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: 1

Introduction to microbiology and its scope.

1. Introduction to microbiology

Session 2

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

1. Introduction to microbiology

Session: 3

Introduction to Prokaryotes and Eukaryotes.

2. Introduction to prokaryotes and eukaryotes

Session: 4

Study of ultra-structure and morphological classification of bacteria.

3. Morphology of bacteria

Session: 5

Nutritional requirements, raw materials used for culture media.

4. Nutritional requirements

Session: 6

Physical parameters for growth, growth curve.

5. Physical parameters for growth, growth curve

Session: 7

Isolation and preservation methods for  pure cultures.

6. Isolation and preservation methods for pure cultures

Session: 8

Cultivation of anaerobes, quantitative measurement of bacterial growth (total & viable count).

7. Cultivation of anaerobes

Session: 9

Study of different types of phase contrast microscopy.

8. 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: 11

Identification of bacteria using staining techniques.

1. Staining techniques

Session: 12

Simple, Gram’s staining, Acid fast staining.

2. Simple, Gram’s staining, Acid fast staining

Session: 13

Biochemical tests (IMViC)

3. Biochemical tests (IMViC)

Session: 14

Study of principle, procedure, merits, demerits and applications of sterilization.

2. Sterilization

Session: 15

Physical, Chemical, Gaseous and  Mechanical method of sterilization.

2. Sterilization

Session: 16

Equipment employed in large scale sterilization.

4. Equipments Employed in Large Scale Sterilization

Session: 17

Sterility indicators

5. Sterility indicator

Session: 18

Study of morphology, classification, reproduction and cultivation of Fungi.

1. virus & fungi

Session: 19

Study of morphology, classification, replication, and cultivation of  Viruses.

1. virus & fungi

Session 20

Classification and mode of action of disinfectants.

Factors influencing disinfection, antiseptics.

Evaluation of disinfection, antiseptics.

2. Disinfectants

Session: 21

Evaluation of bactericidal & Bacteriostatic

3. Evaluation of bacteriostatic and cidal

Session: 22

Sterility testing

4. Sterility testing

Session: 23

Sterility testing of ophthalmic  products (solids) according to IP, BP and USP.

4. Sterility testing of Pharmaceuticcals

Session: 24

Sterility testing of ophthalmic  products (liquids)  according to IP, BP and USP.

4. Sterility testing of Pharmaceuticcals

Session: 25

Sterility testing of ophthalmic  products (other sterile) according to IP, BP and USP.

5. Sterility Testing of Products (Solids, Liquids, Ophthalmic and Other Sterile Products) According to IP, BP and USP

Session: 26

Designing of aseptic area, laminar flow equipment.

1. Design of aseptic area

Session: 27

Study of different sources of contamination in an aseptic area.

1. Design of aseptic area

Session: 28

Methods of prevention of  contamination.

2. Source of contamination

Session: 29

Clean area classification.

3. Clean area classification

Session: 30

Principles and methods of different microbiological assay.

4. Microbial assay

Session: 31

Methods for standardization of antibiotics.

5. Standardization of antibiotics

Session: 32

Assessment of a new antibiotic.

6. Assessment of new antibiotics

Session: 33

Methods for standardization of vitamins.

5. Standardization of vitamins and amino acids

Session: 34

Methods for standardization of amino acids.

5. Standardization of vitamins and amino acids

Session: 35

Assessment of a new antibiotic.

6. Assessment of new antibiotics

Session: 36

Types of spoilage.

1. Spoilage

Session: 37

Factors affecting the microbial spoilage of pharmaceutical products.

1. Spoilage

Session: 38

Sources and types of microbial contaminants.

2. Source and types of microbial contaminants

Session: 39

Assessment of microbial contamination and spoilage.

3. Assessment of microbial contamination and spoilage

Session: 40

Preservation of pharmaceutical products using antimicrobial agents.

4. Preservation of pharmaceuticals

Session: 41

Evaluation of microbial stability of formulations.

5. Microbial stabillity evaluation of formulations

Session: 42

Growth of animal cells in culture.

6. Animal cell culture

Session: 43

General procedure for cell culture.

7. Cell culture procedure

Session: 44

Primary, established and transformed cell cultures.

7. Cell culture procedure

Session: 45

Application of cell cultures in pharmaceutical industry and research.

7. Cell culture procedure

Session: 46

Gram staining Procedure.

Session: 47

Antimicrobial assay.

Microbial assay

Session: 48

Animal Cell culture techniques in deatils.

Animal cell culture techniques_11zon

Session: 49

Design and Construction of a Mini Laminar Airflow Cabinet
to Support Laboratory Activities in Aseptic Condition.

Design and Construction of a Mini Laminar Airflow Cabinet

Session: 50

Isolation techniques in microbiology.

Isolation techniques