Module Details

Module Code: PHAR S8021
Full Title: Health and Safety for the (Bio)Pharmaceutical Industry
Valid From:: Semester 1 - 2020/21 ( September 2020 )
Language of Instruction:English
Duration: 1 Semester
Credits:: 5
Module Owner::
  • annamarie rogers
  • Edel Healy
Departments: Life and Health Sciences
Module Description: The aim of this module is to provide students with a knowledge of health and safety legislation relevant to
the biopharmaceutical industry including the ability to recognize, evaluate and manage the relevant hazards
through a range of relevant risk assessment techniques
Module Learning Outcome
On successful completion of this module the learner will be able to:
# Module Learning Outcome Description
MLO1 Evaluate the statutory requirements for the management of relevant hazards in the Biopharmaceutical Industry
MLO2 Design appropriate risk assessment methodology and implement safety management systems.
MLO3 Appraise chemical classification, labelling and Packaging requirements and biological agent risks according to current legislation and codes of practice
MLO4 Assess methods of Environmental Monitoring and waste management
MLO5 Evaluate how workplace health hazards can be monitored and controlled
Pre-requisite learning
Module Recommendations
This is prior learning (or a practical skill) that is strongly recommended before enrolment in this module. You may enrol in this module if you have not acquired the recommended learning but you will have considerable difficulty in passing (i.e. achieving the learning outcomes of) the module. While the prior learning is expressed as named DkIT module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
No recommendations listed
Module Indicative Content
Safety, Health and Welfare at Work Act 2005 and associated regulations
Identify the employers and employee's role with regard to health and safety in the manufacturing sector. Know the essential components of a Safety Statement.
Risk Assessment
Principles of Risk Assessment; Undertake a risk assessment; Determine control measures, procedures and required documentation e.g. HAZOP ,SWIFT
Chemical Hazards
Chemicals Act; Classification, Labelling & Packaging Regulations; Chemical Hazards; Code of Practice (chemical agents); REACH
Biological Hazards
Biological Agents Regulations; Biohazards; Methods of prevention, control and disposal of biohazards; Biosafety; Code of practice for health and safety at work (biological agents) Regulations 2013 and 2020
Occupational Hygiene
Evaluation of health hazards; Mechanisms of control; Ventilation Control; Respiratory Protection mechanisms.
Environmental Hazards in Manufacturing
Waste storage and disposal, emissions, environmental impact of raw materials and packaging. Environmental Management System.
Machine, Gas, Electricity & Fire Safety
2007 Safety, Health and Welfare at Work (General Application) Regulations; Audits and safety checks; Control systems; Fire safety, protection and extinction
Module Assessment
Assessment Breakdown%
Course Work30.00%
Module Special Regulation


Part Time On Campus

Course Work
Assessment Type Class Test % of Total Mark 30
Marks Out Of 0 Pass Mark 0
Timing Sem 1 End Learning Outcome 1,2,3,4,5
Duration in minutes 0
Assessment Description
A 2 hour in-class exam
Assessment Type Project % of Total Mark 50
Marks Out Of 0 Pass Mark 0
Timing n/a Learning Outcome 2,3,4
Duration in minutes 0
Assessment Description
Complete a
chemical/environmental/biological risk
Assessment Type Practical/Skills Evaluation % of Total Mark 20
Marks Out Of 0 Pass Mark 0
Timing n/a Learning Outcome 2,3
Duration in minutes 0
Assessment Description
Students will complete two virtual H&S
lab simulations (based on chemical &
biological safety) and complete a quiz
upon completion.
No Final Examination
Reassessment Requirement
No repeat examination
Reassessment of this module will be offered solely on the basis of coursework and a repeat examination will not be offered.

DKIT reserves the right to alter the nature and timings of assessment


Module Workload

This module has no Full Time On Campus workload.
Workload: Part Time On Campus
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact Lecture Every Week 2.00 2
Practical Contact Chemical Safety & Biosafety Virtual Laboratories Once per semester 0.20 3
Independent Study Non Contact No Description Every Week 3.00 3
Directed Reading Non Contact No Description Every Week 3.00 3
Total Weekly Learner Workload 8.20
Total Weekly Contact Hours 2.20
Module Resources
This module does not have any book resources
This module does not have any article/paper resources
Other Resources