Location & Layout
The Taichung plant is located at the Central Taiwan Science Park (3F, No.28, Keya West Rd., Daya District, Taichung City, Taiwan). The plant facility occupies approximately 4000 m2 of space, which includes 3 significant sites: PEG Production Area, API Production Area and Filling Plant.
PEG Production Area
Except the protein production line, a dedicated, clean and controlled PEG production area is also located in PharmaEssentia Taichung site. In this area, the high purity PEG intermediate is produced with high yield via chemical synthesis. This specially designed drug intermediate is used in the PEGylation step and provide excellent selectivity which is the guarantee of the pure final drug product.
API Production Area
To commit the highest quality of product, PharmaEssentia has devoted to production with state-of-the-art techniques include 1500m2 of area encompasses single use facilities, cleanness control of production together with closed system. Solid application of current GMP principles comprising ICH guideline, European Annexes, PIC/S and FDA guidance has promised the certification of European recently and also the rest of the world in the future.
Filling Plant
The Filling Plant at PharmaEssentia Taichung choose the automation filling line machine, SV125, equipped with the RABS (Restricted Assess Barrier System) those are made in Germany by the leading brand of filling line machine, OPTIMA PHARMA GmbH. This filling line machines are designed for a variety of container form such as Pre-Filled Syringe, Vial and Cartridge. This filling line machines provide the maximum protection and complete security for both of aseptic filling of product and personnel.