MCRO06012 2019 Pharmaceutical Microbiology
Full Title
Pharmaceutical Microbiology
Transcript Title
Pharmaceutical Microbiology
Code
MCRO06012
Attendance
N/A %
Subject Area
MCRO - 0511 Microbiology
Department
LIFE - Life Sciences
Level
06 - Level 6
Credit
05 - 05 Credits
Duration
Semester
Fee
€
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
John Barrett Phd.
Programme Membership
SG_SPHAR_B07 201900 Bachelor of Science in Pharmaceutical Science with Drug Development
SG_SPHAR_H08 201900 Bachelor of Science (Honours) in Pharmaceutical Science with Drug Development
SG_SPHAR_C06 202100 Higher Certificate in Science in Pharmaceutical Science
Description
The aim of this module is to introduce the student to both the theory and practical aspects of microbiology related to the production of a range of biomedical products, including pharmaceuticals, medical devices and immunodiagnostic materials. Students will be provided with the opportunity to acquire knowledge of the subject matter through a variety of lecturer led activities and self-directed study. Such activities will include traditional and interactive lectures, problem solving and revision tutorials and laboratory practical classes. Theoretical and practical problems will be employed to assist students in the development of their analytical and problem solving capabilities.
Learning Outcomes
On completion of this module the learner will/should be able to;
1.
Understand microbial ecology and its relationship to biomedical products manufacture.
2.
Understand the importance of environmental monitoring as a regulatory and quality control requirement.
3.
Collect, manipulate and interpret numerical data relating to microbiological analysis.
4.
Understand the importance of, and work in compliance with, health and safety policies and good laboratory practice as it pertains to microbiology laboratories.
5.
Be able to design and execute experiments, systematically collect and analyze data, identify sources of error, and interpret the results and reach logical conclusions.
6.
Operate basic laboratory instruments used in industrial microbiological monitoring.
7.
Cooperate and work effectively with peers and be able to demonstrate a commitment to the process of developing such skills.
Module Dependencies
Prerequisites
Analytical Microbiology
Indicative Syllabus
Indicative Theory:
•1. Ecology of micro-organisms in industrial environments.
•2. Methods of control of micro-organisms in industrial environments.
•3. Sterile products manufacture, non-sterile products manufacture.
•4. Bioburden and pyrogen testing.
•5. Sterility testing (sampling, test methods, repeat test criteria).
•6. Industrial water treatment systems.
•7. Industrial water quality standards (water for injection, sterile water for injection, water for inhalation, water for irrigation, purified water).
•8. Air quality in industrial environments.
•9. Environmental monitoring - water, air, personnel and work surface monitoring.
•10. Identification of micro-organisms - genus level, species level.
Indicative Practical:
•1. Bioburden testing - contact, surface swab and rinse method.
•2. Air sampling - standard methods for sampling.
•3. Personnel monitoring - garment sampling, finger sampling.
•4. Water sampling - standard methods for sampling, cultivation, enumeration and identification of contaminants.
•5. Pyrogen test - LAL and turbidometric test.
•6. Sterility testing - USP and EP sterility test standard methods.
•7. Environmental monitoring - test methods, interpretation of results and action limits.
•8. Identification of micro-organisms.
Coursework & Assessment Breakdown
Coursework & Continuous Assessment
65 %
End of Semester / Year Formal Exam
35 %
Coursework Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Mid term assessment | Coursework Assessment | UNKNOWN | 15 % | Week 7 | 1 |
| 2 | Health and safety compliance - safe handling of microbes, safety glasses compliance | Coursework Assessment | UNKNOWN | 5 % | OnGoing | 4 |
| 3 | Post practical assessments | Coursework Assessment | UNKNOWN | 30 % | OnGoing | 3,5,7 |
| 4 | Practical skills assessment | Coursework Assessment | UNKNOWN | 10 % | OnGoing | 6 |
| 5 | Report preparation and submission | Coursework Assessment | UNKNOWN | 5 % | OnGoing | 5 |
End of Semester / Year Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Final theory examination | Final Exam | UNKNOWN | 35 % | End of Term | 1,2 |
Full Time Mode Workload
| Type | Location | Description | Hours | Frequency | Avg Workload |
|---|---|---|---|---|---|
| Lecture | Tiered Classroom | Lecture | 2 | Weekly | 2.00 |
| Practical / Laboratory | Science Laboratory | Laboratory Work | 2 | Weekly | 2.00 |
| Independent Learning | UNKNOWN | Self Study | 4 | Weekly | 4.00 |
Total Full Time Average Weekly Learner Contact Time 4.00 Hours
Module Resources
Non ISBN Literary Resources
Brock Biology of Microorganisms -
Michael T. Madigan, Kelly S. Bender and Daniel H. Buckley
Edition: 15TH Copyright: 2018 Publisher: Pearson, Published: 2018
Text Only - 15th edition. ISBN13: 9780134261928
Microbiology: Laboratory Theory and Application, - 3rd edition
Michael J. Leboffe and Burton E. Pierce
Edition: 3RD 16 Copyright: 2016 Publisher: Morton Publishing Co.
Published: 2016. ISBN13: 9781617314773
Microbiology - 2nd edition
Edition: 2ND 16 Copyright: 2016 Publisher: Garland Publishing
Published: 2016. ISBN13: 9780815345138
Medical Microbiology - 8th Edition Patrick R. Murray PhD (Author), Ken S. Rosenthal PhD (Author), Michael A. Pfaller MD (Author) Published: 2019. ISBN-13: 978-0323299565
Medical Microbiology - 8th Edition Patrick Murray Ken Rosenthal Michael Pfaller. Elsevier Published Date: 28th October 2015. ISBN: 9780323299565
Other Resources
Journals:
Annual Reviews in Microbiology
Microbiology and Molecular Biology Reviews
Nature Reviews in Microbiology
Trends in Microbiology