Critical Time-Temperature Dependent Container Closure Integrity (CCI) Through the Sealed Drug Product Life Cycle

Discusses CSR and RSF with respect to changes over time and with temperature variations, and how this affects CCI over the life cycle of a drug.

Sealing force (CSR & RSF) is time dependent, decays exponentially and levels off eventually, crucial for the sealed drug life cycle. Numerical nonlinear modeling fit can be developed and used to calculate CSR & RSF of rubber stoppers throughout the sealed drug life cycle.

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