UNIQUE SERIES AKTU Syllabus
BP308T

Pharmaceutical Microbiology (Theory)

L-T-P3-0-0 Credits3 Session2026-27 TypeTheory
Appears in 1 semester

B.Pharm · Sem 3 (Core)

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Syllabus

5 units · 45 lecture hours
Unit1

Unit 1

9 hrs

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)

Unit2

Unit 2

9 hrs

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.

Unit3

Unit 3

9 hrs

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

Unit4

Unit 4

9 hrs

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

Unit5

Unit 5

9 hrs

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

Course Objectives6 points
  • The objectives of this course are to:
  • 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 (COs)5 outcomes

After completion of the course student will be able to:

  1. CO1Explain the basic concepts of microbiology and the role of microorganisms in pharmaceuticals.
  2. CO2Identify and differentiate microorganisms using staining and biochemical techniques.
  3. CO3Evaluate microbial contamination sources and apply GMP-based strategies for contamination control.
  4. CO4Describe microbial spoilage mechanisms and select appropriate disinfectants, antiseptics, or preservatives.
  5. CO5Compare various sterilization methods and assess their effectiveness and validation parameters and perform microbial limit and sterility tests in compliance with pharmacopeial guidelines.
Recommended References (Preferably latest editions):8 books
  1. Pelczar, M. J., Chan, E. C. S. and Krieg, N. R. Microbiology: Concepts and Applications. McGraw-Hill.
  2. Prescott, L. M., Harley, J. P. and Klein, D. A. Microbiology. McGraw-Hill.
  3. Hugo, W. B. and Russell, A. D. Pharmaceutical Microbiology. Blackwell Science.
  4. Waites, M. J., Morgan, N. L., Rockey, J. S. and Higton, G. Industrial Microbiology: An Introduction. Blackwell Science.
  5. Denyer, S. P., Hodges, N. A. and Gorman, S. P. Microbiology. Wiley-Blackwell.
  6. Atlas, R. M. Handbook of Microbiological Media. CRC Press.
  7. Sandle, T. Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control. Elsevier.
  8. Sutton, S. V. W. Microbiology in Pharmaceutical Manufacturing. PDA/DHI Publishing. Course Title Course Type

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Official AKTU syllabus

This subject is on page 84, 85, 86, 87 of the original AKTU PDF.

Official AKTU syllabus PDF ↗