BP303T. Pharmaceutical Microbiology (Theory)

Unit-I

• Introduction, history of microbiology, its branches, scope, and 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 and quantitative measurement of bacterial growth (total & viable count).
• Study of different types of phase contrast 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 methods of sterilization.
• Evaluation of the efficiency of sterilization methods.
• Equipment 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.
• Evaluation of bactericidal & bacteriostatic actions.
• Sterility testing of products (solids, liquids, ophthalmic, and other sterile products) as per IP, BP, and USP.

Unit-IV

• Designing of aseptic area, laminar flow equipment.
• Study of different sources of contamination in an aseptic area and methods of prevention.
• Clean area classification.
• Principles and methods of different microbiological assays.
• Methods for the 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 the pharmaceutical industry and research.