TY - JOUR T1 - Risk mitigation of drug shortages - A new concept for vials designed to improve fill & finish performance JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol DO - 10.5731/pdajpst.2020.011585 SP - pdajpst.2020.011585 AU - Holger Roehl AU - Stephanie Mangold AU - Florian Maurer AU - Diana Loeber Y1 - 2020/01/01 UR - http://journal.pda.org/content/early/2020/09/30/pdajpst.2020.011585.abstract N2 - Drug shortages are a severe threat to human health and life. The situation in the U.S. even became this critical, that FDA formed a task force in 2018 in order to identify root causes and potential solutions [1]. Manufacturing issues, including rejects and disruptions during fill & finish processes, are a main root cause for inefficient drug manufacturing and resulting delays within the supply chain [2, 3]. This is of particular relevance as the standard pharmaceutical vial filling process can introduce various damages to containers starting from cosmetic defects as scratches or abrasions to fatal events like glass breakage [4]. To overcome the occurrence of undesirable interventions, (e.g. breakage from introduced damages), SCHOTT developed the EVERIC™ smooth vial. It is characterized by a coated outer surface in such a way that the excellent pristine properties of a produced glass surface are preserved. To this, 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 analyse 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 [5, 6, 7, 8]. Container strength has been analysed before and after line processing of outside coated as well as of uncoated vials. The results demonstrate the strength-preserving effect of the coating in comparison to uncoated vials. Furthermore, the 100% cosmetic inspection proved that the number of rejections can be significantly reduced. Thus, the preserving effect of the outer surface modification of the glass containers has been demonstrated impressively. In addition, analyses of filled media and washing water revealed no residues of the coating material. The vial quality obtained from the surface modification greatly improves the line performance by nearly eliminating all undesirable effects affecting the machinability. ER -