ScinoPharm Injectable Plant
Compliant with international GMP standards and cleanroom standard; aseptic filling
Adopt single-use, sterile filling consumables
Single-use consumables are adapted for fluid transport tubing and temporary storage bags for sterile filtration and compounding requirements. This reduces the possibility of cross-contamination because of cleaning and repeated use. The customized process following the customer’s product requirements.
Production equipment overview
Grade A isolators are used in segmented production lines to minimize the sterile operation space and human interference on the aseptic environment. Separately, to fulfill the highest safety standards, compounding isolators are operated at negative pressure. Moreover, our filling lines are capable of handling bulk solutions that contain organic solvents or are oxygen sensitive.
Production line for nested pre-filled syringe/cartridge packaging
- Adopt pre-sterilized syringe packaging materials
- Nested packaging of pre-filled syringe/cartridge formats of all sizes
- Flexible design for rapid changeover of parts, adaptable to various liquid formulations in pre-filled syringe/cartridge formats
Vial production line
Our vial filling facility for liquid or lyophilized injectables (2–100 mL) comprises the following equipment:
- Vial washing machine
- Depyrogenation tunnel
- Filling/stoppering machine
- Capping machine
- External vial washer
- Note that auto loading and unloading system and lyophilizer for vials; total shelf area of 10 m2 with the capacity to process up to 19,000 units per batch of 10 mL or 15 mL ISO standard vials.
- Terminal sterilizer
Other Equipment
- Autoclave, parts washer, compounding isolator, Grade A isolator
- Process Information Control System (PICS), digital management and storage of process and environmental monitoring information
- Microbial and chemical test equipment
