Shielded Isolator with Integrated Dispensing System for Syringes
THECLA is a class A shielded isolator with integrated dispensing system, equipped with laminar flow on the whole of the main chamber and specifically designed for dispensing radiopharmaceuticals (namely 68Ga) under sterile conditions and in accordance with CGMP guidelines.
Material introduction chamber (airlock) with air quality complying with Class B “At rest” (EEC-cGMP)
Dispensing chamber with air quality complying with Class A “At rest” (EEC-cGMP) and equipped with laminar flow over the entire area
Semi-automatic integrated dispensing system for syringes
68Ge/68Ga generator housing compartment
Dose calibrator compartment equipped with pneumatic system
Final product extraction system in shielded container by means of specific compartment
THECLA Class A shielded isolator with integrated dispensing system mainly consists of:
a Class A main chamber, featuring a shielded front door with hand access and equipped with a Comecer dose calibrator mod. IBC Dose Calibrator (measurement range up to 2 Ci)
a Class B pre-chamber for materials introducing, located under the work surface of the main chamber
a built-in semi-automatic dispensing system for syringes
a syringe unloading system to extract the final product inside shielded containers.
The THECLA isolator has a compact and essential design, as well as being supplied with standard equipment: this makes the THECLA isolator extremely easy to use, meaning that it is one of the most competitive shielded isolator on the market.
Thanks to its small size, it can be positioned in confined spaces, also against the rear wall and with little space on the side: indeed, maintenance is carried out from the front wall.
Shielded and hinged front door of the main chamber equipped with glass and hand doors for manipulation
Shielded chamber under constant negative or positive pressure (upon request)
50 mm lead shielding on the entire Class A work area
Filtration system to generate laminar flow in the Class A chamber, made with HEPA H14 absolute filtering cartridge
Filtration system for Class B chambers with HEPA H14 absolute filtering cartridge
Air outlet filtration system made with active carbon filtering cartridge
304 AISI stainless steel front coverings, easy to decontaminate, separates the laboratory area (front) from the technical cabinet (rear)
316L AISI stainless steel work chambers with Mirror-Bright internal surface finish, TIG continuous welds, and widely rounded corners
Epoxy-coated carbon steel support structure
1/8” technical gas supply lines with shut-off valves, which can be controlled from the outside
6 mm technical gas supply line with shut-off valves, which can be controlled from the outside
Cable inlet via multi-diameter seal system
Protected power supply sockets controlled from the operator panel
Temperature and humidity sensor
Connection for DOP test (filter sealing test) for absolute filters
Possibility of installing a Geiger-Muller probe to detect radioactivity inside the cell and door interlock management