PHARMACEUTICAL MICROBIOLOGY

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 physicalparameters for growth, growth curve

Isolation and preservation methodsfor pure cultures

Cultivation of anaerobes

Quantitative measurement of bacterial growth (total & viable count).

Study of different types of phase constrast microscopy, dark fieldmicroscopy 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. 

Sterlization (Alternative Note)

Evaluation of the efficiency of sterilization methods.

Equipments employed in large scale sterilization. 

Sterility indicators. 

Unit III 

Study of morphology, classification, reproduction/replication and cultivation of 

• Fungi 
• Viruses 

Classification and mode of action of disinfectants

Factors influencing disinfection, antiseptics and their evaluation. Forbacteriostatic and bactericidal actions 

Evaluation of bactericidal & Bacteriostatic. 

Sterility testing of products (solids, liquids, ophthalmic and other sterileproducts) according to IP, BP and USP. 

Unit IV

Designing of aseptic area, laminar flow equipments; study of differentsources of contamination in an aseptic area and methods of prevention,clean area classification.

Principles and methods of 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 ofpharmaceutical 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, general procedure for cell culture, Primary, established and transformed cell cultures.

Application of cell cultures in pharmaceutical industry and research.

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 (Latest edition) 

1. W.B. Hugo and A.D. Russel: Pharmaceutical Microbiology, Blackwell Scientific publications, Oxford London. 

2. Prescott and Dunn., Industrial Microbiology, 4 th 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