MANU7007 Validation Science Project 2025 : Validation of a 5,000L Bioreactor for Cell Culturing
| University | Munster Technological University (MTU) |
| Subject | MANU7007: Validation Science |
Table of Contents
1.0 Design features:
Task 1: Place concise and precise detail into Table 1:
| System: | |
|---|---|
| Purpose: | |
| Supplier: | |
| Application: | |
| Key Features Description (what it is?): |
Task 2: Construct a table of parameters for operation of the system
| Parameter | Conditions | Rationale |
|---|---|---|
Task 3: Based on design features and conditions, construct a drawing (Figure 1)
2.0 Results.
Task 4: Identify THREE IQ tests (Table 3) under the headings: IQ Test No, Qualification Test Name, Verification/Checking Purpose (what are you checking?). Include comprehensive detail for the Rationale i.e. the why, how and impact if failure occurred.
| Test No | Qualification Test Name |
Verification/Checking Purpose-what are you checking? |
Rationale | Ref |
|---|---|---|---|---|
| IQ-1 | ||||
| IQ-2 | ||||
| IQ-3 |
Task 5: Identify THREE OQ tests (Table 4) under the headings: OQ Test No, Qualification Test Name, Verification/Checking Purpose (what are you checking?). Include comprehensive detail for the Rationale i.e. the why, how and impact if failure occurred.
| PQ Test No | Qualification Test Name |
Verification/Checking Purpose |
Ref |
|---|---|---|---|
| OQ-1 | |||
| OQ-2 | |||
| OQ-3 |
Task 6: Identify THREE considerations for completing PV (Table 5)-what do you need to verify for in PV
| Test No | Qualification Test Name |
Verification/Checking Purpose-what are you checking? |
Rationale | Ref |
|---|---|---|---|---|
| PQ-1 | ||||
| PQ-2 | ||||
| PQ-3 |
Task 7: Identify THREE CQA, THREE CQI and THREE CPP of the process and include rationale to below in Table format (Tables 6-7).
| No | CQA | CQI | Why Critical? What does it effect? |
Ref |
|---|---|---|---|---|
| 1 | ||||
| 2 | ||||
| 3 |
| No | CPP | Why Critical? What does it effect? | Ref |
|---|---|---|---|
| 1 | |||
| 2 | |||
| 3 |
- HINT: Check out ISPE for Pharmaceutical Engineering Guides for New and renovated Facilities Volume 5 Commissioning and Qualification.
- Reference your information presented.
- Be concise and precise-fit concise and precise information into the tables provided. Sentences are only required not long paragraphs.
References
- The department recommends the use of the Harvard Referencing System. Information on this is given in CANVAS.
Appendix I-CHAT GPT Statement
Appendix II-1 page summary of how the project was completed and Reflection
Appendix III -Brain storming tool
Appendix IV-Meeting Minutes
- Include minutes of meetings (see minutes template). Summarise how the project was conducted and managed. What tools were used (social media, email etc)
- Include-date, time, venue, action items, actions completed (from previous meeting), issues.
- Include meeting with lecturer as a meeting minute
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Submission
DUE WK8 Monday 3rd Nov 13.00
Submit ONE hard copy (print out)-details to be confirmed.
Submit ONE project report online through CANVAS.
Your project will be processed through SIMULARITY on CANVAS for a similarity score.
Marks detected for similarity scores above 20%.
Marks deducted for late submission
Marks deducted or 0% marks will be given to team members not contributing
Important to note in project writing:
- Figure captions underneath
- Table captions above
- Include page numbers and No capitals mid sentence
Appendix I: CHAT GPT Statement
Copy and paste for each team member
| Student Name | Was CHAT GPT used | Name of Tool | Research words/statements used | Extent of Tool applied | What sections applied |
|---|---|---|---|---|---|
Appendix II: 1 Page summary of how project was conducted, what tools used and a reflection
Meet as a Team- face to face/online etc
What media platforms used-ZOOM, TEAMS, Whatsapp etc
How were documents shared-Googleapps etc?
Reflection
If you had to redo the project again what would you do differently?
Page 5 of 9
Appendix III: Brainstorming tool:
| Topic is: | |
|---|---|
| What is the main subject: | |
| Relevant Definitions to research | |
| Purpose in Biopharma-where used: | |
| Validation aspects: | – How does it interact in the process? – Direct/indirect system? – How does the system Impact on product’s quality? – If something goes wrong what/how would this impact? |
| Design features: What will the system do?
How does it work? What considerations will need to be decided on? |
Appendix IV:
Meeting Minutes
| Date | |
|---|---|
| Time | |
| Place | |
| Meeting called by: | Type of meeting: |
| Facilitator: | Note taker: |
| Attendees: |
Minutes
| Agenda item: | Discussion: |
|---|---|
| Action items | Person responsible | Deadline |
|---|---|---|
| ✓ | ||
| ✓ | ||
| ✓ | ||
| ✓ | ||
| ✓ | ||
| ✓ |
| Discussion topic | Action items | Status |
|---|---|---|
| 1. | 1. |
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Project Titles
| Project | Project Title |
| A | Validation of Cell Culturing: Qualification of a
Bioreactor (5,000L)
|
| B | Validation of Mixing Tank for Media prior to use in USP: Qualification of a Vessel Tank
(5,000L)
|
Marking Scheme
Deliverables:
- DESIGN (15 marks) Design Tables 1 (5 marks)
Design Conditions (5 marks)
Drawing (5 marks) - RESULTS: Body of work (66 marks)
OQ Table (18 marks)
PQ Table (18 marks)
PV (9 marks) iv. CQA defined-table (9 marks)
CQI (3 marks)
CPP Table (9 marks)
- Project Report and Project Management (19 marks)
Structure, Presentation, Table of Contents (4 marks)
Appendix I- Brainstorming (5 marks)
Referencing Format (2 marks) iv. References: Source of material (3 marks)
Project Management -minutes of meetings (5 marks)
| Design Features and Drawings (15 marks) | Body of Work –Results (66 marks) | Presentation, Structure, Table of Contents and List of definitions (4 marks) | Brain Storming-
Appendix I (5marks) |
Application of
Harvard Referencing System (2 marks) |
Ref Sources (3 marks) | Project Mgt
& team effort (5 marks) |
|
| EXCELL |
High level of detail and covers all main points in details. Publication LEVEL Implementation level in manufacturing (70%) |
High standard of results delivery Accurate results Detailed rationale and understanding delivered. References used Publication LEVEL (70%) |
Contains all main sections.
Exceptionally written/grammar Excellent standard of presentation and struture Excellent presentation of information using diagrams/tables Flow is good and easy to read. Publication LEVEL (70%) |
Excellent detail and understands the use of the unit operation
(70%) |
Used correctly.
Referencing format correct in text used. Publication Level
|
Excellent source and broad range of references from difference sources
(80%)
Excellent sources, variety of references used (70%)
Publication LEVEL |
Professional level |
| VG | Contains majority of main points.
Missing details for operation.(60%) |
Main aspects of results included in report. More effort in rationale development required.
One or two minor gaps, lacking detail/information in a few places. References used (60%) |
Contains all main sections. High standard of writing, and presentation.
Tables/diagrams included. Captions for tables/diagrams could be better. Few grammar or spelling errors. (60%) |
Comprehensive-more detail required in places (60%) | Harvard referencing system used correctly
Slight error in the referencing format correct in text used (60%) |
Very good level of research.
Recent publications Broad research from different sources from engineering and science (60%) |
Completed and
Clear. |
| Gmore work | Missing major details for operation.
Requires re-work of information for implementation and operation. (40%)
|
Main aspects presented but gaps in information in the results.
Attempted rationale. Lacking examples/details in a lot of places. Information vague and not complete. Further clarity required. References used (40%) |
Fair attempt of layout/ generally expressed.
Presentation effort made. Many grammar and spelling mistakes. No captions. Missing sections (40%)
|
Average-gap presents and has a vague idea of its operation (40%) | Some references used in introduction and discussion More effort. (50%). | Good effort, could have researched more.
4-8 references. |
Average effort |
| A lot
more effort |
Major gaps, for implementation and operation
Inadequate detail. Complete rework (<40) |
Gaps in the results.
Missing results in one section. Incorrect results in places but attempt given. Rationale incorrect or poor detail or vague (35%)
Wrong focus. Significant aspects not mentioned. No rationale given in a lot of places (<35%) |
Presentation, structure, layout and grammar mistakes.
Very little effort. No use of tables/diagrams. No cations (40%) |
Major gaps/wrong perspective (<40%) | Attempt at referencing system used but not the Harvard system. No references used/attempt made in text (40%).
Referencing system mixed up.
|
Attempt to lacking | Attempt to Lacking |
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