Pharmaceutical Microbiology (Theory)

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Deepankar ratha

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Course Name : Pharmaceutical microbiology

Code(Credit) : BPHT2103(4-0-0)

Course Objectives

  1. To understand  methods of identification, cultivation and preparation of various microorganisms.
  2. To understand the importance and implementation of sterilization in pharmaceutical processing and industry.
  3. To learn different sterility testing of pharmaceutical products.
  4. To carried out microbiological standardization of pharmaceuticals.
  5. To understand the cell culture technology and its application in pharmaceutical industry.

Learning Outcomes

  1. Explain the history of microbiology.
  2. Explain the classification and characteristics of microorganisms.
  3. Compare the anatomy and physiology of prokaryotic and eukaryotic cells.
  4. Define the nutrition and nutrition types of microorganisms.
  5. Explain the growth and control of microbial populations.
  6. Explain microbial metabolism.
  7. Explain microbial genetic.
  8. Discuss the microbial world except bacteria.
  9. Identify the microbial diseases.
  10. Explain the principles of sterilization and desenfection.
  11. Discuss the bacterial relationships in the different environments

Course Syllabus

MODULE-01

1.Introduction, history of microbiology, its branches, scope and its
importance. Introduction to Prokaryotes and Eukaryotes.
2.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).
3.Study of different types of phase constrast microscopy, dark field
microscopy and electron microscopy.

MODULE-02

1.Identification of bacteria using staining techniques (simple, Gram’s &Acid
fast staining) and biochemical tests (IMViC).
2.Study of principle, procedure, merits, demerits and applications of physical,
chemical gaseous,radiation and mechanical method of sterilization.
3.Evaluation of the efficiency of sterilization methods.
4.Equipments employed in large scale sterilization.
5.Sterility indicators.

MODULE-03

1.Study of morphology, classification, reproduction/replication and
cultivation of Fungi and Viruses.
2.Classification and mode of action of disinfectants
Factors influencing disinfection, antiseptics and their evaluation. For
bacteriostatic and bactericidal actions.
3.Evaluation of bactericidal & bacteriostatic.
4.Sterility testing of products (solids, liquids, ophthalmic and other sterile
products) according to IP, BP and USP.

MODULE-04

1.Designing of aseptic area, laminar flow equipments; study of different
sources of contamination in an aseptic area and methods of prevention,
clean area classification.
2.Principles and methods of different microbiological assay.

3.Methods for standardization of antibiotics, vitamins and amino acids.
4.Assessment of a new antibiotic.

MODULE-05

1.Types of spoilage, factors affecting the microbial spoilage of
pharmaceutical products, sources and types of microbial contaminants,
assessment of microbial contamination and spoilage.

2.Preservation of pharmaceutical products using antimicrobial agents,
evaluation of microbial stability of formulations.
3.Growth of animal cells in culture, general procedure for cell culture, Primary, established and transformed cell cultures.
4.Application of cell cultures in pharmaceutical industry and research

 

 

Recommended Books (Latest edition)
1. W.B. Hugo and A.D. Russel: Pharmaceutical Microbiology, Blackwell Scientific
publications, Oxford London.
2. Prescott and Dunn., Industrial Microbiology, 4th edition, CBS Publishers & Distributors,
Delhi.
3. Pelczar, Chan Kreig, Microbiology, Tata McGraw Hill edn.
4. Malcolm Harris, Balliere Tindall and Cox: Pharmaceutical Microbiology.
5. Rose: Industrial Microbiology.
6. Probisher, Hinsdill et al: Fundamentals of Microbiology, 9th ed. Japan
7. Cooper and Gunn’s: Tutorial Pharmacy, CBS Publisher and Distribution.
8. Peppler: Microbial Technology.
9. I.P., B.P., U.S.P.- latest editions.
10. Ananthnarayan : Text Book of Microbiology, Orient-Longman, Chennai
11. Edward: Fundamentals of Microbiology.
12. N.K.Jain: Pharmaceutical Microbiology, Vallabh Prakashan, Delhi
13. Bergeys manual of systematic bacteriology, Williams and Wilkins- A Waverly company

Session Plan

Session 1

Introduction and history of microbiology.

https://www.youtube.com/watch?v=YNRPO0WE3fM&t=448s

Session 2

Branches of microbiology,its scope and importance.

https://www.youtube.com/watch?v=MtWrJrceVIM

Session 3

Introduction to prokaryotes and eukaryotes,nutritional requirement of bacteria.

https://www.youtube.com/watch?v=RQ-SMCmWB1s

https://www.youtube.com/watch?v=qxVVFFVHEoM

Session 4

Study of structure and morphological classification of bacteria

https://www.youtube.com/watch?v=sI5DeXnW9Js

Session 5

Raw materials used for culture media and physical parameters for growth.

https://www.youtube.com/watch?v=DlCWzhPV2dU

Session 6

Session 7

Isolation and preservation methods for pure cultures.

isolation-preservation-

Session 8

Session 9

Quantitative measurement of bacterial growth (total & viable count)

https://www.youtube.com/watch?v=_hlZFv0nag4

Session 10

Session 11

Session 12

Identification of bacteria using staining techniques(gram staining,simple staining)

stainingbacteria

Session 13

Acid fast staining and biochemical tests (IMViC)

stainingbacteria

Session 14

Principle procedure, merit, demerit, and application of physical,chemical and gaseous methods of sterilization.

https://www.youtube.com/watch?v=cSMBtSQWetI

Session 15

Principle procedure, merit, demerit, and application of radiation and mechanical methods of sterilization.

https://www.youtube.com/watch?v=bHwOW2YfYJo

https://www.youtube.com/watch?v=M53ggboAl2I

Session 16

Evaluation of the efficiency of sterilization methods.

sterilization

Session 17

Equipment's employed in large scale sterilization.

large-scale-sterilization

Session 18

Session 19

Study of morphology & classification of fungi and viruses.

morphology-fungi-

morphologyof virus

Session 20

Reproduction & cultivation of fungi and viruses

fungi-reproduction

Session 21

Classification and mode of action of disinfectants

https://www.youtube.com/watch?v=_8MouGg-sr0

Session 22

Factors affecting disinfection,antiseptic and their evaluation for bacteriostatic and bactericidal actions.

disinfectants-converted

Session 23

Evaluation of bactericidal and bacteriostatic.

https://www.youtube.com/watch?v=T-EtvHUNTNg

Session 24

Session 25

Study of different sources of contamination in an aseptic area and methods of prevention.

https://www.youtube.com/watch?v=TjLVgCWDhGU

Session 26

Clean area classification.

clean area

Session 27

Principles and methods of different microbiological assay.

https://www.youtube.com/watch?v=liUjyrk_9BE&t=764s

Session 28

Session 29

Methods for standardization of vitamins and amino acids.

https://www.youtube.com/watch?v=TFDkCgeJsuk

Session 30

Assessment of a new antibiotic.

https://www.youtube.com/watch?v=3szZFDDAHtk&t=233s

Session 31

Factors affecting the microbial spoilage of pharmaceutical products.

https://www.youtube.com/watch?v=DtHj396-3rI&t=39s

Session 32

Session 33

Session 34

Factors affecting the microbial spoilage of pharmaceutical products.

https://www.youtube.com/watch?v=DtHj396-3rI

Session 35

Source and type of microbial contaminants

pharmaceuticalspoilage

Session 36

Assessment of microbial contamination and spoilage.

pharmaceuticalspoilage

Session 37

Preservation of pharmaceutical products using antimicrobial agents

https://www.youtube.com/watch?v=I_1jNtkVWH4

Session 38

Evaluation of microbial stability of formulations

https://www.youtube.com/watch?v=KXTLPmUzXrw&t=428s

Session 39

Growth of animal cells in culture

https://www.youtube.com/watch?v=6Wdyyu-vQsU

Session 40

General procedure for cell culture

cellculture

Session 41

Primary ,established and transformed cell culture.

cellculture

Session 42

Application of cell cultures in pharmaceutical industry and research.

https://www.youtube.com/watch?v=mpAP0Mi0IV4

Books/ References.

1. W.B. Hugo and A.D. Russel: Pharmaceutical Microbiology, Blackwell Scientific
publications, Oxford London.
2. Prescott and Dunn., Industrial Microbiology, 4th edition, CBS Publishers & Distributors,
Delhi.
3. Pelczar, Chan Kreig, Microbiology, Tata McGraw Hill edn.
4. Malcolm Harris, Balliere Tindall and Cox: Pharmaceutical Microbiology.
5. Rose: Industrial Microbiology.
6. Probisher, Hinsdill et al: Fundamentals of Microbiology, 9th ed. Japan
7. Cooper and Gunn’s: Tutorial Pharmacy, CBS Publisher and Distribution.
8. Peppler: Microbial Technology.
9. I.P., B.P., U.S.P.- latest editions.
10. Ananthnarayan : Text Book of Microbiology, Orient-Longman, Chennai
11. Edward: Fundamentals of Microbiology.
12. N.K.Jain: Pharmaceutical Microbiology, Vallabh Prakashan, Delhi
13. Bergeys manual of systematic bacteriology, Williams and Wilkins- A Waverly company

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