MCRO06002 2008 PROCESS MICROBIOLOGY

General Details

Full Title
PROCESS MICROBIOLOGY
Transcript Title
PROCESS MICROBIOLOGY
Code
MCRO06002
Attendance
N/A %
Subject Area
MCRO - Microbiology
Department
ASCI - Applied Sciences
Level
06 - NFQ Level 6
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2008 - Full Academic Year 2008-09
End Term
2019 - Full Academic Year 2019-20
Author(s)
John Barrett Phd.
Programme Membership
SG_SSCIE_H08 201600 Bachelor of Science (Honours) SG_SSCIE_C06 201600 Higher Certificate in Science SG_SSCIE_H08 201700 Bachelor of Science (Honours) SG_SSCIE_C06 201700 Higher Certificate in 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
Co-requisites
None
Incompatibles
None

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 Continuous Assessment UNKNOWN 15 % Week 7 1
2 Health and safety compliance - safe handling of microbes, safety glasses compliance Continuous Assessment UNKNOWN 5 % OnGoing 4
3 Post practical assessments Continuous Assessment UNKNOWN 30 % OnGoing 3,5,7
4 Practical skills assessment Continuous Assessment UNKNOWN 10 % OnGoing 6
5 Report preparation and submission Continuous 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
Laboratory Practical 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

Denyer S.P.  and, Rosamund M. Baird, R.M.  Guide to Microbiological Control in Pharmaceuticals and Medical Devices (Second Edition). 2006. CRC Press.

Denyer, S.P., Hodges, N.A. and Gorman, S.P. Hugo and Russell's

Pharmaceutical Microbiology. 2004. Blackwell Publishing.

Hewitt, W. Microbiological Assay for Pharmaceutical Analysis: A Rational Approach. 2003. Interpharm/CRC.

Easter, M.C. Rapid Microbiological Methods in the Pharmaceutical Industry.2003. Interpharm/CRC.

Kevin L. Williams. K.L. Endotoxins: Pyrogens, Lal Testing, and Depyrogenation    (Drugs and the Pharmaceutical Sciences: a Series of Textbooks and Monographs).2001.

Alexander S.K. and Strete D. Microbiology: a photographic atlas for the laboratory. 2001. Benjamin Cummings.

Other Resources

Journals:

Annual Reviews in Microbiology

Microbiology and Molecular Biology Reviews

Nature Reviews in Microbiology

Trends in Microbiology