Comecer - Model BBST Series -Shielded Isolators for Dispensing
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.
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.
- 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.