BP501TP

LJ UNIVERSITY
LJ INSTITUTE OF PHARMACY
SEMESTER: V
Subject Name: Pharmaceutical Microbiology
Subject Code: BP501TP
Scope: To study all categories of microorganisms especially for the production of alcohol antibiotics, vaccines,
vitamins enzymes
Objectives: Upon completion of the course the student shall be able to
1. Introduction to microbiology and Introduction to Prokaryotes and Eukaryotes.

2. To study different types of microscopy and staining techniques for identification of bacteria.
3. Study of sterilization and Disinfecatnts including its calssification and evaluation of efficiency. Sterility testing of
products as per IP, BP & USP.
4. Basic understanding to aseptic area and its components. Principles and methods of different microbiological assay.
5. Isolation and preservation methods for pure cultures and Microbial spoilage.
Teaching scheme and examination scheme:
Teaching Scheme Evaluation Scheme

Theory Practical
Theory Tutorial Practical Total
External Internal External Internal
3 1 4 8 75 25 75 25
Sr. No. Course Contents Hours

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,
1 Study of morphology, classification, reproduction/replication and cultivation of 10
Fungi and Viruses.
Isolation and preservation methods: Isolation and preservation methods for pure cultures,
cultivation of anaerobes, quantitative measurement of bacterial growth (total & viable
count).
Study of different types of Microscopy: phase constrast microscopy, dark field
microscopy and electron microscopy
2 8
Identification of bacteria using staining techniques (simple, Gram’s &Acid fast
Staining) and biochemical tests (IMViC).
Sterilization: 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.
3 Disinfectants: Classification and mode of action of disinfectants Factors influencing 12
disinfection, antiseptics and their evaluation. For bacteriostatic and
Bactericidal actions. Evaluation of bactericidal & Bacteriostatic.
Sterility Testing: Sterility testing of products (solids, liquids, ophthalmic and
other sterile products) according to IP, BP and USP.
Aseptic Area: Designing of aseptic area, laminar flow equipment; study of different sources
4 of contamination in an aseptic area and methods of prevention, clean area 08
classification.
Microbiological Assay: Principles and methods of different microbiological assay. Methods
f o r standardization of antibiotics, vitamins and amino acids. Assessment of a new
Antibiotic.
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.
5 07
Growth of animal cells in culture, general procedure for cell culture, Primary,
established and transformed cell cultures. Application of cell cultures in
pharmaceutical industry and research.
Total Hours 45
Practical
1. Introduction and study of different equipments and processing, e.g., B.O.D. incubator, laminar flow, aseptic hood,
autoclave, hot air sterilizer, deep freezer, refrigerator, microscopes used in experimental microbiology.
2. Sterilization of glassware, preparation and sterilization of media.
3. Sub culturing of bacteria and fungus. Nutrient stabs and slants preparations.
4. Staining methods- Simple, Grams staining and acid fast staining (Demonstration with practical).
5. Isolation of pure culture of micro-organisms by multiple streak plate technique and other techniques.
6. Microbiological assay of antibiotics by cup plate method and other methods
7. Motility determination by Hanging drop method.
8. Sterility testing of pharmaceuticals.
9. Bacteriological analysis of water
10. Biochemical test.
Recommended Books:
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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LJ UNIVERSITY

1. Introduction to microbiology and Introduction to Prokaryotes and Eukaryotes.

Teaching scheme and examination scheme:

Teaching Scheme Evaluation Scheme

Sr. No. Course Contents Hours

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