• Valor? Glass: Transforming the Pharmaceutical Glass Packaging Industry

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    Throughout its history, Corning has focused on research and development — empowering our leading scientists and engineers to develop solutions to problems that matter. In October 2019, the company announced that a leading pharmaceutical manufacturer received FDA approval of Corning Valor? Glass for use as a new primary package for a marketed drug product.

    Our development of this innovative packaging solution builds on over a century and a half of groundbreaking work in glass. Whether it’s Dr. Jonas Salk’s use of our PYREX? vessels to help produce his life-saving polio vaccine, or the invention of low-loss optical fiber that ushered in the Information Age with previously unimaginable connectivity, Corning product developments have focused on meeting our customer challenges and improving, and often enabling, healthier lives.

    In the quest to build a better pharmaceutical glass container, Corning’s experience and expertise has made it uniquely positioned to take on this challenge. “Corning exists to transform and optimize this ancient material for advanced, modern applications,” explains Jeff Evenson, Corning executive vice president and chief strategy officer.

    Our first question before starting work on any new innovation is “why?” What is the need and how do we hope to solve it? When we thought about the glass containers that have been used in the pharmaceutical industry for years, we knew that this conventional borosilicate glass was invented in the 1800s for general glassware use. It was simply adopted by the pharmaceutical industry, not specifically designed for its needs. Simply put, as drug therapies have advanced, the glass containers they are stored and transported in, and administered from, have largely stayed the same. Ultimately, the needs of the pharmaceutical industry have evolved. It was time for a better glass.

    Since its inception, the goal driving the creation of Valor Glass was clear – to address the many problems facing pharmaceutical manufacturers including glass container damage and breakage, the need for improved quality, and most critical – ensuring drug purity. Minimizing chemical interactions between drugs and their containers is paramount. The safe storage and delivery of drugs is fundamental to providing reliable access to medicines essential to the public’s wellbeing.

    While drug recalls resulting from broken or cracked glass vials or other packaging-related issues were relatively rare, the associated financial cost of glass-related incidents was significant, and often required time-consuming investigations to determine the source.

    To begin, Corning’s chairman and CEO, Wendell Weeks assembled an accomplished team of our top scientists and engineers from across disciplines. It was led by a veteran Life Sciences project manager, a Corning research associate with extensive related experience and two Corning glass reliability experts. This team’s unique perspectives and insights, combined with deep understanding of the pharmaceutical manufacturing process provided by customers, came together to drive this revolutionary innovation and move the project forward.

    The process of developing any new product is a time-consuming and meticulous one, with rigorous testing, marked by numerous advances and setbacks. We applied our expertise in glass science, optical physics, vapor deposition, precision forming, and extrusion to develop a 21st century glass container to meet the needs of modern high-speed manufacturing and to help protect patient safety through improved quality.

    Specifically designed for pharmaceutical applications, the unique properties of Valor? Glass come down to three c’s: composition, chemical strengthening, and coating. In addition to its increased strength and uniform surface, Valor Glass’ composition offers another major advantage – it eliminates the root cause of delamination, or the flaking of glass partices from the inside of the vial walls?into the drug solution. In 2011, the Food and Drug Association issued an advisory to pharmaceutical manufacturers concerning risks associated with delamination and requesting innovation in glass packaging. The root cause of delamination is boron evaporation. Valor Glass does not contain boron, therefore eliminating the possibility of delamination.

    The development of Valor Glass also included a strong collaboration between Corning and pharmaceutical giants Merck and Pfizer — all driven by the quest for higher-quality and more reliable drug packaging.

    In July 2017, at “Made in America,” week, a special White House event celebrating American manufacturing, President Trump did his best to break a new Valor vial. The vial showed its unique formulation and strength. It remained intact even after he exerted 1,000 pounds of force — the equivalent of a punch from a professional boxer.

    Valor Glass has been specifically designed for pharmaceutical applications, and the 2019 FDA approval makes Valor Glass the first and only fundamentally new glass composition to be approved since the advent of borosilicate glass more than 100 years ago. This innovative glass packaging solution has been designed with superior chemical durability. It resists damage and breakage and reduces glass particulate generation. By helping to provide more reliable access to state-of-the-art medicines, the ultimate beneficiaries of Valor Glass will be patients.

    In the words of Ron Verkleeren, vice president and general manager, Corning Pharmaceutical Technologies, “We believe that Valor Glass is the future of parenteral glass packaging for manufacturers. This FDA approval is an important first step on our journey to create a new standard in pharmaceutical glass packaging. It’s great news for patients, for the industry, and for Corning."

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    Valor? Glass is engineered with higher internal energy than conventional packaging. Damage introduced on filling lines or during shipping can create sub-visible flaws and cracks in conventional pharmaceutical packaging that can compromise drug product sterility and result in serious contamination.

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    Glass Delamination: Getting to the Root Cause

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    Delamination has existed as a fundamental glass challenge for pharmaceutical manufacturers for decades. Corning leveraged over 167-years of glass and material science expertise to launch a root-cause analysis to study the issue. The result? We’ve eliminated the problem.

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