Module Details
Module Code: |
ZPHA C3101 |
Module Title:
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Control of Contamination and Infection
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Title:
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Control of Contamination and Infection
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Module Level:: |
7 |
Module Coordinator: |
Paula Rankin
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Module Author:: |
Dina Brazil
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Module Description: |
To allow Pharmacy Technicians to understand the fundamental theoretical and practical microbiological principles of infection and contamination control in a range of healthcare /pharmacy settings.
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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 |
Describe the nature of micro-organisms and outline the relevance of micro-organisms in a range of settings. |
LO2 |
Discuss the relevance of contaminants and healthcare associated infections (HAI) to the work of a Pharmacy Technician. |
LO3 |
Explain the principles of infectious disease and describe how transmission can be prevented and controlled in a range of settings. |
LO4 |
Describe the factors that control the growth of microorganisms in the environment, clinical and industrial settings and demonstrate the efficacy of physical and chemical methods of sterilisation/preservation/ disinfection. |
LO5 |
Explain how to apply the requirements of cGMP/cGPP and quality in the manufacture/preparation of sterile products. |
LO6 |
Develop competency in microbiological techniques for the handling, monitoring and control of microorganisms. |
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 |
Basic concepts in microbiology
Basic concepts in microbiology . Ubiquitous nature and metabolic diversity of microorganisms. and their interactions with humans and the environment.
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Contamination, prevention and monitoring
Sources of animate and inanimate contamination in the manufacture or use of sterile and non sterile products including pyrogens. Parenteral and sterile products. Sampling , bioburden testing, environmental monitoring, objectionable and indicator organisms. Risk assessment . Aseptic techniques in a preparation setting.
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Pathogens: Infection Control
Concepts of pathogens including emerging and opportunistic pathogens, healthcare acquired infections (HAI). Antibiotic resistance and stewardship. Principles of infectious disease transmission. Breaking the chain of infection. Aseptic techniques in healthcare setting. Standard and transmission based precautions.
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Microbial control and monitoring.
Control of microbial growth.Physical and chemical methods of sterilisation and disinfection of equipment and materials. Filter sterilisation of air and liquids. Validation of these methods. Biological indicators. D, Z and F values. Preservatives.
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Quality aspects of aseptic manufacturing/preparation.
Overview of the principles of cGMP /cGPP for sterile and non sterile products. Risk assessment. Quality control and quality assurance systems. The importance of validation and monitoring. Trending, alert and action levels, OOS. The importance of documentation and SOPs. Overview of clean room design and classification. HEPA filters, unidirectional air flow cabinets, isolators, biological safety cabinets.
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Practical
1. cGood Microbiological Practice and Health and Safety. Using SOPs. Correct personal laboratory and clean room behaviour and attitudes including: correct hand washing and gowning. Principles of validation.
2. Preparation and sterilisation of microbial media. Validation of heat sterilisation. Biological indicators. Determination of D, Z and F values.
3. Aseptic cultivation of microorganisms on solid and liquid selective, differential and other media.
4. Isolation and enumeration of micro-organisms from environmental sources, raw materials and finished products. Serial dilutions and viable count.
5. Environmental, hard surface and air microbial monitoring recording and interpretation.
6. Demonstration and interpretation of stains including the Gram stain.
7. Identification protocols using multiwell phenotypic systems eg API.
8. Evaluation of the relative effectiveness of chemical substances as anti-microbial agent. Challenge tests. LAL pyrogen testing.
9. Working in a unidirectional air flow environment. Transfer techniques. Aseptic techniques. Validation of aseptic techniques via broth test.
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Module Content & Assessment
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Assessment Breakdown | % |
Continuous Assessment | 60.00% |
Practical | 40.00% |
AssessmentsFull Time
No End of Module Formal Examination |
Part Time
No End of Module Formal Examination |
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 |
Lecturer Supervised Learning |
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Contact |
This item involves classroom activities, lectures, discussions, problem solving. |
12 Weeks per Stage |
2.00 |
24 |
Practicals |
|
Contact |
The practical component is essential and allows not only the development of practical skills and competencies but also the application of theory into practice and the development of appropriate interpretive skills in a structured environment. The aims of the practicals are to:
• allow students to develop the required technical competencies, attitudes and behaviours in microbiology and aseptic techniques in the light of underpinning knowledge;
• develop appropriate recording and reporting |
12 Weeks per Stage |
2.00 |
24 |
Independent Learning |
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Non Contact |
Independent learning includes: class preparation, assessments, practical preparation and reports. It will be supported by interactive and other resources on Blackboard that will be available throughout the year providing a blended approach. Where appropriate, a flipped classroom approach will be used where learners will actively engage with material before class or lab learning activities. Formative assessments with feedback will be available to allow learners to check their learning. |
15 Weeks per Stage |
13.47 |
202 |
Total Weekly Contact Hours |
4.00 |
Workload: Part Time |
Workload Type |
Workload Category |
Contact Type |
Workload Description |
Frequency |
Average Weekly Learner Workload |
Hours |
Lecture |
|
Contact |
This item involves classroom activities, lectures, discussions, problem solving. |
12 Weeks per Stage |
2.00 |
24 |
Practicals |
|
Contact |
The practical component is essential and allows not only the development of practical skills and competencies but also the application of theory into practice and the development of appropriate interpretive skills in a structured environment. The aims of the practicals are to:
• allow students to develop the required technical competencies, attitudes and behaviours in microbiology and aseptic techniques in the light of underpinning knowledge;
• develop appropriate recording and reporting |
12 Weeks per Stage |
2.00 |
24 |
Independent Learning Time |
|
Non Contact |
Independent learning includes class preparation, assessments , practical preparation and reports. It will be supported by interactive and other resources on Blackboard that will be available throughout the year providing a blended approach. Where appropriate, a flipped classroom approach will be used where learners will actively engage with material before class or lab learning activities. Formative assessments with feedback will be available to allow learners to check their learning. |
15 Weeks per Stage |
13.47 |
202 |
Total Weekly Contact Hours |
4.00 |
Module Resources
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Recommended Book Resources |
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Michael T. Madigan,Kelly S. Bender,Daniel H. Buckley,David A. Stahl,W. Matthew Sattley. (2020), Brock Biology of Microorganisms, 14 th. Pearson, p.1120, [ISBN: 9780134874401].
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David M. Carlberg. (2005), Cleanroom microbiology for the non-microbiologist, CRC Press, Boca Raton, [ISBN: 9780849319969].
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ITCarlow Practical Workbook. (2021), ITCarlow Practical Workbook, [ISBN: IT CARLOW].
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Denyer, S.P., Hodges, N.A., Gorman, S.P. and Gilmore, B. F. T., eds. (2011), Hugo and Russell's Pharmaceutical Microbiology, 8th. Wiley, Wiley-Blackwell., Chichester, [ISBN: 978 14443306].
| This module does not have any article/paper resources |
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Other Resources |
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Health Protection Surveillance Centre. (2021), HSE Infection Prevention and Control
Guidance and Framework,
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HSE. (2020), Infection Prevention and Control,
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HSE. (2020), Health Care Associated Infection and
Antimicrobial Resistance,
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Health Products Regulatory Authority. (2014), Health products regulatory authority, Dublin,
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European Union Guide to cGMP
http://ec.europa.eu/enterprise/pharmaceu
ticals.
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EudraLex - Volume 4 - Good Manufacturing
Practice (GMP) guidelines. (2008), Annex 1 Manufacture of Sterile Medicinal
Products, Brussels, European Commision,
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Working group of the HPAI Aseptic
Services Special Interest Group (ASSIG). (2013), National Guidelines for Aseptic
Preparations in Irish Hospital Pharmacy
practice,
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