14MHFI8 - Selection, structure and validation of equipment in pharmaceutical engineering

Course specification
Course titleSelection, structure and validation of equipment in pharmaceutical engineering
Study programmeChemical engineering
Lecturer (for classes)
Lecturer/Associate (for practice)
Lecturer/Associate (for OTC)
    Condition/Облик условљености
    The goalThe objective of the course is to give students necessary engineering knowledge of work principle, design solutions, selection methods, validation and exploitation of equipment in pharmaceutical industry.
    The outcomeThrough the planned syllabus and project assignment, students gain necessary knowledge about equipment used in different production phases in pharmaceutical industry. Students will be able to apply this knowledge in engineering practice.
    Contents of lecturesIntroductory considerations. Current technical regulations. Conditions that equipment in pharmaceutical engineering (PE) should fulfil, in accordance with good manufacturing practice (GMP) for medical drugs. Systems for providing energizers and process fluids. Elements for air filtration: HEPA (high-efficiency particulate air) filters and ULPA (ultra-low particulate air) filters – structure and work principle. Basics of heating, ventilation and air-conditioning (HVAC) systems design. Different constructions of reactors in PE; quantities needed for calculation of the reactor structure. Providing the heating and cooling. Storage tanks. Mixing elements; types of stirrers, basic geometric measures, driving systems. Selection of stirrers for production processes in PE. Systems for mechanical and thermal sterilization, examples of implemented solutions. Structures of grinding machines used in PE: mills, disintegrators, cutting machines - selection criteria. Design solutions of equipment for separation, sieving and calibration. Equipment for agglomeration and homogenization. Structures and work principles of drying equipment in PE. Tableting, capsule filling and coating machines - selection criteria. ; Pipelines: material and manufacturing, dimensioning and assembling, welded joints, pipeline accessories. Structures of measuring, regulating and safety elements. ; Putting together designed entities and assembling the technological lines in pharmaceutical industry. Pharmaceutical equipment validation. Exploitation of equipment in PE and maintenance for achievement of projected service life.
    Contents of exercisesAnalysis of designed solutions for equipment and plants in PE. Calculation of pressure vessel for infusion solution preparation. Dimensioning and calculation of different types of sterilizers. Example of clean room design and selection of filters in accordance with projected air purity class. Example of device validation in PE.
    1. Handouts from lectures and material from practices
    2. M. Rakin, S. Putić, N. Tomović, B. Gnjatović, Equipment in pharmaceutical engineering, handbook, Faculty of Technology and Metallurgy, University of Belgrade, 2010 (in Serbian).
    3. M. Jovanović, Z. Đurić, Fundamentals of industrial pharmacy, Nijansa, Zemun, 2005 (in Serbian).
    4. Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP), International Society of Pharmaceutical Engineers, 2010.
    5. P. Cloud, Pharmaceutical equipment validation, The ultimate qualification guidebook, Interpharm/CRC Press, 1998.
    6. M.E. Aulton, Pharmaceutics – The Science of Dosage Form Design, Harcourt Publishers Limited and Elsevier Sci. Limited, 2002.
    Number of hours per week during the semester/trimester/year
    LecturesExercisesOTCStudy and ResearchOther classes
    Methods of teachingLectures, examples of constructed solutions of equipment and computational exercises in the classroom (using computer and video beam, overhead projector and blackboard). Project assignment using licensed MS Office and CAD software packages in small groups.
    Knowledge score (maximum points 100)
    Pre obligationsPointsFinal examPoints
    Activites during lectures10Test paper
    Practical lessons30Oral examination40