Filling line
Patented sterile capper loader
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.