Module Details

Module Code: BIOM6004
Title: Contamination Control
Long Title: Contamination Control
NFQ Level: Fundamental
Valid From: Semester 1 - 2016/17 ( September 2016 )
Duration: 1 Semester
Credits: 5
Field of Study: 4213 - Microbiology
Module Delivered in: 5 programme(s)
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:
# Learning Outcome Description
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.
Dependencies
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 MTU 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
 
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.
Module Content & Assessment
Assessment Breakdown%
Coursework40.00%
End of Module Formal Examination60.00%

Assessments

Coursework
Assessment Type Short Answer Questions % of Total Mark 15
Timing Week 7 Learning Outcomes 1,2
Assessment Description
Written examination
Assessment Type Practical/Skills Evaluation % of Total Mark 25
Timing Week 12 Learning Outcomes 4
Assessment Description
Technical report writing. Oral examination of lab components.
End of Module Formal Examination
Assessment Type Formal Exam % of Total Mark 60
Timing End-of-Semester Learning Outcomes 1,2,3
Assessment Description
End-of-Semester Final Examination
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 University reserves the right to alter the nature and timings of assessment

 

Module Workload

Workload: Full Time
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact Classroom Instruction Every Week 2.00 2
Lab Contact Practicals Every Second Week 1.00 2
Independent & Directed Learning (Non-contact) Non Contact Student Study Every Week 4.00 4
Total Hours 8.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
Workload: Part Time
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact Classroom Instruction Every Week 2.00 2
Lab Contact Practicals Every Second Week 1.00 2
Independent & Directed Learning (Non-contact) Non Contact Student Study Every Week 4.00 4
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. CRC Press, [ISBN: 978-0748406159].
  • Regine Eibl, Dieter Eibl. (2011), Single-Use Technology in Biopharmaceutical Manufacture, Wiley, p.369, [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). 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. 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,
    http://www.pmtc.ie
  • Website, Good guideline documents,
    http://www.ispe.org
 
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