Equipment

State-Of-The-Art Filling Facility

We have recently completed our state-of-the art filling facility in Wuxi, China. The facility covers an area of 2550m2/ 27450 sqft. We have established an integrated fill and finish equipment solution for the filling process. Our aseptic filling operations take place in a Grade A isolator and RABS area with Grade C background. We have equipped the manufacturing facility with three filling suits. This provides us with the flexibility and resources to manufacture to your specific needs and requirements. As a result, we would also have the capability to meet current demand. However, we have also prepared capacity to be able to meet future demand. In addition, we operate our facility and aseptic fill and finish manufacturing according to GMP standards.

Equipment and Technology

We have established an integrated fill and finish manufacturing system with single use filling solutions. Our sound and reliable fill and finish equipment and 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
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
Washing and Depyrogenation
  • 2 linear washing/drying/ depyrogenation machines
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.

Your Fill and Finish CMO Partner