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Industrial Training Report PDF
Industrial Training Report PDF
21 DAYS
FROM AUGUST 24 TO SEPTEMBER 11, 2003.
SUBMITTED TO:
FACULTY OF PHARMACY
UNIVERSITY OF DHAKA
DHAKA.
SUBMITTED BY:
ROLL NO- 42
REGISTRATION NO- HA 2074 (1996-97)
B. PHARM (HONOURS) EXAM-2000
UNIVERSITY OF DHAKA
DHAKA.
Acknowledgements
Company History
Novartis (Bangladesh) Limited (NBL) came into existence with the global merger
of Ciba-Geigy and Sandoz, two Swiss health care concerns in 1997. From early
1970, Novartis - then known as Ciba-Geigy - engaged in trading with various
chemical and healthcare products in Bangladesh. The Bangladesh group
company was incorporated in 1973 with the 40% participation of Bangladesh
Chemical Industries Corporation (BCIC). In a first joint venture agreement of both
partners in 1980 the investment in a crop protection formulation plant in
Chittagong was implemented. In a second joint venture agreement in 1988 NBL
and BCIC invested in a pharmaceuticals production plant in Tongi, which
operated as from 1990 with life-saving products fitting the needs of the country. In
2000 Novartis decided on a global basis to spin-off the agro business and
henceforth to concentrate on healthcare. This affected also Bangladesh group
company. The former crop production business of NBL will continue, also with the
business partner BCIC, under Syngenta as a separate legal entity. In January
2003 the Generics sector of NBL has undergone a substantial expansion of its
production capacity to strengthen the export business of pharmaceuticals, which
already go to many countries in Asia Pacific and Latin America and soon also to
Europe. In May 21, 2003 Novartis Generics officially changed its name to
Sandoz.
Page 1 of 40
Observations
g. Packaging.
Quality assurance department.
a. Quality control.
b. In-process control.
Product development department.
Supply chain management department.
a. Material management.
b. Purchase department.
Production planning and co-ordination department.
Technical service department.
Information technology department.
Human resource department.
Page 2 of 40
Production
Dispensing:
The process by which active ingredient and excipients are received from ware house into the
production area and weighing materials according to dispensing order sheet (DOS) is called
dispensing.
In case of different batch of same product, excipients of both batches are weighted first then
active ingredients are weighted. There is no need of change over of instrument used in
production area. This process reduces the possibility of contamination.
Instruments available:
Balance.
Name: Metler Toledo (area B)
Capacity: 150kg; 6kg.
Plastic Platform (reduces particle formation than wooden platform)
Exhaust system.
Limitations and solutions:
According to Good Manufacturing Practice (GMP) the balance should not be replaced from
their original place, but balances are frequently replaced for various reason. This may cause
weight variation from batch to batch. More sophisticated balance may be used.
Solution:
Balance built in floor may be used in place of replaceable balance.
Exhaust duct used in dispensing area is not sufficient to remove dust particle that
Solution:
Exhaust system with large opening may be used as in production area A.
Lighting system in the dispensing area suitable for the deposition of dust particles.
Solution:
Page 3 of 40
Lighting systems should be such type that the dust particle could not be deposited on light;
which are also difficult to clean.
Tiles are used in walls which causes dust particle deposition that is also difficult to clean.
Fungal growth may occur in the floor during damp season.
Solution:
PVC walls and terrazzo (cement and crushed marble) floor may be used which is easy to
clean, repair and relatively cheap. To reduce fungal growth up to 1% of a fungi static such as 8hydroxyquinoline, pentachlorophenol may be added to the paint.
Some ingredients are moisture sensitive. For their stability humidity control (dry syrup-
relative humidity below 30%) is essential in every step of manufacture. In dispensing area B
has no humidity control system.
Solution:
It is essential to control humidity to increase stability.
Granulations:
Granulation is the process in which powder particles are made to adhere to form larger
particles called granules. Granules are usually used in the production of tablets or capsules.
Purpose of granulation:
Machines available:
Machines
Solid mixer
In-plant training report.
Production area
A
T.K. Mixer.
Artofex 3
Page 4 of 40
(capacity 100kg)
(capacity 320kg )
Aeromatic
Solace
Final mixer
BHOLE mixer
Not present
Solace multimill.
Russel shifter.
Types of granulation:
Three types of granulation techniques are used Dry granulation
Wet granulations
Spray granulation
Dry granulation:
This method is applied for drugs which do not compress well after wet granulation or those
which are sensitive to moisture. It may be performed following two ways-
Page 5 of 40
Process one:
Process two:
1. Weighing.
1. Weighing.
2. Shifting.
2. Shifting.
3. Dry mixing.
3. Dry mixing.
4. Addition of disintegrants.
5. Lubrication.
5. Addition of disintegrants.
6. Lubrication.
Wet granulation:
Wet granulation involves the massing of the powder mix using a solvent. The solvents used must
be volatile, so that they can be removed by drying, and nontoxic.
Steps involved:
1) Weighing.
5) Drying.
2) Shifting.
6) Crushing.
3) Dry mixing.
7) Addition of disintegrants.
4) Wet mixing.
8) Lubrication.
Spray granulation:
This technique utilizes the technology of fluid bed drier. Heated air is blown through a bed of
unmixed powders and mixes the powders. Granulating liquid is pumped through a spray nozzle
over the particle.
Multimill and shifter frequently used in granulation technique. Production A and production B
use these two instruments by shifting. It reduces productivity.
Solution:
To increase productivity these instruments are essential in both areas.
In-plant training report.
Page 6 of 40
No final mixer (e.g. BHOLE MIXER) present in production area B; which is essential for quality
product.
Solution:
It is essential to install a final mixer.
Compression:
Compression of powder means reduction in bulk volume of a material as a result of displacement
of the gaseous phase. Compression technique used for the manufacture of tablet.
Machines available:
Manestry (unipress): single rotary, 20 punch.
Clit machine: double rotary, 29 punch.
Se-Jong tablet machine: single rotary, 30 punch.
Tablet machine parts:
Hopper.
Fed frame.
Compression sration.
Feed paddles.
Ejection cam.
Ejection station.
Pre-compression roller.
Stages of compression:
1. Feed frame over die.
2. Fill.
3. Scrapping.
In-plant training report.
High friability.
Weight variation.
Low hardness.
Capping/lamination.
Variable hardness.
Mottling.
Bisection or embossing.
Vacuum system used in both Clit and Se-Jong tablet machine to introduce granules, that
reduce the requirement of manpower & increase productivity but it produce dust particle which
contaminate environment. Manestry tablet machine has no such problem.
Solution:
Automatic hopper as Manestry may be used or protective covering my use to prevent dust
formation.
weight of tablet digitally controlled in both Manestry and Se-Jong tablet machine that reduce
weight variation and also easy to control than clit machine which is manually controlled.
Solution:
Establishment of digitally control system for Clit machine, granules that have better flowing
property may be compressed without any weight variation.
Pre-compression roller reduce the air inside the granules, that reduce cracking problem
Solution:
Granules with better compressibility can be easily compressed. If problem (Cracking) arises with
this machine direct compression (Ludipress LCE) agent may be used.
Tablet coating
In-plant training report.
Page 8 of 40
It is the process by which a layer of polymer or sugar applied on core tablet for various reasons is
called coating.
Types:
o
o
o
o
Sugar coating.
Film coating.
Powder coating.
Enteric coating.
Coating machines:
Manestry accela cota (capacity 150kg)
Se-Jong (capacity 150kg)
NR-cota (capacity 30kg)
Sugar coating:
Sugar coating is the traditional method of coating tablet. It involves the successive application of
sucrose-based solutions to tablet cores in suitable coating equipment.
Steps:
Actual steps
1.
2.
3.
4.
5.
6.
Used steps
1.
2.
3.
4.
Page 9 of 40
Here coating is performed by only four steps; which may cause stability problem of drug and
may not fill the purpose of coating.
Solution:
If there is no reduction of productivity, all referred steps may be followed. It may improve the quality
of coated product. Product development may improve the process.
Coating solution is applied manually- that may cause serious damage of core.
Solution:
It is essential to use spray system for accuracy of coating and stability of drug.
Film coating:
Film coating is a modern technique of coating procedure requires very small time compared to
sugar coating. It involves less steps and coating problem.
Steps:
o Introduction of liquor solution.
o Coloring.
o Polishing.
Factors considered during coating procedure:
Following factors have to be considered during coating procedureI. Rotation of coating pan.
II. Inlet air velocity.
III. Pressure of air inside coating pan.
IV. Inlet air temperature.
V. Outlet air temperature.
Coating problems:
Logo-briging.
Edge chipping./ Erosion.
Picking and Sticking.
In-plant training report.
Cracking.
Twining.
Tablet to tablet color variation.
Page 10 of 40
Blocking.
Orange pill/ roughness.
Loss of logo definition.
Peeling.
Erosion.
Encapsulation
Encapsulation is the process of manufacture of capsule. Capsules are solid dosage forms in which
the drug substance is enclosed in either a hard or soft, soluble container or shell of a suitable form
of gelatin.
Types of capsule:
Hard gelatin capsule.
Soft gelatin capsule.
Hard gelatin capsule:
It is referred to as the dry filled capsule; consist of two sections, one slipping over the other, thus
completely surrounding the drug formulation.
Soft gelatin capsule:
It is a soft, globular, gelatin shell, somewhat thicker than that of hard gelatin capsules. The gelation
is plasticized by the addition of glecerin, sorbitol or a similar polyol.
Machines available:
Machine: BOSH (for hard gelatin capsule)
In-plant training report.
Page 11 of 40
Channel: Single.
CPM: 300; CPH: 18,000.
Output: 36 (per-rotation)
Machines criteria:
In a tablet machine one die fill with granules at a time from a hopper, but in a capsule machine
shell fill from hopper through different channel and thus final weight adjusted by trial and error
method.
Weight of capsule adjusted by trial and error method; it is a time consuming process and there
is possibility of weight variation.
Solution:
Replacement of old machine by newer one.
Packaging
Packaging can be defined as an economical means of providing, presentation, protection,
identification/information, containment, convenience and compliance for a product during storage,
carriage, display and use until such time as the product is used or administered.
Packaging materials provide protection to the product in following ways:
Mechanical hazards:
Puncture.
Light.
Climatic hazards:
Vibration.
Moisture.
Abrasion.
Temperature.
Pressure.
Atmospheric gas.
Biological hazards:
Page 12 of 40
Microbiological.
Pilferage.
Other infections.
Types of packaging:
Packaging can be divided into two ways:
Primary packaging.
Blister packaging.
Strip packaging.
Bottle filling and sealing.
Secondary packaging.
Primary packaging:
In case of primary packaging, packaging material comes to the direct contact of the finished goods.
So its quality should be strictly maintained.
Blister packaging:
Blister packaging involves forming heat softened plastic film or around a deep-drawn pocketed
mold to make a plastic tray (thermoforming), filling with a solid dosage form product and sealing
with push through or peel able covering.
Composition:
Heat softened plastic film:
Chemically films used are polymer in nature. Polymers used are polyethylene (PE), poly vinyl
chloride (PVC), poly vinyl di-chloride (PVDC) etc. Films used may be of one, two or three layered;
depending on nature (moisture sensitivity) of finished product. Its thickness may vary from 250-300
micrometer.
Covering materials:
Covering material is usually preprinted or plane aluminum. Its standard thickness is about 25
micrometer. The covering material has a printing primer on one side and a heat sealing lacquer on
the other, which faces the product and forming film.
Machines:
Packaging machine:
In-plant training report.
Page 13 of 40
Formation of pocket for product (tablet or capsule) using heat softened plastic film.
Introduction of product into pocket (manually or mechanically).
Sealing of product by covering material (printed or without printed).
Cutting.
Conveying to packaging section by conveying belt.
Strip packaging:
A strip package is formed by feeding two webs of a heat sealable flexible film through a heated
roller. The product is dropped into the pocket formed prior to forming the final set of seals.
Machines:
Packaging machine:
Name: Gansons (Capacity 1600 capsule/hr).
Printing machine:
Name: Image (to print batch no and expiry date).
Associates have to observe:
o Vacant capsule shell.
o Chute flow of capsule.
Page 14 of 40
In case of strip packaging machine voltage up and down may change temperature of heated
roller, which may cause leakage problem.
Solution:
A voltage stabilizer may set for strip packaging machine.
Conveying belt is not using to convey strips to packaging area that cause deformation of strips
before packaging.
Solution:
To set a conveying belt for prevention of deformation of strips.
Packaging.
Precaution:
Humidity is strictly maintained during filling of dry syrup. Here dehumidifier is used to maintain RH
below 30%.
Secondary packaging:
Secondary packaging mainly used for the following purposes:
To improve handling property of large amount products.
To facilitate transport of product.
To withheld shock during shipment.
To prevent the product from environmental hazards (moisture, temperature etc.).
Page 15 of 40
Quality assurance
Instruments available:
Friabilator:
Name: Pharma Test.
It is used to determine the capacity of tablet to withstand shock during coating, packaging and
shipment. It is expressed as percentage.
W
Friability (%) = 1 2 100
W1
Here,
W2=weight after friabilation.
W1=weight before friabilation.
Hardness tester:
Name: Pharmatron.
Tablet hardness is the important measurement of IPC; as it control the disintegration time of the
tablet and also size of tablet.
Disintegrator:
Name: Sotax DT3.
In-plant training report.
Page 16 of 40
Disintegration is the process of conversion of tablet into smaller particle. Core tablet disintegration
performed in deionized water (temp-37.4C). Enteric coated tablet disintegration time determined
in 0.1% HCl solution.
2 tablets
20
15
10
Page 17 of 40
Responsibilities:
Receiving of materials from ware-house:
Right materials supplied or not (according to DOS).
Amount of materials supplied (according to DOS).
Condition of the container.
Dispensing:
Cleanliness of dispensing area.
Presence of production officer.
Random weighing of material.
Accurate tag used or not.
Balance is calibrated or not.
Granulation:
Assure cleanliness of granulator, dryer ect. According to Standard Operating Procedure
(SOP) instrument cleaned before 15 days can be used in granulation procedure.
Temperature of inlet and outlet air.
Moisture content of dried granules.
Compression:
Cleanliness of compression area and instruments e.g. die, punch etc.
Right die, punch used.
Tablet size and shape.
Tablet color.
Tablet imprint.
Tablet hardness.
Tablet friability.
Disintegration time.
Weight variation.
Coating:
Cleanliness of coating area and instrument eg. Coating pan, spray system etc.
In-plant training report.
Page 18 of 40
Encapsulation:
Packaging:
Environment monitoring.
Sanitation and cleaning.
Machine validation assuring. Etc.
So the quality assurance personnel are always conscious about the quality of the product by taking
consideration into above factors. It requires large manpower to do all the functions accurately.
Page 19 of 40
Functions:
Quality control department has functions in the following areas:
Documentations.
Raw materials.
Finished products.
Packaging materials.
Documentations:
Raw materials:
Validation of-
Name of materials.
Sampling of materials.
DOS.
Descriptions.
Solubility.
POS.
Identity:
SOP.
IR absorption.
UV absorption.
BMR.
Chromatography.
Maintenance of log
Melting point.
book of instruments.
Assay.
Purity and quality.
Data input of various
Microbial limit.
tests in BMR.
Finished products:
Packaging
materials:
Packaging materials:
Description.
Identity.
Printing.
UV absorption.
Color.
Chromatography.
Message.
Assay.
Dissolution.
With product:
Impurities.
Batch no.
Microbial limit.
Exp date.
Printing.
Name: Shimadju.
Name: Perkinelmer.
FTNIR- Genesis:
Name: Buchi.
Name: Metrohm.
Viscometer:
Name: Brookfield.
Page 20 of 40
Page 21 of 40
Microbiology laboratory:
Functions:
Microbiology laboratory is the part of quality control. It has following responsibilities
Antibiotic assay.
Acceptable limit
Media used
Bacteria
103 CFT/gm
TSA
Fungi
102 CFT/gm
SDA
Pathogenic micro-organism
Acceptable limit
Media used
E. coli
MCA
Enterobacteriaceae
VRBGA
Salmonella
DCA
Pseudomonas aeruginosa
CA
Staphylococcus aureus
BPA
Microbial limit test performed for the validation batches (usually first 5 batches) then MLT
performed after a definite batch interval.
Page 22 of 40
Media preparation.
Autoclaving.
Specific method for specific organism.
Incubation.
Colony count.
Instruments:
To conduct the above steps following instruments are used Autoclave (Microbial media sterilized by using the condition temperature 121C, pressure
15 Psi for 15-20 minutes).
Incubator (Two types of incubator are available; one control temp. between 35-37C other
between 20-25C. Use of incubator depends upon microbial type).
Horizontal laminar-flow workbench (Use to transfer MO to the media without external
contamination).
Reuteri centrifugal air sampler (Used to find bacteria and fungal contamination).
The plant has only solid section, so there is less possibility of microbial hazard. But for the
safety of patient and also for stability of product it is essential to control and measure
contamination.
Page 23 of 40
Reservoir
Gradient
Controller
Pump
Mixing
Chamber
Recorder
Resorvoir
Fraction
Collector
Analytical
Column
Pump
Solvent conditioning
Column
Detecror
Injector
Precoloum
Figure: Block diagram of a complete HPLC. Directly connected lines are necessary only for
gradient elution.
In-plant training report.
Page 24 of 40
Analytical column:
Here the actual separation takes place. It is usually a stainless tube, usually 5 to 25 cm long
with 2 to 4.6 cm diameter. It is packed with the stationary phase. Silica gel is the material most
frequently employed for micro particulate column packing. It may be used as such for
absorption chromatography, but more often liquid phases for partition chromatography are
bonded chemically to its surface. These include alkyl groups with the chain length of 1, 2, 8 or
18 carbons, cyanopropyl groups, phenyl groups and ion exchanger. Chiral stationary phases
also used for the separation of optical isomers.
Detector:
Ultraviolet-visible spectrometer.
Fluorescence spectrotometer (sensitivity pictogram range)
Differential refractometer.
Based on electrochemical measurements:
Amperometry.
Columetry.
Polarography.
Photoconductivity.
Functions:
Product development (PD) department has following functions:
Document development.
Galenical development.
Analytical development.
Packaging development.
Page 25 of 40
Document development:
Product development department generate batch manufacturing record (BMR), dispensing
order sheet (DOS), packaging order sheet (POS) initially for a newly launched product and also
maintain the document of their functions.
Galenical development:
Galenical development involves the development of the functions of production area for the
production of a product. It develops the formulations by trial and error method.
Steps of development:
Trial batch
(if criteria fulfilled)
Validation batch.
(if criteria fulfilled)
Production batch.
Instrument used:
Granulator:
Compression machine:
Name: Solace.
Name: Jaguar.
Capacity: 2 kg.
Capacity: 6 station.
Coating machine:
Capacity: 2 kg.
Analytical development:
Analytical development involves the development of the functions of quality control department
for the production of a product.
Page 26 of 40
Development work:
o Assay procedure of API.
o Assay procedure of impurities.
o Stability testing.
o Validation of instruments used.
Routine work:
o API analysis (if source changed).
o Stability testing (on going process).
o Process validation.
Stability testing:
Stability testing helps in the prediction of the shelf life of a product. It is based on the
application of the Arrhenious equation:
E
k = Ze RT
Condition.
Name of exp.
Time of exp.
Shelf life
Temp.
%RH
40C
75%
6 month
1 year.
30C
70%
Follow up stability.
On going
Stable period.
20C
60%
Follow up stability.
On going.
Stable period.
Packaging development:
Packaging development involve the design of primary and secondary packaging for a particular
product or routine check of the packaging materials.
Development functions:
a.
b.
c.
d.
e.
Page 27 of 40
Product
Solution:
To develop a pharmacological assay department for better development.
Functional responsibility:
o
o
o
o
o
o
o
Page 28 of 40
Planning considerations:
Various lead time.
Raw
materials
Safety stock.
and
packaging
Service level.
Ensure production continuity.
materials.
Closing stock.
Production capability.
Production capacity.
Production sequencing.
Page 29 of 40
MM department give
order
to
purchase
department
to purchase materials if
not available.
Production
Product
If materials available
in ware house MM
give order to supply
materials
for
production.
Page 30 of 40
Ware house:
Ware house is a store room to store raw materials, packaging materials and finished goods.
The main functions of ware house are given below:
a.
b.
c.
d.
e.
f.
g.
h.
Packaging materials
Raw materials
For export.
Special storage environment (temperature and humidity) required for some product for
Solution:
For better stability it is essential to establish an area that can provide special storage
environment.
In-plant training report.
Page 31 of 40
Marking and card system used for ware house. It creates hazardous condition of ware
house. It is difficult to find the materials without the help of the system used.
Solution:
It can be developed by using following tools:
a. Arrange the materials alphabetically and fix the sticker on self accordingly.
b. Separate store for raw, finished and packaging materials.
c. To maintain a completely separate quarantine area.
Special features:
Gas and
Steam.
Page 32 of 40
Lubrication:
Lubrication of machineries routinely to prevent friction and subsequent damage.
Incinerator:
To destroy waste material by using fire. Here materials used for once and have no more used
usually destroyed.
Service:
Car workshop.
Carpeting.
Painting.
Maintaining heating, ventilation and air conditioning (HVAC) system.
Instruments used for the supply support:
Electricity:
Required electricity mainly obtained from DESA, incase of load shedding heavy duty generator
provide electricity.
Generator:
Type: diesel operated.
Capacity: 1050 kilowatt.
Requirement: 450 kilowatt.
Compressed air:
Compressed air is provided by oil free compressor. Air is passed through passed various grade
of filter to eliminate particle. These prevent contamination from oil and dust particle.
Name of compressor: Sullair.
Functional mechanism: air is passed through a screw system device.
Steam:
A boiler is used to boil water to110C and produce steam for production area B. Heat is
generated by using gas. Generated steam is used in fluid bed dryer.
Page 33 of 40
Cold water:
Chiller is used to produce cold water (6C) for HVAC system (to cool the air). After circulating
this cold water through close looped HVAC system temperature become 12C. This raised
temperature is released to environment through another closed loop system of water circulation
system. Here temperature of water changed from 37C to 30C and temperature released. So
there no loss of water.
Capacity of chiller: 250 ton.
Hot water:
Boiler is used to produce hot water (110C) for HVAC system (to dry the air). After circulating
this hot water through close looped HVAC system temperature become 90C. This loosed
temperature is used to develop HVAC system. The hot water also flows through a close looped
system and thus no loss of water.
Water supply:
Water is supplied to plant by using a deep tube well. It supplies water from 120m deep of soil.
Waste water management:
Water used in plant released to environment after proper treatment. At first water is passed
through the various grade of filter to remove particle and bacteria cultivated in treatment plant
to engulf dissolve chemicals. It prevents water contamination.
Deionized water plant:
In pharmaceutical plant deionized water used in place of normal water as the ion present in
water may produce some adverse reaction to product and also may alter chemical assay.
Page 34 of 40
U.V. sterilization
Regeneration:
Anionic: NaOH 30%
Cationic: HCl 32%
With water.
Water collected
and pH
maintained
between 6.5-8.5.
Released to
environment.
O3 treatment.
Reservoir tank
of DI water.
Page 35 of 40
Filter F9
Filter F8
Blower
Cold
duct 12C
Room
22C/55%RH
Filter H11
Hot
duct28C
TMV mixing
box.
Return:
Room
Filter F8
Filter F9
Blower
Page 36 of 40
Advantages:
Environment of individual room can be controlled.
Recycled air contains less amount of dust particle than obtain from environment; it
reduces stress on filter used. But returned air from granulation room contain large
amount of dust hence air is not recycled here.
Pneumatic system provides automatic control of environment.
Information technology
Novartis (Bangladesh) Limited has introduce network communication within Novartis and also
with the mother and sister concern all over the world through SAP in May 2000. It may call the
neuron of Novartis.
This software is developed by Germany. For installation it cost approximately 7-crore BDT.
Now using charge per year is 4500 Swiss frank. Now NOVARTIS (BANGLADESH) LIMITED
has 72 SAP users. Net communication is maintained by radio link and locally communication
with fiber optic. This program is based on advanced business application program (ABAP)
language.
Infra-structure:
Infra-structure
Networking
LAN
WAN
Communication
MAN
Lotus
notes
Voice over
phone
Page 37 of 40
Customer
relationship
management
Sales/distri
bution unit
Central ware
house
Finance
Ware
house
Material
management
Controlling
Product
planning
Purchase
order
Process
industry
Ware
house
Quality
assurance
Ware
house
Tools used:
o Employee allocation.
o Payroll.
o Personnel management.
o Planning/counseling
Motivation of employee:
HR department motivate employee by using following factorso Leave.
o Salary.
o Provident fund.
o Gratuity.
o Medical.
o Leave fair assistance (LFA).
o Workers participation profit fund (WPPF).
In-plant training report.
Page 38 of 40
Conclusion
Page 39 of 40
Page 40 of 40