Assessing the impact of container marking implementation

Abstract

Amgen is implementing new capabilities across the Amgen manufacturing network in order to code containers at the unit-level to reduce the possibility of mix-ups of unlabeled drug products. In order to prepare for the roll-out of these new capabilities, an assessment of the impact to throughput, packaging yield and eject rates was conducted. Discrete event simulation was utilized to assess the impact of implementing these new container marking capabilities on a vial inspection and packaging line at one of Amgen's key manufacturing sites. The impact assessment confirms that the new capabilities will have no impact to the throughput of the production line and minimal to no impact on packaging yield and eject rates. This assessment provides confidence that implementation can move forward without concerns of negative impacts to the production lines.