Module Details
| Module Code: |
BIOM6003 |
| Title: |
Cleanroom Management
|
|
Long Title:
|
Cleanroom Management
|
| NFQ Level: |
Fundamental |
| Valid From: |
Semester 2 - 2017/18 ( January 2018 ) |
| Field of Study: |
4213 - Microbiology
|
| Module Description: |
This module introduces the student to the use of cleanroom technology in the medical technologies industries. It covers cleanroom classification, standards and design materials, HEPA systems and filtration, cleanroom practices, control and monitoring.
|
| Learning Outcomes |
| On successful completion of this module the learner will be able to: |
| # |
Learning Outcome Description |
| LO1 |
Classify a cleanroom to ISO 14644-1, EU GMP and FDA standards. |
| LO2 |
Identify the principles of cleanroom design and construction for various types of manufacturing operations. |
| LO3 |
Describe policies for cleanroom behaviour and define what materials and clothing are cleanroom compatible. |
| LO4 |
Explain the validation requirements for cleanrooms and describe how a monitoring program is established. |
| LO5 |
Specify the mechanisms for the removal of particulate contamination from cleanroom air. |
| 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).
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| None |
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 |
|
Cleanrooms
Clean room classification and standards. Types of clean rooms, and their various applications in the pharmaceutical and medical device industry. Fundamentals of air filtration: principles of HEPA filtration and design of cleanrooms to include HVAC systems. Systems of air classification: ISO 14644 standard, EU GMP and FDA standards and Federal Standard 209. Alarm levels
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Materials and Equipment for clean rooms
Selection of walls, ceilings, floor materials and equipment. Barrier/Isolator technology. Air showers, weighing cabinets and material pass-through corridors.
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Clean room practices
Clothing and housekeeping practices for the clean room staff and maintenance contractors. Critical control of clean room entrance practices. Standard Operating Procedures for clean room work.
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Clean room test equipment and monitoring
Monitoring the viable and non-viable particle counts, environmental monitoring, air flow rates and air flow patterns, pressure differentials, filter leak and seal testing, testing gloves in Isolator units and RABs.
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Cleaning, Decontamination & Segregation
Introduction to positive/negative air pressure environments and their use in segregating working areas within clean rooms. Review of personal behaviour in clean rooms and how this influences clean room contamination. Cleaning strategies and sterilization and decontamination of isolator units.
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Indicative Practical Programme
Entry and Exits procedure and garbing, Environmental Monitoring, Characterisation of a HVAC system, particle counting in RABs.
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Module Content & Assessment
|
| Assessment Breakdown | % |
|---|
| Coursework | 100.00% |
Assessments
| No End of Module Formal 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 |
|---|
-
W. Whyte. (2010), Cleanroom technology, John Wiley & Sons, Chichester, West Sussex, U.K., [ISBN: 9780470748060].
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Sandle, T.; Saghee, M. R.. (2013), Cleanroom management in pharmaceuticals and healthcare, Euromed Communications Ltd, [ISBN: 1899015833].
| | Supplementary 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].
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Whyte, W.. (2000), Cleanroom Design, 2nd Ed.. Wiley, [ISBN: 978-0471942047].
| | This module does not have any article/paper resources |
|---|
| Other Resources |
|---|
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Hard or Soft Copy, Course Notes.
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