Talia Series
The series of TALIA Radiopharmacetucals Dispensing Isolator is a family of Class A isolators equipped with laminar flow on the entire main chamber.
The radiopharmaceuticals dispensing isolator can house automatic modules or fractioning systems in sterile conditions and in observance of cGMP standards.
- Product extraction system in shielded container by means of specific drawer. The extraction occurs by means of a double airlock system with air quality complying with Class B “At rest” (EEC-cGMP) and Class C “At rest” (EEC-cGMP)
- 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
- Chambers tightness ensured by inflatable gasket system, placed on the perimeter of the openings
- Shielding elements made with primary ingots (Pb 98% + Sb 2% purity)
- Filtration system to generate laminar flow in the Class A chamber, made with ULPA U15 absolute filtering cartridge
- Air inlet filtration system made with HEPA absolute filtering cartridge with 99.995% efficiency
- Air outlet filtration system made with active carbon filtering cartridge
- Isolator management, automation and workflow control by means of an operator interface developed in accordance with GAMP regulation and compliant with CFR21 Part 11 requirements
- 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
- Protected power supply sockets controlled from the operator panel
- Shielded, sealed inputs for radio-fluids which can be equipped with a “pneumatic dragging” system
- Cable inlet via multi-diameter seal system
- Set up for product extraction system equipped with “Pass-through dose calibrator”
- Set-up for second material introduction chamber (airlock) with air quality complying with Class A “At rest” (EEC-cGMP), provided with laminar flow over the entire area and manipulation gloves
- Set-up for waste compartment with air quality complying with Class B “At rest” (EEC-cGMP), provided with a passing tunnel with sealed, shielded doors complying with Class B “At rest” (EEC-cGMP)
- Set-up for semi-automatic Bubble Point Test integrated with COMECER dispensers
- Tele-pliers on special ball bearings for high sensitivity and precision-movement handling
- Set-up for the Geiger probes for measurement of the radioactivity present inside the cell
- Set up for ventilation isolation valves and connection to hydrogen peroxide solution generators (AVC LIGHT) for the dispensing chamber and the material introduction chamber
- Set up for automatic leak tests on the dispensing chamber and material introduction chamber
- Set-up for particle counter sensor in the main chamber and in the preparation chamber in “class A”
- Connection for DOP test (filter sealing test) for absolute filters
- Connection for sanitation system with VPHP (vapor-phase hydrogen peroxide) through manual or automatic valves
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