Pharmaceutical Glass Upgrade Helps Drive High Quality Development of Chinese Pharmaceutical Packaging Industry

Author: Chunmei Lin

Vice President and General Manager, Greater China,

Corning Life Sciences Market-Access Platform (MAP)

As the pharmaceutical industry in China is geared to international standards and its innovative development in recent years, as well as the increasing requirements for drug safety, more and more attention has been paid to the upgrade of pharmaceutical packaging material. The need for high-quality pharmaceutical packaging and containers to help improve drug quality and safety continues to grow.

Pharmaceutical glass is known as one of the most preferred packaging materials within the industry for its good chemical stability and bio-compatibility, which is widely used in the packaging of vaccines, high-end infusion agents, antibiotics, general powders, lyophilized products, blood, biological agents and other pharmaceuticals. Pharmaceutical glass could mainly be categorized into medium borosilicate glass, low borosilicate glass, and soda-lime glass by the ranking of generic properties. Among them, medium borosilicate glass (also known as Type I glass) is the global standard for primary packaging.

Compared to low borosilicate and soda lime glass, medium borosilicate glass has higher acid and alkali resistance and can better handle rapid cooling and heating. In addition, compared to the other two forms of glass tubing, medium borosilicate glass has greater chemical stability. Finally, medium borosilicate glass has a lower occurrence of precipitation and pH value change when coming into contact with a drug for long periods of time. These attributes can help preserve the drug’s chemical properties. Medium borosilicate glass is widely used for injectable pharmaceutical products, such as ampules, vials, infusion bottles, cartridges, and prefilled syringes.

China has attached great attention to the supervision of pharmaceuticals since the practice of the 13th Five-Year Plan. China issued the Technical Requirements for Consistency Evaluation of Chemical Generic Drugs (Injections) on the Market (Draft for Comments) in December 2017, where it states packaging materials and containers that are contacting with pharmaceuticals directly and used for injections should meet the packaging material standards issued by CFDA, and low borosilicate glass and soda-lime glass are not suggested to adopt in such cases. This Draft is helping drive the upgrade of pharmaceutical glass from low borosilicate glass to medium borosilicate glass.

China's 14th Five-year Plan and Vision 2035 also explicitly require pharmaceutical safety, promote pharmaceuticals development with high-quality and advance the modernization of drug regulatory system and capacity to protect and boost public health. Injections were officially included in the Consistency Evaluation in May 2020, which stipulated that the quality and performance of packaging materials and containers used for injections should not be lower than that of reference product to guarantee the quality consistency between drug product and reference product. Since injection is playing an important part in current generic drugs, this move is expected to stimulate the needs for medium borosilicate glass in China. Since then, the number of injection varieties and specifications that applied to pass the Consistency Evaluation has increased rapidly.

At present, China is transferring from low borosilicate glass to medium borosilicate glass in injections packaging materials. Though the market demand is strong, we have observed that vials with medium borosilicate glass can be in short supply. We believe that a driver of this is limited capacity in medium borosilicate glass tubing globally. In general, we believe that the urgent demands for higher quality pharmaceutical glass will promote the stable growth of the overall market, driven by a series of policies from China's drug regulatory authorities, the positive momentum of China's economic development and the improving requirement on drug safety.

Meanwhile, the unexpected outbreak of COVID-19 in 2020 and the unrelenting global pandemic in 2022, have exerted tremendous influence on social development and people's lives. All countries have been racing to develop and produce vaccines at the fastest pace and maximize the vaccination number, and China has made a remarkable achievement in the fight against the epidemic. In front of COVID-19, the demand for vaccines and critical drugs is surging, but the capacity of medium borosilicate glass tubing is limited, which is a big challenge for the industrial chain of pharmaceutical glass packaging. Therefore, it’s significant to build a strong domestic supply chain for critical components that enable vaccines and vital medicines.

Corning is one of the leading glass suppliers in the world with more than 170 years of expertise in glass manufacturing. Since the invention of the composition for PYREX? glass in 1915, Corning has always been a reliable partner in medical and pharmaceutical industries. With our continuous technical improvement and innovation, Corning has played an important role in many scientific breakthroughs and advances in the field of human medicine.

Corning entered the pharmaceutical glass industry with the acquisition of Gerresheimer’s glass tubing business in 2015. Since this time, Corning has worked to improve the quality and productivity of our tubing product by leveraging our expertise in glass and material science. Corning’s glass tubing business has become one of the world's leading suppliers of medium borosilicate glass tubing, with two facilities in New Jersey, USA and Pisa, Italy.

As a multi-national company, Corning is following our “In China, For China, With China” operating philosophy and has been in China for more than 40 years with more than $9 billion of total investment, 21 plants and over 6,000 employees.

After the outbreak of COVID-19, Corning quickly decided to invest in the capacity expansion of medium borosilicate glass tubing in China, making a positive contribution to the fight against the pandemic and protection of human health. After 18 months of intensive construction and support from all sides, Corning hosted an opening ceremony for its glass tubing facility in Bengbu on November 18, 2021. The new facility will expand Corning’s high-quality glass tubing manufacturing capacity by 20,000 tons per year to support China’s growing demand for cost-effective, high-quality Type I borosilicate glass tubing.

Since the start of the global health pandemic, Corning products have enabled the delivery of over five billion doses of COVID-19 vaccines worldwide. We will continue to partner with Chinese converters to further accelerate the supply of medium borosilicate glass tubing manufactured in Bengbu, advancing the pharmaceutical glass packaging industry upgrade in China and the on-time delivery of vital drug products.

Also, Corning’s high-quality glass tubing manufacturing facility in Bengbu plant will support the production of Corning’s latest vial technology. Corning Velocity? Vials are Type I borosilicate glass vials, externally coated with Corning’s patented low coefficient of friction (COF) coating. Compared with traditional vials, Velocity Vials can improve filling line efficiency and help to improve product quality.

Specifically speaking, Velocity Vials can help address a fundamental concern with fill-finish manufacturing by reducing glass-to-glass and glass-to-metal friction on the vial’s outer surface. Glass friction can cause vial jams, tip overs, and glass breakage, which can affect filling line efficiency and speed. Glass-to-glass friction can also lead to an increase in particle generation and reduce the yield rate due to vial cracks and breaks.

Compared to traditional vials, the uniform protective coating on Velocity Vials can increase filling line efficiency by 20% to 50% and enable up to a 96% reduction in glass particulates. According to the experimental data, Velocity Vials with a low friction coating exhibited a 3X?reduction in crack generation when subjected to simulated filling line damage compared to conventional pharmaceutical vials.

In May 2021, one of the world's leading vaccine suppliers China National Biotec Group Company Limited (CNBG), joined Bengbu Innovation Venture Capital Company Limited, as an investor in Corning Pharmaceutical Glass Company Limited, part of Corning’s Pharmaceutical Technologies business portfolio. Corning will work with CNBG to bring Corning’s new Velocity? Vials into the Chinese market. At present, Velocity Vials have passed the multiple filling tests on the existing filling lines of CNBG. The results showed that Velocity Vials could effectively improve production efficiency and product quality.

As two leading upstream and downstream manufacturers in Chinese pharmaceutical industry, this in-depth cooperation between Corning and CNBG can help promote the upgrade of China’s pharmaceutical packaging materials, drive high-quality development of Chinese pharmaceutical industry, and help advance a new stage of pursuing excellence in pharmaceuticals manufacturing and drug safety. We expect Velocity Vials can be broadly adopted across CNBG’s pharmaceutical products portfolio to support more effective and safer delivery of pharmaceutical products.