How important is the quality of glass in pharmaceutical packaging?
Glass is the ideal material for parenteral packaging because of its chemical durability, hermeticity, strength, cleanliness, and transparency. While glass is inherently strong, the practical strength is influenced greatly by the inherit flaws. Conventional pharmaceutical packaging has not evolved in parallel with drug formulations, high-speed processing equipment, or storage applications. Conventional glass vials are highly susceptible to exterior damage or flaws during the converting process, transit, and on pharmaceutical manufacturing lines.
Many factors limit the speed and efficiency of pharmaceutical filling machines, including the type of glass vial being processed. Traditionally, filling machines have been deliberately slowed down to reduce physical interactions between the machine and conventional borosilicate glass vials. Stress and friction generation on turntables, tracks, and trays, particularly at junctions between intermittent and continuous motion, can lead to glass breakage and human line interventions, which risks contamination of sterile environments. Economically speaking, vial breakage during the production of an expensive drug (e.g., an antibody) can be costly since it decreases the yield and effective batch-size, extends the clean-in-place CIP procedure during line stoppage, and wastes drug resources.
For these reasons, key industry stakeholders looked for another glass packaging solution designed for pharmaceutical manufacturing to maximize strength and minimize breakage. In response to these industry issues, Corning set out to develop an innovative packaging solution with improved chemical durability and damage resistance designed to protect 21st Century drug products and optimize manufacturing processes.
How do you see this market today? Impact of Covid-19?
The growth of the pharmaceutical industry in emerging economies is driving the market. The glass packaging manufacturers and suppliers are focusing on shifting their base to countries like India, Brazil, etc. as a result of increasing opportunities offered by the pharmaceutical industry in these countries, especially in the generics sector.
The 21st century has witnessed multiple epidemic and pandemic infectious diseases including those caused by the SARS, H1N1 influenza, Ebola, and SARS-CoV-2 viruses. While the consequences of these events have been wide-ranging and varied, one constant is the ripple effects sent through the entire global and Indian pharmaceutical value chain, including drug development and testing, manufacturing, and distribution.
The race for effective Covid-19 vaccines has rallied over 100 research groups and billions of dollars in global funding to identify safe and effective products. Several promising candidates are moving into human trials. Such additional demand may lead to over 1B+ additional doses which will create pressure on the existing supply chain and impacting fill/finish as well. The likely surge in demand is placing pressure on pharmaceutical manufacturers to produce at unprecedented rates. Pharmaceutical companies and contract manufacturers have started to invest heavily in cutting-edge aseptic fill/finish technologies to increase production capacity and overall equipment effectiveness.
India is the third-largest pharmaceutical industry globally (by volume) and holds strategic importance in the global scheme of things. According to the government’s committee, India will need 6 crores vials for Covid-19 vaccine shots in the first 6 months of the vaccine being available. While India has strong partners to support the growing demand, it also needs to prepare a future-ready blueprint to ensure there are no gaps and we can seamlessly deliver millions of vials and similar packaging solutions.
What makes Corning Valor Glass so different from its competitors? Corning’s market share in India?
Valor Glass is purpose-built for the pharmaceutical industry to enhance the storage and delivery of drugs, provide more reliable access to medicines essential to public health, and optimize manufacturing efficiency. A boron-free composition, Valor Glass eliminates delamination helping to protect patients by improving packaging quality.This innovative packaging technology is chemically strengthened and has a protective low coefficient exterior coating that helps resist damage and breakage and reduce glass particulates while increasing throughput.
Compared to conventional borosilicate vials during the lyophilization process, Valor vials significantly reduce damage and breakage and may lower manufacturing costs. The chemical strengthening process for Valor vials imparts compressive stress on the glass surface that typically exceeds the tensile stresses generated in the freeze-thaw process dramatically reducing the potential for breakage. In addition to protecting the vial surface, Valor Glass’s low coefficient of friction coating enables a faster chamber during the lyophilization process and improved manufacturing efficiency with a higher run and uptime rates. Based on recent trials, Valor vials demonstrate superior performance in low-temperature processes compared to conventional borosilicate. The advanced parenteral glass packaging technology of Valor Glass enables the potential for reduced start-to-finish times and improved yields which may reduce the total cost of quality as well as manufacturing cost.
From a finish perspective, Valor Glass can enable drug manufacturing fill lines to run at much higher speeds while maintaining 80+% efficiency and higher yields than are possible with conventional containers. Increased speed improves capacity for producing COVID-19 counter measures. A drop-in solution, Valor® technology has demonstrated an increase in throughput of 20-50%, thereby lowering unit cost and enabling capacity expansion or network optimization.
What are your future plans? Any launches?
India is a strategic market for Corning, and we will continue to invest and introduce meaningful products and technologies that would drive the pharmaceutical industry forward. With Corning Valor Glass, we aim to support customers with a global footprint to help them improve glass quality and achieve high production output.
Any plans to Make in India?
Innovation is the core proposition that Corning has harnessed to move up the growth trajectory, with consistent investments across markets globally. We already have an optical fiber manufacturing facility in Chakan, Pune, and also operate Corning Research Centre India at Chakan.
We see great potential and growth in the Indian market, and we continue to evaluate the right partnerships with stakeholders across the business ecosystem. Corning has been actively participating in India’s development, working with local experts to develop and apply Corning’s breakthrough technologies that significantly improve people’s lives.