Scope: Study of all categories of microorganisms especially for the production of alchol antibiotics, vaccines, vitamins enzymes etc.. Objectives: Upon completion of the subject student shall be able to;
- Understand methods of identification, cultivation and preservation of
various microorganisms - To understand the importance and implementation of sterlization in
pharmaceutical processing and industry - Learn sterility testing of pharmaceutical products.
- Carried out microbiological standardization of Pharmaceuticals.
- Understand the cell culture technology and its applications in pharmaceutical
industries.
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.
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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.
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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.
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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.
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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.