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 degrees 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 degrees 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.
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