Process

BioTechnologie

  • Critical Process Parameters specifications
  • Process Risk Analysis Assessment according to P-FMEA standard and by setting up the new RAPA approach
  • Sanitary Design, Appropriate Material & Internal Finish Specifications according to ASME-BPE2012
  • Critical Instruments, Equipment spcifications & sizing optimization of at least the following:
  • Reactor, mixer, melting & formulation tanks, TCM, heat exchanger, evaporator, crystallizer, condenser, peristaltic, centrifugal & volumetric pumps
  • Incubator, fermentation skid, centrifuge, homogenizer
  • Sterile filtration, ultra filtration and (TFF) tangential filtration flow & Dia-filtration & Dia-Filtration skid
  • Integrity Test & Water Intrusion Test / WIT
  • Depyrogenation oven & tunnel & steam sterilization autoclave, (Sterilization Out Place / SOP)
  • Sterilization In Place / SIP
  • Freeze dryers (Lyophilisation), chromatographic columns
  • Aseptic filler, capping machine

API & Pharma

  • IBC (In Bin Containement) Tote, dispensing & closed transfer systems, mill & blender, high-shear granulator & dry formulation, fluidized bed dryer
  • Compactor & pellets press, coater
  • Printer, blistering & label machines
  • Process risk analysis assessment based on FMEA/AMDEC, Hazop
  • Technical specifications for control system (PLC) & critical instruments
  • Process & safety features design & optimization
  • http://www.linkedin.com/pub/aziz-chraibi-phd-eng/b/a38/170

Pharma Bio Expert, your cGMP Regulation & Engineering Compliance Partner