Class B
GMP
SYNT
The SYNT cell was designed to house automated radiopharmaceutical synthesis modules, ensuring a controlled and safe environment in accordance with the latest GMP guidelines.
Used in contexts of:
Designed and Manufactured by Tema Sinergie
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Key Features
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Ventilation air intakes
SYNT hot cells are equipped with a turbulent airflow ventilation system. The incoming air is filtered through an H14 HEPA filter, while the exhaust air is extracted by an H14 HEPA fan and an activated carbon filter. The ventilation system ensures a controlled-contamination environment that complies with Class B GMP requirements.
Pressure Gauge
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 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.
Upper Synthesis Chamber
All simulation rooms are equipped with:
- a removable support shelf
- sliding, removable tray: to facilitate operations with the synthesis modules
- Integrated video camera
Lower Synthesis Chamber
All simulation rooms are equipped with:
- a removable support shelf
- a sliding, removable tray to facilitate operations with the synthesis modules
- built-in camera
PC Arm Mounts
Touchscreen control panel
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.
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
Inflatable Seals
SYNT cells are equipped with inflatable pneumatic 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:
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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;
in the event of a power outage, the seals remain inflated for 1 hour, ensuring that safety conditions are maintained.
OTHER hotcells
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