Injectable Manufacturing Services
Being one of the top suppliers of high potent/ oncological APIs worldwide to regulated markets, ScinoPharm is poised to provide the service to customers with high potent/ oncological injectable drug products. With the new injectable plant completion in Tainan campus in Taiwan in 2017 and together with well-established API capability, ScinoPharm is able to offer high quality pharmaceuticals from API to final dosage form under one roof with greater flexibility, reliability and efficiency.
The injectable plant was designed and built to comply with the stringent global GMP requirements. Two separate aseptic filling lines are installed respectively for the manufacturing of cytotoxic injectables in liquid/lyo vial format and high potency liquid products in cartridge or prefilled syringe format. Both lines are adopting state-of-the-art isolator technology and are to utilize disposable technology as much as possible. Also included in the organization of injectable plant, aside from the support from API organization, are analytical capability and formulation development capability. The intent is to move towards becoming a full spectrum service provider that meets client’s entire needs from API to dosage form as well as from early development to commercialization
The features of ScinoPharm Injectable Plant are summarized as follows:
Single Use Technology for Product Contact Path
- Use of disposable materials to prevent cross contamination caused by improper cleaning.
- Customized filling process in accordance with requests.
Production Equipment Highlights
To reduce the risk of sterility breakage and to minimize human interference in Grade A environment, operations of aseptic filling/stoppering/capping are carried out in Grade A isolators. Separately, for safety concerns, compounding isolators operated at negative pressure are applied to ensure that the activities of API dispensing and bulk solution preparation are all contained in a closed system. Our filling lines are capable of handling the bulk solution that contains organic solvent or is sensitive to oxygen.
Aseptic filling of high potency drugs in pre-filled syringe/cartridge
- Pre-sterilized container in nest/ tub
- All sizes of pre-filled syringe/cartridge packaged in nested format
- Flexibility design for rapid changeover of format parts to adapt to a wide variety of liquid formulations
Vial filling for liquid or lyophilized injectables (in 2-100 mL vials), comprising of:
- Washing machine
- Depyrogenation tunnel
- Filling/stoppering machine
- Capping machine
- External vial washer
- Auto loading and unloading system, and lyophilizer having total shelf area of 10 m2 with capacity to process 10 mL or 15 mL vial up to 18,000 units)
- Terminal sterilizer
- Autoclave, parts washer, compounding isolators, Grade A isolator
- Process Information Control System (PICS), Building Automation System (BAS)
- Microbial lab: Sterility test isolator, microscope, auto Gram stainer, MALDI Biotyper, biological safety cabinet, incubator, automatic colony counter, bacterial endotoxin analyzer, air sampler, particle counter etc.
- Chemical lab: CCI - leak tester, liquid particle counter, optical comparator, osmometer, GC, HPLC/UPLC, TOC analyzer etc.