Contract Manufacturing

PaizaBio has two decades of experience in China in the highly technical business of aseptic fill-and-finish. During this time, we have established a reputation for our quality, integrity, and thorough and responsive project management.

Filling line Filling line

Patented sterile capper loader Patented sterile capper loader

Patented sterile capper feeder Patented sterile capper feeder


Filling

  • 8 high-speed filling and stoppering lines that can fill 8, 10, or 12 vials at a time
  • All filling operations are done in a Class 100 Grade A curtained area with Grade B background
  • Each product can have its own pump/pipe pieces
  • Vial sizes are ranged from 2 ml to 50 ml
  • Daily filling volume in excess of more than one million vials, based on vial size
  • Output of the fastest filling machine at approximately 550 VPM
  • Environmental monitoring is performed before, during and after the filling process
  • Fill-weigh is checked manually every 30 minutes during filling
  • HEPA filters are recertified semi-annually
  • Smoke studies are routinely performed in Grade A/B area

Formulation

  • 4 formulation tanks with total capacity up to 3000L
  • Automatic on-line weighing systems
  • ISO 7/8 Grade C Room Classification
  • Liquid filtration performed in a closed system

Vial washing

  • 8 linear vial washing/drying machines
  • Sterilizing tunnels depyrogenate vials
  • Rubber stoppers are washed and sterilized on-site to meet endotoxin, bioburden and particulate requirements

Vial Capping

  • 10 high-speed capping machines that cap 13mm or 22mm vials
  • All capping operations are done in a Class 100 Grade A curtained area with Grade B background
  • Environmental monitoring is performed before, during and after the capping process.

We can deliver the highly technical and critically demanding parental aseptic fill-and-finish processing you need to command market share in China with quality, precision, efficiency, and above all, confidence. Start a conversation about your project. Contact Us.