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A Functional Suitability Assessment of Aseptically Reprocessed Bromobutyl Parenteral Packaging Components
Leyba, Claire Elaine
Leyba, Claire Elaine
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Abstract
As the pharmaceutical industry seeks to improve sustainability and operational efficiency, the potential recycling of unused aseptically processed elastomeric packaging components presents a compelling opportunity. This thesis investigates the impact of repeated ATEC vessel processing bromobutyl serum stoppers in the context of functional suitability and intrinsic subvisible particulate matter burden. This study evaluates critical functional performance attributes of primary elastomeric closure components in accordance with USP <382>, including container closure integrity, needle penetration force and fragmentation. In parallel, subvisible particulate matter was assessed through USP <788> methods, as well as one orthogonal characterization technique: HIAC light obscuration, membrane microscopy, and Micro Flow Imaging, respectively. Visual inspection and dimensional analysis were also evaluated using vendor specifications for the components.
Results demonstrated that reprocessed stoppers retained their shape, size, and functional integrity, and met all compendial acceptance criteria. Particulate levels remained below 1/3 of the USP <788> threshold, a benchmark commonly used in industry for individual components; however, MFI analysis revealed a high prevalence of silicone oil droplets in reprocessed stoppers, likely attributable to repeated silicone exposure during the second ATEC processing cycle. This finding suggests that while reprocessing is viable, further optimization of the ATEC recipe may be warranted to minimize particulate risk.
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Date
2025-08-31
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University of Kansas
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Keywords
Pharmaceutical sciences, Chemistry, Aseptic, ATEC, Bromobutyl, CCIT, Packaging, Parenteral