Plant design and manufacturing principles in (bio) pharmaceutical

production
Coursework brief 2014
Hand-in date:
Hardcopy on Thursday 19th March 2015 by 1pm (to General Office) and
Electronic copy via the Turnitin on Canvas by midnight Thu 19 th March 2015. The
coursework hardcopy will not be marked unless the electronic copy is submitted.
The coursework is based around writing up the exercises you will do in the workshop on
Friday 30th January. You should also bring in additional knowledge gained during the
lectures this week and from your reading.
Description: You work for an engineering consultancy firm and have been asked by a
company who has a process to produce DNA vaccines to propose a concept design for a
new facility with an order of magnitude cost and schedule for the project. The document
needs to include the details of the design and layout of the facility along with information
on its qualification. You should also include details of the likely staff involved with the
project. (Remember this is about design of the facility not the process). The style and
presentation should be appropriate for issue to a client. (N.B. Elaborate binding is not
expected).
Word count: ~4000 - 5000 words (~15 pages including figures and tables).
Harvard Referencing System must be used. Information on how to use it will be
posted on Canvas.
Useful texts:

Bennett B and Cole G (eds) (2003). Pharmaceutical production: an engineering

guide. Rugby: IChemE (available through www.knovel.com)

Medicines Control Agency (2002). Rules and Guidance for Pharmaceutical

Manufacturers and Distributors. London: The Stationary Office. (Note that latest
edition is 2007)

Good design practices for GMP pharmaceutical facilities / Andrew A. Signore,

Terry Jacobs. New York; London: Informa Healthcare, 2008.

Quality in the manufacture of medicines and other healthcare products / John

Sharp. London: Pharmaceutical Press, 2002.

The brief is a deliberately general, allowing you scope to produce what you think
is relevant and appropriate, however take the following into account:
1) You are discussing the design of the facility and NOT the design of the process. It will
be necessary to provide brief details about the process (such as those given in the
workshop), but this is just to set the scene and to put your facility design into context.
2) You can use the workshop as the basis for your report. You must include in your
report at least two room data sheet specifications; material, people and waste flow
diagrams and a full layout of plant site based on the information given to you by
Roland Grzybek in order to illustrate your ideas and suggestions. These pages are in
addition to the 15 pages written report.
3) The word limit is just that - the maximum that you should write and is a guide. Tables,
diagrams, and a list of reference at the end of your report will not count towards the word
count. The overall balance between detailed drawings and text is up to you, but you must
show that you understand what you are doing and provide sufficient detail. Evidence of
supplementary reading will also enhance your marks. The Harvard referencing system
which is the system adopted by the University must be used throughout your report. Its
guidelines are posted in Canvas.
4) The brief says that "you have been asked by a company who has a process to
produce DNA vaccines to propose a design for a new facility." You are therefore
producing a report for a customer/client. You need to structure your report accordingly.
There is no prescribed structure, but think about what your client will need e.g. an
executive summary, contents page, conclusion etc.
5) There is no "correct" answer. Produce something professional and relevant and you
will be fine!