Transitioning to Corning® Valor® Glass Vials: Enhancing Durability and Efficiency in Pharmaceuticals

Traditional borosilicate glass vials, while being a long-standing staple in pharmaceutical packaging, can present certain limitations that may pose some challenges to drug manufacturers and healthcare providers.

Corning introduced Valor® glass vials, the first and only fundamentally new glass composition to be approved by the FDA for use as a primary package for a marketed drug product since the advent of borosilicate glass more than 100 years ago.¹ Valor glass vials offer superior chemical durability, mechanical strength, and damage resistance which are important features for maintaining the integrity and safety of injectable drugs. The vials are made of an aluminosilicate glass composition, which incorporates aluminum oxide (alumina) and silicon dioxide (silica) as primary components.

The following section explains the benefits of using Valor glass vials compared to traditional vials in pharmaceutical applications.

Features of Corning® Valor® Glass Vials

Eliminates glass delamination and minimizes extractables & leachables (E&L)

All glass vials release ions into their contents based on interactions of the glass with the liquid drug product. Based on published studies,² the root cause of delamination is the evaporation of boron and alkali species from the glass surface during the high-temperature tubular conversion manufacturing process. These volatile species recondense on the interior of the vial to create a chemically heterogeneous surface, particularly in the heel of the vial. This region is more susceptible to glass corrosion and, together with several other factors, may result in the formation of (sub)-visible glass flakes in pharmaceutical products.

Valor glass vials, on the other hand, eliminate this cause of delamination through the absence of boron oxide from its composition.³ This significantly enhances the chemical stability of the vials, which is crucial for maintaining the purity and efficacy of pharmaceutical products, particularly those that are sensitive or reactive. Consequently, this results in safer medications with reduced risk of contamination, leading to better patient outcomes.

Moreover, Valor glass vials exhibit low levels of extractables, making them ideal for pharmaceutical products sensitive to pH shifts. Studies have demonstrated they produce equivalent or lower extractable levels than traditional borosilicate glass vials under accelerated testing across various pH conditions.⁴ This makes Valor glass vials an excellent choice for maintaining the purity and efficacy of stored pharmaceutical products.

Superior performance under low temperature processing conditions

Valor glass vials are particularly strong and resistant to damage, allowing them to endure extreme conditions during pharmaceutical processing, transportation, and even the freeze-thaw cycles. They are proven to perform reliably in lyophilization,⁵ whereby they have demonstrated no difference in residual moisture levels or cake cosmetics when compared to traditional uncoated borosilicate vials. This strength allows Valor glass vials to excel in temperature-sensitive applications, such as cold storage and freeze-drying. Notably, they maintain exceptional breakage resistance at temperatures as low as -196°C and ensure effective container closure integrity (CCI) down to -80°C, providing secure, robust storage for sensitive pharmaceuticals in extreme environments.

Resists cracks and breakage

Valor glass vials offer unparalleled mechanical durability, distinguishing them from traditional borosilicate glass vials. Damage incurred during pharmaceutical processing or shipping can create flaws and cracks in traditional glass vials. Cracks can provide pathways for liquids, gases, or microbes to enter the vial, compromising the drug's integrity and posing serious risks⁶ to patients.

They are engineered with a low coefficient of friction (CoF) coating on the exterior of the vial. This facilitates smoother handling and processing, reducing the likelihood of surface-to-surface abrasion between vials, or damage on filling lines or during shipping that can make traditional vials more prone to breakage or cracking. Additionally, they are chemically strengthened to further increase their resistance to breakage and prevent the formation of cracks. In laboratory testing conditions, Valor glass vials provided at least 30x better protection against cracking relative to conventional vials.

Valor glass vials are ideal for hazardous products, such as radiopharmaceuticals or cytotoxic drugs, due to their superior resistance to breakage. This protects healthcare workers and patients from potential exposure to harmful drug contents.

Increased fill/finish efficiency

Valor glass vials feature a low CoF external coating that improves fill/finish efficiency. By reducing surface friction, the vials move more smoothly along production lines, minimizing the likelihood of them sticking together during automated processing or when handled at high speeds. Valor glass vials have demonstrated over 80% efficiency at maximum filling speeds up to 750 vials per minute,⁷ compared to conventional borosilicate vials, which typically achieve 60-70% efficiency at speeds of up to 450 vials per minute. The coating also protects against surface damage, ensuring the vials maintain their integrity throughout processing and shipping, making them ideal for efficient, large-scale pharmaceutical manufacturing. This technology is particularly crucial during demand surges e.g. the ones triggered by pandemics such as COVID-19.

West Offerings

Drug development is an arduous process with several challenges, including the urgency for rapid market entry, navigating stringent regulatory requirements, and managing limited resources. Also, the cost of taking products from the research and development phase through to market is extremely high. To streamline this complex process, West has developed the Ready Pack® containment solution, a proven Ready-to-Use sterile packaging solution that offers the highest quality components to protect, store, and deliver drug product using Valor glass vials. With multiple options for stoppers and seals available, the Ready Pack containment solution portfolio ensures flexibility and compatibility to suit various drug applications.

Valor glass vials, designed to ISO 8362-1:2018 dimensions, are Type I glass according to USP <660>, are compliant with JP 7.01 and meet the criteria for Type I glass according to Ph Eur. 3.2.1. and YBBs. (Valor glass is aluminosilicate glass but satisfies all test requirements described in the various pharmacopeia for borosilicate Type I glass). These vials offer superior chemical durability, eliminate glass delamination, and are available in various packaging sizes and configurations to accommodate diverse pharmaceutical products.

With Valor glass vials, pharmaceutical manufacturers can significantly reduce contamination risks, streamline production processes, and improve overall productivity. Choosing Valor glass vials is an investment in quality and efficiency, helping manufacturers aim to meet the highest standards in drug development and delivery.

Ready Pack is a registered trademark of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.

Corning and Valor are registered trademarks of Corning Incorporated.

West Pharmaceutical Services, Inc. is the exclusive distributor of Corning Valor® glass vials.

For more information about Valor and how West can help, click here, contact an Account Manager or Technical Customer Support (TCS) representative.

References

1. Corning. Corning Announces FDA Approval of Valor Glass for Packaging of Marketed Drug Product [Online] Available from: https://www.corning.com/worldwide/en/about-us/news-events/news-releases/2019/10/corning-announces-fda-approval-of-valor-glass-for-packaging-of-marketed-drug-product.html [Accessed on 11 Dec 2024].
2. Swift R, Schaut R, Flynn CR, Asselta. Glass containers for parenteral products. In Parenteral Medications, 4th Edition, pp. 425-250. CRC Press, 2019.
3. Boltres B, Tratzky S, Kass C, Eichholz R, Nass P. There is still room for improvement: presentation of a neutral borosilicate glass with improved chemical stability for parenteral packaging. PDA J Pharm Sci Technol. 2016:70(4):346-352.
4. Kramer and Schaut. A Revolutionary Glass Package Designed Specifically for Pharmaceutical Use. Corning White Paper.
5. Corning. Valor Lyo Glass: Enhanced Mechanical Properties While Preserving Lyophilized Cake Requirements [Online] Available from:https://www.corning.com/content/dam/corning/media/worldwide/global/documents/ValorLyoPaper061819v3.pdf [Accessed on 23 May 2024].
6. Enhancing Patient Safety through the Use of a Pharmaceutical Glass Designed To Prevent Cracked Containers. PDA Journal of Pharmaceutical Science and Technology, Vol. 71, No. 6, November-December 2017. Robert A. Schaut et al.
7. Stabilizing the Supply. Pharmaceutical Manufacturing [Online] Available from: http://www.pharmamanufacturing.com/articles/2019/stabilizing-the-supply/ [Accessed on 23 May 2024].

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