Comparative Deterministic Cold Storage Headspace Analysis–Multi-sourced Injectable Container Closure Systems

Abstract

a vial containing clear fluid is shown with a syringe | Image Credit: ©Graham - stock.adobe.com

A critical function of container closure systems—defined as one vial, one stopper, one seal, or one press-on cap—used for the packaging of injectable drug products is to maintain closure integrity over the life cycle of the drug product when exposed to a range of storage and transportation temperature conditions. Many injectable drugs are packaged in glass vials affixed with an elastomeric closure secured by an aluminum seal using sufficient crimping seal force to obtain the target residual seal force to assure container closure integrity (CCI). And more recently, interest in closures comprised of press-on caps pre-assembled with stoppers. The development of advanced therapy medicinal products (ATMPs), vaccines, insulins, and many biologics requiring extreme cold storage management pose CCI challenges not encountered at ambient and base cold storage temperatures impacted by differences in packaging component coefficients of expansion and elastomer viscoelastic transition to a glass-like state beyond -50 °C. ATMPs, including cell, gene, and RNA therapies, are collectively defined as a class of highly innovative novel drugs requiring complex cold chain logistics, driving sustained growth of the cold chain medicine market and a need for injectable primary packaging capable of maintaining CCI at extreme cold storage (-80 °C) temperatures. This study evaluates the best-in-class elastomer compounds, formulations, and coatings, affixed with aluminum seals and press-on caps to Type I borosilicate tubular glass vials conforming to the International Organization for Standardization (ISO 8362) injection containers requirements.

Peer-reviewed

Article submitted: September 23, 2024.
Article accepted: January 3, 2025.

About the authors

Robert Popilock is strategic marketing manager, and Jay Harkins is senior product manager, both at DWK Life Sciences LLC, Millville, NJ, and Felix Brosi is head of Global Product Management at DWK Life Sciences GmbH, Mainz, Germany.

Article details

BioPharm International®
Vol. 38, No. 2
March 2025
Pages: 21–27

Citation

When referring to this article, please cite it as Popilock, R.; Harkins, J.; and Brosi, F. Comparative Deterministic Cold Storage Headspace Analysis–Multi-sourced Injectable Container Closure Systems. BioPharm International 2025 38 (2).