PFT402 - Microbiology II

Outline info
Semester
School
Last revision date 2017-05-29 00:41:09.736
Last review date 2017-07-17 00:16:29.237


Subject Title
Microbiology II

Subject Description
This laboratory and lecture subject highlights microbiological tests related to pharmaceutical plant sanitation, product contamination, antibiotics, disinfectants and microbial growth and inactivation calculations. (Lecture and Lab)

Credit Status
One credit toward the Industrial Pharmaceutical Technology Certificate Program

Learning Outcomes
Upon successful completion of this subject the student will be able to:

1. Discuss the importance of microbes in pharmaceutical manufacturing, quality control and complying with regulatory requirements.

2. Conduct an environmental analysis of microbial contamination.

3. Conduct an analysis of unpurified and purified waters available to manufacturers of pharmaceuticals.

4. Perform raw material/finished product testing for microbial contamination.

5. Conduct Preservative Challenge Testing following U.S.P. recommendations and demonstrate a basic understanding of several types of preservatives used in cosmetics and pharmaceuticals.

6. Demonstrate an understanding of the chemical disinfectants available in biotechnology such as: phenolic compounds, quaternary ammonium compounds, chlorine, iodophores, alcohols, ethylene oxide and formaldehyde.

7. Demonstrate a basic understanding of the mode of action of antibiotics, antibiotic resistance and susceptibility, and how antibiotic sensitivity and potency are determined.

8. Demonstrate an understanding of physical agents used in industry to control microbial contamination including steam, dry heat, and radiation.

Cheating and Plagiarism
Each student should be aware of the College's policy regarding Cheating and Plagiarism. Seneca's Academic Policy will be strictly enforced.

To support academic honesty at Seneca College, all work submitted by students may be reviewed for authenticity and originality, utilizing software tools and third party services. Please visit the Academic Honesty site on http://library.senecacollege.ca for further information regarding cheating and plagiarism policies and procedures.

Discrimination/Harassment
All students and employees have the right to study and work in an environment that is free from discrimination and/or harassment. Language or activities that defeat this objective violate the College Policy on Discrimination/Harassment and shall not be tolerated. Information and assistance are available from the Student Conduct Office at student.conduct@senecacollege.ca.

Accommodation for Students with Disabilities
The College will provide reasonable accommodation to students with disabilities in order to promote academic success. If you require accommodation, contact the Counselling and Disabilities Services Office at ext. 22900 to initiate the process for documenting, assessing and implementing your individual accommodation needs.

Prerequisite(s)
PFT401 - Microbiology  I

Topic Outline
14 Week Delivery Mode
Lecture:
  Introduction to Pharmaceutical Microbiology
Review:  Bacteria, Viruses, Yeasts and Moulds Characteristics, Classification, Significance.  Laboratory Safety and WHMIS

Lecture: Microbes in the Environment, Plant Sanitation
Review: Microbial Dilutions and Plate Counts
Lab: Gram Stains

Lecture: Airborne Contamination and Infections, Aseptic Techniques
Lab: Excercise #1, Testing for Airborne Contamination

Evaluation of Results from Exerc. #1

Lecture: Microbes and Water. MPN Testing, Water for Pharmaceutical Manufacturing
Lab: Exerc #2 - Standard Analysis of Water
Exerc #3 - Examination of Distilled Water

Evaluation of Results from Exerc #2 and Exerc #3
Lecture: Mathematical Expressions of Bacterial Inactivation
Exerc #10 Bacterial Killing Curves

Lecture: Antibiotics: Mode of Action, Resistance, and Tests for Susceptibility and Potency
Exerc. #7 - Isolation of Antibiotic Producing Microbes from Soil

Lab: Evaluation of Results from Exerc #7
Identification and Purification of Antibiotic Producing Microbes
Exerc. #8 - The Microbial Assay of Antibiotics

Lecture: Sterilization Methods
Evaluation of Results from Exerc. #8
Lab: Calculation of Antibiotic Concentration
Exerc #6 - Sterility Testing of Various Commercial Products

Lab: Exerc #9 - Haemocytometer Counts and Plate Counts

Lecture: Sterility and Testing of Pharmaceuticals, Pyrogens, Sources of Contamination
Lab: Exp - Effect of Alcohol on Staphylococcus Aureus

Lecture: Disinfectants and other Antimicrobial Agents

Review and Topics of Interest, Studies in Microbiology, Career Opportunities

7 Week Delivery Mode
Lecture: Introduction to Pharmaceutical Microbiology. Characteristics and Significance of Bacteria, Fungi, and Viruses
Laboratory safety and WHMIS, Aseptic techniques, Microbes in the environment, Airborne Contamination and Air Sampling Techniques
Lab:  Ex. 1.  Testing for airborne contaminants
          Ex. 2.  Effect of alcohol on various microbes

Lecture: Microbes and water, water treatment methods, MPN testing, Water for Pharmaceutical Manufacturing, mathematical calculations
Lab:  Evaluations of Results of Ex. 1 & 2
         Ex. 3  Standard analysis of water
         Ex. 4  Examination of distilled water

Lecture: Microbial interaction in soil, antibiotics production by soil microbes sterilization methods, sterility and testing of pharmaceutical products, pyrogens, sources of contamination and various contaminants
Lab:  Evaluation of results of Ex. 3 & 4
         Ex. 5  Isolation of antibiotic producing microbes from soil
         Ex. 6  Sterility testing of various commercial products

Lecture: Mathematical calculations, serial dilutions, bacterial counts
Lab:  Evaluation of results of Ex. 5 & 6
         Gram staining, identification of antibiotic producing microbes

Lecture: Antibiotics: Mode of action, resistance and tests for susceptibility and potency Calculations of antibiotics concentration, graph plotting
Lab:  Ex. 7  The Microbial Assay of Antibiotics

Lecture: Mathematical expressions of bacterial inactivation, bacterial counts, growth calculations
Lab:  Ex. 8  Haemocytometer counts and plate counts
         Evaluation of results of Ex. 7

Observation on plate counts, Ex # 8

Mode of Instruction
Lectures, practical lab sessions, audio-visual presentations

Prescribed Texts
(Pkg) MICROBIOLOGY AN INTRODUCTION W/MASTERING MICROBIOLOGY, 11th Edition; Tortora/Funke/Case; Publisher: Addison Wesley Longman   ISBN 978-0-321-76738-7 Pearson Education Canada

Reference Material
None

Required Supplies
All students must wear a laboratory coat and safety glasses while in the lab.  This requirement is mandatory and consistent with safe practice.  Anyone not having the mandatory requirements will be asked to leave the lab. Students are also required to have a bulb for pipettes.

Promotion Policy

Grading Policy
A+ 90%  to  100%
A 80%  to  89%
B+ 75%  to  79%
B 70%  to  74%
C+ 65%  to  69%
C 60%  to  64%
D+ 55%  to  59%
D 50%  to  54%
F 0%    to  49% (Not a Pass)
OR
EXC Excellent
SAT Satisfactory
UNSAT Unsatisfactory

For further information, see a copy of the Academic Policy, available online (http://www.senecacollege.ca/academic-policy) or at Seneca's Registrar's Offices.


Modes of Evaluation
Assignments

  • Assignments are due at the beginning of the class on which they are due.
  • A late penalty of 10% per day is assessed for late assignments, including those not handed in at the beginning of class when due.
  • Material will not be accepted after one week following the due date and/or when the marked material is returned to students, whichever comes first.
  • Assignments are to be prepared by computer.

Absenteeism and Exams
  • Students should be aware that absenteeism almost guarantees an inability to achieve satisfactory grades.
  • Students who are absent for an examination due to an emergency (e.g., motor vehicle accident, hospitalization or death in the family) may provide official documentation within five days of the missed exam and be provided a deferred exam at a later date.  Official documentation includes a death notice or an original doctor’s certificate identifying the date, length of time expected absence and the specific reason for the absence.  Examinations missed without official documentation and approval result in a grade of zero.
  • There are no deferred options for missed tests.  The value of missed tests, at the discretion of the Faculty, will be added to other evaluation components

English Proficiency
  • All written work should demonstrate the following characteristics for clarity and conciseness:
-writing is consistent with the rules of English grammar
-spelling and punctuation are correct
-sentences are structured correctly
-main ideas are supported with specific, relevant examples and reasons
-work flows logically through supporting statements/paragraphs
-work is arranged in correct format (e.g., as a report, essay)
-up to 10% of the final grade may be deducted on all work if the above English competencies are not met.

Format for Assignments
  • Students must use the standard, APA style for quoting sources.   Help is available at:  http://library.senecacollege.ca

LAB COURSES
Laboratory Attendance

The laboratory component is essential and therefore it is strongly recommended  that you attend all labs.  Any missed labs must be supported with a legal document with three days of the lab.  Any student who fails to attend 2 scheduled laboratory classes for a 7 week subject and more than 3 laboratory classes for a 14 week subject will not pass the subject.    

Laboratory Safety
Students are required to review and understand the safety procedures and guidelines outlined on the first class and sign the sheet to this effect before beginning work in the laboratory.  Students must also wear a lab coat and safety glasses when conducting experiments.
A student who arrives without the proper safety equipment will not be permitted to participant in the lab but will be asked to leave the class.  The student will receive no grade for the lab missed.

Grading is based on the following marking scheme:
Testing for Airborne Contamination/Equipment 5%
Examination of Distilled Water 10%
Microbial Assay of Antibiotics 10%
Effect of 70% alcohol on a population of Staphylococcus Aureus 5%
Sterility Testing of Pharmaceuticals 10%
Calculating Dilutions, Suspensions, Bacterial Counts, Growth & Inactivation 10%
Quiz 10%
Assignments 10%
Final Exam 30%

Other Evaluation Considerations
The student is expected to comply with the Safety Rules for working in the laboratory, sign the safety contract, and WILL NOT UNDER ANY CIRCUMSTANCES WEAR CONTACT LENSES in the laboratory.  The student will know where all safety equipment is located in the laboratory and will be familiar with WHMIS concepts and signage.

PLEASE RETAIN THIS SUBJECT OUTLINE FOR POSSIBLE FUTURE USE IN SUPPORT OF CREDIT APPLICATIONS AT OTHER EDUCATIONAL INSTITUTIONS

Approved by: Denis Gravelle