Design of a Cleaning Change Over Reduction Strategy for a High Volume Product in a Packaging Line

Abstract

Currently packaging operations are trying to reduce the downtime and operational cost among others activities to enhance efficiency and overall process performance. Based on this objective, pharmaceutical packaging operations defined, proved and validated a process that allowed to use five released bulk lots be combined into one packaging lot. The strategy proved to be efficient for operational cost, unproductive time reduction and cross contamination. An identified disadvantage was that if a quality event was noticed in the release product, no bulk segregation could be done. Once each bulk lot is added into the filler machine or product bottle, it was mixed with previous bulk lots and it cannot be determined which tablet belongs to a specific bulk. Redesigned batch record includes a table to estimate the bulk traceability when it is packaged as Combolot. A project to develop a sub-lot numbering system was identified as future wok for this research. Key Terms ⎯ Cleaning validation, campaign, change over, combined lots, packaging lots, process improvements.