PHAEDRA COMBO Series Synthesis and Dispensing Shielded Isolator

Phaedra Combo series is a family of shielded isolators specifically designed to combine, in a single system, a shielded housing for synthesis modules and a fractioning area in sterile conditions (Class A LAF), in compliance with the cGMP regulations. For this reason, they are also equipped with a Class B pre-chamber for materials input.

Used in Radiopharma Production For R&D Radiochemistry and Radiopharma Synthesis Filling Dispensing Dose Calibration
 
PHAEDRA-COMBO Synthesis and dispensing hot cell

Highlights

  • Synthesis chamber up to Class B air quality
  • Dispensing chamber Class A air quality with laminar flow
  • Gloves pre-chamber Class B air quality
  • Waste compartment Class B air quality
  • Modular design and flexible configuration
  • Synthesis and dispensing in a single cell
  • Ideal for aseptic dispensing of vials or syringes in cGMP field
  • Ergonomic and responsive thanks to the combination of gloves for manipulation and tele-pliers
  • Extraction system for vials and syringes in transport shielded container equipped with pass-through dose calibrator
  • Compact solution, also suitable for small laboratories
  • Touch-screen operator panel
  • Tele-pliers with “QuickPlug” system for quick tight release
  • Dose calibrator (available in the 2 Ci or 20 Ci versions)
  • Waste compartment

Its features guarantee the radioprotection of the operator and the maximum effectiveness of the decontamination and cleaning procedures. The housing for the synthesis modules is hermetically sealed and shielded on each side, and maintained in negative pressure for the production (with automatic modules) of radiopharmaceuticals.
An internal shielded conduit can be used to transfer them into the main Class A chamber.
The main chamber is equipped with a tele-plier that allows high-level handling operations in total safety. Manual operations can also be performed through two hand passage doors that guarantee compliance with radiation protection regulations.The tele-plier is equipped with the “QuickPlug” system that allows its rapid extraction without loss of seal and classification, so that the isolator can quickly switch between tele-plier and manual operations.
The working area of ​​the main chamber is designed to ensure excellent ergonomics during the use of the various devices that can be installed inside it (calibrator, dispenser, waste compartment and unloading system for bottles and syringes).

Main Features

  • Shielded and hinged front door of the main chamber equipped with glass and hand doors for manipulation.
  • Class A, 75 mm lead shielding on the entire work area
  • Dose calibrator compartment equipped with pneumatic system to move the vial in the well
  • Filtration system to generate laminar flow in the Class A chamber, made with ULPA U15 absolute filtering cartridge
  • Hinged front door of the material input chamber made of Plexiglas and equipped with glove flanges
  • Filtration system for Class B chambers with HEPA H14 absolute filtering cartridge
  • Technical cabinet to contain the control box for the synthesis module and any HPLC pump
  • Air outlet filtration system made with active carbon filtering cartridge
  • Chamber tightness ensured by inflatable gasket system, placed on the perimeter of the openings
  • Shielded chamber under constant negative or positive pressure (upon request)
  • 316L AISI stainless steel work chambers with Mirror-Bright internal surface finish, TIG continuous welds, and widely rounded corners
  • 304 AISI stainless steel front coverings, easy to decontaminate, separates the laboratory area (front) from the technical cabinet (rear)
  • 12” touch-screen operator panel to check and trace the critical parameters of the machine both in “at rest” or “in operation” mode.
  • Radio-fluid airtight shielded inlets in the synthesis and dispensing chambers
  • Airtight shielded capillary passage between the synthesis chamber and the dispensing chamber
  • Cable inlet through multi-diameter airtight system in the synthesis and dispensing chambers
  • Protected electric power supply socket in the synthesis and dispensing chambers controlled from the operator panel
  • Temperature and humidity sensor
  • Connection for DOP test (filter sealing test) for absolute filters in the synthesis and dispensing chambers
  • Semi-automatic Bubble Point Test can be installed, integrated with COMECER dispensers
  • Possibility of installing a Geiger-Muller probe to detect radioactivity inside the cell and door interlock management

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