CHEP9008 - Facilities & Utilities

Module Details

Module Code: CHEP9008
Title: Facilities & Utilities
Long Title: Facilities & Utilities
NFQ Level: Expert
Valid From: Semester 1 - 2024/25 ( September 2024 )
Duration: 1 Semester
Credits: 5
Field of Study: 5240 - Chemical & Process Eng
Module Delivered in: 1 programme(s)
Module Description: This module explores pharmaceutical/biopharmaceutical facilities & utilities from a GMP compliance, mechanical and architectural perspective while also considering regulatory guidance and requirements.
 
Learning Outcomes
On successful completion of this module the learner will be able to:
# Learning Outcome Description
LO1 Critique a biopharmaceutical facility from a mechanical, environmental, architectural utilities and in working towards a sustainability perspective.
LO2 Specify utilities deemed critical for GMP compliance.
LO3 Formulate engineering considerations for technology transfer and new product introductions.
LO4 Interpret typical facility utilities regulatory citation warning letters in terms of engineering solutions.
Dependencies
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 MTU module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
Incompatible Modules
These are modules which have learning outcomes that are too similar to the learning outcomes of this module. You may not earn additional credit for the same learning and therefore you may not enrol in this module if you have successfully completed any modules in the incompatible list.
No incompatible modules listed
Co-requisite Modules
No Co-requisite modules listed
Requirements

This is prior learning (or a practical skill) that is mandatory before enrolment in this module is allowed. You may not enrol on this module if you have not acquired the learning specified in this section.
No requirements listed
 
Indicative Content
(Bio)pharmaceutical Facility Architectural:
Facility design & concepts, flows and their impact, placing the facility on the site, envelope building shell design and visual design influences, modular, construction issues, seismic considerations, facility design methodologies, building information modelling (BIM) contracting.
(Bio)pharmaceutical Mechanical:
Mechanical systems & environmental controls, risk tools to classification & HVAC design, typical HVAC design parameters, sustainability in the context of biopharmaceutical facility design. Aide Memoire 07121104 classifications, PIC/S and EMA application of ISO14644.
Critical Utilities GMP Compliance:
Critical utilities from a regulatory perspective: potable water, purified water, water for injection, pure steam, clean compressed air, process gases. validation for critical utilities: plans, commissioning, qualification, process, lifecycle and revalidation, decommissioning and retirement.
Engineering Considerations for Technology Transfer:
Review engineering consideration examples of tech. transfer scenarios. Environmental, waste treatment, bulk solvent.
GMP Manufacturing Execution Systems (MES):
MES Strategy for control and compliance, MES life cycle, operation phase configuration management, backup and recovery of software & data, record retention, achieve and retrieval, business continuity and contingency planning, periodic review.
Manufacturing Plants
Overview of different manufacturing plants at a high level i.e.: API plant, biologics plant, oral solid dosage tableting plant. Sterile versus non-sterile operational requirements & associated GMP.
Module Content & Assessment
Assessment Breakdown%
Coursework50.00%
End of Module Formal Examination50.00%

Assessments

Coursework
Assessment Type Short Answer Questions % of Total Mark 25
Timing Week 5 Learning Outcomes 1
Assessment Description
In-class assessment of a biopharmaceutical facility from a mechanical, environmental and architectural utilities perspective.
Assessment Type Short Answer Questions % of Total Mark 25
Timing Week 11 Learning Outcomes 1,2,3
Assessment Description
In class short answer questions
End of Module Formal Examination
Assessment Type Formal Exam % of Total Mark 50
Timing End-of-Semester Learning Outcomes 1,2,3,4
Assessment Description
End of semester formal exam
Reassessment Requirement
Repeat examination
Reassessment of this module will consist of a repeat examination. It is possible that there will also be a requirement to be reassessed in a coursework element.

The University reserves the right to alter the nature and timings of assessment

 

Module Workload

Workload: Full Time
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact Theory on course topics and discussion of industry relevant examples. Every Week 3.00 3
Independent & Directed Learning (Non-contact) Non Contact Review of lecture notes, recommended material and in-class topics. Every Week 4.00 4
Total Hours 7.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
Workload: Part Time
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact Theory on course topics and discussion of industry relevant examples. Every Week 3.00 3
Independent & Directed Learning (Non-contact) Non Contact Review of lecture notes, recommended material and in-class topics. Every Week 4.00 4
Total Hours 7.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
 
Module Resources
Recommended Book Resources
  • Potdar, Manohar A.. (2017), Pharmaceutical Facilities: Design Layouts and Validation, 2nd. [ISBN: 9788178003283].
  • Atkin, Brian; Brooks, Adrian. (2015), Total Facilities Management, 4th. Wiley, [ISBN: 9781118655].
  • Terry Jacobs, Andrew A. Signore. (2016), Good Design Practices for GMP Pharmaceutical Facilities, 2nd. CRC Press, p.0, [ISBN: 9781482258905].
Supplementary Book Resources
  • International Society for Pharmaceutical Engineering. (2018), ISPE Good Practice Guide: Technology Transfer, 3rd. [ISBN: 9781946964151].
This module does not have any article/paper resources
Other Resources
 
Module Delivered in
Programme Code Programme Semester Delivery
CR_ERNPI_9 Master of Science in Regulated New Product Introduction & Technology Transfer 2 Mandatory