Class A
EU GMP
NMC DSI
The Mod. NMC DSI laminar flow shielded isolator is specifically designed for both manual and automatic preparation of FDG doses for PET diagnostics and isotope doses used in conventional nuclear medicine, in accordance with GMP procedures.
Used in contexts of:
Designed and Manufactured by Tema Sinergie
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Key Features
Features
Shielded Window
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.
Features
Operator panel with touchscreen PC
The PC touchscreen operator panel serves as the interface for managing the isolator’s functions. Thanks to its unique features, the system stores and saves all operations related to the cell, allowing for the tracking of all operational events and alarms. Fully integrated into the exterior finish, its sleek design makes the cell perfectly suited for integration into the walls of the pharmaceutical cleanroom.
The PC touchscreen operator panel supports up to 4 password-protected access levels, ensuring that each operator working on the machine can act only within their area of responsibility and, at the same time, allowing the RSO to monitor the events managed by each user through data traceability.
Features
Manometer
The high-precision pressure gauge monitors the pressure status of the main working area, which is continuously displayed by the Magnehelic gauge located on the front of the cell, providing a real-time indication of the correct operating pressure and, therefore, of the safety condition.
The standard range of the pressure gauge is from -250 Pa to +250 Pa, and it is programmable by the operator. The chamber is designed to function properly under both negative pressure (to protect the operator) and positive pressure (to protect the material being processed) conditions.
Features
Shielded Ports
The NMC DSI isolator is equipped with two doors: a lead-shielded door and a polycarbonate door 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.
Features
PC Stand and Adjustable Arm
The isolator is equipped with a support shelf for the PC and, if necessary, the dose calibrator control unit, mounted on a movable arm.
The support shelf is available in the standard configuration—with a double shelf supporting the laptop on top and the dose calibrator control unit below—or in the NMC-μ configuration: a closed stainless steel enclosure houses the touchscreen PC running the μDDS-A software.
Additional Features
Pre-Chambers
The isolator is equipped with two GMP Class B Pre-Chambers to prevent direct contact between the Grade A internal environment and the external environment:
- The left-side antechamber for the lead-lined transport container
- The right-side antechamber for loading and unloading consumables and syringes
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Additional Modules
Add-ons
DOSE CALIBRATOR
Dose Calibrator with Motorized Actuator
Additional Features
DOSE CALIBRATOR
The NMC DSI can be equipped with an actuator for dose calibrators 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.
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