The shielded isolators series, mod. BBST, is a family of Class A radiopharmaceutical isolators, equipped with laminar flow on the entire main chamber. They can house automatic modules or fractioning systems in sterile conditions and in observance of cGMP regulations.
Shielded Isolators for Dispensing: Comecer BBST Series
Modular design and flexible configuration
Touch screen for hot cell and dispensing system
Airtight connections for radioactive fluids
Fluid supply lines made of AISI316L stainless steel with ball shut-off valves
DOP test connections (filter leakage test)
Internal pressure automatic adjustment by modulating valves
Designed for housing automatic modules or fractionation systems in sterile conditions
High sensitivity tele-pliers (movement by ball bearings)
Semi-automatic bubble point test touch screen controlled
VPHP connections with hot cell and pre-chambers (manual valves, automatic optional)
Dose calibrator (available in the versions 2 Ci or 20 Ci) with touch screen console
Product extraction system (Drawing System)
cGMP compliant
Illuminate™ MI: IIoT manufacturing intelligence platform and factory-floor management.
The shielded isolators series, mod. BBST, is expressly dedicated to filling, calibrating and fractioning operations on vials/syringes.
The machine is ideal for small/medium vial productions (batches of 10-15 vials per batch) and, if requested expressly, for small syringe productions (batches of 3-5 5 ml syringes per batch). The cell guarantees maximum protection for the operator against ionising radiation through complete shielding, the air seal between the chambers and the use of tele-pliers.
These characteristics, along with the integrated measuring tools, make it particularly suitable for radiopharmaceutical dose preparation, in accordance with cGMP regulations.
In terms of GMP production, the cell features a ventilated pre-chamber for introducing materials.
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ISO 45001 Health and Safety Management System
ISO 14001 & ISO 50001 Environmental and energetic management system
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