VOMP3006: Site master plan for a new aseptic manufacturing facility, and the design of its environmental control and clean utility systems: Principles of Pharmaceutical Facility Design, Report, TUD, Malaysia
| University | Technological University Dublin (TUD) |
Assignment Instructions:
Write a 3,000-word report to give senior management the information they need to make informed decisions about a new aseptic manufacturing facility. The report should cover the 5 key sections of:
- Production Logistics
- Process Flow
- Site Master Plan
- Cleanroom Layout
- Utility Support Systems
There are details about what you need to cover for each of the key sections in the following pages. The report should be supplemented with relevant diagrams as noted in the section descriptors below.
Make sure to include your rationale for the proposed layouts, explaining how your proposed design meets the regulatory and GMP requirements of product quality and patient safety.
As well as the 5 sections of the report, you should also include a 300 word Introduction and a 300 word Conclusion, remembering that your audience for this report is the senior management team who will be making the decision about the new manufacturing facility.
Don’t forget to include your reference list / bibliography at the end.
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Big Idea 1 – Production Logistics: How much Product is to be manufactured?
What you should cover:
Describe the sequence for the determination of manufacturing logistics for a typical biopharmaceutical product.
Big Idea 2 – Process Flow
What you should cover:
- Sketch, label and describe process flow diagrams illustrating typical biopharmaceutical unit operations for the sequential manufacture of both drug substances and drug products.
Big Idea 3 – Site Master Plan: What will the site look like?
What you should cover:
- Sketch and describe a hypothetical site master plan layout to incorporate drug substance, drug product and finished pharmaceutical activities.
Big Idea 4 – Cleanroom Layout for Aseptic Processing
What you should cover:
- Sketch and describe the configuration of a hypothetical cleanroom environment for aseptic processing (e.g. for vial filling operations).
Big Idea 5 – Utility Support Systems
What you should cover:
- (Major supporting point a) Describe process support and utility systems encountered on a typical biopharmaceutical facility.
- (Major supporting point b) Describe the similarities and differences between pharmacopeia grade purified water (PUW) and water for injection (WFI).
Conclusion
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