Gallia 50

Hot Cell For 68-Gallium

GALLIA 50 hot cell is specifically designed to accomplish the latest GMP guidelines for the complete 68Ga preparation cycle:

  • Generator elution
  • Synthesis or cold kit processing
  • Dispensing
  • Waste management
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EQUIPMENT

  • Generator area for max n. 3 68Ga generators (n. 2 if the optional Waste Chamber is required)
  • HMI: operator software interface for handling, system control, data saving and display
  • Laminar air flow and temperature check sensor
  • Particle counter connection predisposition
  • Dose calibrator shielded area
  • Main double door: Shielded Door for radioprotection and Polycarbonate Door for air-tight and gloves mounting. The 2 doors are independent and open separately
  • Multi diameter sealed pass-through system for cables (Roxtec)
  • N. 1 GMP Class B pre-chamber for the introduction and extraction of cold kits, cassettes and syringes
  • Arm-tray to support laptop, and/or dose calibrator control unit and/or MorGaNA/ µDDS-A laptop, and printer

OPTION

  • Shielded and ventilated waste chamber, with door opening on the front
  • Dose calibrator up/down automatic lift
  • MorGaNA cold kit processing system or µDDS-A automatic dispenser
  • Tray for synthesis module
  • Lead pot container
  • Humidity sensor
  • VHP connection predisposition
  • Radiation monitor of the hot cell exhaust ventilation duct
  • GM tube connection to the ENVIRO area monitoring net
  • External PC for audit trail and alarm log file, saving into uncorruptible files

Active Safety

  • Software control for cell parameters (negative pressure, filter clogging, ventilation status, UV light timer, etc.)
  • N. 1 manometer for continuous pressure status visualization
  • N. 1 U.V. antibacterial lamp
  • AIS: GM tube for door interlock system that prevents the main door opening when the activity level inside the cell overcomes the alarm threshold (the threshold can be set by the operator)

OPTION – CES: GM tube continuous radiation monitor on hot cell exhaust air, to control the radioactive gas release, via closure of inlet and outlet ducts until a complete decay.

Ventilation and Air-tight

  • Laminar Air Flow on total surface
  • Working area air quality classification: GMP grade A
  • Air speed (electronically controlled): 0,45 m/s ±20%
  • lnlet filter: HEPA H14
  • Main filter: ULPA U15
  • Outlet filter HEPA H14 + active charcoal
  • The inflatable seals grant a Class Il air tightness (ISO 10648:2). This feature classifies the hot cell to the range of an isolator

OPTION: Anemometer with laminar air flow check

© 2020 TEMA SINERGIE S.p.A
Fiscal Code n. 00970310397
Business Register of Ravenna n. 00970310397  |  R.E.A. 111877
Capital Stock € 2.000.000,00 paid-up