Pharmaceutical Systems

  • Critical Parameters specifications
  • Design Risk Analysis Assessment according to D-FMEA standard
  • Sanitary Design, Appropriate Material & Internal Finish Specifications according to ASME-BPE2009
  • Critical Instruments, Equipment spcifications & sizing optimization of at least the following:
  • Clean In Place / CIP
  • Washing In Place / WIP
  • One Pass Sanitary (Shell & Tubes) Cooling Heat exchangers (for pure steam sampling)
  • Clean Out Of Place / Washers
  • Vacuum & deduster
  • HVAC, FFU, PLC, BMS, EMS, Access Card control, Aseptic rooms’ doors electrical interlock
  • HEPA filters
  • Thermal decontamination & neutralization skids

Pharma Bio Expert, your cGMP Regulation & Engineering Compliance Partner