Case Study 6 - Capacity Analysis

The evaluation of process and scheduling options for the refit of a suite within an existing contract manufacturing facility. The new recombinant protein product is to be manufactured in parallel within a second suite already used to manufacture an existing product. Both production suites shared common resources such as CIP and solution preparation. In addition to simulating the refitted suite, the project objectives also focused on the impact of the proposed changes on the existing manufacturing process.

Aims & Objectives

  • Design validation for the refit
  • Analysis of different process options
  • Assessment of impact on existing operations
  • Capacity prediction
  • Determination of media and buffer preparation & hold requirements
  • Assessment of utility availability during concurrent operation

Results

  • Existing suite process validated against recorded data
  • Prediction of utility availability
  • Quantification of effects on existing suite
  • Demonstrated feasibility of proposed engineering options
  • Disposable bag utilisation and storage requirements
  • Prediction, and diagnosis of utility unavailability issues
  • Comparison of different process options and schedules