Pharmaceutical Microbiology (Theory)
Teacher
Rasmita Jena
Category
Core Courses
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Course Name : PHARMACEUTICAL MICROBIOLOGY
Code(Credit) : BPHT2103(4-0-0)
Course Objectives
Study of all categories of microorganisms especially for the production of alcohol antibiotics, vaccines, and vitamins enzymes etc.
CO PO mapping
| CO | Statements | PO MAPPING |
| CO-1 | Understand methods of identification, cultivation and preservation of various microorganisms | PO1, PO6 |
| CO-2 | To understand the importance and implementation of sterilization in
pharmaceutical processing and industry |
PO1, PO6, PO10, PO11 |
| CO-3 | Learn sterility testing of pharmaceutical products. | PO1, PO10, PO11 |
| CO-4 | Carried out microbiological standardization of Pharmaceuticals. | PO1, PO5, PO10 |
| CO-5 | To acquire and demonstrate competency in laboratory safety and in routine and specialized microbiological laboratory skills applicable to microbiological research or clinical methods, including accurately reporting observations and analysis. | PO1, PO5, PO11 |
Course Syllabus
MODULE-01
1.Introduction, history of microbiology, its branches, scope and its
importance. Introduction to Prokaryotes and Eukaryotes.
2.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).
3.Study of different types of phase constrast microscopy, dark field
microscopy and electron microscopy.
MODULE-02
1.Identification of bacteria using staining techniques (simple, Gram’s &Acid
fast staining) and biochemical tests (IMViC).
2.Study of principle, procedure, merits, demerits and applications of physical,
chemical gaseous,radiation and mechanical method of sterilization.
3.Evaluation of the efficiency of sterilization methods.
4.Equipments employed in large scale sterilization.
5.Sterility indicators.
MODULE-03
1.Study of morphology, classification, reproduction/replication and
cultivation of Fungi and Viruses.
2.Classification and mode of action of disinfectants
Factors influencing disinfection, antiseptics and their evaluation. For
bacteriostatic and bactericidal actions.
3.Evaluation of bactericidal & bacteriostatic.
4.Sterility testing of products (solids, liquids, ophthalmic and other sterile
products) according to IP, BP and USP.
MODULE-04
1.Designing of aseptic area, laminar flow equipments; study of different
sources of contamination in an aseptic area and methods of prevention,
clean area classification.
2.Principles and methods of different microbiological assay.
3.Methods for standardization of antibiotics, vitamins and amino acids.
4.Assessment of a new antibiotic.
MODULE-05
1.Types of spoilage, factors affecting the microbial spoilage of
pharmaceutical products, sources and types of microbial contaminants,
assessment of microbial contamination and spoilage.
2.Preservation of pharmaceutical products using antimicrobial agents,
evaluation of microbial stability of formulations.
3.Growth of animal cells in culture, general procedure for cell culture, Primary, established and transformed cell cultures.
4.Application of cell cultures in pharmaceutical industry and 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, 4th edition, CBS Publishers & Distributors,
Delhi.
3. Pelczar, Chan Kreig, Microbiology, Tata McGraw Hill edn.
4. Malcolm Harris, Balliere Tindall and Cox: Pharmaceutical Microbiology.
5. 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
Session 4
Nutritional requirements, Raw materials used for culture media and physical parameters for growth.
Session 5
Session 6
Staining technique
Session 9
Equipment used in Large scale sterilization
Session 15
Sterility testing of Pharmaceuticals as per USP, BP
Session 23
Sources and types of microbial contaminants
Session 24
Assessment of microbial contamination
Books/ References.
1. W.B. Hugo and A.D. Russel: Pharmaceutical Microbiology, Blackwell Scientific
publications, Oxford London.
2. Prescott and Dunn., Industrial Microbiology, 4th edition, CBS Publishers & Distributors,
Delhi.
3. Pelczar, Chan Kreig, Microbiology, Tata McGraw Hill edn.
4. Malcolm Harris, Balliere Tindall and Cox: Pharmaceutical Microbiology.
5. 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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