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
Are You Searching Answer of this Question? Request Ireland Writers to Write a plagiarism Free Copy for You.
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
http://www.turnitin.com/
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. |
Get Solution of this Assessment. Hire Experts to solve this assignment for you Before Deadline.
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 |
Stuck in Completing this Assignment and feeling stressed ? Take our Private Writing Services
A student shared this brief with our team; personal details have been removed. Our Validation Science desk works on tasks like this and can guide you on how to approach it.
As you can see from the above example, many Ireland students struggle with bioreactor validation tasks—especially structuring IQ, OQ, PQ tests and applying Harvard referencing. If you face similar issues, our thesis writing help, expert-led support for Biopharma & Engineering Assignments, and reliable Ireland Assignments ensure AI-free, plagiarism-free solutions that meet your university’s standards.
