Sterile work

Latest specification sterile areas for IMP manufacture and radiopharmacy

  • Constructed to comply with EU GMP
  • Electronic environmental control to all areas:
    • Internal temperature 21°C (± 2°C)
    • Maximum 65% humidity
  • 500 Lux lighting
  • Isolator rooms:
    • 2 Envair CDC-F glove isolators (negative pressure)
    • 1 Envair CDC-F Technetium isolator (negative pressure)
    • minimum of 55 air changes/h
    • minimum of 45 Pa above atmospheric pressure
    • intercom to other manufacturing areas
  • Cherwell surface air sampler
  • ‘In’ and ‘out’ hatches to all areas for optimum work flow
  • Interlocked doors
  • Synchronised clocks

We have extensive experience of preparing solutions for IV infusion and parenteral injections.

We QP-release all sterile doses.