Chapter 4&5
Chapter 4&5
CHAPTER IV
PROTOTYPE
4.1 Sketch of Product
Our non alcoholic liquid cough medicine, has a shape of plastic bottle
made by polystyrene and sealed by aluminium foil. The volume of our product is
30 ml. We can drink it directly just shake it for a while, take the seal off, and drink
it. We dont have to drink water after drinking out product because actually, our
product is already have much water content.
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So, we make products based on the type of cough that is needed. There are
3 types of cough, which are dry cough, chesty cough, and also cold flu cough.
Based on that, we make just 2 types of medicine cough with different main active
substance in each of that. We combine the cold flu cough and the chesty cough
because the active substance is not too dangerous.
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CHAPTER V
PRODUCT MANUFACTURING
5.1 Market Segmentation
The main target of our consumer is segmented based on two
considerations. The first is the geographical location and the second consideration
is based on the market class segmentation (based on the income). In the first
consideration, we consider our product to be distributed only in Indonesia. The
consideration is based on some reasons. The first is Indonesia has a very high
population. Based on the data from United Nations, Department of Economic and
Social Affairs, Population Division, as on the year of 2015 the population of
Indonesia is reaching 255,708,785 and according to the same source the
population of the south east asia country in the same year is approximately 633
million people. It means that the population of Indonesia has a share of 40%
population in ASEAN that makes it a very good opportunity to be capitalized.
The other reason is the increasing amount of the Indonesian people
spending to any products related to health. Based on the data from the Business
Monitor International the Indonesians people spending on health product has
reached the number of 194 trillion rupiah in 2011. The number is projected to
grow in a constant rate of 13.9% each year. The growth rate then becomes the
basis on forecasting the growth of Indonesian people on medicine in couple years
ahead.
The market of our products itself, the OTC (over-the-counter) drug market
is also increasing in Indonesia. According to the research done by BMI, the
research considers Indonesia to be the most attractive market in South East Asia
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The relatively low cost and easy availability of OTCs and a difficult
financial situation still preclude many from visiting doctors, instead driving them
to self-medication. Such factors are encouraging the sale of herbal medicines.
Deficient health insurance in Indonesia is also pushing the consumption of OTCs
as many patients cannot afford to pay for their prescriptions and are forced to rely
on low-cost consumer health products although the government aims to address
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this issue. Similarly, according to Kalbe Farma's statements from August 2013,
consumers in the country are purchasing healthcare products despite fears over
inflation and economic slowdown. Moreover, the activity of pharmacy chains
supports the development of the OTC market. Companies such as Apotek K-24
and Century have not only made OTC products more accessible and affordable,
but have also increased consumers' knowledge of drugs, and their confidence to
self-medicate. The growing number of new communicable diseases will further
stimulate the OTC market over the coming years, as patients seek to prevent
contracting infection by any means possible. Environmental factors, such as
severe air pollution in urban areas and contamination of water supplies, are
causing deterioration in health across the country, thus also assisting sales of
OTCs as consumers attempt to manage their ailments.
To take a look deeper, the increasing the market of the OTC products is
also affecting the sales of the cough medicine product which is the part of the
OTC markets. The research done by the BMI in 2014 shown that the cough
medicine market sales is also increasing each year. Reaching the sales of $423.9
million in 2010.
From the data above, we could calculate the OTC medicine sales
estimation for the year of 2018 by using the linear regression method. We are
using the 2018 data because we estimate that we need 3 years from now to
develop our plant and product to be ready to enter the market.
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450
400
350
300
250
200
150
100
50
0
2002
2004
2006
2008
2010
2012
Year
$ 687,874,000 13,000
IDR
=Rp8.9 ntrillion
US $
Rp8.9 trillion
=445,000,000 pack
20,000 / pack
From the data above, then we could calculate also the demand of the
cough and cold medicine per day by dividing it with the total days a year of 365.
Daily demand=
445,000,000 pack
packs
=1.219 .180
365 days
day
Company
Darya Varia Group
Indofarma
Kalbe Farma
Kimia Farma
Pyridam Farma
Production (bottles)
800,000
11,000
40,000,000
10,000,000
1,105,920
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Table 2
5.1 Production supply for every cough medicine company (contd)
Company
Tempo Scan Pasific
Bristol Myers Squlb Indonesia
Bayer Indonesia
Dankos Laboratories
Total Production
(source: WHO)
Production (bottles)
7,200,000
2,400,000
49,000,000
8,000,000
118,516,920
= Demand Supply
= 267.000 million bottles 118.516 million bottles
= 148.484 million bottles
148.484
100 =55.61
267
From the data above, we assumed that our product, non-alcoholic liquid
cough medicine can cover the 5% of the deficit. The value is quite small because
we consider our product as a new product and has no marketing budget as big as
our competitors. The production capacity will be 16 million bottles per year.
Table 5.2 Production capacity per year for every cough medicine company
Company
Darya Varia Group
Indofarma
Kalbe Farma
Kimia Farma
Pyridam Farma
Tempo Scan Pasific
Production (bottles)
800,000
11,000
40,000,000
10,000,000
1,105,920
7,200,000
Table 5.2 Production capacity per year for every cough medicine company (contd)
Company
Production (bottles)
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2,400,000
49,000,000
8,000,000
16,000,000
134,516,920
16 millions
=11.9
134,516 millions
Basis
Yearly production (L)
Ingredients
Dextrometorphan Polistirex
Pseudoephedrin HCl
Chlorpheniramine Maleat
Paracetamol
Pepermint oil
Alcohol
480.000
Composition
Composition (%)
0,0083
0,0208
0,0001
1,3889
0,0278
0
Needs (L)
39,84
99,84
0,48
6.666,72
133,44
0
Ingredients
Propylene Glycol
Water
Composition
Composition (%)
5
57,4125
Needs (L)
24.000
275.580
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Fructose syrup
Color additives content
Suqqus Liquiritae
Sucrose
Benzoic acid
Sodium benzoate
methyl-paraben, propylparaben, butyl-paraben
Sorbitol
Essence
Carboxyl Methyl Cellulose
0
0,1
0,4639
35
0,2
0,2
0
480
2.226,72
168.000
960
960
0,1
480
0,05
0,025
0
240
120
0
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Production lines and tanks are prepared for CIP and sanitation.
Automatic control allows repeatability in the manufacturing process,
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various Active Pharmaceutical Ingredients (API) and Excipients are dispensed for
processing.
In the tank 1 all the excipients are mixed with the sugar syrup. The mixture
of sugar syrup and excipients is taken to the tank 2 where Active Pharmaceutical
Ingredients (APIs) are mixed. The solution from the tank 2 is taken to the co-mill
and homogenizer where all the raw materials are mixed uniformly to form a
homogeneous solution. This solution is pumped into the tank 3 where it is stored
before filling in the bottles. At this stage, a Quality Check is carried out to check
various quality-related aspects of the raw materials. It the solution is approved
during the quality check, it is taken to the filling section.
In the filling section, the bottles are filled as per the requirement where the
specified quantity is dispensed by the machine. After filling the bottle, the capping
takes place and the bottle is sealed. The sealed bottle, is taken for inspection
where the bottle is checked for quality related aspects like :
- Right amount of liquid filled in the bottle
- Bottle is air tight and sealed properly
- Any cracks in the bottle
- Leakage of liquid from the bottle, etc.
After filling the bottle, the labelling takes place. In labelling section, the
various manufacturing details are printed onto the primary pack like batch
number, date of manufacturing, maximum retail price of the therapeutic, etc. as
required by Food and Drugs Act.
Additionally, secondary packing is done for the oral liquids in cardboard
boxes and in corrugated boxes. The packed oral liquids go through QC for final
inspection.
5.5.1 Quality, Standart and Technology
The plant should adhere to the norms laid out in standards. Additionally, if
the unit is set-up for export of pharmaceutical products then should meet the
norms of US FDA, UK MCA, WHO, etc. as required in the export markets.
It should be noted that as the proposed unit would be involved in contract
manufacturing, the manufacturing process related technology would be provided
by the principal organisation for which the contract manufacturing would be
carried out. The proposed unit would not be involved in the basic formulations
related research in the initial years.
Additionally, the manufacturing technology would not differ from other
regions as the same is not region specific. As far as the cough medicine
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A. Mixer
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Spesification
Application
Voltage
Working state
Mixer Type
Cooling system
Heating medium
Heating method
Price
Value
Liquid with Suspended Solids
110V ~ 480V
Vacuum / Normal Pressure
Agitator
Cooling water
Water / Oil / Steam
Electric / Steam
US $1,000 - 50,000 / Set
(Source : wuximixers.en.alibaba.com)
Table 5.5. Technical Parameter
(Source : wuximixers.en.alibaba.com)
Table 5.6. Spesification
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(Source : wuximixers.en.alibaba.com)
B. Filling Machine
Filling and Capping Machine adapt 316SS pump to fill different type of
liquid , syrup, lotion , shampoo.
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C. Packaging
For packaging unit, we use manual methods (human) to packages the
cough medicine syrup in bottles to package which contain 4 bottles for each
package. In packaging unit, we split this section to two jobs. First packing jobs,
this jobs have a responbility to packages the cough medicine syrup in bottle to the
packages and the second is sealing jobs, this jobs have responbility to seal the
packages. Each jobs will be did by 5 peoples for each shift.
5.7 Mass and Energy Balance
5.7.1 Mass Balance
The calculation of production capacity in the previous section leads to the
discussion of mass balance of Cough Zero medicine production. From the final
result of market share, the maximum capacity that needs to be prepared for our
manufacturing unit is 11.000 bottles per cycle. In liquid cough medicine
manufacture process, there will be four cycles in a day to optimize the resources
that we had. In this mass balance, will be described details of components needed
to produce in one cycle. The mass balance can be seen from the tables below :
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Basis (mg)
396000
Compositio Compositio
Daily production
Ingredients
Dextromethorphan
n (%)
0,0083
n (mg)
32,868
Polistirex
Pseudoephedrin HCL
Chlorpheniramine Maleat
Paracetamol
Pepermint Oil
Suqqus Liquiritae
Propylene Glycol
0,0208
0,0001
1,3889
0,0278
0,4639
5
82,368
0,396
5500,044
110,088
1837,044
19800
27362,81
Ingredients
Compositio
Compositio
n (%)
57,4125
35
0,2
0,2
0,1
0,05
0,025
n (mg)
227353,5
138600
792
792
396
198
99
368230,5
Water
Sucrose
Benzoic Acid
Sodium Benzoate
Paraben
Sorbitol
Essence
Total
input/day
395593,3
The calculation of mass balance will devided into five parts, which are :
pre mixing, homogenizing, tank storage, filling & capping, and packaging. These
mass balance is made based on the block flow diagram of the process and weight
basis in the begining of market demand.
Table 5.8. Calculation for the mass balance of pre mixing process
Unit
Process
Material
Mixer
Pre-
Active
Dextromethorphan
mixing
Compound
Polistirex
Pseudoephedrin HCL
Input
Ouput
(mg)
(mg)
32,868
32,8023
82,368
82,2033
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Chlorpheniramine
0,396
0,3952
Paracetamol
5500,044
5489,0439
Pepermint Oil
110,088
109,8678
Suqqus Liquiritae
1837,044
1833,3699
Maleat
Table 5.8. Calculation for the mass balance of pre mixing process (contd)
Unit
Process
Material
Propylene Glycol
Input
Ouput
(mg)
(mg)
19800
19760,4
27362,80
27308,0823
Unit
Process
Input
Ouput
(mg)
(mg)
227353,
226898,7
93
Sucrose
138600
138322,8
Benzoic Acid
792
790,416
792
790,416
Paraben
396
395,208
Sorbitol
198
197,604
Essence
99
98,802
Intermediate
27362,8
27308,08
Product
08
238
395593,
394802,1
308
214
Material
Water
Sodium
Homogen
Homogen-
Addition
-ator
ation
Material
Benzoate
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Unit
Process
Material
Input (mg)
Ouput (mg)
Tank Storage
Storage
Bulk
394802,1214
394012,5171
Unit
Process
Material
Input (mg)
Ouput (Bottle)
Filler
Bulk
394012,5171
10945
Unit
Process
Material
Input (mg)
Ouput (Box)
Packaging
Packaging
Bottled Product
10945
2736
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No
Equipment
Electric Power
(kW)
Number of Equipment
Equipment
Production Target of
Total
Capacity
Equipment
Operation
Unit
Value
Unit
Time
(min)
Stirer
5,5
Lt/Cycle
22.802
Lt
45
Pump I
Lt/hr
22.802
Lt
45
Homogenizer
15
Lt/Cycle
329.661
Lt
60
Pump II
Lt/hr
329.661
Lt
60
Filtration System
Lt/Cycle
329.661
Lt
45
Pump III
Lt/hr
329.661
Lt
45
Heating System
36
Lt/batch
329.661
Lt
60
Filling
1,5
Bottle/hr
10.945
Bottle
120
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Based on literature, the power loss due to table plant energy requirement is
14% of the total power usage for overall process. Therefore, the power which
PLN supplied is 114% of total power requirements each day. The details is
described below.
Table 5.14 Calculation for total power needed
(Total power /
PLN) kWh
day) kWh
Stirer
4,7025
4,125
0,5775
Pump I
0,855
0,75
0,105
Homogenizer
17,1
15
2,1
Pump II
2,28
0,28
Filtration System
Pump III
1,71
1,5
0,21
Heating System
41,04
36
5,04
Filling
3,42
0,42
No
Equipment
Loss
From the table above, we know that the energy requirement to maintain the
manufacture process/ day for Ms.Marble, marble cleanser is 71.1075 kW with
14% energy loss.
5.8 Schedulling
5.8.1 Duration of Manufacture
The production process of cough medicine occurs in batch conditions. In
order to maximize the production of cough medicine, production carried out for
14 hours per day. This is because in order to minimize losses due to the cessation
of work tools. In addition, with this production operations can maximize the
performance of the human resources available. Factory can operate for all year.
Meanwhile, experienced a period of operation of this plant and maintenance
purpose of the tool factory was supervised once in a month.
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The duration of cough medicine production based on the time needed for
mixing, homogenizing, storing, filling, and packanging. Our calculation is based
on mixing in order to make the solution more homogeneous, the mixing time is a
function of Reynolds Number. The process of mixing that occurs is the process of
mixing with liquid as feed.
By using the specification tool that has been obtained, then the
calculations can be done. Here are reviews of specifications of mixing tanks are
used.
Mixer Spesification :
= 43 rpm
= 100cm
= 1.2 m
= 1.5 m
= 39.4 inch
= 47.2 inch
= 59 inch
MIXING
Mixing process in preparation of making marble cough medicine are
divided into two mixing: pre-mixing process and homogenation. Mixing both is
done at the time of insertion of the feed that comes from a mixture of active
compound and additive.
For the first mixing process, the process can take place by the following
equation.
2
=10.75
121.24
d
D
2.3
( )
=1240.5
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t b=
500
1240.5
=
=44.8 minutes
2.3
d
39.4 2.3
N
43
D
47.2
( )
( )
Mixing process in the acid granulation takes time to reach steady state, the time
required for mixing for 44.8 minutes.
The second mixing process in the acid granulation can determine by the
following equation.
(43) ( 39.4 )2 (0.644709)
N d2 S
=10.75
=10.75
=1.76 102
709.53
Based on graphic on Chemical Process Equipment, Chapter 10, we can
determine tmixing time.
tb N
d
D
2.3
( )
=1022.7
500
1022.7
=
=60.2 minutes
2.3
d
39.4 2.3
N
43
D
59
( )
( )
Mixing process in the acid granulation takes time to reach steady state, the
time required for mixing for 60,2 minutes.
FILTRATING
Based on our
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t=
1 minutes
10945 bottles
180 bottles
t=60.80 minutes
Based on the above calculation, the operating time required to package our
products is 60.8 minutes.
PACKAGING
Based on our human resources capability, we have the capability of
packaging using human resources to package the products as much as 45.6 packs
per minute. We achieved our production in 2736 as one cycle of the packaging.
Thus, the time required is as follows. Based on our setting, the operating time
required to package our products is 1 hour.
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Based on Figure 2.9, Cough Zero production time in 1 cycle lasts for 5
hours but we can start new process cycle after preparing and filling our mixing
tank in 3 hours. Because of that we can make 4 cycles in 14 hours. We also can
know the start time and end time of a process by looking at the beginning and the
end of the boundary the rectangle when drawn vertically can be obtained starting
time and the completion of process. In table 8.1, we can identify the processes that
take place in accordance with the color.
Table 5.15. Total Time for Each Cycle
Cycle
Start
(minute)
Finish
(minute)
Hour/Day
195
375
555
300
480
660
660
4.75
4.75
4.75
Based on table 2.15, it can be seen that for a day to do the cough medicine
production for 4 cycles. The finish time at fourth cycle is 660 minutes per day or
14 hours per day. If we add an unexpected events and supervising, we can
maintain our production everyday. So, we can conclude that our estimation is still
can be accepted. The variable that can be changed in this method is the filling and
packages machine.
5.9 Utilities and Plant Maintenance
Aspects of sanitation and hygiene in the plant, especially in the production
unit is a thing that should not be ruled by us . Especially for companies that
produce medicine, as well as for the convenience of employees sanitation and
hygiene will greatly affect the product. Sanitation is planned to control the
environment, raw materials, production, equipment, and workers in order to
prevent mixing of the ingredients that are not in want into the product .
5.9.1 Plant Sanitary
In our cough medicine syrup plant, sanitation and hygiene should be
highly considered because it is directly and indirectly affect the quality of the
products. Building construction has either to protect employees, machinery , and
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industrial equipment in it.The outdoor courtyard and the exterior of the building
or plant should be neat, well-maintained, and free of garbage. Maintenance always
done and that is responsible for the general section. Place of the loading and
unloading of goods, parking lots , and roads for vehicles should always be clean .
Drainage must be well maintained and ensured water flow so well that
there is no stagnant water. Trash or waste water must be sealed so as not to invite
pests and microbes. The dumpster must be well maintained and regularly
transported garbage, it has been entrusted to the janitors who do the cleaning
every day. Besides the lighting must be adequate and easy to clean. For easy
cleaning , the buildup of material at least 25 cm from the wall.
To obtain a work environment that is safe and comfortable, the building
must be equipped with sanitary facilities are made based planning meets the
requirements of engineering and hygiene. Sanitation facilities are provided by the
company, namely water supply facilities, disposal and others.
Production floor must also be designed in such a way to be able to support
its production process. Production using ceramic flooring in all areas of the plant.
The purpose is other than the use of ceramic tile is water-resistant material made
from a ceramic material would easily cleaned considering the condition of the
production process. When there are spills it will be easy to clean spills, in addition
to improving the hygiene of the floor should always be clean.
Additionally spaces in the plant should be divided into spaces that do not
require high hygienic, semi high hygiene hygienic to require workers to wear
masks, gloves, etc. to maintain hygiene.
5.9.2
Equipment Sanitation
Sanitary equipment becomes an important aspect in the industry. This is
because the equipment that we use actually direct contact with food that will be
processed. Therefore we have to apply some cleaning methods in the industry,
especially equipment, consisting of:
a. Foam or soap
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Cleaning the HSA is used to clean the outer layers of the equipment. This
cleaning chemicals increase touch time with a chemical solution with mechanical
pressure and low temperature.
b. High Pressure
Increasing the mechanical pressure to help remove dirt. This cleaning method
is sometimes added detergent and increase the temperature to increase cleaning
efficiency.
c. Clean Out of Place ( COP )
Cleaning is done to the engine parts that can be separated. Cleaning is done in
containers containing chemicals are heated.
d. Clean in Place ( CIP )
Clean up for the inner surface of the tank and piping. Chemical solution put
into the tank circuit to clean the inside. Time, temperature and pressure chemically
altered as needed to achieve maximum cleaning for our equipment such as mixer,
blancher etc.
Basically, the CIP is a dry process without the need to remove the insulation
hydrodynamic (dismantling), where in the cleaning process is done with the
cleaning fluid to circulate in all channels through which the product . The cleaning
fluid can contain detergents where mechanics will lift the existing crust . CIP
process is divided into 2 types:
Single Use
The cleaning process with the use of disposable (one cycle) and sanitizer
detergent solution , and to further direct disposal (discharge). For the efficiency of
the cleaning process required flow turbulence at very high flow rates , the
consequences will be using a lot of water and effluent that great anyway . The
advantage of this process is expensive and requires a small place process .
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Reuse Systems
Cleaning process that uses a cleaning fluid and would be used again at
the beginning of the cycle (subsequent) as much as possible. This process is more
expensive and requires more space to position the CIP equipment.
This method is applied to our synthetic meat plant because although
initially more expensive to buy the tools, but the process will happen
continuously, just need to control . In contrast to single use systems that are much
cheaper but the tools we have to buy on a regular basis and periodically monitor
anyway.
5.9.3
a. Electricity
The power usage in Cough Zero production process is obtained by
summing each equipment power requirement. The energy is supplied by PLN.
The power usage is based on equipments energy specification and duration of
equipment operation. The energy balances is made for rough estimation of our
plant for each cycle, excluding electricity needs.
For instance, in cleaning process, it requires water pump to force the raw
material especially to make it clean with blanching.. However the power used is
not fully efficient, there are energy losses in each equipment due to heat loss of
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The location is an Industrial Area which the land are ready to built and
33
equipment technician.
Far from citizens housing
Wide Roads facilitate entry to this area, It is 5 km from the Cileunyi toll gate
and within distance to the container terminal of Gedebage which is essential for
transporting goods. Availabily of manpower as it is close to center of excellence
like Institute of Technology Bandung (ITB) and University of Padjadjaran
Bandung (UNPAD). This industrial estate is fully supported by PLN and PT
Telkom for the infrastructures. We can dispose of industrial waste into Citarik
river, so we do not need any place and special treatment for our industrial waste.
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