MANU7007 Validation Science Project 2025 : Validation of a 5,000L Bioreactor for Cell Culturing

Table of Contents

1.0 Design features:

Task 1: Place concise and precise detail into Table 1:

Task 2: Construct a table of parameters for operation of the system

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.

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.

Task 6: Identify THREE considerations for completing PV (Table 5)-what do you need to verify for in PV

Task 7: Identify THREE CQA, THREE CQI and THREE CPP of the process and include rationale to below in Table format (Tables 6-7).

• 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

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

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:

Appendix IV:

Meeting Minutes

Minutes

Project Titles

Marking Scheme                                                                                                                                           

Deliverables:

1. DESIGN (15 marks) Design Tables 1 (5 marks)
   Design Conditions (5 marks)
   Drawing (5 marks)
2. 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)

3. 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)