PH2S107 - Commissioning & Qualification of Equipment and Systems 01 Jan 2022 - 31 Aug 2028 | Version 1
Associated Module Information
| Module Code: | PH2S107 | ||
|---|---|---|---|
| Module Title: | Commissioning & Qualification of Equipment and Systems | ||
| 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: | SEP 2023 | Final Year of Intake: | |
| Date Closed: | |||
| Credit Value: | 20 | Credit Level: | 5 |
| 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 is to define the testing requirements for a range of typical mechanical, process, instrumentation and automation systems used in the manufacture of medicinal products. This will range from standard good engineering practices (GEP), standard commissioning approaches, and specific regulatory focused qualification testing.
Content Summary
Indicative Syllabus:
• Interpreting P&IDs
• Traceability matrices: from URS to specifications, and from URS to PQ
• Equipment verification check sheets
• Instrument verification check sheets
• Piping verification check sheets
• Operational verification check sheets
• Defining the contents of IQ, and OQ protocols
• Populating a cleaning validation IOQ protocol
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 | Prepare and execute validation testing protocols and qualify equipment, instruments and piping systems, along with automated systems. |
| LO2 | Understand the design specifications used to generate testing scripts, and when and where testing scripts are needed during the project lifecycle. |
| LO3 | Interpret Process & Instrumentation Diagrams (P&IDs). |
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 complete the validation protocol for an equipment system including the population of IQ/OQ checksheets | 0 | 3000 | 100 | No | 40 |
Assessment Matrix
| Assessment Type | Learning Outcomes | ||
|---|---|---|---|
| LO1 | LO2 | LO3 | |
| Report 1 | ✔ | ✔ | ✔ |