Explora One

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Explora One
 
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Hardware Features


Equipment Integration

  • Designed to use three-manifold cassettes (three sets of five-stopcocks), available from multiple vendors
  • Supports 18O [H2O] recovery in dedicated bottle
  • Digital vacuum gauge on the front of the module
  • Three radiation detectors placed for trap and release cartridge, reactor and intermediate cartridge

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Integrated HPLC System

  • Deuterium lamp allowing 190-750 nm variable wavelength
  • 3 mm path length UV flow cell
  • 4 m fiber optic UV connector cables, allowing the flow cell to be the only UV detector component installed inside the shielded enclosure
  • HPLC pump with 0.001-10 ml/min flow rate range and integrated pressure sensor
  • Fully automated delivery of production from synthesis to HPLC loading loop and injection on to column
  • HPLC purification control requires only start product collection and stop product collection input from user

 



Integrated Reformulation System

  • Cassette-based reformulation system with a dedicated five-stopcock manifold
  • Separate solvent hook for rinse solvent bag
  • Radiation detector placed for reformulation SPE cartridge
  • Reformulation control seamlessly integrated into production sequence
  • Dedicated pressure and vacuum port


Agency Approvals

  • CE Mark

Regulatory Compliance Features


Features that simplify regulatory compliance

  • Sequences used for production may not be altered once published
  • Production sequences include radiotracer specific self-tests
  • Explora One automatically generates production reports including all the details of the production such as hardware kit identification, reagent set batch numbers, graphs of radioactivity, vacuum and temperature data, and other major synthesis steps
  • Production reports are radiotracer specific
  • Explora One is built around a cassette-based disposable fluid pathway
  • The control system has three different levels of user log in
  • Each user of the system has a unique User ID and password
  • Production records are stored on a secured drive which may only be directly accessed by the original equipment manufacturer
  • The end user of the system may only access production records in a read-only format
  • Production records may not be deleted or changed once created
  • Once started, all production sequences are recorded. If a run is aborted at any time after initialization, this action is recorded
  • Production material information (e.g. lot number of chemical consumables kit) is stored as a part of the production record, thereby linking all production information in the same record
  • Comments may be entered periodically throughout production runs, allowing for all relevant production information to be captured in a single production record

 


Hardware Dimensions and Installation Requirements


Main Module (Inside the Shielded Enclosure)

  • Width: 56.3 cm (22.17 inches)
  • Depth: 40.0 cm (15.75 inches)
  • Height: 42.4 cm (16.69 inches)
  • Weight: 44 kg (97 pounds)
  • Minimum required clear space inside shielded enclosure (to allow for ventilation, etc.) is 58 cm W x 42 cm D x 44 cm H (23 inches W x 17 inches D x 18 inches H)


Support Components (Outside the Shielded Enclosure)

  • HPLC pump, UV detector, Linutop, router and UI computer


Storage and Installation Requirements

  • Operating Temperature: 10 °C - 50 °C (41 °F - 104 °F)
  • Operating Humidity: ≤55%, non-condensing
  • Storage Temperature: 4°C - 32°C (40°F - 90°F)
  • Storage Humidity: 30% - 70%
  • Electrical Supply: either 100-120 VAC, 2.0 A, 50-60 Hz or 200-240 VAC, 1.0 A, 50-60 Hz.
  • Electrical Stability: no more than ±10% voltage fluctuation
  • Supply Gases:
    • Compressed Air at 6-8 bar (87 psig to 116 psig)
    • ≥99.995% Pure Nitrogen at 3-8 bar (43 psig to 116 psig)

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