Class B
GMP-Compliant
RES 1
RES 1 is a GMP Class B shielded isolator.
It is designed to house radiopharmaceutical synthesis modules for research and development and complies with the latest GMP guidelines.
RES 1 guarantees radiation protection for the operator, ensuring maximum safety.
Used in contexts of:
Designed and Manufactured by Tema Sinergie
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Key Features
Additional Features
Shielded Port
Shielded main door with 2 shielded glove ports and a polycarbonate door with gloves
The RES 1 chamber is equipped with 2 independent hinged doors:
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Polycarbonate (PC) door with integrated gloves
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Shielded door with glove ports
A hermetic seal is ensured by the polycarbonate door, which isolates the sensitive materials inside the chamber from the surrounding environment and protects the operator from any radioactive gases that may be generated during the process.
Additional Features
Anteroom
RES 1 is equipped with a front-loading, drawer-type antechamber with double doors, compliant with GMP Class C, designed to prevent direct contact between the internal environment and the potentially contaminated external environment.
This solution allows for the introduction and removal of materials and components without compromising the classification of the internal area, while maintaining the environmental conditions required by GMP regulations.
Additional Features
Vial Extraction and Lead Pot Removal
Vial extraction system (double-door tunnel) and drawer for removing the lead pot with automatic lid positioning
Additional Features
Tele-Gripper
The cell is equipped with one shielded telescopic gripper, complete with a lead ball and an airtight bellows.
The remote-controlled gripper allows the operator to easily reach and handle all objects within the work area, ensuring safe and precise operations even in hard-to-reach areas.
Additional Features
Operator panel with touchscreen PC
The PC touchscreen operator panel serves as the interface for managing the hot cell’s functions. Thanks to its unique features, the system stores and saves all operations related to the hot cell, allowing users to track all events and operational alarms. Fully integrated into the chamber’s exterior finish, it ensures a seamless design that makes the chamber perfectly suited for integration into the walls of the pharmaceutical cleanroom.
The PC touchscreen operator panel allows for the management of 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.
Additional Features
Arm with PC Mount
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.
The pressure range can be programmed by the operator according to the adopted protocol. The most commonly used operating pressure is -100 Pa.
Ventilation Area Filters
Additional Features
Shielded Window
The chamber is equipped with a leaded glass window located on the lead-shielded front door.
The leaded glass is integrated into the shielded door, and its frame is appropriately shielded to ensure continuous radiation protection.
The window is not positioned exactly in the center of the door but is slightly offset to the right to allow for easier use of the remote-controlled gripper.
Additional Features
Inflatable Seals
RES 1 is equipped with inflatable seals that ensure a Class II airtight seal in accordance with ISO 10648-2.
The inflatable seals are equipped with sensors and actuators that enable the following functions:
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automatic inflation and deflation;
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continuous monitoring of the seals’ status, with alerts to the operator in the event of any abnormal conditions;
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maintenance of inflation for 1 hour in the event of a power outage, to ensure system safety and containment.
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