Pharmaceutical Microbiology – B. Pharma 3rd Semester Complete PDF notes
Scope: Study of all categories of microorganisims especially for the production of alchol antibiotics, vaccines, vitamins enzymes etc..
Objectives: Upon completion of the subject student shall be able to;
1. Understand methods of identification, cultivation and preservation of various microorganisms
2. To understand the importance and implementation of sterlization in pharmaceutical processing and industry
3. Learn sterility testing of pharmaceutical products.
4. Carried out microbiological standardization of Pharmaceuticals.
5. Understand the cell culture technology and its applications in pharmaceutical industries.
Pharmaceutical Microbiology Course content:
Pharmaceutical Microbiology Unit I
Introduction, history of microbiology, its branches, scope and its importance.
Introduction to Prokaryotes and Eukaryotes
Classification of Microorganism,
Maintenance of Pure Culture,
Environmental Factor affecting microbial growth.
Biochemical reaction in identification of microorganism.
Quantitative measurement of bacterial growth (total & viable count).
Study of different types of phase constrast microscopy, dark field microscopy and electron microscopy.
Pharmaceutical Microbiology 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 Dry Heat Sterilization, Moist Heat Sterilization, Chemical Gaseous Sterilization, Radiation Sterilization and Filtration sterilization. Pasteurization and tyndallization.
Evaluation of the efficiency of sterilization methods.
Validation of sterilization.
Equipments employed in large scale sterilization.
Pharmaceutical Microbiology Unit III
Study of morphology, classification, reproduction/replication and cultivation of Fungi.
Study of morphology, classification and cultivation of Viruses.
Replication of Virus.
Study of morphology, classification, reproduction/replication and cultivation of Bacteria.
Classification and mode of action of disinfectants
Disinfectants Evaluation, Factors influencing disinfection, antiseptics and their evaluation. Phenol coefficient tests
Evaluation of bactericidal & Bacteriostatic.
Sterility testing of products (solids, liquids, ophthalmic and other sterile products) according to IP, BP and USP.
Rickettsiae and Spirochetes.
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 – General Method. Tube Assay or Turbidimetry, Methods for standardization of antibiotics, vitamins and amino acids.
Assessment of a new antibiotic.
Pharmaceutical Microbiology 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.
PHARMACEUTICAL MICROBIOLOGY (Practical)