An Exploratory Review of Elastomeric Closures in Pharmaceutical Packaging: From Material Science to Regulatory Compliance
DOI:
https://doi.org/10.38032/jea.2026.02.003Keywords:
Elastomeric closures, , Parenteral products, Extractables and leachables, Bromobutyl rubber, Chlorobutyl rubber, Regulatory complianceAbstract
Elastomeric closures are essential primary barriers in parenteral drug packaging, ensuring the stability, efficacy, and sterility of pharmaceutical products. This review traces the evolution of these components from early natural materials to modern synthetic elastomers, specifically bromobutyl and chlorobutyl rubber. It evaluates material science by comparing the physicochemical properties, advantages, and limitations of industry-standard rubbers. The multi-stage manufacturing process—including compounding, molding, vulcanization, and sterilization—is analyzed alongside the stringent quality control and Good Manufacturing Practices (GMP) required to prevent defects. The article addresses the critical challenge of extractables and leachables (E&L), detailing the regulatory landscape, testing methodologies, advanced detection techniques, and toxicological risk assessments. The impact of advanced surface coatings and future trends, such as sustainable materials, ready-to-use (RTU) systems, and thermoplastic elastomers, are also discussed. Ultimately, this article synthesizes current knowledge to provide a holistic overview for researchers, manufacturers, and regulatory professionals in the pharmaceutical field.
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