Packaging Cold Chain Program Improvement

Abstract

With the growing trend of biologic medicines coming to the market, a packaging engineering group needed to create an internal cold chain process to meet market demand in this area of cold shipments; although there is a process in place from a compliance quality perspective, there wasn’t one from the packing side. The lack of the process in packaging resulted in gaps in the projects from one project to the next and, in some cases, some rework was required. To address these issues, the project team met and defined roles and responsibilities, determined process steps using best practices and research found and, most importantly, established the requirements needed for each project moving forward. A metric was also created to measure the effectiveness of the new process and ensure measureable improvement. A pilot is being conducted to measure the rework metric and confirm improvements are found. Key Terms ⎯ Biologic medicines, pharmaceuticals, sustainability, temperature control packaging.