Class B
EU GMP
RES 2
RES 2 is a Class B GMP isolator for radiopharmaceutical research, featuring turbulent airflow throughout the entire work area. It allows for the synthesis and handling of radiopharmaceuticals in a controlled and safe environment, in compliance with the latest GMP guidelines.
Inflatable seals ensure airtightness in accordance with ISO 10648-2, while the ventilation system maintains constant internal pressure and air exchange rates even under failure conditions, such as clogged filters or damaged seals and gloves. Operations can be performed using remote-controlled grippers and/or manipulators.
Used in contexts of:
Designed and Manufactured by Tema Sinergie
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Settings and Customization
A radiological monitoring system based on a Geiger-Müller tube constantly monitors the radiation levels inside the cell and, if safety thresholds are exceeded, automatically prevents the main door from opening, ensuring the operator's safety.
Ventilation System
RES 2 is equipped with a turbulent airflow ventilation system.
The incoming air is filtered through an H14 HEPA filter.
Exhaust air is drawn in by a fan through an H14 HEPA filter and an activated carbon filter.
The ventilation system ensures a clean-air environment that complies with GMP Class B standards.
Indoor Work Area
The interior chamber is made of 3 mm AISI 316L stainless steel with a Mirror Brite finish, rounded corners, and polished welds to facilitate cleaning and prevent liquid leakage. The work surface features raised edges to contain any spills and ensure greater operational safety.
Pneumatic elevator for a dose calibrator
The RES 2 is equipped with a pneumatic lift for the dose calibrator, which can be controlled via a foot pedal or a touchscreen operator panel.
The system is removable and connected to the calibrator well insert. The vial and syringe holder 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.
LED Lighting
The chamber is equipped with cool-light LED lighting, which is ideal for maintaining a sterile work environment. The LED modules can be easily replaced directly from the main operating area.
Additional Features
Teleplier
The hot cell is equipped with one shielded remote-controlled gripper, complete with its lead sphere and hermetically sealed bellows.
The telescopic gripper helps the operator easily reach all items in the work area.
The telescopic gripper helps the operator easily reach all items in the work area.
Additional Features
Anteroom
Shielded and ventilated auxiliary pre-chamber (double-door drawer)
Additional Features
Vial Extraction System
The cell is equipped with a double-door tunnel-type vial retrieval system, designed to ensure proper GMP classification cascading and to meet the air cleanliness requirements for the various environmental classes.
The vial retrieval drawer incorporates an automatic positioning system for the lid of the lead-shielded container (lead pot).
When the operator opens the drawer, the system automatically positions the lid on the shielded container, protecting the operator from direct exposure to radiation emitted by the vial.
The lid is then manually locked into place, whether for containers with a twist-lock closure or those with a screw-on closure.
Additional Features
Shielded front door + polycarbonate inner door and gloves
RES 2 is equipped with 2 independent hinged doors:
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a polycarbonate (PC) door with integrated gloves
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shielded door
The polycarbonate door ensures an airtight seal, isolating the sensitive materials inside the chamber from the surrounding environment and protecting the operator from potential exposure to radioactive gases generated during the process.
Additional Features
Manometer
The high-precision pressure gauge monitors the pressure in the main working area, which is continuously displayed by the indicator 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.
Touchscreen Control Panel with Integrated PC
Additional Features
Window Screen
RES 2 is equipped with a leaded glass window located in the center of the lead-shielded main front door.
The leaded glass is integrated into the shielded door, and its frame is specially shielded to ensure continuous radiation protection throughout the entire structure.
Additional Features
Inflatable Seals
RES 2 is equipped with inflatable seals that ensure a Class II airtight seal (ISO 10648-2). The inflatable seals are equipped with sensors and actuators that enable the following operations:
- automatic inflation and deflation;
- checking the status of the seals and alerting the operator to any abnormal conditions;
- in the event of a power outage, the seals remain inflated for 1 hour for safety reasons.
PRODUCT OPTIONS
Components and Additional Features
Telemanipulators
Pre-wired for 2 remote controls (not included)
Internal Protective Cover
Option to insert an internal protective cover.
Additional Features
Telemanipulators
RES 2 is designed to accommodate the installation of 2 remote control units.
The remote controls are optional.
The configuration varies depending on the brand and model of the remote controls to be installed (to be specified when ordering the cell).
Additional Features
Internal Protective Cover
Coating of the interior surfaces of the RES 2 cell to protect against aggressive vapors
A protective coating can be applied to the interior to prevent corrosion caused by chemical agents.
This coating incorporates the inert substance “MagnaCoat 3005,” providing chemical resistance and insulating properties.
The coating ensures high resistance to gas permeation, providing good mechanical stability and protection against abrasive corrosion.
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