterior Chambers
The NMC Ga-68 is equipped with two hermetically sealed transfer chambers (pre-chambers) with electrical interlocks, compliant with GMP Class B (ISO 6), designed to prevent direct contact between the clean, sterile internal environment and the potentially contaminated external environment.
The two transfer chambers are:
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Generator pre-chamber: designed to accommodate up to 2 generators (2 square-section generators or 2 cylindrical generators).
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Inlet/Outlet pre-chamber: dedicated to the insertion and removal of syringes, vials, and single-use materials.
Glove Compartments
The NMC Ga-68 isolator is equipped with two ports: a lead-shielded port and a polycarbonate port with gloves.
The airtight seal is ensured by the polycarbonate door, which isolates the materials from the surrounding environment and protects the operator from radioactive gases that may be produced inside the cell during the process. Sealing is provided by a gasket, controlled by proximity sensors, which inflates when the operator closes the polycarbonate door.
The standard configuration is equipped with butyl gloves.
The airtight seal is ensured by the polycarbonate door, which isolates the materials from the surrounding environment and protects the operator from radioactive gases that may be produced inside the cell during the process. Sealing is provided by a gasket, controlled by proximity sensors, which inflates when the operator closes the polycarbonate door.
The standard configuration is equipped with butyl gloves.
Technical Area
Additional Features
Window Screen
The isolator is equipped with a leaded glass window located in the center of the door, mounted at a 10° angle to provide a better and more ergonomic view. Its structure is specially shielded to ensure continuity of radiation protection with the rest of the door.
Additional Features
Pressure Gauge
The high-precision pressure gauge monitors the pressure in the main working area, which is continuously displayed on the dial located on the front of the chamber, providing a real-time indication of the correct operating pressure (safe operating condition).
The pressure range can be programmed by the operator according to the adopted protocol. The most commonly used operating pressure is -100 Pa.
Additional Features
Inflatable Seals
The NMC Ga-68 hot cell is equipped with inflatable seals to ensure a Class II airtight seal (ISO 10648-2).
The inflatable seals are equipped with sensors and actuators that enable the following operations:
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automatic inflation/deflation;
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monitoring the condition of the seals and alerting the operator in case of abnormal conditions;
in the event of a failure, the seals remain inflated for safety reasons.
Additional Modules
Optional Components
ELEVATOR FOR DOSE CALIBRATOR
The NMC Ga-68 can be equipped with three different types of dose calibrator lifts: electric, vacuum, or pneumatic.
µ DDS-A
The cell can be equipped with the µ DDS-A automatic dispenser.
Additional Features
ELEVATOR FOR DOSE CALIBRATOR
The NMC Ga-68 can be equipped with a dose calibrator actuator for syringes and vials, controlled via a foot pedal or touchscreen operator panel.
The system is removable and connects to the calibrator well insert. The holder for vials and syringes is made of PE and can be easily disassembled for cleaning without the use of screws or tools, thanks to a snap-fit locking system.
Additional Features
µ DDS-A
The cell can be equipped with the µ DDS-A automatic dispenser, which allows for the safe and rapid dispensing of PET and SPECT radiopharmaceutical doses into shielded syringes, without any operator intervention.
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