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  1. 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. 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. 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. 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