PH1S083 - Pharmaceutical Facility Design 01 Jan 2022 - 31 Aug 2028 | Version 1
Associated Module Information
| Module Code: | PH1S083 | ||
|---|---|---|---|
| Module Title: | Pharmaceutical Facility Design | ||
| Faculty: | Faculty of Computing, Engineering and Science | ||
| Faculty Group: | Applied Sciences | ||
| Faculty Sub Group: | Chemistry and Pharmaceutical Science | ||
| Module Leader: | Suzanna Kean | ||
| Module Team: | |||
| First Intended Intake: | Final Year of Intake: | ||
| Date Closed: | |||
| Credit Value: | 20 | Credit Level: | 4 |
| Language: | English | ||
| Percentage of Module Taught in Welsh: | 0 | ||
| Equivalent Module: | |||
| HECOS codes: | 100144 - pharmaceutical engineering | 100185 - safety engineering | |
| HECOS Code Weighting: | 50 | 50 | |
Document Version Information
| Version | 1 |
|---|---|
| Valid From | 01 Jan 2022 |
| Valid To | 31 Aug 2028 |
Module Aims
The aim of this module is to give candidates a strong grounding in the modern pharmaceutical science and engineering concepts of the environmental controls (air) and clean utility systems design that underpin an aseptic manufacturing facility and the quality systems used in this highly regulated environment to ensure the manufacture of safe and effective medicines for the public.
Content Summary
Indicative syllabus:
• mass balances and the process flow diagram
• clean utility generation and distribution system design
• process design for equipment sizing
• cleanroom layout and environmental controls design for material and personnel flows
• aseptic processing and vial filling
• site master planning and the project lifecycle for new equipment and systems
This module is delivered through open/distance learning resource packs, pre-recorded lectures, problem-solving exercises and case studies.
Learning and Teaching Methods
| Activity Type | Hours |
|---|---|
| Independent Study | 100 |
| Directed Study | 64 |
| Formative Assessment - Independent | 36 |
| Total Hours Selected | 200 |
Learning Outcomes
| # | Learning Outcome |
|---|---|
| LO1 | Understand the calculation of the mass balance for a process and the Quality Systems approach to pharmaceutical manufacturing. |
| LO2 | Define the Cleanroom layout and the Environmental Controls pressure profiles necessary to meet the materials and personnel flows of a regulated manufacturing environment and define the piping, instrumentation and process control design for the generation and distribution of clean utility systems |
| LO3 | Describe the aseptic processing requirements of a vial filling operation. |
Module Requisites
N/A
Assessment Criteria
| Assessment Category | Assessment Type | Description | Duration | Word Count | Weight (%) | Best of? | Pass Mark |
|---|---|---|---|---|---|---|---|
| Asynchronous Assessment | Report 1 | Assignment to develop a site master plan for an aseptic manufacturing process and the design of its environmental control and clean utility systems. | 0 | 3000 | 100 | No | 40 |
Assessment Matrix
| Assessment Type | Learning Outcomes | ||
|---|---|---|---|
| LO1 | LO2 | LO3 | |
| Report 1 | ✔ | ✔ | ✔ |