Beijing Minhai Biotech is a listed enterprise mainly engaged in the R&D, production, and sales of biological vaccines. It is also a modern technology-based enterprise oriented towards health. It has successively developed nearly 30 innovative vaccine varieties with independent intellectual property rights and leading domestic and international technologies. Among them, the "acellular DTaP-Hib combined vaccine" is a domestic initiative, which has won the Beijing Science and Technology Award and the Chinese Pharmaceutical Association Science and Technology Award. It has the domestic independent intellectual property quadrivalent vaccine and holds the commanding height of international vaccine technology.
Solution Description:
Taking PCS7 and BATCH as the main core control system, through the efficient integration with third-party process equipment, adopting modular design, intelligent debugging tools, and a user-friendly operation interface, it realizes the full automation control of the production process. It introduces advanced automation technologies and tools to reduce human intervention and ensure the accuracy and stability of key steps and links of the project. By establishing a sound project implementation process management system, each operation step is equipped with detailed document records and support to ensure process traceability and standardization. At the same time, it raises the requirements for CSV (Computerized System Validation), strictly follows quality standards and regulatory requirements, and ensures system compliance and reliability.
Implementation Effect:
Through the IT/OT integration technology, it improves production efficiency and equipment operation efficiency, reduces costs, and optimizes resource utilization
It records and manages production data in real-time, ensuring the authenticity, integrity, and traceability of data
The CIP, SIP, and process formulas can be flexibly adjusted to meet diverse process requirements
The product quality and market competitiveness are enhanced, the market share is consolidated and expanded, and the enterprise's leading position in the industry is enhanced
The project strictly follows the GMP of the National Medical Products Administration to ensure the compliance of all production and inspection data
Cooperative Projects and History:
2021, HIB and Tetanus Fermenter Automation Control Project (PCS7 + BATCH)
