Plant and Apparatus Engineering in PBT
Component code / course code: (PBT13-AAB)
Semester: winter / summer
ECTS credits: 3
Lecture hours per week (SWS): 2
Lecturer: Prof. Dr. Friedemann Hesse
Course language: English
Prerequisite: Recommendation: Fundamentals of Process Engineering, Thermal and Mechanical Process Engineering.
Objectives (Learning Outcome): Students who have successfully completed this module,
- can apply the relevant design criteria in biopharmaceutical manufacturing processes (technologies in measurement and control technology, clean room design, sterile technology and in the planning of biopharmaceutical production facilities).
- know the process variables, the laboratory and application-oriented process measurement and control technology as well as the reference to operational practice.
- know the functional principles and the mode of operation of measuring, actuating and control elements as well as the possible sources of error.
- know the planning phases of a pharmaceutical plant from pre-project planning to commissioning and are familiar with the design aspects of fittings as well as the possibilities and limits of different membrane filter tests.
- know planning contents, planning tools, required qualification documents, qualification and validation processes as well as risk analyses.
- know the basics of sterile and cleanroom technology (terminology, history and structural conditions, cleanroom classes).
- know the relationship between particles, germs and cleanroom class, the difference between turbulent mixed flow and low-turbulence displacement flow.
- can plan premises for the production of active pharmaceutical ingredients with the aid of the relevant regulations.
Lecture topics (content): Plant design in the pharmaceutical industry: documentation and information (databases, flow diagrams: Block flow diagram, process flow diagram, P&I flow diagram), equipment, pipe classes, layout planning, pipe routing, support areas for production, feasibility studies, contracts and risks, approval procedures, official requirements, plant planning with phase model, project planning (concept, basic and detail engineering, safety analyses, operating manual), planning tools, qualification documentation, qualification and validation, risk analysis (FMEA).
- Technical basics in plant engineering for hygienic and sterile applications: Selection criteria for plant and equipment components (materials, sealing technology), surface finishes and connection types, valve function principles, diaphragm valves for sterile processes, poppet valves for steam, valves in control applications.
- Integrity test on membrane filters: physical basics of the test procedures, bubble point test, forward flow test, water intrusion test, integrity test equipment.
Teaching format (e.g. online/in person lecture/Seminar/Lab etc.): Lecture
Examination: Written exam (60mins)
