High Performance Vial Containment for Your Sensitive Drug

Today’s environment of fast-paced vaccine technology development poses a heightened need for high quality production and standards. As governing bodies continue to modernize regulations, manufacturers have an obligation to ensure compliance with sterile manufacturing environments and robust quality expectations. Modern vaccine technologies require primary packaging components capable of performance within the cold chain. An essential element of meeting the demands of modern vaccines is ensuring high product quality through comprehensive risk mitigation.

The expansion of emerging vaccine technologies, such as mRNA vaccines, nanoparticle vaccines, viral-like particle vaccines, and universal vaccines, demonstrate the diverse needs in drug development and manufacturing. Drug product innovation has created a need for drug containment systems to accommodate drug attribute needs, such as cold temperature storage. The cold chain logistics market for vaccines is anticipated to grow to a value of $5.9B by the year 2034 at a 5.3% compound annual growth rate from 2025. ^[1] Drug container closure system options should enable successful container closure integrity (CCI) performance in the cold chain.

Emerging vaccine technologies require intentional selection of a container closure system to ensure drug stability and safety. The common technology for containment of vaccines is borosilicate glass vials. However, drug-specific demands require consideration of vials composed of alternative materials to minimize packaging-associated risk and improve CCI performance.

The need for an alternative is addressed in an updated report by West scientists: Vaccine Primary Packaging: Daikyo Crystal Zenith® Cyclic Olefin Polymer (COP) Vial. These vials have excellent performance features:

• Low levels of extractables
• Low levels of interaction with drug products
• Reduced drug protein aggregation
• Resistance to breakage
• Quantified oxygen and CO2 permeability at various temperatures including cryogenic, essential for performance in the cold chain
• Compatibility with elastomer stoppers with FluroTec® barrier film
• Worldwide approval of CZ containment for an array of drug products including: monoclonal antibodies, vaccines, proteins, peptides, small molecules, and gene therapies

The whitepaper reinforces a key message: Container closure system selection must ensure integrity across manufacturing, storage, distribution, and administration. For next-generation vaccines, COP vials offer a data-supported alternative that addresses compatibility, durability, and cold chain performance.

Daikyo Crystal Zenith vials are an excellent alternative to glass vials. Rather than replacing glass universally, COP vials provide manufacturers with an additional, data-supported option. With West data and support, an assessment can be made to determine if a container closure system based on these vials can meet the requirements of any of the various vaccine platforms under consideration. For more information, contact an account manager or Technical Customer Service representative.

Learn more and download the new free whitepaper by clicking here.

FluroTec® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
Crystal Zenith and FluroTec technology are licensed from Daikyo Seiko, Ltd

^[1] InsightAce Analytic Pvt. Ltd. “Vaccine Cold Chain Logistics Market Size, Share & Trends Analysis Report By Service (Storage, Packaging, Transportation), By Packaging Method, By Mode of Transportation, By Holding Temperature Range, By Container, By Region, And Segment Forecasts, 2025-2034.” https://www.insightaceanalytic.com/report/global-vaccine-cold-chain-logistics-market/1127