MiniMa: Manual R&D hot cell
Comecer MiniMa hot cell is an airtight and shielded dispensing box ideal for R&D manual operation.
MiniMa can be used for either manual syringe dispensing of radiopharmaceuticals or for use in combination with (semi-) automatic dispensing systems of various brands.
Chamber tightness ensured by static gasket system
Frontal large window
Dose calibrator compartment
Waste compartment
Hand passage doors
The box with an integrated lead glass viewing window comes with two arm openings (shielded in closed position) and one large shielded door on the front side for bringing items in or out. The internal workspace is provided with an opening on the lower floor to the right, under which, in a particular shielding 50 mm lead, can accommodate an ionization chamber. There is also a second opening on the left to access the Waste group, shielded in lead.
Although the shielding is an integral part of the MiniMa hot cell, the dose calibrator is offered as a separate item, including a PC based version where the special fan-less mini PC is integrated in the bottom part of the box.
The inner housing is complete stainless steel with inner light and one integrated power socket. The outside body and the closed bottom part are in AISI304 stainless steel. The shielded ionization chamber and the shielded waste unit are integrated in this closed bottom part, where the waste-unit has a lockable, shielded door for easy removal of the actual waste bin.
All shielding of the dispensing box working area, including the lead glass window, the two arm openings, the side door, the waste compartment and its external door, are 30 mm of lead. The ionization chamber is shielded with 50 mm lead.
Standard the box comes with a Hepa filter on the air inlet and a charcoal filter on the air-outlet as well gloves in the arm-openings.
BBS Series: Shielded Cells for Synthesis Modules
The series of shielded cells for synthesis modules model BBS, has been specially designed to host specific automatic synthesis modules for the production of radiopharmaceuticals for experimental use or daily production in cGMP radiopharmacy.
The BBS cell, single or double (lined horizontally or vertically), triple and also quadruple, can have different configurations for the overall dimensions, shielding and various accessories.
Modular design and flexible configuration
Available in Pb 75 or 100 mm shielding
Shielded and hinged front door
Air quality in the work chamber complies with Class B “At rest” (EEC-cGMP)
7” touch-screen operator panel to check and trace the critical parameters of the machine both in “at rest” or “in operation” mode
Illuminate™ MI: IIoT manufacturing intelligence platform and factory-floor management.
Configurable Parameter
The number of chamber
The thickness of the shield
Doors with or without lead glass
The presence of lower or side technical compartments designed to hold accessory components
The power supply dedicated to the geographical area of installation
The possibility to accommodate different types of synthesis modules.
Features and Benefits
Shielded chambers under constant negative pressure
Air inlet filtration system made with HEPA absolute filtering cartridge with 99.995% efficiency
Air outlet filtration system made with active carbon filtering cartridge
Set-up for automatic leak test
Protected power supply sockets controlled from the operator panel
Removable tray for synthesis module
Set-up for the Geiger probes for measurement of the radioactivity present inside the cell.
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.
Modular design and flexible configuration
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
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.
BBST COMBO Series: Synthesis and Dispensing Hot Cell
The BBST COMBO Hot Cell is a synthesis and dispensing hot cell specially designed to combine in one system a shielded housing for synthesis modules and a fractionation system in sterile conditions, in accordance with cGMP standards.
Modular design and flexible configuration
Touch screen for hot cell and dispensing system
Designed for housing automatic modules or fractionation systems in sterile conditions
Liquid waste collection system
Solid waste collection system
Dose calibrator (available in the versions 2 Ci or 20 Ci) with touch screen console
cGMP compliant
Illuminate™ MI: IIoT manufacturing intelligence platform and factory-floor management.
The Synthesis and Dispensing Hot Cell is equipped with:
A main shielded chamber (dispensing area), maintained in class “A LAF” by a combined system “air tight – laminar flow”
Pre-chamber (Class B), with two glove ports
A shielded chamber (synthesis area) (Class B), with an upper technical compartment
Vials/syringes drawing system (Class B)
Solid and liquid waste area (Class B)
Thanks to these characteristics, together with measurement equipment, the hot cell is right for producing and preparing doses of radio medicines, complying with the EC-GMP laws.