Pharmaceutical Microbiology - B. Pharma Third Semester Complete PDF notes

BP 303 T. PHARMACEUTICAL MICROBIOLOGY (Theory)

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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.

Course content:

Unit I

Introduction, history of microbiology, its branches, scope and its importance.

Introduction to Prokaryotes and Eukaryotes

Classification of Microorganism,

Maintenance of Pure Culture,

Nutritional Requirement,  

Environmental Factor affecting microbial growth.

Biochemical reaction in identification of microorganism.

Growth curve,

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 Dry Heat Sterilization, Moist Heat Sterilization, Chemical Gaseous Sterilization, Radiation Sterilization and Filtration sterilization. Pasteurization and tyndallization.

Sterilization Classification.

Evaluation of the efficiency of sterilization methods.

Validation of sterilization.

Equipments employed in large scale sterilization.

Sterility indicators.

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.

Disinfectants

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.

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 – General Method. Tube Assay or Turbidimetry,  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.

BP 303 P. PHARMACEUTICAL MICROBIOLOGY (Practical)

PHARMACEUTICAL MICROBIOLOGY (Practical) Lab Manual