Risk Mitigation of Drug Shortages-A New Concept for Vials Designed to Improve Fill and Finish Performance.

Abstract

Drug shortages are a severe threat to human health and life. The situation in the U.S. became so critical, that the U.S. Food and Drug Administration formed a task force in 2018 in order to identify root causes and potential solutions. Manufacturing issues, including rejects and disruptions during fill and finish processes, are a main root cause for inefficient drug manufacturing and resulting delays within the supply chain. This is of particular relevance as the standard pharmaceutical vial filling process can introduce various damages to containers starting from cosmetic defects, such as scratches or abrasions, to fatal events like glass breakage. To overcome the occurrence of undesirable effects (e.g., breakage from introduced damages), SCHOTT developed the EVERIC smooth vial. It is characterized by an outer surface coated in such a way that the excellent pristine properties of the produced glass surface are preserved. In addition, the glass-to-glass friction is reduced and sustainable to different environmental conditions caused during processing. A comparative filling campaign was performed on a commercial line at Hoffmann-La Roche to analyze the efficiency of such a surface modification. In this case, SCHOTT's silicone-free coating option was used, possibly being the preferred solution for certain highly silicone-sensitive biological drugs. Container strength was analyzed before and after line processing of coated as well as uncoated vials. The results demonstrated the strength-preserving effect of the coating in comparison to uncoated vials. Furthermore, the 100% cosmetic inspection proved that the number of rejections could be significantly reduced. Thus, the preserving effect of the outer surface modification of the glass containers was demonstrated impressively. In addition, analyses of the filled media and washing water revealed no residues of the coating material. The vial quality obtained from the surface modification greatly improved the line performance by nearly eliminating all undesirable effects affecting the machinability.