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Module Code - Title:

CH6042 - BIOPROCESS SAFETY

Year Last Offered:

2025/6

Hours Per Week:

Lecture

2

Lab

0

Tutorial

1

Other

0

Private

7

Credits

6

Grading Type:

N

Prerequisite Modules:

Rationale and Purpose of the Module:

To provide an understanding of the principles of managing process safety in the bioprocess/biopharma sector. To familiarise the student with: - The main process hazards in the bioprocess/biopharma sector - The main process safety management systems and analysis/assessment techniques used to control the associated risks to acceptable levels.

Syllabus:

An overview of the bioprocess/biopharma sector in terms of the related bioprocess safety considerations - Bioprocess hazards - Bioprocess safety management practices and systems - Bioprocess safety considerations in the design of bioprocess unit operations - Bioprocess risk analysis/assessment techniques

Learning Outcomes:

Cognitive (Knowledge, Understanding, Application, Analysis, Evaluation, Synthesis)

On successful completion of this module students will be able to: 1. Describe the bioprocess safety considerations pertaining to the range of operations used in the bioprocess/biopharma sector and the bioprocess life cycle 2. Describe the ratings associated with various bioprocess safety hazards 3. Describe the key parts of an effective bioprocess safety management system 4. Describe the bioprocess safety considerations relevant to the design of typical bioprocessing facilities and unit operations 5. Apply industry-standard risk analysis/assessment techniques to bioprocess unit operations

Affective (Attitudes and Values)

On successful completion of this module students will be able to: recognise and embrace the need for an effective bioprocess safety management system that ensures the control of bioprocess safety risks to acceptable levels.

Psychomotor (Physical Skills)

On successful completion of this module students will be able to: undertake a meaningful risk analysis/assessment of a bioprocess unit operation which incorporates the identification of the relevant process safety hazards, an evaluation of the related risks, and the proposal of appropriate control measures to reduce these risks to acceptable levels.

How the Module will be Taught and what will be the Learning Experiences of the Students:

This module will be taught through online lecture and tutorials.

Research Findings Incorporated in to the Syllabus (If Relevant):

Prime Texts:

AICHE (2010) Guidelines for Process Safety in Bioprocess Manufacturing Facilities , CCPS, Wiley

Other Relevant Texts:

Mannan, S. (2012) Lees' Loss Prevention in the Process Industries , Elsevier
Mannan, S. (2013) Lees' Process Safety Essentials , Elsevier
Kletz. T. (2019) What went wrong? , Elsevier
Marshall, V. and Ruhemann, S. (2000) Fundamentals of Process Safety , Inst of Chemical Engineers UK
Kletz. T. (1998) Process Plants: A Handbook for Inherently Safer Design , CRC Press
King, R. and Hirst, R. (1998) King's Safety in the Process Industries , Elsevier

Programme(s) in which this Module is Offered:

Semester(s) Module is Offered:

Spring

Module Leader:

Peter.Davern@ul.ie