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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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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
Hebei Daily | Information Technology Powers Production of 2 Million Bottles (Bags) of Large-Volume Infusions—A Glimpse Inside Workshop 312 of Shisiyao Group
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发布时间：2024-01-05
【概要描述】
On December 20, 2023, at the bottle-making and filling/sealing station in Workshop 312 of Shijiazhuang Sihua Pharmaceutical Group, a robotic arm swiftly grasps the bottles “blown” out by the bottle-blowing machine and immediately conveys them upside down along the automated conveyor belt. As the bottles reach the filling and sealing stage, they are filled with medication at a rate of 300 bottles per minute and then capped before being transported by the conveyor to the loading area. The entire process is fully automated, with operators only needing to set parameters and perform operations via a touch-screen interface.
On December 20, 2023, at the bottle-making and filling/sealing station in Workshop 312 of Shijiazhuang Sihua Pharmaceutical Group, a robotic arm swiftly grasps the bottles “blown” out by the bottle-blowing machine and immediately conveys them upside down along the automated conveyor belt. As the bottles reach the filling and sealing stage, they are filled with medication at a rate of 300 bottles per minute and then capped before being transported by the conveyor to the loading station. The entire process is fully automated under system control, requiring only parameter settings and operation via a touch screen by the operators.
Duan Guangqian, director of Workshop 312, stated that the workshop has integrated its bottling and bottle-making machines into a continuous production line, thereby eliminating the need for temporary storage and intermediate handling of bottle blanks. The bottle-making machine employs a one-step molding process, which offers advantages in terms of yield and energy efficiency; moreover, inverting the bottles during production helps reduce the likelihood of foreign objects entering the product stream. In the loading process, two fully automated loading/unloading robots alternate in picking up bottles, enabling four rows of bottles to be placed on the sterilization cart in a single operation, significantly boosting operational efficiency.
Large-volume parenteral solutions, commonly referred to as “large infusions,” are sterile liquid preparations with a volume of 50 mL or more that are administered directly by intravenous infusion. They are widely used in clinical practice. In the domestic market for large infusions, the barriers to entry are relatively low, making it crucial to achieve economies of scale in order to reduce production costs.
At one end of the workshop, raw materials for bottle bodies and caps are processed; at the other end, finished large-volume infusion packages, once packaged, are conveyed directly via a spiral conveyor to the automated three-dimensional warehouse. From the intake of raw materials to the delivery of finished products, all operations in Workshop 312 are handled by a single operator, and thanks to the application of information technology, every stage is seamlessly integrated and operates with high efficiency.
On the second floor of the workshop, in the materials area, raw materials for bottle and cap production and those for preparing pharmaceutical solutions are neatly stacked on shelves, while automated transport vehicles shuttle back and forth. With the raw materials located right next to the production area, intermediate handling steps have been eliminated. “When needed, the automated transport vehicles follow instructions to deliver the materials directly to the feeding zone,” said Duan Guangqian. Both the delivery of bottle-making raw materials and pharmaceutical-formulation raw materials is now computer-controlled, enabling precise batching. From the second floor to the first floor, materials can be conveyed by gravity, further minimizing energy consumption.
On the second floor of the workshop, in the water-production area, large storage tanks labeled “Purified Water” and “Water for Injection” are neatly arranged. In Workshop 312, filtered “Grade I Water” is first prepared in advance by the power workshop—separate from the main workshop—and then conveyed to the water-production area, where it is further processed by the purified-water production system and stored in the “Purified Water” tanks. Subsequently, a thermal-pressure distillation system is used to produce “Water for Injection,” which is then stored. During the preparation of pharmaceutical solutions, a digital centralized compounding system is employed to achieve full automation—from raw-material charging through concentrated compounding to dilute compounding—thereby enabling quality control at the source.
Injection molding and cap-assembly positions, sterilization, packaging—compared with other large-volume parenteral solutions production workshops at Shisi Pharmaceutical Group, Workshop 312 has implemented information systems in many processes, resulting in improved labor efficiency and reduced production costs.
In this regard, Fu Zhihui, a sterilization operator, has profound personal insights. He has worked in the sterilization department since 2006. “At first, I felt like I was just a porter,” Fu Zhihui said. Back then, he had to use a handcart to transport several tons of large-volume intravenous solutions to the sterilization cabinets, and there were months when he wore out several pairs of shoes. Later, as parts of the sterilization process became automated, he gradually transitioned away from manual labor and was able to devote more of his energy to quality control. Today, in Workshop 312, he can use a tablet to remotely control the opening and closing percentages of the sterilization cabinet valves according to actual needs. “Currently, a single on-duty operator can sterilize hundreds of thousands of bottles of large-volume intravenous solutions each day,” Fu Zhihui noted.
Large-volume infusions are administered directly into the bloodstream; therefore, while reducing production costs, it is imperative to ensure even greater product quality assurance. In Workshop 312, the Manufacturing Execution System (MES) enables electronic management of production processes and equipment. By operating tablet computers, staff can manage basic production information, issue production instructions, and execute production tasks. Paper-based records have been replaced with electronic batch records, and predefined upper and lower limits have been set for relevant data points; any deviation from these limits at any stage results in non-release, thereby ensuring that quality remains under control.
In addition to maximizing the application of information technology in production process control, data generated by various pieces of equipment in Workshop 312 are no longer siloed. In this workshop, data from production equipment, utility systems, and other equipment required for manufacturing are collected and monitored in real time; critical equipment data at key process nodes are also stored in a historical database, enabling analysis and traceability of past performance. Centralized data collection across all equipment helps eliminate information silos, ensuring that corporate decision-makers, management, and operators can promptly access relevant information to support improvements in product quality and production efficiency.
Workshop 312 is designed to produce 2 million bottles (or bags) of large-volume parenterals per day, placing its production capacity among the world’s leading. The workshop was completed and entered trial operation in September 2023, and in December it obtained GMP (Good Manufacturing Practice) certification. “In today’s fiercely competitive market, only by committing to product quality and cost control can enterprises gain a competitive edge,” said Wu Hengyao, President of Shisi Pharmaceutical Group. He added that improving quality while reducing costs will raise the entry barriers and market concentration in the large-volume parenteral market, thereby enhancing the competitiveness of domestic pharmaceutical companies.
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