(494b) Pilot Plant Scale-down to Troubleshoot A Commercial Crystallization Process

A case study of commercialization of a new process involving production of a solids product via intermediate crystallization is presented, in which small-scale, multi-throughput reactions, crystallizations, and separations were conducted in vials at the 1 ? 5 gram level, to create a virtual, multi-throughput pilot plant to diagnose off-spec performance in the commercial unit. Confidence in the mini multi-pilot approach was gained via correlation with performance observed during earlier unit operations at the 1 ? 4 liter scale, piloted during initial process development. Scale-down to allow rapid response, side-by-side testing to elucidate impacts of trace chemistry was paramount to successful post startup troubleshooting.