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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
How Does Shijiazhuang Sihua Pharmaceutical Group’s Soft-Bag Infusion Production Line Achieve World-Leading Daily Capacity? By Adopting Innovative Thinking and Innovation.
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发布时间：2023-10-12
【概要描述】
To reduce levels of insoluble particulates and other quality indicators, Shisi Pharmaceutical Group has undertaken 32 major technological upgrades over the past two decades, involving the construction of new production lines or the modernization and upgrading of existing ones. On September 29, a reporter visited the upright soft-bag infusion production workshop located in the Shijiazhuang Economic and Technological Development Zone and, through the cleanroom’s glass partitions, observed the newly completed, state-of-the-art digital production line, which required an investment of RMB 320 million.
How small is 10 micrometers? It’s one-sixth the diameter of a human hair.
According to national standards, in the large-volume parenteral solutions industry, the number of insoluble particles larger than 10 microns per milliliter of liquid must not exceed 25. At Shijiazhuang Sihua Pharmaceutical Group, this limit has been reduced to fewer than one particle per milliliter. Yet the company has not stopped there; it continues to strive toward the ultimate goal of zero particles.
To reduce levels of insoluble particulates and other quality indicators, Shisi Pharmaceutical Group has undertaken 32 major technological upgrades over the past two decades, involving the construction of new production lines or the modernization and upgrading of existing ones. On September 29, a reporter visited the upright soft-bag infusion production workshop located in the Shijiazhuang Economic and Technological Development Zone and, through the cleanroom’s glass partitions, observed the newly completed, state-of-the-art digital production line, which required an investment of RMB 320 million.
Inside the workshop, robotic arms move up and down in seamless, integrated operations for bottle-making and filling, while unmanned forklifts shuttle back and forth. With the exception of a handful of technicians closely monitoring computer screens, workers are virtually nowhere to be seen—hardly believable given that this production line boasts a world-leading daily capacity of 2 million bags.
“Fully automated injection molding and cap-assembly integrated systems, fully automated powder-conveying systems, high-efficiency thermal-pressure distillation water machines…” Shi Siyao Group President Wu Hengyao spoke knowledgeably about each of these state-of-the-art, intelligent production devices.
“If we don’t innovate, we’re headed for a dead end,” said Wu Hengyao with deep conviction. Over the years, he has watched as the number of companies that once competed alongside him has dwindled from more than 100 to just a dozen or so. Even a difference of a mere fraction in a single performance metric can cause a product to lose its market foothold and leave a company with no place to stand—so breaking through requires relentless innovation.
For this very reason, Shisiyao Group never dares to slow down its pace of innovation: each year it allocates 10% of its sales revenue to R&D and 20% to technological upgrading. “We have never hesitated to invest in equipment,” Wu Hengyao explained as he walked through the facility. For instance, the latest filtration system used to produce water for intravenous solutions has dramatically improved all key quality parameters of the process water, reducing organic and inorganic impurities as well as microbial contamination to virtually zero—and thereby significantly enhancing the competitiveness of our products.
At Shisi Pharmaceutical Group, there is an automated R&D team that was established with an investment of RMB 40 million. This substantial investment once sparked considerable debate, but in Wu Hengyao’s view, the expenditure has been well worth it.
“The ability of our production line to undergo repeated upgrades and iterations is entirely due to this highly specialized team,” said Wu Hengyao. “Many off-the-shelf devices available on the market simply fail to meet our requirements; only by pursuing independent R&D can we stand out in the fiercely competitive market.”
From raw materials to finished products, the process involves 246 quality control checkpoints, and not a single step can afford to fail. Plastic packaging for injectables is typically not washed with water; however, due to factors such as electrostatic attraction, insoluble particulates adhering to the inner surface are difficult to remove. Despite repeated improvements by quality assurance personnel, the results have consistently fallen short of expectations.
“Since the conventional approach was no longer viable, we boldly shifted our R&D strategy and became the first in China to develop negative-ion air-blowing technology for cleaning,” said Liu Qingping, Executive Deputy General Manager of the Quality Management Center. In response to the tendency of plastic packaging to generate static electricity and attract particulates, quality engineers deployed airflow technologies such as negative-ion clean compressed air for cleaning, which significantly reduced the number of airborne particles. The new technology was swiftly implemented on the company’s new production lines.
Over the past 20 years, the soft-bag infusion production line has undergone an average of 1.6 major technological upgrades per year. In 2005, the company pioneered the introduction of a fully enclosed, integrated wash-fill-seal non-PVC plastic-bottle infusion production line in China, increasing production efficiency several-fold; in 2010, a non-PVC multilayer co-extruded film double-tube, double-valve infusion production line was commissioned, enabling the company’s products to enter the international market…
“To further enhance quality precision, we have adopted the concept of parameter-based release,” Wu Hengyao explained. “We manage data in a modular fashion, allowing release only when each stage meets its specified standards, thereby ensuring that the final product quality is up to standard and that quality is controllable at every step.”
The breakthrough journey of a single production line epitomizes Shisi Pharmaceutical Group’s decades-long commitment to deep-rooted innovation. By mastering core technologies, the company has opened up vast new markets, achieving annual main-business revenue exceeding RMB 6 billion, with 80% of its profits generated by new or upgraded products. The enterprise has been recognized among China’s Top 100 Pharmaceutical Companies; its multilayer co-extruded infusion film has been named a National Single-Champion Product; its quality-control technology for soft-packaged large-volume parenterals has won the Provincial First Prize for Scientific and Technological Progress; and its expertise in controlling insoluble particulate matter has been designated as a provincial quality benchmark. Currently, the company’s soft-bag infusion products account for half of the domestic market.
Pharmaceutical companies represented by Shisi Pharmaceutical Group form the “main artery” of Shijiazhuang’s biopharmaceutical industry, serving as a vivid case study for observing its development. “Through this company’s innovative practices, I have keenly felt the robust momentum driving Shijiazhuang’s biopharmaceutical sector and glimpsed its bright prospects,” said Zhao Bingqin, Director of the Department of Economics at the Party School of the Shijiazhuang Municipal Committee. She added that an increasing number of independently developed “Made in Shijiazhuang” products are now proudly recognized as “China’s Best Medicines,” providing strong support for Shijiazhuang to become the first city this year to see its biopharmaceutical industry’s operating revenue surpass RMB 100 billion.
Background Link
Shijiazhuang Biopharmaceutical Industry
The company boasts 18 national-level innovation platforms and 167 provincial-level innovation platforms, with a total of six Class 1 innovative drugs already on the market and 73 Class 1 new drugs currently in development. Five enterprises—Shiyao Group, Huayao Group, Yiling Pharmaceutical, Shisi Pharmaceutical Group, and Shenwei Pharmaceutical—have been ranked among the Top 100 Chinese pharmaceutical companies.
In 2022, a total of 189 enterprises above designated size generated operating revenue of RMB 85.5 billion, emerging as a new engine for economic growth in Shijiazhuang. In the first half of this year, operating revenue increased by 15.6% year on year. The 2023 target is to lead the biopharmaceutical industry in surpassing RMB 100 billion in operating revenue. (Originally published in Hebei Daily.)
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