International Pharmaceutical Industry Journal speaks with Edouard Pagnoud, Product Line Manager – Vial Stoppers at Aptar Pharma, about the evolving expectations for elastomeric closures under USP <382>. The discussion explores the importance of evaluating closures as part of the complete Container Closure System (CCS), the value of worst-case scenario testing, and how system-level performance data can help pharmaceutical manufacturers build robust, risk-informed qualification strategies for sterile injectable products.
With USP <382> establishing a performancebased evaluation framework for elastomeric closures in sterile injectable production, passing a specification test is no longer sufficient. The standard requires evaluation within the full Container Closure System (CCS) – vial, stopper, cap, drug formulation, and access devices, and demands that performance be demonstrated not only at release, but throughout the product’s entire shelf life and point of use. Edouard Pagnoud, Product Line Manager for Vial Stoppers at Aptar Pharma, explains Aptar Pharma’s approach to providing pharmaceutical partners with confidence in how their products will perform when it matters most, including under worst-case scenarios.
Under USP <382>, primary responsibility for CCS qualification rests with the drug product manufacturer. What drives Aptar Pharma’s decision to evaluate closures under worstcase conditions, beyond what is required of a primary packaging supplier?
Edouard: It comes down to a deliberate choice about the scope of our role. As an elastomeric closure solutions provider, our obligation is to deliver closures that meet performance requirements under recommended conditions. We have chosen to go further. Aptar Pharma evaluates its stoppers under worst-case scenarios, larger needle gauges, repeated multi-piercing, and aggressive sterilisation, to map precisely where performance begins to change.
Fragmentation and self-sealing results are not just compliance markers; they tell you how the stopper’s elastomeric structure actually responds under puncture stress. A drug manufacturer who reads those results that way can build a risk assessment on real mechanistic understanding rather than assumptions, and that changes every packaging decision they make downstream.
Which stopper properties most directly drive functional performance, and how do formulation, sterilisation, and geometry each contribute?
Edouard: Hardness and elasticity are the primary material drivers, determined by the rubber formulation and further influenced by sterilisation. Higher hardness increases penetration resistance, modifying piercing force, fragmentation behaviour, and selfsealing response. Gamma sterilisation amplifies these effects by hardening the elastomer. Within our portfolio, 6720GC (Bromobutyl) exhibits higher inherent hardness than 6422GS (Chlorobutyl).
