Formulation – Cytotoxic Liquid and Lyophilisation

Experience in handling cytotoxic compounds since 1983 and since then has improved to handle different formulation and presentation such as sterile powder filled vials (lyophilized); injectable liquid  ampoules. The sterile oncology manufacturing facility is designed for Band-5 compounds with PPEs. The lines are located in the oncology factory building together with the oral production line. The sterile oncology operation consists of a sterile liquid filling line, equipped with washing machine, depyrogenating tunnel, filling/capping, sealing, external washing machine and a glovebox in the dissolution area. The liquid filling machine is also connected to a freeze dryer. The Facility has an ampoule filling machine and the line is equipped with multiple packaging and labelling lines.

The Facility has classified areas for aseptic processing to minimize biological contamination. All personnel involved in the sterile operations are fully qualified on aseptic techniques and Japanese quality standards.