The newly built automated production control system for Foot-and-Mouth Disease inactivated vaccine in Lanzhou of Shenlian Biopharmaceutical is the first fully automatic animal vaccine production line in China. This project utilizes an advanced process automation system to achieve automation in production and operation, while providing comprehensive and open data information for operational management. The automation system directly controls modules such as media preparation, buffer preparation, inactivation and purification, emulsification, bioreactor, wastewater collection and treatment, centrifuge, and related auxiliary equipment. It also interacts with devices such as CIP stations for data exchange.

The project adopts DCS and fieldbus technology, configures the software platform and implements engineering design in accordance with ISA S88 requirements. The production process involves biopharmaceutical fermentation and purification, and all validation support documents are completed under the guidance of GAMP5. The total number of PO points for the entire project is around 2,500.

In addition to the conventional requirements for the reliability, functional completeness, maintainability, user-friendliness of the human-machine interface, and analyzability of data of the control system, this project also requires targeted design solutions for the following application characteristics:

●　Implementation and documentation system that meets regulatory validation requirements
●　Standardization and flexibility based on ISA S88
●　Customized automation for complex process equipment
●　Electronic batch reports and records
●　Monitoring and management of process equipment status
●　Monitoring equipment suitable for clean areas

Based on the above requirements, Wellthinic has chosen PCS7 as the DCS platform for this project. PCS7 is an automated control system developed by Siemens, which is a fully integrated, structurally complete, and functionally robust system oriented towards the entire production process and equipment management. It has high reliability and stability, utilizing high-speed, large-capacity controllers and an efficient client/server architecture that supports centralized, top-down configuration methods. Additionally, PCS7 offers a comprehensive and user-friendly human-machine interface, as well as a fully open structure that can communicate with management layers and seamlessly integrate with fieldbus technology.

In addition, PCS7 has the following features that make it a suitable process control platform for this project:

●　The product design fully complies with electronic signatures and electronic records, supporting development in accordance with GAMP requirements.
●　Simatic Batch software fully meets ISA S88 standards and seamlessly integrates with the PCS7 system.
●　Supports customized development for various process objects.
●　Using Simatic Batch can automatically generate complete electronic batch reports.

Fully automated process production

The entire process flow is monitored and controlled in real-time by the DCS. For the inactivation, purification, and formulation stages of the vaccine, the DCS system designs different control logics based on varying process requirements, thereby enhancing the overall automation level of the factory.

Standardized, traceable, and reusable software design documentation

All programming and hardware equipment are supported by corresponding documentation, which meets the requirements of the FDA in the United States and the GMP in the European Union. This ensures that clients have the necessary documentation support for future upgrades and modifications.

Recipe Control Based on ISA S88 Standards

In response to the formula control requirements of the project, technical documentation that complies with ANSI/ISA S88 standards has been compiled. The standard formula program for the batch control system provides customized batch reports after the completion of each batch. This not only reduces the workload of personnel but also improves the accuracy of data, while ensuring its traceability.

Evolution from the conventional CM/EM/UNIT structure to the CM/CG/EM/UNIT structure: The newly added CG is used to resolve the limit on the number of valves called by SFC programs, thus avoiding logical confusion caused by repeated calls to equipment. At the same time, it simplifies the program structure, greatly enhancing the readability of the code and design documentation.

Effectively interact and control signals with third-party PLCs

Network communication with third-party equipment ensures the real-time and reliability of data on the DCS. Data acquisition from reaction tanks and CIP cleaning systems allows for the output of reports, while coordination between the water system, large centrifuges, and reaction tanks ensures smooth operation. The DCS's control over the entire system guarantees the automated operation of the factory.

Through the system, automatic control of the process flow, analysis of equipment operating status, and real-time data management are achieved, comprehensively enhancing the factory's automation and quality control levels, providing robust support for vaccine quality and safety.