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Bosheng: Pioneering the Pharmaceutical Packaging Materials Industry

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Media Reports

发布时间：2019-08-17

【概要描述】 The year 2019 marks a special milestone for Bosheng: since the company was founded in 2001, it has now reached its 18th anniversary. These have been 18 years of both hardship and twists and turns—years in which relentless effort has paved the way for continuous achievements. Over this period, Bosheng has grown from scratch to become a major player, standing out in an intensely competitive market. Today, Bosheng is at the peak of its vitality, with momentum firmly on its side. We have every reason to believe that, leveraging our proprietary pharmaceutical packaging technology and with the strong support of our parent group, Bosheng’s future is bright and promising.

Bosheng: Pioneering the Pharmaceutical Packaging Materials Industry

Company Profile of Bosheng

Jiangsu Bosheng Medical New Materials Co., Ltd. (hereinafter referred to as Bosheng) was established in 2001 and is a high-tech enterprise specializing in the production of innovative pharmaceutical packaging materials, including pharmaceutical butyl rubber stoppers (including coated stoppers), polyisoprene gaskets, and multilayer co-extruded medical infusion films. Currently, the company serves as the chair unit of the Pharmaceutical Rubber Stopper Professional Committee of the China Pharmaceutical Packaging Association.

Several of the company’s products have been filed with the U.S. FDA as DMFs, and all of its products have obtained NMPA registration. The company’s trademark “BEST” has been recognized as a “Famous Trademark of Jiangsu Province,” and its products have been awarded the title of “Jiangsu Provincial Famous Brand Product.” The R&D center has been designated as a “Provincial Enterprise Technology Center,” a “Provincial Engineering Technology Research Center,” and a “Key R&D Institution of Jiangsu Province,” with a total of eight products having been certified as “Jiangsu Provincial High-Tech Products.” The company serves as the undertaking entity for the National Torch Program project (specialized rubber stoppers for ceftriaxone sodium) and the National Key New Product program (poly-p-xylene-coated rubber stoppers).

The vitality of pharmaceutical packaging material companies stems from their ability to stay attuned to market trends and continuously meet customers’ stringent standards and emerging requirements for such materials. As China’s healthcare reform continues to deepen, pharmaceutical formulations are being impacted by new reform policies, including the evaluation of generic drug consistency and centralized drug procurement. Pharmaceutical industry “Integration will be accelerated; the linked review and approval of excipients, APIs, and drug formulations also means that pharmaceutical packaging material companies will face a process of survival of the fittest. For Bosheng, this presents both opportunities and challenges,” said Yao Guoyuan, General Manager of Bosheng Company.

In 2015, following its acquisition by Sihua Pharmaceutical, Bosheng entered a phase of high-quality development. In 2018, the company achieved year-on-year growth of 11% in sales revenue, 21% in profits and taxes, and 31.3% in rubber stopper sales, outperforming industry peers.

An analysis of Bosheng Company’s counter-trend growth in both volume and price reveals that the primary driver is its unwavering commitment to high-quality products. “It is precisely by winning over the market with superior-quality products that we have achieved such outstanding results,” said General Manager Yao Guoyuan with full confidence in an interview with the author. Continuously strengthening the competitive edge of product quality remains Bosheng Company’s steadfast pursuit.

Quality Builds Competitiveness

“Market competition shows no favoritism; only quality is the cornerstone of cooperation, and we cannot tolerate the slightest defect in quality or reputation. Only when our products are truly top-notch can we speak with confidence and win the favor of customers in the marketplace.” Chen Dahong, head of the Quality Department, explained that Bosun has long upheld a rigorous quality-control system throughout its production and operations. Key measures include establishing internal quality standards, implementing a supplier-audit program, and conducting stringent incoming-inspection tests to ensure the quality of raw materials. The company rigorously controls quality at four critical stages: first, ensuring strict procurement standards by thoroughly vetting and regularly evaluating suppliers’ qualifications and creditworthiness; second, enforcing stringent inspection procedures so that any nonconforming raw or auxiliary materials are barred from entering the facility; third, maintaining tight control over material input, preventing nonconforming intermediate products from advancing to the next production stage and strictly adhering to standardized operating procedures; and fourth, ensuring that no substandard products leave the factory.

Bosheng Company has rigorously established a documented and comprehensive quality management system in strict accordance with the latest GMP requirements. It has also assigned QA personnel to each production workshop to conduct end-to-end oversight of process flows, environmental cleanliness, and manufacturing operations, ensuring that any operational deviations are promptly corrected. Through multi-level quality control at every stage, the company effectively prevents the entry of nonconforming raw materials, the transfer of nonconforming semi-finished products to subsequent processes, and the shipment of nonconforming finished products.

At the inner-packaging station for rubber stoppers, the author observed that the production environment closely resembled that of the intravenous solution manufacturing workshop at Sihua Pharmaceutical, with equally stringent cleanliness standards. Remarkably, the cleanliness level of this small-scale rubber-stopper production facility even matches that of the intravenous formulation production area! Sensing the author’s curiosity, the head of the Quality Department explained: “In our relentless pursuit of superior quality, we have aligned our production environment with pharmaceutical GMP requirements, conducting operations within a cleanroom and achieving an A-grade environment under a C-grade background—exactly the same as that of a pharmaceutical manufacturing plant. We are unwavering in our commitment to delivering products of the highest possible quality, so there is absolutely no room for doubt about our standards.” Chen Dahong’s words lingered in the author’s mind long after she had spoken.

Deep Integration of Software and Hardware to Drive Intelligent Manufacturing

In the pharmaceutical packaging materials sector, the widespread adoption of highly automated and intelligent equipment has revealed that its advantages extend beyond cost reduction; it also delivers significant improvements in manufacturing processes and product quality.

Recognizing this critical need, and with strong support from the Group, Bosheng has benchmarked itself against world-class standards,引进ing state-of-the-art production and testing equipment from overseas. The company boasts cutting-edge blown-film and slitting lines, along with an online inspection and feedback system that effectively ensures timely correction of quality deviations in infusion films. Bosheng also operates an advanced automated rubber stopper production line; its manufacturing facilities are designed and built in strict accordance with GMP standards. The company has pioneered the implementation of a no-clean rubber stopper manufacturing process within the industry and is equipped with a four-stage water-for-injection (WFI) system featuring multi-effect distillation and steam-water separation. TOC is monitored online to ensure that the quality of no-clean rubber stoppers meets CP, EP, and USP standards. In addition, a fully automated, online visual inspection system for rubber stopper appearance further enhances product quality assurance, significantly bolstering the company’s “hard” capabilities in smart manufacturing.

In addition, Bosheng has made substantial efforts to enhance its “soft” capabilities. It has implemented an intelligent information-management system that ensures product quality is fully traceable and readily auditable. Tian Renhe, Technical Director of Infusion Film, demonstrated to the author that by simply accessing the production record for a particular batch of infusion film in the intelligent information-management system, one can clearly view the process parameters and visual quality of that roll of film, as well as identify who performed each operation and who conducted the corresponding inspection. “This maximizes product quality assurance and truly enables dynamic quality management,” he said.

“In full alignment with the Group’s commitment to ‘ensure that no project falls behind for 15 years,’ Bosheng’s technological upgrade initiative is not merely a straightforward update or overhaul of equipment and processes; it is a comprehensive, system-wide, and integrated undertaking.” It is precisely these intelligent solutions that give Bosheng its distinctive competitive edge.

Innovation injects strong momentum into enterprises.

As Zhang Lüyi, Chairman of Bosheng Company, put it: “While we aim to grow in scale, we must even more so strive to become stronger and better; the fundamental path to achieving this is innovation.”

Innovative capabilities continue to strengthen, with new products and advanced manufacturing processes driving Bosun’s development. Zhang Enbo, Chief Engineer of Bosun Company, proudly outlined the company’s groundbreaking innovations: Bosun was the first in China to establish a comprehensive R&D system for medical rubber stoppers, thereby breaking the technological monopoly held by developed countries in Europe and North America; the company has mastered the patented vacuum deposition technology for polydimethylsiloxane coatings; its newly developed specialized formulation and manufacturing process for cephalosporin-specific rubber stoppers have filled a domestic gap, making Bosun the only enterprise in China to possess technology for producing radiation-resistant rubber stoppers; furthermore, Bosun was the first to achieve breakthroughs in key control technologies for multilayer co-extruded infusion films, successfully developing China’s first non-PVC five-layer co-extruded composite film and establishing a production facility dedicated to such films. Bosun was also the first in China to obtain registration approval from the National Medical Products Administration for five-layer co-extruded films and among the first in the country to secure registration certificates for three-layer co-extruded infusion films. In addition, products such as sodium ceftriaxone-specific rubber stoppers, coated rubber stoppers, and multilayer co-extruded infusion films have been recognized as High-Tech Products of Jiangsu Province, while the coated rubber stopper has been granted two invention patents.

Driven by the sustained innovation-driven development strategy, Bosheng’s products have gradually secured a commanding position in the market. According to the public disclosure of pharmaceutical packaging material registration information by the Center for Drug Evaluation of the National Medical Products Administration, Bosheng’s halogenated butyl rubber stoppers for injectable solutions (brominated) and its three-layer co-extruded infusion film have both received an “A” rating in the joint review and approval process with the corresponding formulations, making them approved packaging materials for use in marketed formulations. Notably, the halogenated butyl rubber stoppers for injectable solutions (brominated) were among the first batch nationwide to pass the associated review and approval process for rubber stoppers.

In 2018, Bosheng achieved a breakthrough from zero in foreign trade by successfully replacing imported products with its proprietary rubber stoppers for contrast agents and exporting them in bulk to the U.S. market; moreover, the pistons for pen-type syringes marked Bosheng’s first direct export of packaging materials.

Industry standard formulated by Bosheng

“We have cumulatively chaired or participated in the development of six national or industry standards for pharmaceutical packaging materials!” Chief Engineer Zhang Enbo’s tone could hardly conceal his pride.

As the leading organization of the Pharmaceutical Rubber Stopper Professional Committee of the China Pharmaceutical Packaging Association, Bosheng has established a quality control system and standards for raw materials at the very source of medical packaging material production. The company actively aligns its practices with internationally advanced standards set by the FDA, the European Union, and other regulatory bodies, and focuses on accelerating the healthy and sustainable development of the pharmaceutical packaging industry. In doing so, Bosheng has spearheaded or participated in the formulation of six national or industry standards for pharmaceutical packaging materials.

Notably, the China Pharmaceutical Packaging Industry Association standard “Guidance on Compatibility Studies Between Pharmaceuticals and Rubber Stoppers,” drafted and spearheaded by Chief Engineer Zhang Enbo, has been adopted by the Center for Drug Evaluation of the National Medical Products Administration as a key regulatory document for the associated review and approval of pharmaceutical products. The standard’s title was subsequently revised to “Technical Guidance Principles for Compatibility Studies Between Chemical Pharmaceuticals and Elastomeric Seals (Trial),” thereby defining the principal research priorities for elastomeric sealing materials in the coming period and clarifying the direction of development for pharmaceutical packaging material research. Bosun Company’s achievements in building the pharmaceutical packaging materials standards system have earned high recognition from both the national drug regulatory authorities and the industry at large.

The year 2019 marks a special milestone for Bosheng: since the company was founded in 2001, it has now reached its 18th anniversary. These have been 18 years of both hardship and twists and turns—years in which relentless effort has borne fruit and continuous achievements have been made. Over this period, Bosheng has grown from scratch to become a significant player, rising to prominence in an intensely competitive market. Today, Bosheng is in its prime, poised for further growth and success. We have every reason to believe that, leveraging our proprietary pharmaceutical packaging technology and with the strong support of the Group, Bosheng’s future is bright.

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