BIO09067 2016 Biocontamination Monitoring and Control

General Details

Full Title
Biocontamination Monitoring and Control
Transcript Title
BIOCONTAMINATION MONITORING A
Code
BIO09067
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
09 - NFQ Level 9
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2016 - Full Academic Year 2016-17
End Term
9999 - The End of Time
Author(s)
Sharon Barrett, Macdara Bodeker
Programme Membership
SG_SBPRO_M09 201600 Master of Science in Bioprocessing SG_SBPRO_O09 201700 Postgraduate Diploma in Science in Bioprocessing SG_SBPRO_M09 201600 Master of Science in Bioprocessing
Description

This module is taken by Masters students in Pharmaceutical or Biopharmaceutical Science or Engineering. It aims to provide students with a detailed knowledge and understanding of the general principles and methods of Biocontamination control; establishing and verifying the formal system for contamination control and associated test methods and requirements; traditional and modern methods of microbial detection; expressing, interpreting and reporting results; training and documentation requirements. It does this through consideration of facility design, basic microbiology, evaluation of relevant microbes, potential sources of microbial contamination, correction/prevention tools, monitoring and detection methods, consideration of all relevant regulations and case study evaluation. Documentation (including ISO and USP) relevant to biocontamination Control will be addressed. Quality assurance and Quality systems will be addressed in the context of Biocontamination control. 

Learning Outcomes

On completion of this module the learner will/should be able to;

1.

Discuss and critically evaluate the most relevant microbes for the biopharmaceutical industry and the typical sources of each.

2.

Identify and discuss appropriate prevention techniques for each contaminant.

3.

Source and interpret the theory behind the detection test methods available, including traditional and rapid identification testing.

4.

Describe and apply the concept of Biocontamination Control by Design.

5.

Develop and justify an appropriate monitoring regime for a pharmaceutical/biopharmaceutical facility.

6.

Outline and justify an appropriate system/process for Biocontamination control and incorporate all elements of a GMP quality system referencing the relevant standards and regulations associated with biocontamination control.

7.

Describe the relevant regulatory expectations for Biocontamination Control including ICH Q8, Q9 and Q10 and how CAPA can be used in response to a regulatory audit.

8.

Formulate and communicate judgements with regard to Biopharmaceutical contamination case scenarios.

Teaching and Learning Strategies

Online recorded and live lecture, self study through the provision of independent projects.

Module Assessment Strategies

The assessment approach for this module will be 70% Continuous Assessment with a range of assessment methods employed including some of the following: short‑form assessment exams incl. MCQ's, project assignments, practical work, essays, oral presentations, vivas etc. 30% will take the form of a seatscript final examination.

Repeat Assessments

Repeat assessments in the form of online MCQ's LAQs, project assignments, practical work, essays, oral presentations and vivas. A repeat final exam will alos be made available where necessary.

Indicative Syllabus

The following is a summary of the main topics included in this module: general principles and methods of Biocontamination control; establishing and verifying the formal system for control and associated test methods and requirements; traditional and modern methods of microbial detection; expressing, interpreting and reporting results; training and documentation requirements. The module does this through consideration of basic microbiology and specific microbes of relevance, potential sources of contamination, techniques & tools for prevention and correction/removal of biocontamination including, monitoring and detection methods, and case study evaluations. Quality systems will also be addressed particularily ICH (international Committee of Harmonisation) documents, 5, 9, 10 and 11.

 

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
70 %
End of Semester / Year Formal Exam
30 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Continuous Project Project Written Report 40 % End of Semester 1,2,3,4,5,6,7,8,9
2 Viva and presentation Project Oral Exam 10 % End of Semester 1,2,3,4,5,6,7,8,9
3 Continuous Assessment Continuous Assessment Closed Book Exam 20 % OnGoing 1,2,3,4,5,6,7,8,9

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Final seat script terminal exam Final Exam Closed Book Exam 30 % Week 19 1,2,3,4,5,6,7,8,9
             
             

Full Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Online Lecture 2 Weekly 2.00
Independent Learning Not Specified Self study 7 Weekly 7.00
Total Full Time Average Weekly Learner Contact Time 2.00 Hours

Module Resources

Non ISBN Literary Resources

 

Fleming and Hunt's: Biological Safety Principles and Practices (Third Edition)

Editors: Flemming and Hunt

Print ISBN: 1-55581-180-9   

 

Hugo and Russell's: Pharmaceutical Microbiology (Seventh Edition)

Editor(s): Stephen P Denyer, Norman A Hodges, Sean P Gorman

 

Print ISBN: 9780632064670 Online ISBN: 9780470988329.

  

Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements,Second Edition, 2nd Edition By Lucia Clontz.

ISBN: 978‑1‑4200534‑8‑7.

Rapid Microbiological Methods in the Pharmaceutical Industry

 

Editors: Martin C. Easter

 

ISBN: 978‑1‑57491‑141‑1 (hardback) 978‑0‑203‑01087‑7 (electronic).

URL Resources

www.fda.gov

www.ich.org

Other Resources

none

Additional Information

none