Project Overview
To scale up a bench scale hands on pharmaceutical manufacturing process into a semi automated plant comprising 22 distinct steps which were built into eight batch sequenced control processing skids. The key objectives were to increase capacity sufficiently to meet a business opportunity in the USA.
Technical risk assessments of the new concept manufacturing scheme indicated that several of the new unit operations were high risk in terms of manufacturing products of the right quality to meet the critical parameters.
A number of novel techniques were required, and to meet existing quality critical product parameters necessitated considerable development work to identify conditions that repeatedly met specification to the approval of regulatory controls.
