BIO06019 2011 Sterilisation Technologies.

General Details

Full Title
Sterilisation Technologies.
Transcript Title
Sterilisation Technologies.
Code
BIO06019
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_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 general principles and methods of sterilisation focusing primarily on steam sterilisation.         

Learning Outcomes

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

1.

Describe the main forms and types of sterilisation technologies available to the Biopharmaceutical Industry.

2.

Explain the sterilisation concepts of D-value, Z-value, Fo and SAL and their overall importance in the design and operation of sterilisation applications. 

3.

Describe the operation of a typical steam sterilisation application such as an autoclave or an SIP system. 

4.

Compare other forms of sterilisation such as ethylene-oxide, gamma irradiation, dry-heat depyrogenation.

5.

Outline the main steps involved in the overall validation of a typical sterilisation cycle.  

Module Assessment Strategies

A combination of continuous assessment methods and final end-of-term exam.

Indicative Syllabus

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

  • Principles of microbial sterilization.
  • Different forms of sterilization - steam, gamma-ray irradiation, ethylene-oxide.
  • Design of sterile and sanitary processes.
  • Clean steam quality.
  • Bioburden load monitoring.
  • Bowie Dick Testing.
  • Fo calculations.
  • D values and Z values - SAL (sterility assurance levels).
  • BI's for wet and dry loads.
  • Steam hold time requirements.
  • Validation of sterilization cycles.
  • Practical demonstrations relating to sterilisation.

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

‘Contamination Control in Practice: Filtration and Sterilisation'

by Matts Ramstorp.

Wiley. Mar. 2003.

ISBN-10: 3527307761

ISBN-13: 978-3527307760

Other Resources

None

Additional Information

None