Module Details
Module Code: |
ZPHA C3108 |
Module Title:
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Microbiology for Pharmaceutics
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Title:
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Microbiology for Pharmaceutics
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Module Level:: |
7 |
Module Coordinator: |
Paula Rankin
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Module Author:: |
Paula Rankin
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Module Description: |
The aim of this module is to impart knowledge, skills and of key practical and theoretical aspects of pharmaceutical microbiology within the current regulatory framework to learners who may not have previous microbiological experience.
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Learning Outcomes |
On successful completion of this module the learner will be able to: |
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Learning Outcome Description |
LO1 |
Provide evidence of the importance of pharmaceutical microbiology in maintaining product quality and safety in the current national and international legislative and regulatory context. |
LO2 |
Examine and differentiate the key concepts of pharmaceutical microbiology including: isolation, identification and classification of contaminants; factors affecting microbial growth and its control, disinfection/sterilisation. |
LO3 |
Identification and demonstration of the limitations of the data and its use in problem solving in an industrial setting. Be competent in the execution, interpretation and communication of pharmaceutically relevant microbial detection, enumeration and identification protocols. |
Dependencies |
Module Recommendations
This is prior learning (or a practical skill) that is recommended before enrolment in this module.
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No recommendations listed |
Co-requisite Modules
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No Co-requisite modules listed |
Additional Requisite Information
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No Co Requisites listed
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Indicative Content |
Indicative content
LO1 Appreciate the importance of pharmaceutical microbiology in the current national and international legislative and regulatory context.
• Principles of sterile and non sterile processing and manufacture. Hazards and risks posed by microorganisms to the health of the end user of the manufacturing process. Sources of microbial contamination. The importance of cGMP.
• Regulatory frame work, e.g. Pharmacuetical compendia, FDA Eudralex. Regulations. Principles of risk assessment. Validation and verification of methods.. Sterility Assurance.
LO2 Understand the key concepts of pharmaceutical microbiology including: isolation, identification and classification of contaminants; factors affecting microbial growth and its control, disinfection/sterilisation.
• Range and significance of different groups of contaminating microorganisms found in sterile and non-sterile pharmaceutical industries e.g. water, raw, final product. Common misunderstandings regarding microbial contamination.
• Sources of contamination/bioburden.
• Spore formers, moulds , viruses and prions emerging objectionable organisms. pathogens and their products including endotoxin.
• Objectionable organisms, .objectionable organisms, indicator and specified organisms. Significance of biofilms in oligotrophic waters and other environments. Endotoxins and other products. Viruses, viroids and prions.
• Emerging problems/issues e.g. new regulations/ phage contamination.
• Challenge of microbial metabolic diversity. .
• Microbial growth and its control. Physical and chemical methods of disinfection and sterilisation. Biocides and preservatives Validation of control methods Bio indictors. Sterility assurance Biocidal efficacy.
LO3 Be competent in the execution, interpretation and communication of pharmaceutically relevant microbial detection, enumeration and identification protocols .
• Rationale for microbial monitoring techniques for water, air, surfaces raw and finished products. OOS, trends
• Main compendia and other currently approved methods. Rapid and molecular monitoring methods; biosensors, arrays.
• Interpretation of microbial results; bioburden, limits out of specification results; trends, alert and action limits.
• Phenotypic and genotypic identification, current and rapid methods.
Practical component
• The practical component contributes to LO1,2 and 3. Students will practice cGood Laboratory and cGood Microbiological Practice and observe due regard to current occupational health and safety as appropriate.
• Current compendial microbiological detection, isolation and identification techniques.
• Sample preparation, importance of sampling and replication strategies.
• Growth based enumeration and enrichement methods and their limitations. Pharmaceutical complex, selective and differential growth media. Water analysis, Membrane filtration Defined substrate tests. Importance of neutralisation methods.
• Surface microbiology: Swab tests/contact plates Air quality: Settle plates/ Volumetric air quality.
• Bioburden testing and enrichment on liquid and solid samples
• Preservative challenge tests.
• Sterilisation assurance /Bioindicators. Efficacy of disinfection. Antibiotic resistance.
• LAL and other non growth based tests
• Gram stains Rapid ID and classification methods (Biolog/API) Use of Bergerys manual.
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Module Content & Assessment
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Assessment Breakdown | % |
Continuous Assessment | 30.00% |
Practical | 30.00% |
End of Module Formal Examination | 40.00% |
AssessmentsFull Time
End of Module Formal Examination |
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Reassessment Requirement |
Exam Board
It is at the discretion of the Examination Board as to what the qualifying criteria are.
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SETU Carlow Campus reserves the right to alter the nature and timings of assessment
Module Workload
Workload: Full Time |
Workload Type |
Workload Category |
Contact Type |
Workload Description |
Frequency |
Average Weekly Learner Workload |
Hours |
Lecture |
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Contact |
No Description |
12 Weeks per Stage |
1.00 |
12 |
Practicals |
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Contact |
No Description |
12 Weeks per Stage |
3.00 |
36 |
Independent Learning |
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Non Contact |
Pre-practical and pre-lecture activities. Completion of reports and assessments |
15 Weeks per Stage |
5.13 |
77 |
Total Weekly Contact Hours |
4.00 |
Module Resources
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Recommended Book Resources |
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Stephen P. Denyer,Norman A. Hodges,Sean P. Gorman,Brendan F. Gilmore. (2011), Hugo and Russell's Pharmaceutical Microbiology, 8th. Wiley-Blackwell, p.528, [ISBN: 9781444330632].
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Collins, C.H., Lyne, P.M., Grange, J.M., and Falkinham III, J.O., (eds.) 8th ed. London: Arnold. ISBN: 034 0808969.. (2004), Microbial Methods.
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W.B. Whitman.,(ed.) 3rd Wiley Online Library/© 2015 Bergey's Manual Trust. Online ISBN: 978: 1118960608. DOI: 10.1002/978 1118960608.. (2015), Bergey's Manual of Systematics of Archaea and Bacteria,..
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Sandle, T. London: Microbiology Solutions. ISBN: 978-1482596144.. (2014), Risk Management and Risk Assessment for Pharmaceutical Manufacturing: A Contamination Control Perspective.
| Supplementary Book Resources |
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Michael T. Madigan,Kelly S. Bender,Daniel Hezekiah Buckley,W. Matthew Sattley,David Allan Stahl. (2017), Brock Biology of Microorganisms, 15th. Pearson, [ISBN: 9780134261928].
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D.M,. Carlberg (2004) 2ND ed. CRC Press. ISBN: 978 0849319969.. (2004), Cleanroom Microbiology for the Non-microbiologist..
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Sandle, T. Surry, UK: Grosvenor House Publishing. ISBN: 978 1781487686 .. (2012), The CDC Handbook: A Guide to Cleaning and Disinfecting Cleanrooms.
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Saghee, M.R., Sandle, T. and Tidswell, E.C. (eds.). New Delhi : Business Horizons. ISBN: 978 8190646741.. (2011), Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices.
| Recommended Article/Paper Resources |
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Cundell, A.M. (2006). Microbial
Identification Strategies in the
Pharmaceutical Industry. PDA Journal of
Pharmaceutical Science and Technology 60
(2) ,111-123. European Union Guide to
cGMP . Available at http://ec.europa.. Biological and Pharma Bulletin..
| This module does not have any other resources |
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