Full Title Facilites and Utilities.

Short Title Facilites and Utilities.

Code BIO07012
Level 07
Credit 05

Author Tobin, Kieran
Department Applied Sciences

Subject Area Bio Tech/Eng/Chem
Attendence N/A%
Fee

Description
This module aims to provide students with a good understanding of the main support service areas involving both facilities and utilities that underpin the modern biopharmaceutical manufacturing industry.

Indicative Syllabus
General Outline of Facilities and Utilities.

Cleanroom Technology (design, operation and monitoring) and its application for Biopropcessing.

Water Treatment Systems and their applications for Biopharmaceutical Processing.

Cleaning Systems including CIP.

Sterilisation Technologies including SIP.

Other typical Utility Systems.


Learning Outcomes
On completion of this module the learner will/should be able to
  1. Outline the main elements and features of facilities and utilities relating to the modern biopharmaceutical industry.

  2. Explain the key principles of cleanroom technology for Biopharmaceutical Processing. 

  3.  Describe the key elements of a water purification system for Biopharmaceutical Processing. 

  4.  Describe the key principles involved in cleaning and sterilisation including CIP and SIP systems.   

  5.  Perform research on a relevant topic and analyse, evaluate and draw conclusions accordingly.

  6. Communicate and explain scientific data relating to facilities and utilities for biopharmaceutical processing.


Assessment Strategies
A combination of continuous assessment strategies, some laboratory experiments and an end-of-term exam.

Assessment Facilitites
Online teaching technologies.

Module Dependencies
Pre Requisite Modules
None
Co Requisite Modules
None
Incompatible Modules
None

Coursework Assessment Breakdown %
Course Work / Continuous Assessment 70 %
End of Semester / Year Formal Examination 30 %

Coursework Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week
Continuous Assessment Short-form exams and assessments. 1,2,3,4,5,6 70 OnGoing


End Exam Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week
Final Exam 1,2,3,4 30 End of Term


Distance Learning Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Part Time Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload
Lecture Distance Learning Suite Online lecture. 1 Weekly 1.00
Directed Learning Not Specified Directed self-study. 4 Weekly 4.00

Total Average Weekly Learner Workload 5.00 Hours

Full Time Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Online Learning Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Resources
Book Resources
'Pharmaceutical Biotechnology - Concepts and Applications' by Gary Walsh.

Wiley Publications. 2007. ISBN - 978-0-470-01244-4.



ISPE Baseline Guide Volume 6 - 'Biopharmaceutical Manufacturing Facilities'.



ISPE Baseline Guide Volume 4 - 'Water and Steam Systems'.



PDA Technical Report #1 - 'Validation of Moist Heat Sterilisation Processes'.

2007. Supplement Volume 61. No. S-1.
Other Resources
None
Url Resources
Additional Info