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BIOM6004 - Contamination Control

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Title:Contamination Control
Long Title:Contamination Control
Module Code:BIOM6004
 
Credits: 5
NFQ Level:Fundamental
Field of Study: Microbiology
Valid From: Semester 1 - 2016/17 ( September 2016 )
Module Delivered in 5 programme(s)
Module Coordinator: MICHAEL J O MAHONY
Module Author: SANDRA LENIHAN
Module Description: This module introduces the students to the importance of contamination control in medical device and Pharma/Biopharma industries. It covers the nature and sources of contamination, facility design, cleaning equipment and regimes, methods of contamination control and cleaning validation. It also enhances written technical written communication skills.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Identify sources of contamination and take measures to minimise them.
LO2 Identify appropriate steps to control contamination in a bio/pharma/medical device manufacturing facility.
LO3 Review the principles of cleaning validation & develop cleaning validation protocols.
LO4 Undertake practical experiments relevant to contamination control.
Pre-requisite learning
Module Recommendations
This is prior learning (or a practical skill) that is strongly recommended before enrolment in this module. You may enrol in this module if you have not acquired the recommended learning but you will have considerable difficulty in passing (i.e. achieving the learning outcomes of) the module. While the prior learning is expressed as named CIT module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
Level 6 Microbiology or equivalent
Incompatible Modules
These are modules which have learning outcomes that are too similar to the learning outcomes of this module. You may not earn additional credit for the same learning and therefore you may not enrol in this module if you have successfully completed any modules in the incompatible list.
No incompatible modules listed
Co-requisite Modules
No Co-requisite modules listed
Requirements

This is prior learning (or a practical skill) that is mandatory before enrolment in this module is allowed. You may not enrol on this module if you have not acquired the learning specified in this section.

None
Co-requisites
No Co Requisites listed
 

Module Content & Assessment

Indicative Content
Contamination
The nature of contamination: physical, chemical and biological. Sources of contaminants: environment, personnel, product (water, raw materials, utilities) and packaging. Contamination of pharmaceuticals and medical devices and consequences of same.
Controlled cleaning
Cleaning agents and methods (manual and automated) and selection criteria for adoption in a manufacturing facility. Disinfectant testing. Materials/equipment compatibility. Cleaning chemistry principles. Writing standard operating procedures for controlled cleaning practices. Sterilisation and sterile boundaries.
Housekeeping and Contamination Control
Review of good housekeeping practices and procedures. Monitoring the effectiveness of cleaning regimes and agents. Adoption of Barrier /isolator technology. Facility design - dedicated and multi-product. Single use adoption and disposable technology.
Cleaning Validation
Principles of cleaning validation. Established principles; Maximum Acceptable Carry Over, Acceptable Daily Exposure, choice of target molecule and analytical techniques for detection. Sampling methods, location of sampling points and spray coverage testing. Establishing acceptance criteria. Recovery methods. Hold times.
Laboratory Programme
Technical practical induction focusing on laboratory written communication skills. Selective Plate counting. Examination of environmental and surface contamination. Examine the microcidial efficiency of different disinfections. MIC Testing of different disinfections.
Assessment Breakdown%
Course Work40.00%
End of Module Formal Examination60.00%
Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Short Answer Questions Written examination 1,2 15.0 Week 7
Practical/Skills Evaluation Technical report writing. Oral examination of lab components. 4 25.0 Week 12
End of Module Formal Examination
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Formal Exam End-of-Semester Final Examination 1,2,3 60.0 End-of-Semester
Reassessment Requirement
Repeat examination
Reassessment of this module will consist of a repeat examination. It is possible that there will also be a requirement to be reassessed in a coursework element.

The institute reserves the right to alter the nature and timings of assessment

 

Module Workload

Workload: Full Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Classroom Instruction 2.0 Every Week 2.00
Lab Practicals 2.0 Every Second Week 1.00
Independent & Directed Learning (Non-contact) Student Study 4.0 Every Week 4.00
Total Hours 8.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
Workload: Part Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Classroom Instruction 2.0 Every Week 2.00
Lab Practicals 2.0 Every Second Week 1.00
Independent & Directed Learning (Non-contact) Student Study 4.0 Every Week 4.00
Total Hours 8.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
 

Module Resources

Recommended Book Resources
  • Denyer, S.P. & Baird, R.M. 2007, Guide to Microbiological Control in Pharmaceuticals and Medical Devices, 2nd Ed Ed., CRC Press [ISBN: 978-0748406159]
  • Regine Eibl, Dieter Eibl 2011, Single-Use Technology in Biopharmaceutical Manufacture, Wiley [ISBN: 9780470433515]
  • C. K. Moorthy 2004, Contamination Control and Cleanrooms [ISBN: 9781904798064]
  • Ramstorp, Matts 2003, Contamination Control in Practice: Filtration and Sterilisation Filtration and Sterilisation, DC21 (Dewey) Ed., Wiley-VCH Verlag GmbH [ISBN: ISBN: 3527307761]
Supplementary Book Resources
  • Luis Jiminez (ed) 2004, Microbial contamination control in the pharmaceutical industry, Marcel Dekker New York [ISBN: 9780203026267]
  • Madigan, M.T.& Martinko, J. M. 2006, Brock Biology of Microorganisms, 11th Edition Ed., Prentice Hall [ISBN: 0131968939]
  • International Standards Organization, ISO 146444
  • edited by Luis Jiminez 2004, Microbial contamination control in the pharmaceutical industry, Marcel Dekker New York
This module does not have any article/paper resources
Other Resources
  • Website: Pharmaceutical Manufacturing Technology Centre 2015, Good Cleaning Validation Practice (GCVP) , University of Limerick
  • Website: Good guideline documents
 

Module Delivered in

Programme Code Programme Semester Delivery
CR_ECBPO_6 Certificate in Chemical and Biopharmaceutical Process Operations 1 Elective
CR_ECLMP_6 Certificate in Cleanroom Manufacturing Practices 1 Mandatory
CR_EFDPF_6 Certificate in Food Processing Fundamentals 1 Elective
CR_SGMPP_6 Certificate in GMP and Process Operations 2 Elective
CR_SGMPR_6 Higher Certificate in Science in Good Manufacturing Practice and Technology 3 Mandatory

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