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MANU6011 - Calibration Science

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Title:Calibration Science
Long Title:Calibration Science
Module Code:MANU6011
 
Credits: 5
NFQ Level:Fundamental
Field of Study: Manufacturing Engineering
Valid From: Semester 1 - 2014/15 ( September 2014 )
Module Delivered in 4 programme(s)
Module Coordinator: MICHAEL J O MAHONY
Module Author: MARY QUIRKE
Module Description: This module introduces the student to calibration requirements in a GMP environment. Calibration regulations, procedures and terminology are studied.The learner will investigate some analytical equipment relevant to the pharmaceutical and medical device sectors.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Explain the importance of calibration in a GMP environment with reference to the regulations governing the pharmaceutical/medical devices industries.
LO2 Define calibration terminology and perform calculations to determine uncertainties of measure and errors in measuring/analytical instruments.
LO3 Design a calibration protocol for a piece of equipment.
LO4 Manipulate and convert units of measurement and express concentration in various ways
LO5 Describe the operating principles of a range of measuring equipment and their calibration.
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).
8752 MATH6014 Technological Mathematics 1
9837 LSC_MM Maths for Matures
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.

It is recommended that you have a studied a level six mathematics modules.
Co-requisites
No Co Requisites listed
 

Module Content & Assessment

Indicative Content
Calibration
Definition of calibration. Review of the purpose of calibration and frequency of calibration. The role of primary and secondary standards. The role of the National Standards Authority of Ireland (NSAI
Calibration Terminology
Definition of uncertainty of measure, bias, threshold, resolution, instrument sensitivity, % error, qualitative and quantitative measurement and other terms related to the calibration of instruments. Calibration graphs and calculation of associated errors and combining errors. Review of units of measurement and conversion to S.I. units. Ways of expressing concentration.
GMP and Calibration
Review the European and FDA regulations relevant to pharmaceutical and medical device and how they impact on calibration in a GMP environment e.g calibration procedures and calibration systems.
Calibration and Maintenance of Equipment
Loop calibration versus instrument calibration. Smart instruments. Systems for calibration and maintenance scheduling and reporting. Systems for requesting maintenance of equipment. Total Productive Maintenance.
Operation and Calibration of Equipment
The operating principles of a various pieces of equipment used in the pharmachem, medical device industries. Calibration of these items of equipment. Measurement of accuracy and precision.
Laboratory Programme
Practical calibration exercises, using traceable or certified standards (if possible). Calibration of a range of equipment from the following selection: Analytical balance, calipers, pH meter, conductivity meter, hygrometers, UV-Visible spectrometer, IR spectrometer, Karl Fischer Auto-titrator, Gas/liquid chromatograph, microscope, volumetric flasks and graduated cylinders, pipettes, micro-pipettes, temperature and pressure reading devices, flow meters, etc.
Assessment Breakdown%
Course Work100.00%
Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Open-book Examination e.g. GMP Regulations 1,4 15.0 Week 4
Project Industrial project on calibration 1,3,5 25.0 Week 9
Practical/Skills Evaluation Laboratory practice 2,3,4,5 30.0 Sem End
Short Answer Questions 1 hour written examination 1,2,3,4,5 30.0 Week 12
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 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 Practical 2.0 Every Second Week 1.00
Independent & Directed Learning (Non-contact) Student input including laboratory report write up. 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 Practical 2.0 Every Second Week 1.00
Independent & Directed Learning (Non-contact) Student input including laboratory report write up. 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
  • Mike Cable 2005, Calibration: A Technician's Guide, The Instrumentation ISA [ISBN: 9781556179129]
  • Daniel C. Harris 2010, Quantitative Chemical Analysis, 8th Ed., W.H. Freeman New York [ISBN: 9781429218153]
This module does not have any article/paper resources
Other Resources
 

Module Delivered in

Programme Code Programme Semester Delivery
CR_ECBPO_6 Certificate in Chemical and Biopharmaceutical Process Operations 1 Mandatory
CR_EFDPF_6 Certificate in Food Processing Fundamentals 2 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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