PH3S107 - Design and Operation of Cleanrooms 01 Jan 2022 - 31 Aug 2028 | Version 1
Associated Module Information
| Module Code: | PH3S107 | ||
|---|---|---|---|
| Module Title: | Design and Operation of Cleanrooms | ||
| Faculty: | Faculty of Computing, Engineering and Science | ||
| Faculty Group: | Chemical and Environmental Sciences | ||
| Faculty Sub Group: | Chemical and Environmental Sciences | ||
| Module Leader: | |||
| Module Team: | Suzanna Kean | ||
| First Intended Intake: | APR 2022 | Final Year of Intake: | |
| Date Closed: | |||
| Credit Value: | 20 | Credit Level: | 6 |
| Language: | English | ||
| Percentage of Module Taught in Welsh: | 0 | ||
| Equivalent Module: | |||
| HECOS codes: | 100144 - pharmaceutical engineering | ||
| HECOS Code Weighting: | 100 | ||
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 the students an understanding of the design and operation of cleanrooms to control contamination in a production setting, and the aseptic and sterile pharmaceutical manufacturing systems used in this environment. In addition, the module provides an understanding of the formulation goals and objectives for fill/finish sterile injectable drug products.
Content Summary
Indicative Syllabus:
• HVAC Requirements for Manufacture of Sterile Medicinal Products, and aseptic processing – Classified environments
• Area Classification Protection
• Working in a Cleanroom environment, and gowning requirements
•Setting formulation goals: physicochemical and biological properties
•Container closure systems and delivery systems for the administration of parenteral medication to patients
•Formulation additives, adjuvants and preservatives
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 | 86 |
| Formative Assessment - Independent | 14 |
| Total Hours Selected | 200 |
Learning Outcomes
| # | Learning Outcome |
|---|---|
| LO1 | Understand the fundamentals of Heating, Ventilation, and Air Conditioning (HVAC) design in the operation of cleanrooms |
| LO2 | Determine suitable controlled environments for primary and secondary aseptic manufacturing, preventing cross-contamination from materials and personnel flows in Classified Environments and minimizing risks of microbiological contamination to the product, as well as particulate and pyrogen contamination, during aseptic processing |
| LO3 | Determine the formulation goals for a parenteral sterile filled medication |
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 address the design and operation of cleanrooms for the correct manufacture of medicinal products in an aseptic environment, and avoiding cross contamination to ensure product quality and patient safety. | 0 | 4000 | 100 | No | 40 |
Assessment Matrix
| Assessment Type | Learning Outcomes | ||
|---|---|---|---|
| LO1 | LO2 | LO3 | |
| Report 1 | ✔ | ✔ | ✔ |