cGMP Production

Home > Contract Manufacturing > cGMP Production
Manufacturing from lab to commercial scales.

Equipment
All equipments have been validated to meet regulatory requirement including:

 

Air Handling System

CCSB Layout

All our process equipments are manufactured in Taiwan, U.S, Japan or Europe.

Facilities / Capacity
The area of Shulin plant is34,000 square meters with approximately 195 employees. The facilities have been audited and approved by both local and foreign authorities and major customers.
Our facilities consist of 7 areas for fermentation, purification and chemical synthesis for production ranging from kilograms to multiple tons. Fermentation capacity ranges from 75L to 50,000L. Purification and synthesis ranging from 30L to 8,000L. Reactors are made from either  stainless or glass-lined. There are 3 areas for chemical synthesis ,2 areas for downstream purification and  2 areas for fermentation production.Each area has its separate building with segregated clean room to perform filtration, drying, milling, sieving, packaging.


The plant operation areas includes

Production Area 02 100L—6000L 6kg—400kg
Production Area 03 3000L—7000L 300kg--1600kg
Downstream purification Area 05 30L—7000L 1kg—200kg
Downstream purification Area 06 500L—7000L 20kg—150kg
Intermediate area 50L—4000L 50kg—1000kg
Fermentation Area 07 20,000L—30,000L 2kg—300kg
Fermentation Area 08 75L—6,000L 0.1kg—70kg