Kangtai Biological's Vaccine Filling and Packaging Workshop Cleanroom Engineering Project_Deiiang

A newly built vaccine R&D and production base by Kangtai Biological in Shenzhen Guangming New District, constructed in accordance with China's new GMP and EU GMP standards. The base primarily produces products such as the COVID-19 inactivated vaccine and Hepatitis B vaccine. The filling and packaging workshop undertakes core processes like vaccine filling and packaging. The project is equipped with advanced EMS/BMS environmental monitoring systems for real-time monitoring of cleanroom temperature, humidity, and differential pressure, ensuring maximum quality and safety during production.

Client Profile

Shenzhen Kangtai Biological Products Co., Ltd. was established in 1992 and listed on the Shenzhen Stock Exchange's Growth Enterprise Market (GEM) in February 2017 (Stock Code: 300601). It is the first listed vaccine company in South China, focusing on the R&D, production, and sales of human vaccines. Headquartered in Shenzhen, the company has five major R&D and industrial bases located in Beijing and Shenzhen, with production scale ranking among the top in the domestic vaccine industry and a sales network covering 31 provinces nationwide. The company has 11 marketed products, including core offerings such as the 60mcg Hepatitis B vaccine (a global innovation) and the Quadrivalent Vaccine (exclusive in China). To date, it has produced and sold over 1.2 billion doses of Hepatitis B vaccines.

The Kangtai Biological Guangming Vaccine R&D and Production Base is the company's next-generation vaccine industrialization base. The project is being constructed in two phases, with Phase I including facilities such as the vaccine production building and the quality control and R&D building. The filling and packaging workshop officially commenced filling and packaging operations for the COVID-19 inactivated vaccine in May 2021, with 400 production employees working 24/7 in three shifts to ensure vaccine supply.
The workshop is equipped with an EMS/BMS environmental monitoring system that collects real-time cleanroom operational data, ensuring parameters such as temperature, humidity, and differential pressure comply with GMP requirements. The annual production capacity for the Hepatitis B vaccine exceeds 40 million doses. The cold storage warehouse is installed with a "one-use, one-standby" dual refrigeration system, and the temperature monitoring system operates 24/7 for real-time surveillance, ensuring vaccine storage temperatures remain between 2-8℃.