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Technological Breakthrough: Silicone-Oil-Free Polymer Pre-filled Syringes Lead Industry Upgrade

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Technological Breakthrough: Silicone-free Polymer Prefilled Syringes Lead Industry Upgrade

The first fully automated production line for silicone oil-free polymer pre-filled syringes in China, built and put into mass production by Bartfry

"We believe that our products must be able to solve industry pain points to bring value to customers. Traditional glass pre-filled syringes rely on silicone oil spray lubrication technology, and there are issues such as residual heavy metal tungsten, high energy consumption, and high pollution in the production process," said Yin Fumin, General Manager of Bartfry. "Our silicone oil-free system, jointly developed with Shengzhou Group, has broken the technological monopoly of Japan and Europe, forming a complete closed loop from materials to production. It has already been successfully applied in complex formulations, demonstrating significant performance advantages."

02

Capital Empowerment: Synergistic Industrial Resources Accelerate Commercialization

Luhanjie Lu, a partner at Huachuang Capital, the lead investor in this round, stated: "Bartfley's comprehensive capabilities in material science, robotic automation, precision manufacturing, and pharmaceutical-device synergy fill the gap for domestically produced high-end pharmaceutical packaging materials. Huachuang Capital will mobilize industrial resources to help it connect with multinational pharmaceutical companies and biotechnology firms, promoting global certification of its products."

Hongsen Li, a partner at Jinyu Maowu, said: "Bartfley's team is highly efficient, passionate, professional, and has a global perspective. The high-performance injectable packaging materials they have developed are expected to break international monopolies and become a new choice for high-end packaging materials for both domestic and international pharmaceutical and medical device companies, addressing the pain points caused by silicone oil in the industry. Jinyu Maowu will leverage its own ecosystem to empower Bartfley in continuously developing globally leading innovative high-end packaging materials and commercializing products in the medical aesthetics industry."

Tuoxi Technology, as a co-investor and the only company in China to have achieved commercial production of cycloolefin polymers, will provide customized raw material support to Bartfley. This not only strengthens supply chain security, which is most valued in the pharmaceutical industry, but also further enhances its technological barriers.

03

Industry Opportunity: Trillion-level Pharmaceutical Packaging Market Awaits Domestic Substitution

According to the "2025 China Pharmaceutical Supply Chain White Paper" by Artery Network, the global prefilled syringe market size is expected to exceed 8 billion US dollars by 2030, with China accounting for more than 15%. However, the high-end market has long been monopolized by international giants such as Schott, Ompi, and BD, making the demand for domestic high-performance inner packaging materials urgent.

Bart Fry has developed the first UV glue-free/silicone oil-free polymer needle pre-filled syringe for the Chinese biopharmaceutical market.

"The traditional glass pre-filled syringe production process is complex, requiring at least 40 process steps," said Gao Xingyu, executive director of Bart Fry. "Our product, from injection molding to final packaging, is completed entirely under a hundred-grade laminar flow, needing only about 12 process steps. Unlike traditional borosilicate glass products, we do not need silicone oil or UV glue, resulting in lower operational and release costs. Additionally, we have adopted several advanced manufacturing technologies such as X-ray inspection and through-beam light source detection systems, which ensure higher quality and better performance of our products."

04

Professional Solutions

In the past, under the glass prefilled system, industry pain points included insoluble particles and protein aggregation issues caused by silicone oil, as well as tungsten contamination during the process. Currently, the mainstream global silicone-free solutions are the full coating solution represented by West Daikyo of the United States and the coating solution represented by Terumo of Japan, with each having its own advantages and disadvantages. At present, Bartfry has fully mastered both the full coating and coating silicone-free solutions and has completed commercial shipments, providing different silicone-free system products based on the characteristics and needs of the customer's formulation.

In addition, the glass prefilled system requires the use of UV glue to bond the stainless steel injection needle with the glass syringe. The organic pollution and leaching caused by UV glue have also been one of the issues troubling the industry. Batafley is currently the fourth globally and the first in China to break through the one-piece needle technology. Through self-developed automation and precise coordination and control of molds, it can achieve one-piece molding of stainless steel needles and syringes without the need for UV glue, making the product more simple and elegant, and solving the problem of tungsten heavy metal contamination and UV glue leaching from traditional glass systems at the source.

In the past, due to the processing performance limitations of borosilicate glass, many pharmaceutical companies' customization needs could not be met or responded to, and from the perspective of formulation development, there were also many restrictions. After adopting COC/COP materials, the design and molding flexibility are much higher. Batafley can provide customized and personalized solutions for customers based on the characteristics of their formulations, leveraging advanced technical means such as CFD and Ansys.

Bartfry's patented dual-thread, silicone oil-free pre-filled syringe system designed for hyaluronic acid formulations

Can reduce the injection force of 40000cp viscosity hyaluronic acid to 20Nm, which is only 1/4 of the competitors (with standard 27G or 29Gtw needles)

05

Advanced Manufacturing Technology

The company will complete the construction of its second fully automated production line (with an annual capacity of 60 million units) in Q2 2025. This production line is the first fully automated high molecular needle, silicone oil-free pre-filled syringe line in China, breaking the product monopoly of Japanese Terumo and American West companies, achieving a breakthrough for China in this product. At the same time, the pre-filled syringes produced on this line will be the first to use a 100% X-ray online inspection system, ensuring uniform quality when delivering products to customers and enhancing drug safety from the packaging material end.

By deploying the X-ray online inspection system, Batfrey can, for the first time in the industry, inspect the state of stainless steel needles after capping, improving packaging material quality and enhancing drug safety

06

Commercial Application

Bartfley's first silicone oil-free high molecular weight Luer pre-filled product has been registered with the CDE/FDA in 2024 and was first applied to complex injectables such as nanocrystals in the mainland region. The customer's product has already submitted a drug marketing application in 2024.

The dual-chamber silicone oil-free high molecular weight pre-filled syringe has completed its design finalization and procurement contract signing with downstream customers. This is the first time such a product has been finalized and commercially produced in the mainland, allowing customers to complete freeze-drying after filling, marking the company's leading and innovative position in high-end packaging material design, application, and professional technical support.

About Bartfley

Nanjing Bartfley Pharmaceutical Packaging Materials Co., Ltd. is committed to providing safe and efficient inner packaging solutions for injectable drugs to global biopharmaceutical companies through material innovation and intelligent advanced manufacturing. The company holds ISO15378 quality management system certification, and its core team comes from the BioPharma and precision manufacturing fields, offering full-process professional technical support to pharmaceutical companies, from packaging material product design to small-scale production, from customer simulation filling to commercial production.