The quality of drugs produced by pharmaceutical enterprises is related to human life, health and safety. In order to ensure the quality of all stages of the whole drug life cycle, the production process of drugs needs to meet a complete set of strict quality management norms, including GMP, cGMP, GLP, GCP, etc. The purpose of these specifications is to conduct a rigorous, traceable tracking, and verifiable and tight monitoring of the entire life cycle of drugs. To truly realize the requirements of these norms, we must use the means and methods of automation and information technology.

Tianke (Jingzhou) Pharmaceutical Co., Ltd. project covers an area of 230 mu, mainly producing and selling pharmaceutical API and domestic and foreign research and development, production contract products CDMO, CMO (patent API). The project is positioned as a green factory and a smart factory, and the project standards are national GMP, EU EDQM and US FDA standards.

Tianshi Group is the general contractor of Tianye Pharmaceutical project, providing a full range of project planning and design, automation information engineering, clean engineering, mechanical and electrical installation, environmental protection engineering and other services. Automation information engineering, actively play in API information engineering, process automation, utility automation advantages, for tianke pharmaceutical project automation information system planning, single design, control system related hardware and software, instrument system design, automation related weak current design and project procurement, construction and installation, programming, debugging, computerized system verification and a series of services.

Architecture diagram of digital intelligent system

Create the industry intelligent benchmark

The automatic control system of Tianke Pharmaceutical project all adopts DCS system based on Siemens SIMATIC PCS 7 platform (5 sets) and PLC system (9 sets) of TIA Botu (TIA Portal) platform. The points of the whole plant are about 10,000 points, which can realize the automatic control of workshop process, liquid tank area, clean air conditioning, environmental protection, etc. The system architecture is a C / S structure. The site I / O branch station adopts PROFIBUS DP bus and PROFI-net bus to transmit the data to the CPU, which greatly reduces the trouble caused by a large number of cable laying.

In workshop process automation, the group in tianke pharmaceutical project, nitrogen replacement, liquid feeding, reactor temperature control, pressure distillation automatic control, PH, automatic separation, automatic phase transfer and automatic recycling system and a series of advanced synthetic process control technology, make the process parameter control more accurate, minimize human operation and intervention, enhance the controllability in the production process of automatic storage and all process data, can query at any time, to ensure the production process data integrity, traceability, successfully power automatic production.

Information display platform of the central control room

Tianke Pharmaceutical construction process and part of the results display

Practice the concept of high efficiency and green development

For API enterprises, after the implementation of the whole process automatic control system, the next step will consider the implementation of the information system, extract the process production data, open up the data island, complete the integration of the system application, simplify the management, create more value, and improve the efficiency of enterprise decision-making.

In the Tianye Pharmaceutical project, the energy management system designed by The Rising Times Group also provides a more direct basis for management and decision-making. The system is mainly to monitor, record, analyze and guide the energy consumption of the manufacturers, such as water, gas (steam), wind and electricity. Real-time monitoring of the detailed use of various energy sources in enterprises, to provide an intuitive and scientific basis for energy conservation and consumption reduction, to find out the energy consumption weaknesses for enterprises, and to promote the further improvement of enterprise management level and the further reduction of operating costs. Make the use of energy reasonable, control waste, to achieve energy conservation and emission reduction, energy saving and consumption reduction, and then create benefits. Through data analysis, it can help enterprises to carry out real-time assessment of each workshop unit and the main energy-consuming equipment, eliminate waste, and can help enterprises to further optimize the process, so as to reduce the unit energy consumption cost, and improve the comprehensive competitiveness of enterprises.

Combined with the energy management system, the Automation and Information Division of The Times Group has designed and developed a data visualization platform, which can connect with MES system, WMS system, LIMS system and energy management system, turning the information and digital production process into reality, and providing visual decision-making basis for enterprise managers.

Tianke pharmaceutical construction process and some results on display

Tianke Pharmaceutical Energy Management (this data is simulated data)

Build a smart management platform

Pharmaceutical chemical industry encountered in the process of production processing, often have flammable, explosive, corrosive and toxic substances, and the production device trend personnel, once the accident will directly affect the life and health of personnel, lead to extremely serious safety accidents, so the personnel plays a vital role in the drug production quality management. Tianye project personnel safety management system, supports a variety of map effects: 2.5D, tilt photography, 3 D modeling, human and vehicle information, two single three cards, work tickets, etc., based on the powerful map engine, to achieve visual management. A new interactive experience combining data management and user experience, with practical functions and simple and convenient operation. The personnel positioning system based on Bluetooth beacon can achieve second-level high-precision real-time positioning and realize intelligent management of safety production.

Application interface of the Safety Management System (historical track query)

Tianke pharmaceutical personnel safety management system interface details

Within the scope of the whole factory, also set up an independent AI behavior recognition video monitoring system, monitoring the main positions and key areas, can realize workshop personnel without wearing safety helmet, illegal sit, elbow door safety and irregular behavior analysis and alarm and produce records, and timely notify EHS, QA for follow-up processing.

TianPharmaceutical AI Behavior Identification System

In addition to the above key intelligent management system, the factory also set up a scale management system, warehouse temperature and humidity distribution monitoring system, the factory office and research and development network system, comprehensive management platform (including video, entrance guard, gate, attendance, telephone, infrared detection, ring monitoring system), ring monitoring system, combustible toxic gas detection system, etc.

At present, the first phase project of Tianye Pharmaceutical has been completed and started trial production. Through its own high-end production line, Tianye Pharmaceutical leads the national products and the first-class intelligent level of the industry, and has established the internal control quality standards much higher than the domestic and international pharmacopoeia, and has walked in the forefront of the industry intelligence

In the future, The Times will continue to explore cutting-edge technologies, relying on outstanding quality, trusted services and customized solutions to help more pharmaceutical companies practice the digital future..