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Technology

We have established an integrated manufacturing system with single use filling solutions. Our sound and reliable sterile fill and finish manufacturing technology include:

  • Isolator-based aseptic filling of aqueous solution products (2L-150L batch size)
  • RABS-based filling of aqueous solution products with terminal sterilization (superheated water autoclave)

Formulation

  • 2 formulation tanks with total capacity up to 150 L
  • 1 formulation single use mixing system 1-50 L
  • 1 formulation single use mixing system 50-500 L
  • Sterile filtration of ready formulated product
  • All operations performed in closed systems

Vial formulation tank

Filling

  • 1 isolator based vial filling and stoppering line that can fill 1 vial at a time
  • 1 RABS based high speed ampoule filling line that can fill 8 ampoules at a time
  • All ampoule filling operations take place in a Grade A enclosed area with Grade C background
  • All aseptic filling operations take place in a Grade A isolator area with Grade C background
  • Each product can have its own pump tubing and filling needle
  • Vial sizes ranging from 2cc to 30cc
  • Ampoule sizes ranging from 2cc to 20cc
  • Daily batch size of 70 000 ampoules based on smallest vial size
  • Daily batch size of more than 8000 vials based on smallest vial size
  • Environmental monitoring takes place continuously – before, during and after the filling process
  • Manual checks of fill volume throughout the filling process
  • Semi-annually recertified HEPA filters in Grade A
  • Smoke studies are routinely performed in Grade A

Washing and Depyrogenation

  • 2 linear washing/drying/ depyrogenation machines

depyrogenation fill and finish filling depyrogenation

Vial Stoppering and Capping

  • 1 stoppering/capping machine integrated in Isolator filling system for 13mm or 20mm stoppers and caps
  • All capping operations take place in a Grade A isolator enclosure
  • Environmental monitoring is performed before, during and after the stoppering/capping process.
  • Prewashed rubber stoppers are sterilized and meet endotoxin, bioburden and particulate requirements

With the robust filling solutions technology Wuxi Griffin has in place, we are confident that we are able to assist you throughout your sterile fill and finish project. Contact us today to find out how we can help you.