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 constrast microscopy, dark field
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.
Equipments 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 equipments; study of different
sources 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 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, general procedure for cell culture, Primary, established and transformed cell cultures.
Application of cell cultures in pharmaceutical industry and research.
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