Design and Management of Aseptic (PME/ME/CHE643)

This course presents a systematic methodology for the project management of aseptic pharmaceutical manufacturing processes. This includes the associated equipment and the integration of the preliminary design, detailed design, construction, and validation phases of a project to minimize the challenges, and cost and schedule overruns typically associated with implementing these complex processes. The content includes selection of the project team, defining the process requirements the equipment is required to meet, preparation of the equipment user requirements specifications, preparation of the equipment layout, preparation of the equipment budget, preparation of the project schedule, managing the construction of the equipment, managing the testing of the equipment, and installation of the equipment and site acceptance testing. Also addressed will be selection of and dealing with equipment vendors, planning for validation success, and regulatory acceptance. An aseptic manufacturing process case study is used as a basis for the lecture series. The process will be followed from the preparation of the raw data used to determine the process requirements through to final installation and acceptance of the aseptic processing equipment on site.