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Our client needed to assess the impact of new products and related processes, review a proposed move from 24/7 operation to day/extended day work patterns and to secure optimised use of available facilities and resources in a cGMP regulated environment.
The key challenge for the BPE team was to establish a fully agreed set of critical success factors against which to review potential options. A number of process developments and enhanced ways of working needed to be aligned within the project context and regulatory framework.
BPE undertook a two-stage process, a Concept Study to review available options followed by a Front End Engineering Design to provide a +/- 10% Cost Estimate to go forward for Capital Sanction.
BPE produced a comprehensive design report including cGMP, Safety and Constructability Reviews to support the project cost estimate allowing the client management board to decide on project approval.