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ABOUT USSSY Group Limited is a large high-tech pharmaceutical enterprise with coordinated development of R&D and industrialization in multiple fields such as new drugs, generic drugs, characteristic APIs
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INNOVATIONSSY Group Limited has built a relatively perfect scientific research and innovation system with the development mode of “production, learning, research, and application” of multi-disciplinary integration and multi-directional combination.
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RECRUITIt has established high-level innovation platforms such as engineering laboratory and technology research center jointly with Chinese Academy of Sciences, and now has nearly 400 high-level talents in drug research, analysis and clinical research.
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SUBSIDIARIESThe company has a diversified business development pattern of R&D, production and export of new drugs, generic drugs, characteristic APIs, advanced finished pharmaceutical products, biological preparations and pharmaceutical packaging materials.
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CONTACTWe will continue to strengthen innovation-driven development, will vigorously encourage the integration of production and research, strengthen and improve the five domains: new drugs, biological drugs, traditional Chinese medicine, generic drugs and APIs
The Digital Journey of a Bag of Large-Volume Infusion
Category:
发布时间：2023-05-12
【概要描述】
Shijiazhuang Sihua Pharmaceutical Group is a leading enterprise in China’s large-volume parenteral solutions industry. In recent years, the company has comprehensively upgraded its production equipment for large-volume parenteral solutions and adopted digital technologies, significantly enhancing its core competitiveness. In December last year, the company’s application for a digital R&D and design project for its products was selected for the 2022 List of Outstanding Smart Manufacturing Scenarios released by four government departments, including the Ministry of Industry and Information Technology and the National Development and Reform Commission.
Shijiazhuang Sihua Pharmaceutical Group’s largest automated three-dimensional warehouse boasts 60,000 storage locations. Eighteen aisles divide the warehouse into 36 rows, with each row further subdivided into 90 columns and 19 levels. Photo by Hebei Daily reporter Ma Yanming.
At the AI+New Drug R&D Studio of Shijiazhuang No. 4 Pharmaceutical, Li Yuan, Deputy Director of the Innovation Department, is conducting high-throughput virtual screening for new compounds. Photo by Hebei Daily reporter Ma Yanming.
Hebei Daily reporter Ma Yanming
Editor's Note
The report to the 20th National Congress of the Communist Party of China stated: “Accelerate the development of the digital economy and promote the deep integration of the digital economy with the real economy.”
Industrial digitalization serves as the physical backbone of the digital economy. Hebei Province, with its robust traditional industries, has tremendous potential to promote the deep integration of the internet, big data, artificial intelligence, and the real economy. Starting today, Hebei Daily will publish a special series titled “On-the-Ground Investigation: Industrial Digitalization,” in which reporters conduct in-depth field investigations at leading enterprises across key traditional sectors such as pharmaceuticals, steel, and chemicals. The series will highlight these companies’ digital transformation journeys and vividly illustrate the accelerated efforts to build a digitally empowered Hebei. Stay tuned.
Large-volume injectables, commonly referred to as “large infusions,” are sterile liquid preparations with a volume of 50 mL or more that are administered directly into the bloodstream via intravenous infusion and are widely used in clinical practice.
Shijiazhuang Sihua Pharmaceutical Group is a leading enterprise in China’s large-volume parenteral solutions industry. In recent years, the company has comprehensively upgraded its production equipment for large-volume parenteral solutions and adopted digital technologies, significantly enhancing its core competitiveness. In December last year, the company’s application for a digital R&D and design project for its products was selected for the 2022 List of Outstanding Smart Manufacturing Scenarios released by four government departments, including the Ministry of Industry and Information Technology and the National Development and Reform Commission.
Recently, a reporter visited Shijiazhuang No. 4 Pharmaceutical Co., Ltd. for an interview, engaging in in-depth conversations with frontline R&D and production staff across multiple roles and gaining firsthand insight into the digital journey of a bag of large-volume parenteral solution—from the very beginning of production all the way to final shipment.
■ New Drug Development: AI Boosts Efficiency Significantly
Saturday, April 22, Building A4, Shijiazhuang Sihua Pharmaceutical Research Institute.
Before visiting the AI+New Drug Discovery Studio, the reporter had imagined the workspace would be filled with high-end instruments, test tubes, and a variety of reagents. Yet when the reporter met Li Yuan, Deputy Director of the Innovation Department at the Institute of Pharmaceutical Research, all she saw were three computers and a few specialized books on drug design.
“The computer on the left is connected to the server in the first-floor data center; during high-throughput virtual screening, all 96 of its CPU cores operate in tandem,” Li Yuan explained in response to the reporter’s question. She went on to emphasize that, in new-drug development, computational power far outstrips human labor in terms of efficiency.
Li Yuan holds a Ph.D. from Jilin University. Since joining Shijiazhuang No. 4 Pharmaceutical in 2021, she has been spearheading the establishment of a virtual screening and AI-driven drug discovery platform, leveraging big data to accelerate drug development. In 2022, the platform was completed, and Li Yuan initiated the screening and design of a novel molecular entity compound for the treatment of diabetes, kidney disease, and hypertension. “Thanks to virtual screening technology, we have already identified more than 100 new compounds from a library containing approximately 300 million entries—work that would previously have taken at least two to three years,” Li Yuan said. She added that, by harnessing big data, previously daunting tasks such as drug structure design, target identification and validation, and lead compound optimization have become considerably more manageable.
In the field of drug discovery and development, it has long been said that developing a new drug requires ten years and one billion US dollars, with an extremely low success rate. The application of AI technology, however, will significantly enhance the efficiency of innovative drug R&D.
Based on computational chemistry as its theoretical foundation, high-performance computing clusters as its hardware infrastructure, and computer-aided drug design and artificial intelligence algorithms as its software backbone, Shijiazhuang Sihua Pharmaceutical has established a virtual screening and AI-driven drug discovery platform that encompasses a virtual compound library of small-molecule structures at the tens-of-billions scale. Leveraging AI and deep-learning algorithms, this platform enables precise optimization of key pharmacokinetic and toxicological properties, including absorption, distribution, metabolism, excretion, and toxicity, across a wide range of compounds in vivo.
At 5 p.m., Li Yuan arrived at the physicochemical laboratory in the pilot-scale building to conduct tests on small-scale trial samples. She said, “In the past, many screening processes that previously relied heavily on physicochemical experiments have now been replaced by computers, making our work more targeted.”
■ Pharmaceutical solution preparation: closed-loop delivery; “online” is a high-frequency term.
On the morning of April 23, standing in the corridor of the Intravenous Infusion Central Compounding Center in Workshop 208, one could see, through the glass, a maze of interconnected delivery pipelines and towering compounding tanks.
“Today, the Compounding Center prepared a total of 350 tons of pharmaceutical solutions, primarily glucose injection and sodium chloride injection,” said Liu Baocun, Assistant Director of the Compounding Center. On average, the center prepares 25 batches of pharmaceutical solutions each day for the six production lines in Workshop 208.
Liu Baocun explained that the compounding center can be regarded as the “heart” of Workshop 208, with its equipment operating continuously throughout the year. Shijiazhuang Sihua Pharmaceutical has introduced a Swiss powder-conveying system and adopted an internationally advanced, fully automated, computer-controlled compounding system featuring sealed conveying and online weighing. The batching operations for multiple production lines are centrally located within a single compounding unit, which uniformly delivers the finished infusion solutions to each line, thereby minimizing errors and material contamination during the compounding process and improving the yield of finished products.
The preparation of pharmaceutical solutions is inseparable from high-quality water. According to Liu Baocun, Shijiazhuang Sihua Pharmaceutical employs two-stage reverse osmosis filtration combined with high-efficiency thermal-pressure energy-saving distillation technology, enabling automated online monitoring of total organic carbon, temperature, and conductivity, as well as automatic recording, control, and flow regulation. Following rigorous quality control, the water used in large-volume parenteral products meets European Pharmacopoeia standards for parameters such as electrical conductivity and total organic carbon.
■ Quality Control: Automatic Data Transmission and Automated Judgment
For pharmaceutical quality-testing personnel, casually recording test data from various instruments was once a routine part of their daily work. However, at the Physicochemical Testing Laboratory of the Quality Control Department at Shijiazhuang No. 4 Pharmaceutical, using pen and paper to record data is now a thing of the past.
“Today’s primary testing item is the determination of sodium chloride content.” On the afternoon of April 23, Yuan Suqing, head of the physicochemical testing project, told reporters that the Quality Control Department of Shijiazhuang Sihua Pharmaceutical Co., Ltd. began implementing the LIMS laboratory information management system and the LES laboratory execution system in 2020, replacing paper-based record books with electronic ones to enhance compliance in testing.
According to Yuan Suqing, test data can be directly transferred from the instruments to the electronic laboratory notebook, thereby achieving paperless operations. Inspection tasks requiring verification in the production workshop are assigned to inspection teams via the LIMS system based on the specific test items. The LES system can interface with the testing instruments; once the instruments generate results, these are automatically transmitted to the LES system for recording, where the system automatically determines whether the results meet the specified acceptance criteria.
After the testing is completed, the LIMS automatically aggregates the test data to generate a batch record; once the batch record is approved, the final electronic test report is generated.
As planned, the Quality Assurance Department of Shijiazhuang No. 4 Pharmaceutical will go live with the QMS quality management system in July this year. Batch inspection records and inspection reports generated by the LIMS system will serve as the basis for product release within the QMS system’s functionality. When deviations are detected in the inspection data from the LIMS system, the QMS system will automatically capture such deviations and initiate the corresponding deviation management procedures.
■ Product packaging: seamlessly integrated and interconnected with upstream and downstream processes.
Li Kun, shift leader of the packaging team in Workshop 208, has worked at Shijiazhuang No. 4 Pharmaceutical for more than 30 years. In recent years, what has impressed her most is the application of digital and automated technologies.
On the morning of April 24, when we met Li Kun, she was conducting a routine inspection along the packaging production line. “This morning, we were tasked with packaging 2,000 cartons of 1,000-milliliter sodium chloride injection solutions, and we’ve already completed more than 1,700 cartons,” Li Kun said. She added that in the past, it would have been impossible to accomplish such a workload in a single morning.
Li Kun explained that each packaging box contains 12 bags of 1,000-milliliter sodium chloride injection, making it a large-item package that previously could only be handled manually. Last year, the company commissioned a new automated boxing machine and simultaneously introduced visual inspection equipment, thereby eliminating the need for manual handling of large-item packages and enabling electronic verification of batch numbers, production dates, and electronic supervision codes.
“Currently, my primary responsibility is operating the computer to create inbound shipment tasks based on the day’s production varieties and specifications of large-volume infusion products, and to configure the visual inspection program,” said Li Kun. “In the past, a mirror had to be installed on one side of the packaging line so that workers could manually inspect the inkjet codes on the back of the cartons; now, that mirror is no longer needed.”
The head of the Information Center at Shijiazhuang Fourth Pharmaceutical told reporters that the company has taken the lead in the industry by digitally integrating its previously separate production, packaging, and logistics equipment to create a seamlessly connected, intelligent information management system.
According to the company’s Three-Year Smart Manufacturing Plan, over the next three years Shijiazhuang Sihua Pharmaceutical will leverage automation and information technology to build a digital factory that is data-driven across all systems and features intelligent decision-making for key processes and operational links. The goal is to achieve in-depth mining of resources and data, accumulate modeling capabilities, and provide enhanced decision-support for the enterprise.
■ Storage and Transportation: With a simple press, 60,000 storage locations can be accessed on demand.
Large-volume parenteral solutions are characterized by their large volume and heavy weight, placing stringent demands on storage and transportation. As early as 2001, Shijiazhuang Sihua Pharmaceutical Co., Ltd. constructed a multi-level automated warehouse with more than 12,000 storage locations, transforming traditional warehousing operations into a system that allows free selection of storage locations and enables mechanized and automated first-in, first-out (FIFO) inventory management on demand.
On the afternoon of April 24, a reporter visited Shijiazhuang Sihua Pharmaceutical Group’s newly commissioned automated three-dimensional warehouse.
In the control room, several small blue rectangles are moving back and forth on the computer screen in front of Xu Kangze, head of the Storage and Transportation Department. “The blue rectangles represent stacker cranes, while the green ones represent pallets,” Xu Kangze explains. He adds that throughout the entire day on the 24th, 2,000 pallets will be processed—50,000 cartons will be shipped out and 48,000 cartons will be received.
“This volume of goods entering and leaving is just “small potatoes.”” Xu Kangze explained that, among the eight automated storage and retrieval systems at Shijiazhuang Sihua Pharmaceutical Group, this particular system has the largest storage capacity, with 60,000 pallet spaces—each capable of holding 36 cartons—meaning it can accommodate more than 2 million cartons in total.
Upon reaching the second-floor platform, one is met with 18 aisles that divide the automated warehouse into 36 rows, each of which is further subdivided into 90 columns and 19 levels—a scale so vast as to be truly awe-inspiring. “Thanks to the comprehensive utilization of data by our management system, a simple press of a button is all it takes for goods to be automatically stored and retrieved within the warehouse according to need and in the prescribed sequence, ensuring first-in, first-out handling and shipment by batch number,” explained Xu Kangze. He added that with just three or four personnel, it is possible to maintain pinpoint accuracy in tracking the inventory status of every item in stock.
Through the management system, the automated warehouse is also seamlessly integrated with production and transportation processes via data connectivity. By comprehensively leveraging data on batch management, material matching, inventory counts, quality inspection management, and real-time inventory control, the warehouse can effectively manage logistics and costs, enabling managers to gain a comprehensive and rapid overview of all material information and make informed, efficient production scheduling decisions.
■ Reporter’s Notes
Digital Transformation Empowers Pharmaceutical Companies to Rebuild Core Competitiveness
Ma Yanming
In recent years, regulatory policies governing the large-volume parenteral solutions industry have tightened, and market competition has intensified. Under the dual pressures of policy changes and market dynamics, Shijiazhuang Sihua Pharmaceutical has not only pursued corporate transformation and product diversification but also continuously expanded its market share in the large-volume parenteral solutions segment, thereby further solidifying its leading position in the market.
During the interview, the reporter gained a profound understanding of the extensive application of digital technologies across R&D, production, quality control, and other processes. The head of the Information Center at Shijiazhuang Sihua Pharmaceutical stated that the company will regard “information interconnectivity” and “data-driven decision-making” as the core objectives of smart manufacturing, leveraging the mining and utilization of data assets to drive business optimization, innovation, and growth.
Digital transformation has become a consensus across all industries. For pharmaceutical companies, achieving high-quality development requires seizing the new opportunities presented by digital transformation and leveraging digital technologies to foster efficient collaboration and intelligent responsiveness across all production and operational processes, thereby reshaping core competitiveness.
Currently, the overall level of digitalization among domestic pharmaceutical companies is still in its infancy. Hebei Province is a major hub for the pharmaceutical industry; in the process of promoting high-quality development of the provincial pharmaceutical sector, cultivating new competitive advantages, and driving industrial transformation and upgrading, how to better leverage digital technologies remains an area that requires ongoing exploration and in-depth reflection.
We look forward to Hebei’s pharmaceutical companies leveraging specific digital solutions to accelerate new-drug R&D, enhance manufacturing efficiency, reduce marketing costs, strengthen data security, achieve end-to-end digitalization across the entire industry chain, and swiftly implement their digital transformation strategies, thereby ushering in a new era of digital transformation.
(Originally published in Hebei Daily)
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