BIO06016 2011 Cleaning, Sanitisation and Utilities.

General Details

Full Title
Cleaning, Sanitisation and Utilities.
Transcript Title
Cleaning, Sanitis. and Utils.
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
ASCI - Applied Sciences
06 - NFQ Level 6
05 - 05 Credits
Start Term
2011 - Full Academic Year 2011-12
End Term
2019 - Full Academic Year 2019-20
Kieran Tobin
Programme Membership
SG_SGOOD_C06 201600 Higher Certificate in Science in Good Manuf Practive & Technol

This module aims to provide students with a general knowledge and understanding of the main principles and methods of operation for cleaning systems, sanitisation systems and principal utilities involved for Biopharmaceutical processing.     

Learning Outcomes

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


Describe the key principles involved in cleaning systems for Biopharmaceutical Processing including CIP systems.


Describe the key principles involved in sanitisation systems for Biopharmaceutical Processing including detergents, disinfectants etc.


Explain the key elements of a purified water treatment system including the generation of PW and WFI.


List and describe other important utility systems for Biopharmaceutical Processing including Clean Steam, Process Air/Gases etc.


Outline the main analytical technologies and techniques that apply to cleaning, sanitisation and utilities.

Module Assessment Strategies

A combination of continuous strategies and final end-of-term exam.

Indicative Syllabus

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

  • Cleaning agents, caustic and acid cleaning systems, types of residues.
  • Operation of a CIP system  for  a typical Biopharmaceutical Process.  
  • Conductivity and TOC  as  measures for determining rinsewater cleanliness.
  • Sanitisation using a variety of methodologies including detergents, disinfectants, steam (SIP) and hot-water systems etc.
  • The generation and storage of Potable Water, Purified Water and Water for Injection.
  • The generation of clean steam from purified water.
  • Other process utilities including clean steam, process air, process gases etc.
  • Relevant demonstrations associated with this module.

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

ISPE, Water and Steam Systems, Vol. 4., ISPE Baseline Guides., 2001

AWWA and ASCE, Water Treatment Plant Design., McGraw-Hill Professional., 2004

Other Resources


Additional Information