Facility by formulation
- CDMO
- Manufacturing process
- Injection plant
-
Facility by formulation
- 주사제 [Pre-Filled Syringe]
The production lines are under operation following the PICS Guidelines for GMP in Pharmaceuticals. Additionally, the filling environment has been configured with the ready-to-use sterilized tubing (Nest) solution for aseptic manufacturing, automation system (Robot Arm), automatic transfer system for filling material, and RABS (Restricted Access Barrier System) to equip with the system that can package everything, where both syringe blister and shrink wrap packaging are available..
-
step. 01
Preparation
CAPA : 150L
- Load cell (METTLER TOLEDO)
- CIP/SIP
- Automatic transfer system
- Agitator and blade for high viscosity
-
step. 02
Filtration
CAPA : 150L
- Load cell (METTLER TOLEDO)
- CIP/SIP
- Automatic transfer system
- Agitator and blade for high viscosity
-
step. 03
Debagging
CAPA : Semi Auto
- Cutting inside the active RABS with electric blade
-
step. 04
PFS filling
CAPA : 18,000syringe/h
- 1mL, 3mL, 5mL
- High viscosity material available for filling
- Tyvek removal robot arm
- Vacuum controller
-
step. 05
Post-sterilization
CAPA: 8,000 Syringe/each
- Steam + Air fan mixture Type
-
step. 06
Foreign matters inspection
CAPA: 8,000 Syringe/each
- Steam + Air fan mixture Type
-
step. 07
Labeling
CAPA : 18,000syringe/h
-
step. 08
Shrink wrap packaging
CAPA : 12,000Syringe/h
-
step. 09
Weight selection
CAPA : 6,000Case/h
-
step. 10
2D barcode process
CAPA : 6,000Case/h