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AKTU Pharmaceutical Microbiology (Theory) (BP308T) Syllabus PDF – B.Pharm 3rd Semester
Pharmaceutical Microbiology (Theory) BP308T
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Official AKTU syllabus of Pharmaceutical Microbiology (Theory) (BP308T) for B.Pharm 3rd Semester – 3 credits, L-T-P 3-0-0. Read the unit-wise course content, course outcomes, evaluation pattern and recommended books online, or download the PDF.
Syllabus — Pharmaceutical Microbiology (Theory)
Download PDFBP308T · 3 credits · L-T-P 3-0-0
Course Objectives
- Introduce the fundamental concepts of microbiology and its relevance to pharmaceutical sciences.
- Provide insights into the industrial application of microorganisms in the manufacture of pharmaceutical products.
- Provide knowledge Good Manufacturing Practices (GMP) related to microbial contamination control.
- Provide understanding in microbial evaluation techniques such as sterility testing, microbial limit tests, and microbial assay.
- Familiarize students with sterilization technologies, microbial spoilage control, and in vitro cell culture techniques for pharmaceutical research and quality assurance.
Course Outcomes
| CO | Upon successful completion of this course, the students will be able to: |
| No. | |
| 1 | Explain the basic concepts of microbiology and the role of microorganisms in pharmaceuticals. |
| 2 | Identify and differentiate microorganisms using staining and biochemical techniques. |
| 3 | Evaluate microbial contamination sources and apply GMP-based strategies for contamination control. |
| 4 | Describe microbial spoilage mechanisms and select appropriate disinfectants, antiseptics, or preservatives. |
| 5 | Compare various sterilization methods and assess their effectiveness and validation parameters and perform microbial limit and sterility tests in compliance with pharmacopeial guidelines. |
Course Content
| Unit | Topics | No. of |
|---|---|---|
| I | Introduction and role of microorganisms in pharmaceutical industry Fundamentals of microbiology: Microorganisms and medicines, Introduction to various microorganisms, Microbial cultivation, isolation and enumeration. Pharmaceutical importance of microorganisms. Introduction to Microscope (Compound and Electron Microscope) Identification of bacteria using staining techniques -fast staining) and biochemical tests (IMViC). Antibiotics p r o d u c e d by microbiology (Production and uses streptomycin, cephalosporin) | 09 Hours |
| II | Evaluation of microbiological contamination Sources and types of microbial contaminant Control of microbial contamination during manufacture of Nonsterile dosage forms and sterile dosage forms (including Aseptic area), control of Atmosphere, Water, Raw material, Facility, Packaging, Equipment Microbiological spoilage of pharmaceuticals, Factors affecting microbial spoilage of pharmaceuticals. Introduction to Fermentation, types and fermenters. | 09 Hours |
| III | Microbial control and evaluation classification, Biological Safety Level categories. Methods of prevention. Disinfectants, antiseptics, and preservatives, and their evaluation, Factors affecting the antimicrobial activity of disinfectants | 09 Hours |
| IV | Sterilization procedures, assurance and evaluation Physical, chemical, gaseous, radiation and mechanical methods of sterilization, Advances sterilization technologies, Evaluation of efficiency of sterilization; Validation of sterilization procedures and Sterility indicators. Sterility assurance, Bioburden determination, Modelling in predicting microbial growth and death, Test for bacteriostatic, bactericidal activity | 09 Hours |
| V | Microbiological quality control Microbial limit tests and Microbial assay (antibiotics, vitamins and amino acids) Sterility testing of products according to IP, BP and USP Methods for monitoring Water and Air Quality In vitro cell cultures, general procedure for cell culture, Application of cell cultures in pharmaceutical industry and research | 09 Hours |
Recommended References
- Pelczar, M. J., Chan, E. C. S. and Krieg, N. R. Microbiology: Concepts and Applications. McGraw-Hill.
- Prescott, L. M., Harley, J. P. and Klein, D. A. Microbiology. McGraw-Hill.
- Hugo, W. B. and Russell, A. D. Pharmaceutical Microbiology. Blackwell Science.
- Waites, M. J., Morgan, N. L., Rockey, J. S. and Higton, G. Industrial Microbiology: An Introduction. Blackwell Science.
- Denyer, S. P., Hodges, N. A. and Gorman, S. P. Microbiology. Wiley-Blackwell.
- Atlas, R. M. Handbook of Microbiological Media. CRC Press.
- Sandle, T. Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control. Elsevier.
- Sutton, S. V. W. Microbiology in Pharmaceutical Manufacturing. PDA/DHI Publishing.
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