BIO06015 2011 Biocontamination Control Level 6.

General Details

Full Title
Biocontamination Control Level 6.
Transcript Title
Biocontamination Control.
Code
BIO06015
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
ASCI - Applied Sciences
Level
06 - NFQ Level 6
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2011 - Full Academic Year 2011-12
End Term
2019 - Full Academic Year 2019-20
Author(s)
Kieran Tobin
Programme Membership
SG_SASEP_E06 201100 Certificate in Science in Aseptic Processing. SG_SGOOD_C06 201600 Higher Certificate in Science in Good Manuf Practive & Technol
Description

This module aims to provide students with a general knowledge and understanding of the key principles and methods of biocontamination control as it relates to the Biopharmaceutical industry.     

Learning Outcomes

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

1.

Discuss and evaluate the most relevant biocontaminating organisms for the biopharmaceutical industry and the typical sources of each.

2.

Identify and discuss appropriate prevention techniques for each biocontaminant organism.

3.

Describe the theory behind the detection test methods available for biocontaminants including traditional and rapid identification testing.

4.

Develop  an appropriate biocontamination control monitoring regime for a  biopharmaceutical facility.

5.

Outline  an appropriate system / process for biocontamination control and incorporate elements of a GMP quality control system.    

Indicative Syllabus

The following is a summary of the main topics included in this module:

  • Typical biocontaminant organisms related to the biopharmaceutical industry.
  • General principles and methods of biocontamination control.
  • Establishing and verifying the formal system for control and associated test methods and requirements for biocontamination control.
  • Traditional and modern methods of biocontaminant detection and measurement.
  • Expressing, interpreting and reporting biocontamination monitoring results.
  • Training and GMP documentation requirements associated with biocontamination control.
  • Some relevant demonstrations relating to biocontamination control.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
50 %
End of Semester / Year Formal Exam
50 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Continuous Assessment Short-form exams and assignments. Continuous Assessment UNKNOWN 50 % OnGoing 1,2,3,4,5
             
             

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Final Exam Final Exam UNKNOWN 50 % End of Term 1,2,3,4,5
             
             

Part Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Distance Learning Suite Online lecture. 1 Weekly 1.00
Directed Learning Not Specified Directed self-study. 4 Weekly 4.00
Total Part Time Average Weekly Learner Contact Time 5.00 Hours

Module Resources

Non ISBN Literary Resources

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.

 

Rapid Microbiological Methods in the Pharmaceutical Industry

Editors: Martin C. Easter

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

Other Resources

None

Additional Information

None