Facilities

Facilities

Located in the Southern Taiwan Science Park, ScinoPharm has multi-purpose facilities that can manufacture various products. These are specially designed with the advantages of modern API production facilities. This design concept has been described by the US FDA as advanced manufacturing. ScinoPharm’s comprehensive facilities and quality systems passed the FDA review for the seventh time in 2019.

ScinoPharm’s production facilities have 16 cGMP-compliant production lines that can manufacture batches in kilograms to ton scales. The reactor vessels are 20–10,000 l in volume and are made from stainless steel, alloy, or glass-lined steel, of which six production lines can manufacture high potency APIs such as hormones, cytotoxic agents, and APIs for injection formulations. Each existing production line has its own dedicated filtration, drying, grinding, and packaging equipment. Furthermore, the plant’s multi-purpose drying and processing equipment are cGMP-validated and can resolve hurdles encountered during production. The automation of all manufacturing processes and shared systems is realized using the Emerson Delta V process automation system.

Note that differently sized chemical reactors provide flexibility in handling different chemicals reaction processes and in meeting customer requirements with different production volumes. Operations at every stage are compliant to all international cGMP standards and strictly adhere to the international standards of quality, environmental health, and occupational safety.