We have established an integrated manufacturing system with single use filling solutions. Our sound and reliable 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