Impact of Filling Process Interruptions on m-Cresol Concentration in Parenteral Drug Formulations
DOI:
https://doi.org/10.56782/pps.391Keywords:
preservative, insulin, filling process, parenteral formulation, m-cresolAbstract
Ensuring the appropriate concentration of antimicrobial preservatives in multi-dose sterile pharmaceutical formulations is critical for maintaining sterility, quality, and stability throughout the product’s shelf life. However, preservatives such as m-cresol and phenol are known to adsorb onto silicone components used during manufacturing, leading to potential preservative loss. This study investigates the impact of manufacturing process stops, particularly during the filling stage, on m-cresol concentration in dosed cartridges. Laboratory-scale experiments and full-scale manufacturing studies were conducted using solutions containing recombinant human insulin (RHI), insulin lispro, and a placebo solution to evaluate the effects of interruptions in the filling process—such as internal process control (IPC) checks—on the adsorption of m-cresol from pharmaceutical formulations.
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Copyright (c) 2025 Renata Sobieska-Żołądkiewicz, Małgorzata Ulanowicz, Radoslaw Gladysz, Marek Mularewicz
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