Safeguarding life safety, the "pain" and "medicine" of the pharmaceutical industry



From Shennong to digitizing drug research and development, for thousands of years, the pharmaceutical industry has always stood in the front line in the fight against diseases and epidemics, and helped mankind win victory again and again through innovation and breakthroughs. As China enters an aging society, the sharply increased demand for drugs has further promoted the development of the drug market, and China's pharmaceutical industry is rapidly moving in the direction of high quality, entering a critical period of transformation from a "pharmaceutical power" to a "pharmaceutical power".

In promoting the construction of new industrialization, the dual transformation of digitalization and green low-carbon has become the only way for the pharmaceutical industry to achieve high-quality development, and cutting-edge emerging technologies such as digital twin, artificial intelligence, cloud edge collaboration, big data, and carbon reduction have also brought unlimited possibilities for the development of the pharmaceutical industry. The "14th Five-Year Plan" for the development of the pharmaceutical industry clearly puts forward the goals of green, digital and intelligent development of enterprises, in order to promote the upgrading of the pharmaceutical manufacturing capacity system, continuously improve the quality and safety level, promote the digital transformation of the industry, promote the green and low-carbon development of the whole industrial chain and improve the ability to control security risks.

According to statistics, among the 153 factories in the global lighthouse network, there are 22 in the pharmaceutical industry, and there are more than 40 lighthouse factories, but China's local pharmaceutical companies are still blank. Whether it is a newly emerging biopharmaceutical in recent years, or a mature chemical pharmaceutical with the largest volume in the pharmaceutical industry, there is an urgent need to improve efficiency and win the competitiveness of the industry through digital transformation.

From biopharmaceuticals to chemical pharmaceuticals, green "smart" drugs are accelerating

Biopharmaceutical is a kind of pharmaceutical method which makes use of the principles and methods of microbiology, chemistry, biotechnology and pharmacy. In the pharmaceutical industry, the structure and process of biological drugs are the most complex, and the safety evaluation requirements are also more challenging. Its production chain covers material management, raw liquid process, preparation process, packaging process, warehousing and logistics and other links, subject to personnel operation, equipment interaction, material weighing and production standards, often in the actual management of production management at all levels is difficult to cooperate, human error is difficult to avoid, heavy workload of material weighing and a series of problems. It greatly increases the difficulty of risk control of the whole process.

The chemical pharmaceutical industry includes chemical raw materials and chemical preparations, and its raw materials rely on the subdivisions of the chemical industry - the basic chemical industry and the fine chemical industry. Chemical pharmacy emphasizes precise steps so that each chemical reaction is fully controlled. Taking the raw material process as an example, the raw material belongs to fine chemical pharmaceutical, which not only has fixed tube and tank process design, high energy consumption and low efficiency in the production process, but also involves a dangerous process, and core control, cost reduction and efficiency improvement and safe production are its core demands.

Drug safety is a matter of life, and the pharmaceutical industry has always been a highly regulated industry. With the landing of the new medical reform policy, GMP (drug production management practice) certification has become a normal supervision, drug consistency evaluation has become a mandatory requirement of the industry, from biopharmaceutical to chemical pharmaceutical, are facing multiple challenges such as quality, compliance, safety, stability, efficiency and so on.

A seven-step approach to digital transformation empowers the pharmaceutical industry to enhance the four major values

As an expert in digital transformation in the field of global energy management and automation, Schneider Electric has innovated the "seven-step method" of digital transformation from project stage to operation stage with its rich technical reserves and industry practical experience, helping enterprises to carry out efficient management and control of the whole life cycle, and bringing four values of lean and efficient, safety and compliance, openness and transparency, and sustainable development to enterprises. Accelerate digital transformation and achieve sustainable development.

• Schneider Electric Digital Transformation Consulting Services: Covering strategic, operational and technical level consulting, it can help pharmaceutical companies to carry out top-level strategic planning such as lean production, supply chain collaboration, production optimization, smart factory planning, and formulate more in-depth and refined digital transformation strategies, determine digital objectives and implementation plans, evaluate digital priorities and feasibility, and then comprehensively empower organizations to improve corporate efficiency. Achieve better transformation results.

• Integrated design: The software system including AVEVA E3D 3D design software, by integrating engineering, design and simulation functions, can realize engineering digitization, integrated design, end-to-end integration of process simulation and conceptual design, front-end engineering design and detailed design and other engineering design stages, which can help enterprises quickly deploy projects and start projects in the fastest time. Effectively reducing the time required to create project deliverables and maximizing the efficiency of capital projects is the starting point for pharmaceutical companies to establish digital factories and digital twin factories.

• Asset Information Management Center: Based on the AVEVA AIM asset information management platform (digital delivery), it can help pharmaceutical companies build engineering project data centers, through the export of design tools, to the import platform and complete digital delivery of all functions, the data is capitalized, thus laying the foundation for the creation of digital twin factories.

Operations Information Management Center: Through the AVEVA PI System big Data management platform to collect, store and deliver trusted, high-quality operational data, companies can visualize the pharmaceutical manufacturing process and discover insights and value through data analysis. In addition, the AVEVA PI System big data management platform can open up the big data connection from the laboratory to the production line, help pharmaceutical companies accelerate the transformation of research and development results into actual production, and by comparing and analyzing the commercial production status, parameters and results with the research and development data, it can also help enterprises accurately locate the "golden batch" in the production process. Improve production compliance and overall production efficiency.

• Smart facilities: BMS building control systems, EMS environmental monitoring systems, SCADA data acquisition and monitoring systems, PAS process automation systems, etc., are the cornerstones of pharmaceutical companies to create digital. BMS building control system can control the industrial air conditioning unit, according to the different actual conditions in summer and winter, to achieve the stable control of the entire pharmaceutical factory storage environment and drug production environment; EMS environmental monitoring system can monitor the key production areas and equipment environment, real-time view the environmental temperature, humidity and environmental pressure difference of the drug production area, and achieve the data integrity of the production environment record. SCADA system breaks the data island, realizes the efficient acquisition and storage of field equipment data, and ensures the complete traceability of equipment data. The PAS system realizes the flexible batch production of the main process pipeline through the control of the field instrument valve and the batch control software based on ISA88.

• Efficient operation: MES Manufacturing execution system, WMS warehouse management system, EAM asset management system and other information solutions, from the production, material, deviation, equipment, quality, performance, energy and other aspects of the comprehensive integration of standardized production execution process, to ensure that the data is complete and traceable, generate electronic batch records to meet the regulatory needs. Make the production process more sustainable and resilient, and then operate efficiently with digital control.

• Integrated Operations Center: AVEVA UOC Integrated Operations Center creates an IT/OT integration platform to help pharmaceutical companies integrate project phase information, performance information and operational information, and realize command and control from a single site to multiple sites through visualization from workshop to plant and group.

The right medicine, the digital prescription describes the green "smart" medicine blueprint

As digital transformation continues to deepen in the pharmaceutical industry, pioneers in many industries are revolutionizing digital plant planning, construction and operations with the help of Schneider Electric's seven-step approach.

A pharmaceutical factory, for example, used Schneider Electric's AVEVA PI System, PI Server, PI Datalink and PI Vision integrated solutions to digitally upgrade the batch release process for pharmaceutical production. The system can automatically determine the status of the batch and release it, thereby effectively reducing errors and making the entire production process more compliant and transparent, while greatly improving production efficiency. At the same time, the plant also deployed predictive maintenance at the equipment level to reduce costs and increase efficiency by ensuring the stability and safety of production.

In addition, the factory of a well-known medical nutrition company is based on the MES system DMO customized by Schneider Electric to track and manage the entire production process and carry out data statistical analysis. With end-to-end, full-module DMO, the plant achieved continuous transparency and real-time management of its production process, reducing production costs per ton by 3%. In addition, through the automatic statistical analysis of the bottleneck equipment performance, the production efficiency of the entire production line has increased by more than 8%, and with the online correction function of the quality module, the defective product rate has been reduced by 5%.

In the construction of Meriex Suzhou base, Schneider Electric provided a complete set of power distribution, automation and information solutions, including building management and environmental monitoring system BMS, EMS environmental monitoring system, PO power monitoring system, EBO building operation system, and production process automation system PAS based on AVEVA system platform. With more advanced management and control technology and more efficient energy efficiency strategies, we help users promote the construction of automated production lines and improve the management of environmental and production data, and help them achieve sustainable development goals by reducing costs and improving efficiency, creating a benchmarking project in the biopharmaceutical industry.

Every step taken by human beings in the field of life science is precious. The development of the pharmaceutical industry is related to the national economy and people's livelihood, which requires the joint efforts and continuous innovation of the entire industry and enterprises. Based on its many years of technical precipitation and practical experience in the field of life sciences, Schneider Electric will continue to be committed to providing pharmaceutical companies with digital solutions and services covering the whole life cycle, helping customers comply with the safety of production and operation, while promoting the digital and green low-carbon transformation of pharmaceutical factories, enabling the pharmaceutical industry to move towards high-quality and sustainable development.