CLIENT: EirGen Pharma

SCOPE: Process Design & CQV

TIMELINE: May 2016- Present

This project involves the fit-out of an existing building shell with a sterile fill-finish suite, inspection, OSD, QC chemistry and microbiology labs, cold store and warehouse.

Equipment included a sterile vial filling line, lyophiliser, autoclave, parts washer, formulation, blender, granulator, mill, press, coater, clean utilities generations skids.

Our scope of services included the following:

  • Process flow diagrams
  • Process and clean utility design
  • Process equipment URSs and technical specifications
  • HAZOPs
  • pFMEAs
  • Tendering of process equipment
  • Design support
  • CQV of all GMP systems, initially to end of PQ

Please contact linda.nugent@tandempm.ie for futher information.

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