Coursework for Plant design and manufacturing principles in
(bio) pharmaceutical production
Plant design and manufacturing principles in (bio)
pharmaceutical production Coursework brief 2014Hand-in date:
Hardcopy on Thursday 19th March 2015 by 1pm (to General Office)
and
Electronic copy via the Turnitin on Canvas by midnight Thu 19th
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!
PAGE 1
