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Shijiazhuang Fourth Pharmaceutical Group Bosheng Medical Devices: Empowering Industry Optimization While Simultaneously Pursuing Intelligent Upgrades and Green Development.

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Media reports

Time：2022-09-03

Currently, with the rapid advancement of internet, information technology, and automation, the production of pharmaceutical packaging materials is undergoing an upgrade toward automation and intelligentization. Shijiazhuang Siyao Group Jiangsu Bosheng Medical New Materials Co., Ltd. (Bosheng Medical Materials; stock code: 873710), a domestic company specializing in the R&D, production, and sales of new medical packaging materials, is actively transitioning from traditional manufacturing to “intelligent manufacturing.”

Shijiazhuang Fourth Pharmaceutical Group Bosheng Medical Devices: Empowering Industry Optimization While Simultaneously Pursuing Intelligent Upgrades and Green Development.

As the global pharmaceutical industry continues to advance and improve, the related medical packaging industry is also experiencing robust growth. According to preliminary estimates, the global medical packaging market size has been increasing year by year from 2015 to 2021. By 2021, the global medical packaging market had reached a size of 109.3 billion U.S. dollars, with an average annual compound growth rate of 7.87%. The medical packaging market thus holds significant potential for further development.

Pharmaceutical packaging materials are an essential component that significantly influences the final quality, stability, and safety of pharmaceutical products. Currently, China is continuously introducing and upgrading pharmaceutical packaging machinery and materials, and the pharmaceutical packaging industry is poised to enter a brand-new era.

Automation and Intelligence

Promote the optimization and upgrading of the industrial structure.

Currently, with the rapid advancement of internet, information technology, and automation, the production of pharmaceutical packaging materials is undergoing an upgrade toward automation and intelligentization. As a domestic company specializing in the R&D, production, and sales of new medical packaging materials, Shijiazhuang Siyao Group Jiangsu Bosheng Medical New Materials Co., Ltd. (Bosheng Medical Materials; stock code: 873710) is actively transitioning from traditional manufacturing to “intelligent manufacturing.”

Stepping into the newly completed biomembrane production workshop of Bosheng Medical Devices, you’ll find advanced, modern, and intelligent equipment everywhere. The entire workshop uniquely features a dual-corridor design: the outer working corridor (visitor corridor) serves to provide thermal insulation and keep out mosquitoes and other insects, while the inner corridor (clean working corridor) helps prevent cross-contamination. This “high-standard” design and construction of the facility ensures superior product quality and operational efficiency.

According to the staff, Bosheng Medical Devices possesses the country’s first automated, specialized production equipment designed and manufactured specifically for the structure of single-use systems (SUS) membranes used in bioprocessing. This production line is custom-built by a professional manufacturer according to the formulation design requirements. It employs metering pumps to precisely deliver materials layer by layer, thereby ensuring uniform thickness across each layer and also guaranteeing overall uniformity in the membrane’s total thickness.

It is worth noting that the product structure of the seven-layer co-extruded film offers superior physical properties—such as scratch resistance, puncture resistance, rub resistance, and weldability—that surpass those of imported films. The overall performance of this product is fully comparable to any imported film material, making it the “preferred choice” for domestic pharmaceutical companies seeking to replace imported materials with domestically produced alternatives.

Quality is both designed and manufactured. The formulation of medical rubber stoppers and multilayer co-extruded films is a critical factor determining product quality. At the same time, a superior formulation can only be translated into high-quality products when paired with stringent manufacturing processes, reliable equipment, and robust testing methods. Relying on years of accumulated technical expertise, Boshi Medical Devices has independently developed and mastered a series of high-quality formulations and production technologies, forming the company’s unique core competencies—such as the formulation for coated rubber stoppers and their scalable production process, as well as the formulation for single-use multilayer co-extruded biomedical membranes and their scalable production process. The company places great emphasis on product technology and process innovation, and in the future will continue to increase its R&D investment, steadily enhancing its technological, quality, and cost advantages.

With the advancement of technological levels and the rapid development of China’s pharmaceutical industry, the pharmaceutical packaging sector is witnessing an increasing number of new products and technologies. These include novel production processes and processing techniques; cutting-edge production equipment and testing instruments; newly introduced or improved product standards and testing methods; meaningful research theories and academic achievements; and innovative certification and management systems—all of which are highly beneficial to both the pharmaceutical and pharmaceutical packaging industries, driving industrial transformation and upgrading.

New Situation and New Momentum

Empowering the packaging industry to pursue green development

Against the backdrop of increasingly stringent pharmaceutical quality regulation and growing public concern over drug safety, pharmaceutical rubber stopper manufacturers will likewise face stricter management and supervision from both drug regulatory authorities and pharmaceutical companies. Pharmaceutical companies are also continuously raising their quality requirements for pharmaceutical rubber stoppers, shifting their focus from low cost to high quality and high stability. When selecting pharmaceutical rubber stoppers, they will pay closer attention to whether the quality is consistently stable and whether various indicators—such as compatibility with drugs—meet the required standards.

After more than two decades of development and innovation, Bosheng Medical Devices has established itself as a leading industry benchmark in its specialized niche. It is one of the five director units of the Pharmaceutical Rubber Stopper Specialized Committee of the China Association for Pharmaceutical Packaging, and has actively participated in drafting several association standards, including the “Good Manufacturing Practice Guidelines for Pharmaceutical Rubber Stoppers,” the “Implementation Guide for Quality Audits of Pharmaceutical Rubber Stopper Suppliers,” and the “Guidelines for Material Balance Accounting of Pharmaceutical Rubber Stoppers.” In 2016, the association standard “Guidelines for Compatibility Studies Between Chemical Drugs and Elastomeric Seals,” prepared by the company, was adopted and refined by the Center for Drug Evaluation and officially promulgated in 2018. The Notice issued by the National Medical Products Administration on the Release of the Technical Guidance Principles (Trial) for Compatibility Studies Between Chemical Drugs and Elastomeric Seals represents another significant contribution by Bosheng to the development of the industry.

It is reported that Bosheng Medical Devices has taken the lead in establishing a domestic technological system for the development of pharmaceutical rubber stoppers, breaking the technological monopoly held by developed countries, enhancing the company’s independent innovation capabilities, and raising the overall technical level of the domestic industry.

Through independent innovation, we have taken the lead in China in mastering the patented vacuum coating technology for poly-p-xylene. We have overcome technical challenges including the vacuum coating process for rubber stoppers, the bonding process between the film layer and the rubber stopper, and the control of film-layer thickness. Leveraging the film layer’s characteristics—such as its density, chemical stability, and smoothness—we have successfully developed a series of coated rubber stoppers, further reducing drug contamination and effectively addressing the issue of poor stability of rubber stoppers when used with new pharmaceutical products.

In addition, Bosheng Medical Devices has taken the lead in China by successfully developing a new formulation and process for specialized rubber stoppers specifically designed for cephalosporin antibiotics, filling a domestic gap. It is also the only company in China that has mastered the technology for producing radiation-resistant sterilization rubber stoppers. Through actively exploring new development concepts and technologies in pharmaceutical packaging materials, Bosheng Medical Devices has served as an industry benchmark for over 20 years, making outstanding contributions to ensuring the efficacy and safety of medicines for the public and driving technological advancement and industrial development in the pharmaceutical packaging sector.

Looking ahead, Boshi Medical Devices will continue to closely monitor the competitive market environment and the regulatory authorities’ requirements for product quality and green development. We will strengthen our efforts in tackling key core technologies, vigorously promote the R&D of innovative products, enhance our industrialization technology level, and persistently carry out product development work. We will also test domestically produced raw materials and make process adjustments to meet customer needs, ensuring that our products consistently meet both pharmaceutical regulatory standards and customer demands, thereby maintaining our products’ market competitiveness.

Reprinted from: Pharmaceutical Economic News

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