This document outlines a course module in Pharmaceutical Microbiology, including a description of the course, learning outcomes, topics to be covered over 45 lectures and practical labs, assessment methods consisting of assignments, presentations, exams, and required textbooks and study materials. Students will learn about microorganisms relevant to pharmaceutical manufacturing and quality control through lectures, assignments, presentations and hands-on practical labs assessing sterilization techniques, microbial growth inhibition, and assays.

1. FACULTY OF PHARMACY
Course Module
Subject: Pharmaceutical Microbiology Subject Code: PHM 2.3.4
Class: B.Pharmacy Semester – III Total Lectures: 45
Theory: 4 hr/week Practical: 4 hr/week
Lecturer: Mr. Naveen Bimal E-mail:
naveenbimal2005@gmail.com
COURSE DESCRIPTION:
Examine and understand the concepts of Quality Control and Quality Assurance as they apply to the
pharmaceutical industry. Acquire knowledge of microbial production and assay methods. Perform
laboratory procedures while practicing safe, aseptic laboratory technique. Enumerate and identify
micro-organisms from commercial products. Evaluate the antimicrobial effectiveness of
disinfectants, preservatives and antibiotics. Synthesize and analyze an antibiotic. Perform a
microbial assay of a vitamin.
COURSE LEARNING OUTCOMES: Upon successful completion, students will be able to:
1. Explain how microbiology is applied to manufacturing in the pharmaceutical industry.
2. Describe the distribution and relationship of micro-organism to each other and to other living
organisms.
3. Discuss the effects of micro-organisms on human beings and on other animals and plants.
4. Explain their abilities to make physical changes in the environment.
5. Illustrate their reactions to physical and chemical agents.
6. Appreciate /practice sterilization and disinfection techniques.
7. Perform microbial assay of antibiotics, amino acids and vitamins.
8. Evaluate lab activities and results using standard quality control and validation of methods.
9. Proficiently perform laboratory procedures skills currently used by quality control laboratories in
the
Pharmaceutical industry:
 aseptic technique and safe laboratory practices
 isolation and identification of micro-organisms
 assessment of raw materials and finished products by standard microbial testing procedures
 disinfectant and preservative evaluation
 microbial assays of vitamins and antibiotics
Teaching Methods:
Lecture-cum discussion, Assignments, Presentations, Tests and activities
Module Outline:
Lectures Topics
1. Introduction : Historical development
2. Scope of pharmaceutical microbiology
3. Structure of BacterialCell
4. Classification of microbes and taxonomy : Actinomycetes
5. Bacteria
6. Rickettsiae,
7. Spirochetes
8. Viruses
9. Identification of microbes : Stains and types of staining techniques

2. 10. Electron microscopy
11. Nutrition, cultivation and Isolation : bacteria
12. Actinomycetes, Fungi
13. Virus
14. Microbial genetics and variation : Structure of gene
15. Genetic code
16. Transcription
17. Translation
18. Mutation and regulation of gene expresion
19. Bacterial enzymes
20. Disinfectants : Dynamics of disinfection
21. Factors affecting the process of disinfection
22. Evaluation of liquid disinfectants; Methods of measuring microbial growth
inhibition
23. Chemical agents for disinfection
24. Description and uses of antisepsis and preservation
25. Sterlization methods: Introduction
26. Sensitivity of micro-organisms
27. Survival curves for bacterial spores exposed to moist heat, radiations
28. Expression of resistance in terms of D-value and Z-value
29. Sterility assurance
30. Sterilization methods of items used in hospitals, thermolabile drugs and injectables
31. Monitoring of sterilization processes
32. Laminar aseptic hoods and Aseptic processing
33. Sterility testing: Sterility testing of parentrals containing antimicrobials
34. Sterility testing of ophthalmics containing antimicrobials
35. Sterility testing of non-injectables containing antimicrobials
36. Immunology: Infection, Factors influencing infection
37. Immunity (natural and acquired)
38. Antigen containing preparations – Diphtheria, tetanus
39. staphylococcus, plague and BCG vaccine
40. Antibody containing preparation
41. Diagnostic preparations.
42. Microbial assays: of antibiotics
43. -do-
44. Vitamins
45. Amino-acids
Modes of Assessment:
Modes of Assessment Score
Assignment 10
Presentation 10
Mid semester exam 40
st
1 Hourly test 20
2nd Hourly test
Total marks 100

3. Text Book(s) and Study Materials:
1) Hugo and Russel. “Pharmaceutical Microbiology”, 6th edition, 1998, Balckwell Scientific
Publication, Oxford.
2) Prescott LM, Harley GP, Klein DA.” Microbiology”. 5th Edition, V.C.Brown Publishers,
Oxford.
3) Pelczar MJ, Chan ECS, Krieg NR. ” Microbiology”, 5th edition, 1993, Tata McGraw Hill
Publishing company Ltd., New Delhi.
4) Ananthanarayan R, Panikar CKJ. “Textbook of Microbiology”, 5tg edition, 1999, Orient
Longmann Ltd, Chennnai.
5) Gupte S.” The short textbook of Medical Microbiology”, 9th edition, 2006, Jaypee Brothers
Medical Publishers Ltd, New Delhi.
6) Gaud and Gupta, Practical Microbiology, 3rd edition reprint 2008, Nirali Prakashan, Pune.
Topics for Presentation & Assignments
Historical development of microbiology Monitoring of sterilization processes
Scope of pharmaceutical microbiology Laminar aseptic hoods
Structure of BacterialCell Aseptic processing
Classification of microbes and taxonomy Sterility testing of ophthalmics containing
Actinomycetes
antimicrobials
Bacteria Sterility testing of non-injectables
containing antimicrobials
Rickettsiae Sterility testing of parentrals containing
antimicrobials
Spirochetes Antigen containing preparations –
Diphtheria
Viruses Antigen containing preparations – tetanus
Identification of microbes :different Antigen containing preparations –
Stains staphylococcus
Staining techniques Antigen containing preparations – BCG
Electron microscopy Antigen containing preparations – Plague
Nutrition, cultivation and Isolation : Diagnostic preparations
bacteria
Actinomycetes Microbial assays: of antibiotics
Fungi Microbial assays: of antibiotics
Virus Microbial assays: of amino-acids
Structure of gene Microbial assays: of amino-acids
Genetic code Microbial assays: of vitamins
Transcription Survival curves for bacterial spores exposed
to moist heat, radiations
Translation Expression of resistance in terms of D-value
Mutation Z-value
Regulation of gene expression Sterility assurance
Bacterial enzymes Sterilization methods of items used in
hospitals
Dynamics of disinfection Sterilization methods of items used in
hospitals
Factors affecting the process of Sterilization methods of thermolabile drugs
disinfection
Evaluation of liquid disinfectants Sterilization methods of injectables
Chemical agents for disinfection Introduction to Immumology
Description of antisepsis and Infection

4. preservation
Uses of antisepsis and preservation Factors influencing infection
Methods of measuring microbial growth Immunity : natural
inhibition
Sensitivity of micro-organisms Immunity : Acquired
Practical Labs.:
S. No. Name of the Experiment
1. To study the various sterilization techniques.
2. To sterilize glassware by dry heat sterilization.
3. To sterilize given media by autoclaving.
4. To discuss various instruments used in Microbiology.
5. To prepare nutrient agar & nutrient broth for growth of bacterial culture.
6. To perform streak plate technique in Micro Lab.
7. To perform Gram Staining of bacterial cells.
8. To prepare PDA for growth for growth of Fungal culture.
9. To carry out the simple staining method for Fungal culture media.
10. To perform antibiotic sensitivity test by disc diffusion method.
11. To check microbial growth in nutrient media with sample.
Instruction for students:
1. Assignment must neatly presented
2. Late submission is not permissible and will attract minimum awards.
3. Presentation is compulsory
4. Each group is assigned different subject for the presentation day.
5. The presentation day attendance is equivalent to 4 lectures.
6. The synopsis must be submitted one week before the presentation.
7. 75% attendance is mandatory, below this percentage; student will not be allowed to appear in
the examination.
8. The student will record the details of practicals in the practical note book and get it checked
every time from the instructor after the experiment has been completed.s