ELENA Series Shielded Laminar Flow Isolator

ELENA is a laminar flow shielded isolator for manipulation and calibration of beta/gamma-emitting radiopharmaceuticals in accordance with Good radiopharmacy practice for the preparation of radiopharmaceuticals in Nuclear Medicine (simple preparations and extemporaneous preparations).

Used in GMP Radiopharmacy Nuclear Medicine For R&D Radiochemistry and Radiopharma Synthesis Filling Dispensing Dose Calibration
 
ELENA - Shielded Laminar Flow Isolator

Product highlights

  • Modular design and flexible configuration
  • Touch screen for hot cell and dispensing system
  • Technical gases supply lines made of AISI 316L 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
  • Dose calibrator (available in the versions 2 Ci or 20 Ci) with touch screen console
  • cGMP compliant
  • Solid waste collection system
  • Particle counter connection
  • Air-lock for material introduction

The unique plastic manipulation box, ideal for beta-emitting isotopes, and the different shielding thickness available make it suitable for manipulating any type of radiopharmaceutical including those specific for metabolic radiotherapy. ELENA meets all calibration and manipulation fractionating requirements of Nuclear Medicine departments.

It is equipped with a laminar flow work chamber and ventilated pre-chambers for the transit of materials, to house generators and to confine waste.

The machine offers exclusive technical solutions which guarantee unique performance in terms of:

  • Sterility: the laminar air flow work area (Class A according to EEC-cGMP) allows handling radiopharmaceuticals in absolute safe conditions for the product. All the outwards accesses are equipped with airtight interlocked pre-chambers (Class B according to EEC-cGMP)
  • Radiation protection: shields are made to ensure the full protection of the operator
  • Ergonomics: all the components required for the dose preparation are placed within the range of action of the operator’s hands
  • Safety: the main door of the isolator is equipped with a lock system, controlled by an internal double probe G.M. detector
  • Management of the critical parameters: the isolator is equipped with a modern operator panel to control, adjust and export the cell inner parameters, notifications and alarms
  • Versatility: different shielding spacers, make the cell versatile and suitable for different uses. The large internal chamber and the shape of the work surface allow installing automatic synthesis modules or fractionators for syringes and vials
  • Duration through time: the high-quality of the components used ensure duration over time and performance consistency.

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