PHARMACEUTICAL MICROBIOLOGY BP303T

UNIT -01

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 contrast microscopy, dark field microscopy and electron microscopy.

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.

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.

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.

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.