PME 535A Project Report

Suggested Topics

Description
The PME 535 term paper is a team project that should be clear, concise, with assumptions
plainly identified and decisions explained. This is a conceptual design project. It should be an
original work; DO NOT just copy and paste from sources, although up to 25-30% (plus as many
pictures as you feel appropriate) may be copied, with proper references. I will split the class into
teams of students and assign one topic per team. You may split the work among the team
members to fill typical Pharmaceutical Manufacturing Facility project roles as described in
Project Guidelines.

Deliverables and Deadlines

1.

Each team shall submit the project report, there is no limit to pages long (single
spaced), using Microsoft Office. Please submit it electronically into the Term paper
assignment tool for grading, and also provide one paper copy. Only one submission
per team is needed with all team members listed for credit; I will make sure to post
the grade for it to students on the team (usually the same grade for members, unless
you tell me how the work was divided and there are major differences in quality
between the parts). Due by week 13of the course (exact due date will be on the
submission link and class announcement will be made a few weeks before the end
of the term)

I may submit this assignment into TurnItIn (its a web service designed to check the originality
of submitted papers) it is mostly to prevent students from copying papers from previous
semesters. Some degree of non-originality, however, is expected in this type of paper names
and descriptions of equipment, some paragraph you maybe copied from vendors web site and
properly quoted etc., so dont be concerned if you check your paper originality with TurnItIn or
similar software and it tells you that you have 10 or 15% non-original content. You will be able
to see the originality report in TurnItIn or plagerism shortly after submitting your paper.
2.
Teams also submit PowerPoint presentation summary of your reports to share with the
rest of the class. The team presentations will be conducted in class during Week 14 (exact date
will be announced in class). Each team member shall participate in the class presentation to
earn the grade. Plan on 15-20 minutes per team.
Email me your PPT file at least 2 days in advance ( vtrieu@stevens.edu ) so that I can have all
such files ready for the presentations session.

PME 535 Term Paper Topics

The topic of the Term Paper is a conceptual project report for a new pharmaceutical
manufacturing facility. To produce that report you need to read provided project guidelines and
brief description below:

Develop project and facility requirements, process description and process block flow
diagrams for a product or products the plant will make; you select type of products and
production technologies, e.g. a Biopharmaceutical plant with bioprocess platform
technologies or OSD plant: make your own assumptions or do research in those cases

where you need additional information beyond whats provided in the course before
moving on to the next step!

Find online companies offering the equipment you need, and select the models and sizes
you think are most appropriate for your plant.

Develop an equipment list youll need to buy, including type, size/capacity, manufacturer
and model where applicable in other words, dont just say Fluid Bed Dryer, but say
Fluid Bed Dryer model FBD-30XYZ by Glatt, working capacity 30 kg, such and such
options etc. I am looking for an equipment schedule with data that typically would be in
an User Requirement Specifications normally needed to install equipment in a GMP plant.

Develop a list of process rooms (architectural room cards) youll need in your facility to
perform the manufacturing functions for your selected product and indicate which pieces
of equipment will be located in each room.

Develop a conceptual floor plan with cGMP spaces and coordinated GMP flows for the
manufacturing systems that include personnel, materials, equipment, products, wastes, air
flows, etc

I posted in Moodle a sample report from last years class. Its not perfect, but it illustrates the
idea of a conceptual design report. I also have examples of real-world conceptual design
report created by professionals in the field in my office if you wish to see.
Each team will develop such project report for a different type of manufacturing facility:
Team #1: Oral Solid Dosage Manufacturing Facility capable of making drug products in the form
of tablets (uncoated and coated) and hard gelatin capsules. You should be able to produce 200
batches per year, with batch sizes from 300,000 to 3 mln units (tablets or capsules) per batch
depending on the product. Typical tablet/capsule weight may vary from 100 to 500 mg for
different products.
Team #2: Facility for making and packaging creams and ointments. Assume you have 3 different
cream products with batch sizes of 2000 L each, and one ointment product with batch size of 3000
L. Make your own assumptions on the recipe for each product, types of packages that raw
materials come in, types of packages youll produce, etc. Estimate how much of each product
youll be able to produce per year.
Team #3: Facility for making and filling sterile injectable liquid solutions (in vials). Assume that
you have product concentrate (20% solution) stored frozen in 5 kg plastic bags; it needs to be
thawed, diluted in water (WFI) to 2% concentration, then sterile filtered and filled into 5 mL vials
(2 mL per vial). The filled vials are then inspected and packaged into cartons (4 vials per carton).
Batch size is 100 L (after dilution) and it should be aseptically filled in one shift. Estimate how
many vials youll produce per year (make your own assumptions about the speed of the filling line,
days lost to vacations, breakdowns etc.).
Team #4: Facility for producing a Biopharmaceutical product or multiple products using a
platform technology such as Recombinant DNA or Monoclonal Antibodies. The scale will be at
least 5000L up to 20,000L of cell culture using a mammalian cell expression system.

Sources of information
Although you are free to use any sources you can find, here are a few sources that may be useful as
a starting point:
http://www.pharmtech.com
http://www.pda.org
http://www.fda.gov
http://www.ispe.org
http://www.pharmamanufacturing.com
http://www.pharmaceuticalonline.com
http://www.lib.stevens-tech.edu/eresources/dbalpha.html
Encyclopedia of Pharmaceutical Technology Online edition of encyclopedia with full-text
articles available via Stevens Library web site (we have academic subscription available to
all students).

Term Paper guidelines

(These are recommendations, not a strong mandate. Some of them may not be applicable to
the type of paper you are writing, so use your judgment).
Style
Fonts should be as follows:
Title
Headers
Text

14 pt Times New Roman Bold

12 point Times New Roman Bold
12 point Times New Roman

The elements of the paper are listed below in the order in which they should appear:
1. title
2. author name
3. abstract
4. body of paper
5. references
6. appendices
Title & Author Name
The title of the paper should be concise and definitive. Author name should consist of first name,
middle initial, last name.
Abstract
A short abstract (150 words maximum) should open the paper. The purpose of the abstract is to
give a clear indication of the objective, scope, and results of the paper.

Body of the Paper-Text

The chief purpose of the paper is to convey information to others, many of whom may be less
familiar with the general subject than the author. Care should be taken, therefore, to use simple
terms and expressions and to make statements as concise as possible. If highly technical terms or
phraseology are necessary, they should be adequately explained and defined.
All papers should be concise regardless of length. Long quotations should be avoided by referring
to sources. Illustrations and tables, where they help clarify the meaning or are necessary to
demonstrate results properly, are desirable, but they should be kept to a practicable minimum.
Detailed drawings, lengthy test data and calculations, and photographs that may be interesting, but
which are not integral to the understanding of the subject, should be omitted.
Headings
Headings and subheadings should appear throughout the paper to divide the subject matter into
logical parts and to emphasize the major elements and considerations. These headings assist the
reader in following the trend of thought and in forming a mental picture of the points of chief
importance. Parts or sections may be numbered, if desired, but paragraphs should not be
numbered.
Tabulations/Enumerations
Where several considerations, conditions, requirements, or other qualifying items are involved in a
presentation, it is often advantageous to put them in tabular or enumerative form, one after the
other, rather than to run them into the text. It is customary to identify the individual items as (1),
(2), (3), etc., or as (a), (b), (c), etc.
Mathematics
Equations should be numbered consecutively beginning with (1) to the end of the paper, including
any appendices. The number should be enclosed in parentheses (as shown above) and set flush
right in the column on the same line as the equation. It is this number that should be used when
referring to equations within the text.
Equations should be referenced within the text as "Eq. (x)." When the reference to an equation
begins a sentence, it should be spelled out, e.g., "Equation (x)."
Figures
All figures (graphs, line drawings, photographs, etc.) should be numbered consecutively and have
a caption consisting of the figure number and a brief title or description of the figure. This number
should be used when referring to the figure in text. Figures should be referenced within the text as
"Fig. 1." When the reference to a figure begins a sentence, the abbreviation "Fig." should be
spelled out, e.g., "Figure 1."
Tables
All tables should be numbered consecutively and have a caption consisting of the table number and
a brief title. This number should be used when referring to the table in text.

References
Text Citation. Within the text, references should be cited in numerical order according to their
order of appearance. The numbered reference citation should be enclosed in brackets.
Example: It was shown by Prusa [1] that the width of the plume decreases under these conditions.
In the case of two citations, the numbers should be separated by a comma [1,2]. In the case of
more than two reference citations, the numbers should be separated by a dash [5-7].
List of References. References to original sources for cited material should be listed together at the
end of the paper; footnotes should not be used for this purpose. References should be arranged in
numerical order according to their order of appearance within the text.
References to journal articles, papers in conference proceedings, or any other collection of works
by numerous authors should include:
1.
2.
3.
4.
5.
6.

last name of each author followed by their initials

year of publication
full title of the cited article
full name of the publication in which it appeared
volume number (if any) in boldface
inclusive page numbers of the cited article

(2) References to textbooks, monographs, theses, and technical reports should include:
1.
2.
3.
4.
5.
6.

last name of each author followed by their initials

year of publication
full title of the publication (book titles in italic)
publisher
city of publication
inclusive page numbers of the work being cited

(3) References from the web should include:

1.
website
2.
title or reference to subject
3.
date accessed
Sample References
[1] Kwon, O. K., and Pletcher, R. H., 1981, ''Prediction of the Incompressible Flow Over a
Rearward-Facing Step,''Technical Report HTL-26, CFD-4, Iowa State Univ., Ames, IA.
[2] Lee, Y., Korpela, S. A., and Horne, R. N., 1982, ''Structure of Multi-Cellular Natural
Convection in a Tall Vertical Annulus,'' Proc., 7th International Heat Transfer Conference, U.
Grigul et al., eds., Hemisphere Publishing Corp., Washington, D.C., Vol. 2, pp. 221-226.
[3] Sparrow, E. M., 1980, ''Fluid-to-Fluid Conjugate Heat Transfer for a Vertical Pipe-Internal
Forced Convection and External Natural Convection,'' ASME J. of Heat Transfer, 102, pp. 402407.
[4] Sparrow, E. M., 1980, ''Forced-Convection Heat Transfer in a Duct Having Spanwise-Periodic
Rectangular Protuberances,'' Numerical Heat Transfer, 3, pp. 149-167.

[5] Tung, C. Y., 1982, ''Evaporative Heat Transfer in the Contact Line of a Mixture,'' Ph.D. thesis,
Rensselaer Polytechnic Institute, Troy, NY.
[6] Amon, A., Jr., 1995, Electronic Packaging, John Wiley and Sons, New York.
[7] www.fda.gov/cder/guidance/1874dft.pdf, FDA Draft Guidance on Aseptic Processing, as of
3/6/04.