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
• PMT particle 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.