Abstract
A one-year study to establish the container closure integrity (CCI) performance landscape of systems comprising rubber stoppers and glass vials was performed. Focus was addressing the issues of CCI performance versus: (a) time, (b) compression levels and residual seal force (RSF) values, and (c) potential variation in results based upon deterministic measurement method (tracer gas and frequency modulated spectroscopy). To reduce sample size to a manageable number, the study was based upon a design of experiments that considered a range of: (a) stopper formulations, sizes, and configurations; (b) vial sizes, types, and suppliers; (c) compression levels. All systems showed good performance; there was no decrease in CCI with time − highlighting the general robustness of rubber-glass vial systems. Lower compression/RSF values tended to give slightly lower performance and wider scatter in data, and thus should not be recommended for commercial applications. A small amount of oxygen exchange through stoppers was observed for all systems − to be expected since rubber is known to be gas permeable. RSF values decreased initially, then remained constant − consistent with models. Results are consistent with literature.
- Received March 22, 2019.
- Accepted July 22, 2019.
- Copyright © 2019, Parenteral Drug Association
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