BIO06016 2019 Cleaning, sanitisation and utilities

General Details

Full Title
Cleaning, sanitisation and utilities
Transcript Title
Cleaning sanitisation utility
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
LIFE - Life Sciences
06 - NFQ Level 6
05 - 05 Credits
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Stephen Daly, Aodhmar Cadogan
Programme Membership
SG_SASEP_E06 201900 Certificate in Aseptic Biopharmaceutical Operations SG_SGOOD_C06 202300 Higher Certificate in Science in Good Manufacturing Practice and Technology SG_SGOOD_C06 202300 Higher Certificate in Science in Good Manufacturing Practice & Technology

This module aims to provide students with a general knowledge and understanding of the main principles and methods of operation for cleaning systems, sanitisation of systems and the principal utilities involved for Biopharmaceutical processing. Students will develop an understanding of the common residues or soiling that occur in a biomanufacturing environment and the selection of appropriate cleaning agents for each situation. Discussion of critical utilities for water and steam will also be provided.     

Learning Outcomes

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


Identify and describe the types of residue that commonly occur in Biopharmaceutical Processing environments and the appropriate cleaning systems to cope with each, including COP and CIP


Describe the key principles involved in the sanitisation of 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.

Teaching and Learning Strategies

This module will be delivered part time.  It will include lectures augmented by independent learning and directed learning.  Moodle will be used as a repository of educational resources.


Module Assessment Strategies

This module is 50% continuous and 50% final exam.

Repeat Assessments

 Repeat continuous assessment and/or repeat final exam.

Module Dependencies


Indicative Syllabus

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

  • Types of residues and associated cleaning agents, and caustic and acid cleaning systems

  • Operation of COP and CIP systems for a typical Biopharmaceutical Process.

  • Conductivity and TOC as measures for determining rinse-water 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 Coursework Assessment Assessment 50 % OnGoing 1,2,3,4,5

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 End of Semester Final Exam Final Exam Closed Book Exam 50 % End of Semester 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., 2011

AWWA and ASCE, Water Treatment Plant Design., 5th edition, McGraw-Hill Professional., 2012 ISBN: 9780071745727

Journal Resources


URL Resources


Other Resources


Additional Information