PHARMACEUTICAL MICROBIOLOGY- THEORY- BP303T
Credit: 4-0-0
COURSE OBJECTIVES
Sl. No. | Objectives |
01 | Understand the fundamentals of microbiology and its relevance to the pharmaceutical field. |
02 | Demonstrate knowledge of microbial classification, structure, and growth. |
03 | Comply with regulatory standards and ethical guidelines in pharmaceutical microbiology. |
COURSE OUTCOMES
On successful completion of the course, the student will be able to
COs | Description | CO-PO Mapping |
CO-1 | Define microbiology concepts and their pharmaceutical relevance | PO1, PO12 |
CO-2 | Describe bacterial, fungal, and viral morphology and cultivation. | PO1, PO12 |
CO-3 | Identify bacterial identification and sterilization techniques | PO1,PO2,PO3, PO12 |
CO-4 | Distinguish sterilization and disinfection methods. | PO1,PO2,PO3,PO12 |
CO-5 | Explain contamination, spoilage, and preservation of pharmaceuticals. | PO1, PO12 |
SYLLABUS:
Unit I: 10 Hours
a) Introduction, history of microbiology, its branches, scope, and its importance.
b) Introduction to Prokaryotes and Eukaryotes.
c) 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).
d) Study of different types of phase contrast microscopy, dark field microscopy and electron microscopy.
Unit II: 10 Hours
a) Identification of bacteria using staining techniques (simple, Gram’s & and acid-fast staining) and biochemical tests (IMViC).
b) Study of principles, procedures, merits, demerits, and applications of physical, chemical, gaseous, radiation, and mechanical methods of sterilization.
c) Evaluation of the efficiency of sterilization methods.
d) Equipment employed in large-scale sterilization
e) Sterility indicators.
Unit III: 10 Hours
a) Study of morphology, classification, reproduction/replication, and cultivation of Fungi and Viruses.
b) Classification and mode of action of disinfectants.
c) Factors influencing disinfection, antiseptics, and their evaluation. For bacteriostatic and bactericidal actions.
d) Evaluation of Bactericidal and Bacteriostatic Properties.
e) Sterility testing of products (solids, liquids, ophthalmic and other sterile products) according to IP, B,P and USP.
Unit IV 8 Hours
a) Designing an aseptic area, including laminar flow equipment; studying different sources of contamination in an aseptic area and methods of prevention, as well as clean area classification.
b) Principles and methods of different microbiological assays. Methods for standardization of antibiotics, vitamins, and amino acids.
c) Assessment of a new antibiotic.
Unit V 7 Hours
a) Types of spoilage, factors affecting the microbial spoilage of pharmaceutical products, sources and types of microbial contaminants, assessment of microbial contamination and spoilage.
b) Preservation of pharmaceutical products using antimicrobial agents, evaluation of microbial stability of formulations.
c) 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.
Session 2
Introduction, history of microbiology, its branches, scope and its importance
Session: 3
Introduction to Prokaryotes and Eukaryotes.
Session: 4
Study of ultra-structure and morphological classification of bacteria.
Session: 5
Nutritional requirements, raw materials used for culture media.
Session: 6
Physical parameters for growth, growth curve.
Session: 7
Isolation and preservation methods for pure cultures.
Session: 8
Cultivation of anaerobes, quantitative measurement of bacterial growth (total & viable count).
Session: 9
Study of different types of phase contrast microscopy.
Session: 10
Study of different types of dark field microscopy and electron microscopy.
9. Study of different types of dark field microscopy and electron microscopy
Session: 12
Simple, Gram’s staining, Acid fast staining.
Session: 14
Study of principle, procedure, merits, demerits and applications of sterilization.
Session: 16
Equipment employed in large scale sterilization.
Session: 18
Study of morphology, classification, reproduction and cultivation of Fungi.
Session: 19
Study of morphology, classification, replication, and cultivation of Viruses.
Session 20
Classification and mode of action of disinfectants.
Factors influencing disinfection, antiseptics.
Evaluation of disinfection, antiseptics.
Session: 23
Sterility testing of ophthalmic products (solids) according to IP, BP and USP.
Session: 24
Sterility testing of ophthalmic products (liquids) according to IP, BP and USP.
Session: 25
Sterility testing of ophthalmic products (other sterile) according to IP, BP and USP.
Session: 27
Study of different sources of contamination in an aseptic area.
Session: 34
Methods for standardization of amino acids.
Session: 38
Sources and types of microbial contaminants.
Session: 39
Assessment of microbial contamination and spoilage.
Session: 40
Preservation of pharmaceutical products using antimicrobial agents.
Session: 41
Evaluation of microbial stability of formulations.
Session: 45
Application of cell cultures in pharmaceutical industry and research.
Session: 46
Gram staining Procedure.
Session: 49
Design and Construction of a Mini Laminar Airflow Cabinet
to Support Laboratory Activities in Aseptic Condition.