Handwritten Notes
Semester 3
BP 303 T. PHARMACEUTICAL MICROBIOLOGY (Theory)
Unit I
Introduction, history of microbiology, its branches, scope, and its importance.
Introduction to Prokaryotes and Eukaryotes
Study of ultra-structure and morphological classification of bacteria, nutritional
requirements, raw materials used for culture media, and physical parameters for growth,
growth curve, isolation and preservation methods for pure cultures, cultivation of
anaerobes, quantitative measurement of bacterial growth (total & viable count).
Study of different types of phase contrast microscopy, darkfield microscopy and
electron microscopy.
Unit II
Identification of bacteria using staining techniques (simple, Gram's &Acid fast staining) and
biochemical tests (IMViC).
Study of principle, procedure, merits, demerits, and applications of physical, chemical gaseous, radiation, and mechanical method of sterilization.
Evaluation of the efficiency of sterilization methods.
Equipment employed in large-scale sterilization.
Sterility indicators.
Unit III
Study of morphology, classification, reproduction/replication, and cultivation of Fungi and Viruses.
Classification and mode of action of disinfectants
Factors influencing disinfection, antiseptics, and their evaluation. For bacteriostatic and bactericidal actions
Evaluation of bactericidal & Bacteriostatic.
Sterility testing of products (solids, liquids, ophthalmic, and other sterile products) according to IP, BP, and USP.
Unit IV
Designing of aseptic area, laminar flow equipment; study of different sources of contamination in an aseptic area and methods of prevention, clean area classification.
Principles and methods of the different microbiological assay. Methods for standardization of antibiotics, vitamins, and amino acids.
Assessment of a new antibiotic.
Unit V
Types of spoilage, factors affecting the microbial spoilage of pharmaceutical products, sources, and types of microbial contaminants, assessment of microbial contamination, and spoilage.
Preservation of pharmaceutical products using antimicrobial agents, evaluation of
microbial stability of formulations.
Growth of animal cells in culture, the general procedure for cell culture, Primary, established ‹ind transformed cell cultures.
Application of cell cultures in pharmaceutical industry ‹ind research.
Recommended Books (Latest Edition)
1. W.B. Hugo and A.D. Russel: Pharmaceutical Microbiology, Blackwell Scientific publications,
Oxford London.
2. Prescott and Dunn., Industrial Microbiology, 4" edition, CBS Publishers & Distributors, Delhi.
3. Pelczar, Chan Kreig, Microbiology, Tata McGraw Hill ed.
4. Malcolm Harris, Balliere Tindall, and Cox: Pharmaceutical Microbiology.
S. Rose: Industrial Microbiology.
6. Probisher, Hinsdill et al: Fundamentals of Microbiology, 9th ed. Japan
7. Cooper and Gunn's: Tutorial Pharmacy, CBS Publisher and Distribution.
8. Peppler: Microbial Technology.
9. I.P., B.P., U.S.P. - latest editions.
10. Ananthnarayan: Text Book of Microbiology, Orient-Longman, Chennai
11. Edward: Fundamentals of Microbiology.
12. N.K.Jain: Pharmaceutical Microbiology, Vallabh Prakashan, Delhi
13. Bergeys manual of systematic bacteriology, Williams and Wilkins- A Waverly company
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