PRESENTER:

MARINA YUSOFF 2010672752

NUR SYAFIQAH KAMARUDIN 2010847576
CAROLINE APAU 2010488388
AZWADI ALI 2009424756
NURUL AFIQAH MOHD ZAKI 2010802956

PROCESS BACKGROUND/SELECTION


INTRODUCTION
Diabetes is one of the chronic diseases
occurs when the glucose level in blood is
increases due to breakdown of
carbohydrates
Insulin can help to convert excessive
glucose into glycogen to be stored in liver
Human insulin can be produced by
four different methods
Extraction from human pancreas
Chemical synthesis via individual amino
acids.
Conversion of pork insulin of
semisynthesis.
Fermentation of genetically engineered
microorganisms.

fermentation of genetically engineered
microorganisms or can be simply called as
recombinant DNA technology is chosen in
this project
This is because this technique is safe,
high recovery, high purity and almost
same with human insulin
Genetic Modification Organism
GENERAL PROCESS
Consists of fourth teen important steps
35 equipments and reactors involve in this
batch process
Duration for each batch is 6 days
Production for each batch is 1.81 kg
Production per year is 100 kg
Downstream process to improve the
quality of desired product
Fermentatio
n process
Cell
isolation
Cell
Disruptio
n
Centrifugatio
n
Solubilize
Inclusion
Bodies
(IB)
CNBr-
Cleavage
Sulfitolysis Refolding
HIC
column
Enzymati
c
Conversi
on
Reverse
Phase
Chromato
graphy
Second
stage
purification
Polishing
Freeze
Dry
MARKET ANALYSIS
N

Insulin Worldwide Market

Top 10 Countries Number of People with Diabetes

Insulin Worldwide Market
Trends in the Current Depressed
Market
The Price of Insulin
Profit Margin

Break Even Analysis

Break Even Calculation
Variable Cost
Cost Item Formula value
Raw Material RM 286 millions
Waste Treatment RM 27 thousands
Utilities RM 382 thousands
Operating Labour RM 993 thousands
Maintenance and repairs 0.06FCI RM 13 millions
Operating Supplies 0.009FCI RM 1.94 millions
Total
RM 302 millions
Break Even Calculation
Fixed Cost
Cost Item Formula Value
Fixed capital investment FCI RM 215 millions
Local taxes and insurance 0.032FCI RM 6.88 millions
Plant overhead costs 0.708 + 0.036FCI RM 8.45 millions
Total
RM 230 millions
Break Even Calculation
Total Revenue
Total Revenue = Production of insulin x Price of
insulin
Production of insulin = 99.55 kg/year
Price of insulin = RM 11.4 millions
/year
Total Revenue = RM 1.13 billions
Break Even Calculation
Break Even Point (BEP)
BEP = (Fixed cost/ Contribution margin) x Production
Contribution Margin = Revenues Variable Cost
Contribution Margin = RM 834 millions
Fixed Cost = RM 230 millions
Production = 99.55 kg/year

BEP = 27.50 kg/year need to be
produced
Cumulative Cash Flow
Operating Cost for the First Year
Total Cost = Variable Cost + Fixed Cost
Variable Cost = RM 302 millions
Fixed Cost = RM 230 millions
Total Cost = RM 532 millions
Cumulative Cash Flow
Cumulative Cash Flow Analysis
Year Total cost Cumulative cash flow
1 - 532,678,960 - 532,678,960
2 - 372,514,550 - 905,193,510
3
1,136,861,000
231,667,490
4
1,136,861,000
1,368,528,490
5
1,136,861,000
2,505,389,940
6
1,136,861,000 3,642,250,490
7
1,136,861,000 4,779,111,490
8
1,136,861,000 5,915,972,490
9
1,136,861,000 7,052,833,490
10
1,136,861,000 8,189,694,490
11
1,136,861,000 9,326,555,490
12
1,136,861,000 1.05 x 10
10

Cumulative Cash Flow
Cumulative Cash Flow Diagram
-0.2
0
0.2
0.4
0.6
0.8
1
0 2 4 6 8 10 12
C
u
m
u
l
a
t
i
v
e

C
a
s
h

F
l
o
w

(
1
0
1
0
)

(
R
M
)

Year
Payback Period
Conclusion
Market Analysis on Insulin Production
Fixed Capital Investment is RM 215 millions and this cost is
independent of production rate.
The Total Production Cost is RM 532 millions. It is summation
of Variable Cost and Fixed Cost.
The total insulin sale per year is RM 11.4 millions.
Total Revenue = RM 1.14 billions.
Net annual Profit = RM 700 millions
Total Production = 99.55 kg/year
BEP = 27.50 kg/year Productions
Up the BEP, it has been estimated that the plant would gain
some profit and therefore this project can be considered as
profitable as the production rate also is in conjunction with the
supply and demand in Malaysia.
The payback period is estimated about 3 years
SITE SELECTION

Chapter 3 : Site Selection
Comparison between Senai, Pulau Indah and Gebeng between several
criteria
A rating evaluation has been made




After all comparison, we decide to choose Gebeng Industrial Estate Phase
3

Gebeng Pulau Indah Senai
Total Rating 38 37 35
Location Description
a small town and main industrial area in Pahang state in Malaysia
near Kuantan Port
Kuantan is being identified as a Special Economic Zone (SEZ)
located inside East Coast Economic Region (ECER)
located only 5 kilometers from the Kuantan Port in Kuantan City
25km away from the Kuantan town and 250km from the Kuala
Lumpur

Land availability and prices
selling prices RM 15 per sq
can be bought with minimum 3 acres (130680 ft2) up to
maximum 250 acres (10890000 ft2)
So minimum price is RM 1,960,200 for 3 acres

Raw Material Availability
Supply within the Malaysia and imported from the
oversea
Company that responsible for been supplier within
Malaysia is Merck Sdn Bhd, Sigma-Aldrich (M) Sdn.
Bhd, and Fisher CW Medical (M)
Raw materials will be transported from these company
via road
The other raw material imported from oversea is
transported to nearest airport and port.
Transportation Network
Gebeng by-pass between Gebeng Industrial Estate and
Kuantan Port
The by-pass will directly link with the East Coast
Expressway to connect Kuala Lumpur with Kuantan
Kuantan Port is located only 5 kilometers from the
Gebeng Industrial Estate
Sultan Ahmad Shah Airport, Kuantan is approximately
35km from Gebeng Industrial Estate and connected via
Jalan Pintasan Kuantan
Not compacted with other activities, so smooth trafficking
of the import and exporting process
Availability of Utilities
main electricity supplier in Gebeng Industrial Estate is
Tenaga Nasional Berhad (TNB)
Phase I and II is supported by its 132/11kV main intake,
for Phase III, two sources of electricity supply are
available which are and 12/275kV main intake
water supply is Semambu Water Treatment Plant
capacity 2MG/D
main telecommunication supplier is Telekom Malaysia
for instance Integrated Systems Digital Network (ISDN),
digital line, MAYPAC, Internet and video conferencing
Availability of Labour
main labours sources is Kuantan population is
approximately 607,778 persons.
Also involves Kemaman area
Pahang provides access to skilled manpower as which
can be acquired numerous institutions of further studies

Universities Others Facilities
University Teknology MARA
University Malaysia Pahang
International Islamic
University Malaysia

Kolej Islam Pahang,
Politeknik Sultan Haji Ahmad
Shah
Kolej Komuniti Kuantan Kolej
ShahPutra Kuantan
Kolej Poly-Tech MARA
Institut Kemajuan Ikhtisas
Pahang (IKIP) College
Government Incentives
Development of Gebeng Phase III which will be
attraction for the investor to Pahang
The Eastern Industrial Corridor, which is the government
backed economic region developed into an ultra-modern
industrial region
Accelerated capital allowance provides a special
allowance, where the capital expenditure is written off
within 3 years
water supply to 64 MG/D
Building of new pipes and water tanks in Gebeng
Industrial Estate
MATERIAL BALANCE

General Mass Balance
Equation


1 batch approximately 6 days
100 kg/ yr X 1 yr/ 330 days X 6days/batch
= 1.818 kg/batch
330 days/ 1 yr X 6 days/ batch = 55
batches per year
Production rate = 100 kg/year

The calculation is based on the production rate of 100 kg/year of
insulin.
The target production rate per batch is 1.818 kg/batch.
Operating days for the plant is 330 days per year, 24 hours daily.
The system is a steady-state operation.
The system behaves as an ideal condition.
No leakage in the pipes or vessels inside the plant.
All the catalysts used during the process do not contribute to the
mass inside the system.
The total input of substances to compressor, pump, valve, mixer or
heat exchanger is equal to the total output.
All calculations are done in kg/batch


TSB + O
2
+ N
2
+ NH
3
+ H
2
O + kanamycin biomass
(E.coli) + O
2
+ N
2
+ NH
3
+ H
2
O+CO
2
+ kanamycin + ATPs


Overall mass balance: total in = total output
The percentage of air consists of 21% of oxygen, 79% of
nitrogen
870 kg/batch of Ammonium gas is purge into this system
Basis of 43 504 kg/batch air is purge into the fermenter
system

1.4% of oxygen from respiration of bacteria cell is
release as carbon dioxide
Conversion process for TSB is 95%
0.5 kg biomass can be generate for every 1 kg of TSB
consumed
kanamycin does not take part in the reaction so that total
input = total output
74 % of water will be increase after undergo
fermentation process due to biological process that
occurred.



Percentage error of calculation:
Manual calculation = 1.800kg/batch
Simulation = 1.810 kg/batch
Target production = 1.814kg/batch
(1.810-1.800) /1.810 X 100% = 0.55 %
(1.814-1.800)/1.814X 100% = 0.77 %

ENERGY BALANCE


Important in worldwide manufacturing plant to reduce the
cost and energy consumption.

To analyze and optimize the uses of energy in designing
a plant.




The system is assume as an open system
Q-Ws= H+Ek+Ep






The equation reduced to
= =

=H
f
+

= H
f
+ [

]
Ws, Ek and Ep =0

1. Assumptions:

Open system (Q=H) and steady state process
- No moving parts considered in the system
- All equipments are static
Heat from pressure change is neglected
All streams and reactions occur in liquid phase
- Occurs in homogeneous mixture. Thus, solid and gas is not taken into
account.
Heat of mixing, Hm is neglected

2. Basis:

Tref = 25C = 298.15K
P
ref
= 1atm
Mass flowrate is in kg/hour
Heat capacity,Cp get from SUPERPRO library
Using heat of formation method due to the facts that heat of reaction method for certain standard conditions is
unknown.

ENVIRONMENTAL AND SAFETY CONSIDERATION

Role of chemical engineer
Lack of consideration
Negative impact
-Human
-Animal
-Aquatic life

Follow the Malaysia Act & Regulation
-OSHA
-Environment Quality Act
(Air pollution, Scheduled Waste)
-Biosafety Act
Hazard
HIRARC


HAZARDOUS WASTE
Classification
Treatment
Biological Treatment
1.Inject with Chlorine
2.Sterilize the waste
3.Send to the Jabatan Alam Sekitar
Chemical Treatment
Recycle
Send to the Jabatan Alam Sekitar


Management
Recycle
Waste area
Labeling the waste
Put the sign of hazardous area
Disposal to the sanitary landfill