PHARMACEUTICAL MICROBIOLOGY (Theory) syllabus according to PCI

 BP 303 T. PHARMACEUTICAL MICROBIOLOGY (Theory)

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

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. 

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.

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. 

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. 

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.

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