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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 product 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.
Analysis by the integrated project team indicated many of the process steps could be transferred with care into equipment that could be designed/selected for the new duty with a degree of confidence. However, four steps were identified as high risk. Against tight timescales it was decided to run development studies to identify new processing techniques and to then test these at pilot scale.
The work by BPE demonstrated that quality critical parameters could be met to the satisfaction of the regulatory authorities allowing the project to proceed to full design, build, qualification and full beneficial use.