Annexure-PFR - Environmental Clearances

Transcription

Proposed Project for Manufacturing of Synthetic Organic Chemicals
M/s. Anlon Healthcare Pvt. Ltd.
1. EXECUTIVE SUMMARY
1.1 General
M/s. Anlon Healthcare Pvt. Ltd. is a proposed small scale unit to be located at
Survey No. 36/2, Near Toll Plaza on Rajkot-Gondal National Highway at Village
Pipaliya, Taluka Gondal, Dist. Rajkot, Gujarat for manufacturing of various Synthetic
Organic Chemicals (Pharmaceutical bulk drugs & Intermediates) with the total
production capacity of 11.0 TPM.
The proposed project is covered under Category 5(f)-B as per EIA Notification of
Ministry of Environment & Forest (MoEF), dated 14/09/2006 and subsequent
amendments. Therefore, unit requires obtaining Environmental Clearance from State
Level Environment Impact Assessment Authority (SEIAA), Gujarat.
1.2 Salient Features of the plant site

The project site is located at Rajkot District having all basic infrastructure
facilities like availability of water, electricity, fuel, transport, telecommunication
systems etc.

Plant site is about 20 km away from Rajkot City which is well connected by road,
rail and air to rest of India.

The nearest human settlement from the site is at village Pipaliya at distance of
1.5 km.

Availability of trained and skilled manpower in nearby areas.

There is no protected area notified under the Wild Life (Protection) Act (1972) &
Eco-sensitive area notified under Section 3 of the Environment (Protection) Act1986 exists within 10 Km radius areas from the Plant Site.
Pre-Feasibility Report
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1.3 Proposed Products
The unit proposes to manufacture various synthetic organic chemicals viz.
Pharmaceutical Bulk Drugs & Intermediates with total production capacity of 11.0
TPM. Details of proposed products and by product are given in Table – 1 and Table
– 2.
Table 1: Details of Proposed Products:
Sr. No.
Capacity
(TPM)
Product
1.
Bosentan
2.
Rebamipide
3.
Zaltoprofen
4.
Candesartan
5.
Valsartan
6.
Pranlukast
7.
Ticagrelor
8.
Bazedoxifene Acetate
6.00
5.00
Total
11.00
Table 2: Details of Proposed By-Product:
Sr. No.
1.
By - Product
Sodium Bisulfite
Capacity
(TPM)
7.6
Source
Product 6
(APCE)
1.4 Resources Requirements

Land: The total land acquired for the proposed unit is 4,971 sq. m.

Water: The total fresh water requirement for various activities like domestic,
gardening and industrial will be 8.3 KLD. The water requirement for the proposed
project will be met by ground water source through own bore well.

Power: Total 818 KVA (350 HP) power will be required and same will be
procured from Paschim Gujarat Vij Company Limited (PGVCL). In addition to
this, one DG Set of 250 KVA will be installed as stand-by and captive source of
power.

Fuel: Biofuel / Agricultural waste @ 180.0 TPM will be required for the steam
boiler (2 TPH) and Thermic Fluid Boiler (2 Lac KCal.). Diesel @ 125 Lit/Hr. will
be required for DG Set (250 KVA).
Page | 2

Manpower: For the proposed unit about 30 personnel will be employed at the
different level for the operation phase.

Finance: Proposed unit is a small scale unit with capital investment of Rs. 800
Lacs. Capital cost towards Environmental protection measures for proposed
project will be Rs. 150 Lacs.
1.5 Pollution Potential and Mitigative Measures

Water Pollution: There will be wastewater generation from the manufacturing
process, boiler, cooling and washing activities @ 16.6 KLD. This effluent will be
collected and treated in Effluent Treatment Plant (ETP) comprising of primary,
secondary & tertiary treatment. The treated effluent @16.2 KLD will be reused
for process and boiler purposes.

Air Pollution: There will be generation of the flue gas emissions from the steam
boilers, Thermic fluid boiler and DG set. The unit will provide adequate air
pollution control equipments to prevent flue gas emission.
There will be process gas emission of SO2 from the manufacturing of product
Pranlukast. Adequate scrubbing system like alkali scrubber will be provided for
the control of process gas emission.

Hazardous Waste: Hazardous waste will mainly be generated from effluent
treatment plant as well as from manufacturing process viz. Organic Residue,
Inorganic Residue and Spent Solvent. The ancillary source of hazardous waste
generation will be discarded containers/bags from storage and handling of raw
materials and spent/used oil generation from plant & machinery. The unit will
provide an adequate designated area for the hazardous waste storage and will
obtain membership of GPCB approved TSDF/CHWIF for the final disposal of
hazardous waste.

Greenbelt Development: The unit will develop green belt in about 1742.0 m2
area (35% of total land area) within the industrial premises with suitable plant
species.
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2. INTRODUCTION
2.1
Background
M/s. Anlon Healthcare Pvt. Ltd. has been concentrating on manufacturing of
Synthetic Organic Chemicals (Pharmaceutical Bulk Drugs & Intermediates) with
the total installed capacity of 11 TPM. The unit has acquired a land at Survey No.
36/2, Near Toll Plaza on Rajkot-Gondal National Highway at Village Pipaliya, Taluka
Gondal, Dist. Rajkot, Gujarat.
The proposed project is covered under Category 5(f)-B as per new EIA Notification of
Ministry of Environment & Forest (MoEF), dated 14/09/2006 and subsequent
amendments. Therefore, unit requires obtaining Environmental Clearance from State
Level Environment Impact Assessment Authority (SEIAA), Gujarat. As a part of
application for obtaining Environmental Clearance, the unit requires to submit Form-1
and Pre-Feasibility Report of the proposed project.
The objectives of the report are,
a) To assess the feasibility of the proposed project.
b) To identify various sources of pollution and anticipate the impacts of the
proposed project on the environment.
c) To suggest preventive and mitigation measures to minimize the adverse
impacts and to prepare Environmental Management Plan (EMP).
d) Propose the Terms of Reference to carry out EIA Study for the proposed
project.
2.2
Nature of the Project
The unit believes in sustainable development and equally concern about environment
preservation and pollution control. The proposed project is a brown field project. The
unit will provide an adequate Environmental Management System to meet desired
norms of effluent discharge (Water + Air + Solid) as per the statutory recruitments for
their proposed project and also will continue its endeavor for the pollution prevention
and betterment of environment.
2.3
Project Proponent
M/s. Anlon Healthcare Pvt. Ltd. is promoted by its directors Mr. Vaibhav Ramani and
Mr. Punitkumar Rasadia. Details about the promoters are given below:
Page | 4
1. Mr. Vaibhav Ramani aged 30 years and has done Ph. D in Synthetic Organic
Chemistry and looks after new product’s Research & Development and also
manages product manufacturing with experience in operation and maintenance
activities of plant handling. His core expertise is in research and development, pilot
scale ups, plant scale ups, cost cutting in plant process, handling man power. With
multifaceted experience of 7 years ranging from project execution, manufacturing,
quality control, supply chain and marketing including setting strategic direction,
driving financial and operational excellence and providing overall leadership.
2. Mr. Punitkumar Rasadia aged 29 years and has done Post Graduate in Organic
Chemistry. He is directly related with company’s local and overseas sales and
business development. He also handles business clients, meetings and also
foresees future prospective and new ventures. He has an extensive experience of
10 years in finance, banking, mergers and acquisitions, strategic planning,
restructuring operations, export marketing, international business relations,
collaborations and joint ventures. He also looks after group’s financial reporting,
investor relations, financing strategy including debt and equity rising, risk
management and compliance, taxation strategy and planning. His core expertise is
on strengthening strategic partnerships with clients, exploring global markets,
increasing client relevance and evolving the company’s business model.
2.4
Need for the Project & Project Benefits
The proposed project for manufacturing of
Pharmaceutical Bulk Drugs &
Intermediates requires substantial handling of raw materials, goods in process and
finished goods. India's pharmaceutical industry is now the third largest in the world in
terms of volume and 14th in terms of value. The contribution of Gujarat to India’s
pharmaceutical and health sectors can be gauged by the fact that this Western State,
having only 4 percent of the country’s population, which accounts for more than 40 per
cent of medicines manufactured in India.
Demand-Supply Gap
Based on our informal survey of the market with potential customers and various
traders, we have found that there is a big potential for the range of the products we
are planning. API (Bulk drugs) & intermediates of API’s are normally not used in their
basic form, so the demand for basic drugs emanates from formulation industries
manufacturing medicines in various forms. As medicines are highly consumed in all
Page | 5
seasons, there are thousands of companies in India, which are manufacturing tablets,
capsules & syrups of the proposed products.
Imports vs. Indigenous production
Based on the current cost of indigenous raw materials, unit will not have to import any
raw materials as they are produced locally. This will make us very competitive against
imported finished products and we will be able to increase the export of our finished
products to the American and European markets.
Export possibility
Depending on the international demand of products we shall explore the possibility of
exporting the products.
Domestic/Export Markets
Looking the anticipated demand of healthcare sector in domestic as well as global
market and growing volume of pharmaceuticals industry, the proposed project to
manufacture Pharmaceutical Bulk Drugs and & Drugs Intermediates, have no doubt
for the guarantee of the product and its acceptability in the local and international
market.
Employment Generation (Direct and Indirect) due to project
It is expected that the proposed project will require about 118 personnel. So, the
project will provide direct employment to skilled workforce and indirect employment
(transport, services deliveries etc.) to semi-skilled and unskilled workers. Thus, the
project will have numerous induced impacts on society by generating employment
opportunity and will lead to improvement in the social infrastructure in the region.
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3. PROJECT LOCATION & SITE ANALYSIS
3.1
Location
The project is to be located at Survey No. 36/2, Near Toll Plaza on Rajkot-Gondal
National Highway at Village Pipaliya, Taluka Gondal, Dist. Rajkot, Gujarat. The
location map of project site is shown in Figure-1 and the area covering 10 km radial
distance from the project site is given as Figure-2.
3.2 Site Analysis & Infrastructure setup
The salient features of the project site and study area are given below:
1.
Location
: Survey No. 36/2, Rajkot Gondal National
Highway,
District: Rajkot, Gujarat
2.
Geographical Location
: Latitude: 22° 5’ 29.18” N
Longitude: 70° 46’ 58.44” E
Topo Sheet: F42/K-16
3.
Land use of Project site : Non Agricultural Land converted for the Industrial use
4.
Infrastructure Setup : (Distances mentioned below are aerial distances)
5.
6.
(a) Town / Habitation
: Gondal @ 14 km, South
(b) City
: Rajkot @ 20 km, North
(c) Highways
: NH 8-B @ 0.6 km, West
(d) Railway Station
: Ribda Railway Station @ 5 km, NNE
(e) Sea Coast
: Gulf of Kutch @ 100 km, WNW
(f) Domestic Airport
: Rajkot @ 24 km, North
(g) International Airport
: Ahmedabad @ 230 km, ENE
(h) Defence installations
: None
Place of Interest / Tourist
: Riverside Palace (Gondal) @ 14 km
places
South
Protected areas within 10 Km radius from the Plant Site (if, any) :
7.
Displacement of population
: None
8.
Seismic Zone
: The area is falling in Zone- III having
moderate Damage Risk Zone (MSK- VII).
Page | 7
Figure - 1: Location of Project Site
Location of Rajkot District in Gujarat
Location of Project Site in Rajkot District
Page | 8
Figure - 2: Google Image of 10 km Radial Distance from the Project Site
Legends:
Project Site
1
Pipaliya Village
5
Mahika Mota Village
2
Ribda Village
6
Bharudi Village
3
Shahpar Village
7
Mungavavdi Village
4
Bhunava Village
3.3 Details of Alternative Sites and Justification of Site Selection
Page | 9
Unit has already acquired land to establish the proposed unit at Gondal, Dist. Rajkot.
and site selection was guided by many factors like infrastructure, availability of land,
water sources, fuel, transportation, power availability etc. Specific site selection
criteria for the proposed project of M/s. Anlon Healthcare Pvt. Ltd. are given below;

The project site is located in the Rajkot District having all basic infrastructure
facilities like availability of water, electricity, fuel, transport, telecommunication
systems etc.

Plant site is about 20.0 km away from Rajkot City which is well connected by road,
rail and air to rest of India.

The nearest human settlement from the site is Pipaliya village at distance of 1 km
in WNW direction.

Availability of trained and skilled manpower into nearby areas.

Page | 10
4. PROJECT DESCRIPTION
4.1 Details of Products and Production Capacity
The unit proposes to manufacture various Pharmaceutical Bulk Drugs & Intermediates
with total production capacity of 11 TPM. Details of proposed products and by
products along with production capacity are given hereunder in Table – 3(a), Table –
3(b) and Table 4.
Table – 3(a): List of Proposed Products
Sr.
No.
Name of Products
1.
Bosentan
2.
Rebamipide
3.
Zaltoprofen
4.
Candesartan
5.
Valsartan
6.
Pranlukast
7.
Ticagrelor
8.
Capacity
(MT/Month)
6.0
5.0
Total
11.0
Table - 3(b): List of Proposed By-Product:
Sr. No.
1.
By - Product
Capacity
(TPM)
Sodium Bisulfite
7.6
Table – 4: Details of Proposed Products
Sr.
No.
Name of
Products
1.
Bosentan
2.
Rebamipide
IUPAC Name
Synonym
Use of Product
4-tert-butyl-N-[6(2hydroxyethoxy)5-(2methoxyphenoxy)
-2-(pyrimidin-2yl)pyrimidin-4yl]benzene-1sulfonamide
N-(4Chlorobenzoyl)-3-
4-(1,1-Dimethylethyl)-N[6-(2-hydroxyethoxy)-5(2methoxyphenoxy)[2,2'bipyrimidin]-4yl]benzenesulfonamide
Used
in
the
treatment
of
pulmonary artery
hypertension
2-(4Chlorobenzoylamino)-3-
Used for mucosal
protection,
Page | 11
(2-oxo-1,2[2(1H)-quinolinon-4dihydroquinolin-4- yl]propionic acid
yl)alanine
3.
4.
5.
6.
7.
8.
Zaltoprofen
Candesartan
Valsartan
10,11-Dihydro-αmethyl-10oxodibenzo[b,f]thi
epin-2-acetic Acid
2-ethoxy-1-({4-[2(2H-1,2,3,4tetrazol-5yl)phenyl]phenyl}
methyl)-1H-1,3benzodiazole-7carboxylic acid
(S)-3-methyl-2(N-{[2'-(2H1,2,3,4-tetrazol-5yl)biphenyl-4yl]methyl}pentana
mido)butanoic
acid
N-[4-oxo-2-(1Htetrazol-5-yl)-4HPranlukast
chromen-7-yl]-4(4-phenylbutoxy)
benzamide
(1S,2S,3R,5S)-3[7-[(1R,2S)-2(3,4Difluorophenyl)
cyclopropylamino
]-5-(propylthio)3HTicagrelor
[1,2,3]triazolo[4,5
-d]pyrimidin-3-yl]5-(2hydroxyethoxy)
cyclopentane-1,2diol
1-{4-[2-(1Azepanyl)ethoxy]
Bazedoxifene benzyl}-2-(4Acetate
hydroxyphenyl)3-methyl-1Hindol-5-ol acetate
Page | 12
healing of gastro
duodenal ulcers,
and treatment of
gastritis
2-(10-Oxo-10,11Anti-inflammatory
dihydrodibenzo[b,f]thiepi drug used for
n-2-yl)propanoic acid
pain relief
2-(ethyloxy)-1-{[2'-(1Htetrazol-5-yl)biphenyl-4yl]methyl}-1Hbenzimidazole-7carboxylic acid
Used
for
the
treatment
of
hypertension
(2S)-3-Methyl-2(pentanoyl{[2'-(1Htetrazol-5-yl)-4biphenylyl]methyl}amino
)butanoic acid
Used
for
treatment of high
blood pressure,
congestive heart
failure, and to
increase
the
chances of living
longer after a
heart attack.
Used
for
treatment
of
allergy
in
asthmatic
patients
Used
for
treatment
of
thrombotic events
i.e. stroke, heart
attack
4-Oxo-8-(4-(4phenylbutoxy)benzoyla
mino)-2-(tetrazol-5-yl)4H-1-benzopyran
(1S,2S,3R,5S)-3-[7{[(1R,2S)-2-(3,4Difluorophenyl)cyclopro
pyl]amino}-5(propylsulfanyl)-3H[1,2,3]triazolo[4,5d]pyrimidin-3-yl]-5-(2hydroxyethoxy)-1,2cyclopentanediol
1-{4-[2-(Azepan-1yl)ethoxy]benzyl}-2-(4hydroxyphenyl)-3methyl-1H-indol-5-ol
acetate
Selective
estrogen receptor
modulator
4.2
Land and Project Layout
The total land acquired for the proposed unit is @ 4,971.0 m2. Out of total land
available, the unit will develop @ 1,742 m2 (35%) area for the green belt/ gardening
for the betterment of the environment. The detailed break-up of the land is given in
Table - 5 and Key Plan & Plant Layout is shown in Drawing - 1.
Table - 5: Break-up of Plot Area
Sr. No.
Area (m2)
Particular
% of
Total
Land
1.
Process Plant
500.0
10.06
2.
Raw Material & Product Storage
300.0
6.04
3.
Utility
154.0
3.10
4.
Effluent Treatment Plant
125.0
2.51
5.
Green Belt
1,742.0
35.04
6.
Roads
742.9
14.94
7.
Administrative Building
417.0
8.39
8.
Paved Area
640.1
12.88
9.
API Block
350.0
7.04
100.00
Total
4,971.00
Page | 13
Drawing - 1: Key Plan & Plant Layout
Page | 14
4.3
Resource Requirements
[A]
Water
The water requirement for the proposed project will be met by ground water supply
through own bore well. The total fresh water requirement for various domestic,
gardening & industrial activities will be 8.3 KLD.
[B]
Power
Total 818 KVA (350 HP) power will be required for the proposed project and same will
be procured from PGVCL (GEB). In addition to this, 1 DG Set of 250 KVA will be
installed as stand-by and captive source of power.
[C]
Fuel
For the proposed project Bio-fuel/ Agricultural waste will be required for the steam
boilers (2 TPH) & Thermic Fluid Boiler (2 Lac Kcal.) and diesel will be required for
stand-by DG Set. The details of fuel requirement are given in Table - 6.
Table - 6: Details of Fuel Requirement
Sr.
No.
Type of Fuel
1
Bio-fuel/ Agricultural waste
2
Diesel
[D]
Utility
Requirement
Steam boiler (2 TPH) &
Thermic Fluid Boiler
(2 Lac KCal)
180 TPM
DG Set
125 Lit/Hr.
Manpower
The manpower is one of the main resource requirements to operate and maintain the
plant in a better and efficient way. Total 30 personnel will be required for the proposed
project in the operation phase. Details of personnel requirement at various cadres are
as tabulated in Table 7 below:
Page | 15
Table - 7: Details of Manpower Requirement
Description
Management Supervisory
Staff
Staff
Administration
Production &
allied services
Stores &
Dispatch
Others
Total
4.4
Clerks
Company
Workers
Contractor
Workers
Total
1
0
1
1
1
4
2
4
0
8
8
22
0
0
1
1
2
4
0
0
0
0
0
0
3
4
2
10
11
30
Details of Manufacturing Process
1. BOSENTAN
a) Manufacturing Process
5-(2-Methoxyphenoxy)-4, 6-dichloro-2-(pyrimidin-2-yl) pyrimidine reacts with 4-(tertButyl)benzene-1-sulfonamide in presence of Sodium Bicarbonate to give 4-substitutes
pyrimidine which further couples with Ethylene glycol in presence of Sodium
Methoxide in Toluene and Methylene Dichloride solvent media to give desired
Bosentan.
Page | 16
b) Reaction Chemistry
Reaction
Chemistry
Chemical
Name
Gram/Mole
Gram/Mole
NaHCO3
5-(2Methodyphenoxy)4, 6-dichloro-2(pyrimidin-2yl)pyrimidine
4- (tert-Buty)
benzene-1sulfonamide
Ethylene
Glycol
Water
Sodium
Bicarbonate
349
213
62
54
84
Reaction
Chemistry
Chemical
Name
3H2O
2NaCl
CO2
CH3OH
H2O
Bosentan
Sodium
Chloride
Carbon
Dioxide
Methanol
Water
551
117
44
32
18
Page | 17
c) Process Flow Diagram
5-(2-Methoxyphenoxy)4,6-dichloro-2(pyrimidin-2-yl)
pyrimidine
:
4-(tert-Butyl)benzene1-sulfonamide
:
102
Ethylene glycol
:
30
Sodium Methoxide
:
26
Sodium Bicarbonate
:
41
Toluene (Fresh)
:
Toluene (Recovered)
Methylene Dichloride
(Fresh)
(Recovered)
167
Bosentan :
200
Toluene
:
(Recovered)
1,570
Toluene Loss :
Methylene
Dichloride :
(Recovered)
50
100
Effluent :
1,751
:
1,570
114
:
67
Organic Residue :
Process
:
Emissions (CO2)
:
768
Water
:
1,670
Total
:
4,541
Total :
4,541
Capacity, TPM
6.00
Batch size, Kg
200
Working Days
26
Name of Raw Material
Quantity
Kg/Kg
Kg/Batch
of
Product
TPM
Remarks
Input
1.
2.
5-(2-Methoxyphenoxy)4,6-dichloro-2-(pyrimidin2-yl) pyrimidine
4-(tert-Butyl) benzene-1sulfonamide
167.0
0.835
5.01 Reactant
102.0
0.510
3.06 Reactant
3.
Ethylene glycol
30.0
0.150
0.90 Reactant
4.
Sodium Methoxide
26.0
0.130
0.78 Reagent
Page | 18
768
Methylene
:
Dichloride (Loss)
Stage 1
d) Summary of Mass Balance
Sr. No.
67
21
5.
Sodium Bicarbonate
6.
Toluene (Fresh)
7.
Toluene (Recovered)
8.
9.
10.
(Fresh)
(Recovered)
Water
Total
41.0
0.205
1.23 Reactant
100.0
0.500
3.00 Solvent
1,570.0
7.850
67.0
0.335
768.0
3.840
23.04
1,670.0
8.350
50.10
4,541.0
47.10
Solvent
Recovered
2.01 Solvent
Solvent
Recovered
22.705 136.23
Output
1.
Bosentan
2.
3.
Finished
Product
Solvent
47.10
Recovered
2.01 Solvent Loss
Solvent
23.04
Recovered
200.0
1.000
Toluene (Recovered)
1,570.0
7.850
67.0
0.335
768.0
3.840
50.0
0.250
1.50 Solvent Loss
6.
Toluene Loss
(Recovered)
Loss
Effluent
1,751.2
8.756
7.
Organic Residue
113.7
0.569
8.
Process Emissions (CO2)
21.1
0.105
52.53 To ETP
Organic HW
3.41
(CHWIF)
0.63 Atmos. Loss
Total
4,541.0
4.
5.
6.00
22.705 136.23
Page | 19
2. REBAMIPIDE
Stage-1: Charge 4-bromo-3-oxo-N-phenylbutanamide in sulfuric acidand warm
reaction mass up to 45-50 oC. Upon completion of reaction quench reaction mass in
water. Fitler slurry to obtain Bromomethyl-1,2-dihydroquinoline-2-one.
Stage-2: Charge Diethyl 2-aminomalonate Hydrochloride and Triethyl amine in
Methylene Dichloride. Stir reaction mass at 10-15 °C. Charge 4-chloro Benzoyl
Chloride dropwise. Upon completion of reaction add water and separate layers. Distill
out Methylene Dichloride to get diethyl 2-(4-chlorobenzamido)malonate.
Stage-3: Anhydrous Methanol and Sodium Methoxidewere charged in reactor and the
mixture was cooled down to below 5°C. After adding diethyl Diethyl 2-[4(chlorobenzoyl)amino]Malonate, the resulting solution was stirred at below 5°C for one
hour. 4-Bromomethyl-1,2-dihydroquinoline-2-onewas added to the mixture and the
resulting solution was stirred at the room temperature for 16 hours to produce an
intermediate, ethyl 2-(4- chlorobenzoylamino)-2-ethoxycarbonyl-3-[2(1H)-quinolinon-4yl]propionate.
Stage-4: After the completion of the reaction, sodium hydroxide was dissolved in 30
ml of purified water and this aqueous solution was added to the above solution, which
was then stirred at the room temperature for about 2 hours. Subsequently, the
resulting solution was warmed to about 60°C and stirred for 2 hours to complete the
reaction. Methanol was removed through vacuum concentration, and purified water
and conc. HCl were added to the residue for crystallization.
Page | 20
Stage-1
Reaction
Chemistry
Chemical Name
Gram/Mole
H2SO4
4-bromo-3-oxo-Nphenylbutanamide
Sulfuric Acid
256
98
4-(bromomethyl)
quinolin-2(1H)one
238
H2SO4
H2O
Sulfuric
Acid
Water
98
18
Stage-2
Reaction
Chemistry
Chemical Name
Gram/Mole
2HCl
diethyl 2aminomalonate
hydrochloride
4chlorobenzoyl
chloride
triethyl
amine
diethyl 4chlorobenzamido
malonate
Hydro
Chloric
Acid
triethyl
amine
211
175
101
313
73
101
Page | 21
Stage-3
Reaction
Chemistry
Chemical Name
Gram/Mole
NaOMe
4-(bromomethyl)
quinolin-2(1H)one
diethyl 4chlorobenzamido
malonate
Sodium
Methoxide
238
313
54
diethyl 2-(4chlorobenzamido)-2((2-oxo-1,2dihydroquinolin4-yl)
471
NaBr
MeOH
Sodium
Bromide
Methanol
102
32
Stage-4
Reaction
Chemistry
Chemical Name
Gram/Mole
Page | 22
NaOH
2H2O
2EtOH
diethyl 2-(4chlorobenzamido)-2-((2oxo-1,2-dihydroquinolin-4yl)
Sodium
Hydroxide
Water
Rebamipide
Ethanol
471
40
36
371
92
CO2
NaOH
Carbon Sodium
Dioxide Hydroxide
44
40
4-bromo-3oxo-N-phenyl :
butanamide
164
Sulfuric Acid :
150
Water :
Total :
Diethyl 2aminomalonate :
Hydrochloride
4-chloro
benzoyl :
chloride
Triethyl Amine :
Methylene
Dichloride :
(Fresh)
Methylene
Dichloride :
(Recovered)
Bromomethyl-1,2dihydroquinoline- :
2-one
150
Effluent :
900
750
Organic Residue :
14
1,064
Total :
1,064
Diethyl 2-(4chlorobenzamido) :
malonate
Methylene
Dichloride :
(Recovered)
Methylene
:
Dichloride (Loss)
149.1
123.6
155.1
208.8
112
8
Stage 2
8.0
Effluent :
306.7
Organic Residue :
12.3
Total :
647.8
112
Water :
100
Total :
647.8
Intermediate
:
from Stage 1
150
Intermediate
Product from :
Stage 2
208.8
Sodium
Methoxide
Methanol
(Fresh)
Methanol
(Recovered)
Acetic Acid
(Fresh)
Acetic Acid
(Recovered)
Stage 1
:
76.5
:
31
:
diethyl 2-(4chlorobenzamido)2- ((2-oxo-1,2:
dihydroquinoline4 yl)methyl)
malonate
Methanol
:
(Recovered)
Stage 3
282
1169
Methanol (Loss) :
50.1
1169
Acetic Acid
:
(Recovered)
115
:
5.0
Effluent :
66
:
115
Organic Residue :
73.2
Total : 1,755.3
Total :
1,755.3
Page | 23
Intermediate
:
from Stage 3
Sodium
:
Hydroxide
Hydrochloric
:
Acid
282
Rebamipide :
214.8
55
Effluent :
627.5
Organic Residue :
9.2
Stage 4
40
Water :
500
Total :
877
Process
:
Emission
Total :
Gross Input :
4,344
Gross Output :
25.5
877
4,344
Capacity, TPM
6.00
Batch size, Kg
215
Working Days
26
Stage - 1
Sr.
No.
Name of Raw
Material
Quantity
Remarks
Kg/Batch
Kg/Kg of
Product
164.0
0.764
4.58 Reactant
150.0
0.698
4.19 Reactant
750
3.492
20.95
1,064.0
4.953
29.72
150.0
0.698
900.0
4.190
14.0
0.065
1,064.0
4.953
TPM
Input
2.
Sulphuric acid
3.
Water
1.
Total
Output
Bromomethyl-1,21. dihydroquinoline-2one
2. Effluent
3.
Organic Residue
Total
Stage – 2
Page | 24
4.19 Used in 3rd Stage
25.14 To ETP
Organic HW
0.39
(CHWIF)
29.72
Sr.
No.
Name of Raw
Material
Quantity
Kg/Kg
Kg/Batch
of
Product
TPM
Remarks
Input
1.
2.
3.
4.
5.
6.
Diethyl 2aminomalonate
Hydrochloride
4-chloro benzoyl
chloride
Triethyl Amine
(Fresh)
(Recovered)
Water
Total
Output
Diethyl 2-(41.
chlorobenzamido)
malonate
2.
(Recovered)
3.
Loss
4.
Effluent
5.
Organic Residue
Total
149.1
0.694
4.16 Reactant
123.6
0.575
3.45 Reactant
155.1
0.722
4.33 Reactant
8.0
0.037
0.22 Solvent
112.0
0.521
3.13 Solvent Recovered
100.0
0.466
2.79
647.8
3.016
18.09
208.8
0.972
5.83 Used in Next Stage
112.0
0.521
8.0
0.037
0.22 Solvent Loss
306.7
1.428
12.3
0.057
647.8
3.016
8.56 To ETP
Organic H/W
0.34
(CHWIF)
18.09
Stage – 3
Sr.
No.
Name of Raw
Material
Quantity
Kg/Kg
Kg/Batch
of
Product
TPM
Remarks
Input
1.
2.
3.
Bromomethyl-1,2dihydroquinoline-2one
Diethyl 2-(4chlorobenzamido)
malonate
Sodium Methoxide
150.0
0.698
4.19 Reactant
208.8
0.972
5.83 Reactant
76.5
0.356
2.14 Reactant
Page | 25
4.
5.
6.
7.
Methanol (Fresh)
Methanol
(Recovered)
Acetic Acid (Fresh)
Acetic Acid
(Recovered)
Total
Output
diethyl 2-(4chlorobenzamido)-21.
((2-oxo-1,2dihydroquinoline-4yl)methyl)malonate
Methanol
2.
(Recovered)
3.
Methaol Loss
Acetic Acid
4.
(Recovered)
5.
Effluent
6.
Organic Residue
Total
31.0
0.144
0.86 Solvent
1,169.0
5.442
5.0
0.023
0.14 Solvent
115.0
0.535
1,755.3
8.172
282.0
1.313
1,169.0
5.442
50.1
0.233
1.40 Solvent Loss
115.0
0.535
65.99
0.307
73.2
0.341
1,755.3
8.172
49.03
1.84 To ETP
Organic H/W
2.04
(CHWIF)
49.03
Stage – 4
Sr.
No.
Name of Raw
Material
Quantity
Kg/Kg
Kg/Batch
of
Product
TPM
Remarks
Input
2.
diethyl 2-(4chlorobenzamido)-2((2-oxo-1,2dihydroquinoline-4yl)methyl)malonate
Sodium hydroxide
3.
Hydrochloric Acid
4.
Water
1.
Total
282.0
1.313
7.88 Reactant
55.0
0.256
1.53 Reactant
40.0
0.186
1.12 For Crystallization
500.0
2.328
13.96
877.0
4.083
24.49
Output
1.
Rebamipide
214.8
1.000
2.
Effluent
627.5
2.921
Page | 26
6.00 Finished Product
17.53 To ETP
3.
4.
Organic Residue
Process Emission
(CO2)
Total
Organic H/W
(CHWIF)
9.2
0.043
0.25
25.5
0.119
0.71 Atmospheric Loss
877.0
4.083
24.49
Page | 27
3. ZALTOPROFEN
Stage-1: Charge Methanol, 2-(2-(phenylthio)-5-propionylphenyl)acetic acid and
Sulfuric acid. Heat reaction mixture for 65 oC for 5 hours. After completion distill out
methanol cool reaction mixture and add toluene and water. Separate layers. Wash
organic layer with Sodium Carbonate solution. Evaporate organic layer under vacuum.
To the reaction mass charge Trimethylorthoformate, Zinc dust and heat at 50 oC.
Charge bromine slowly. Upon completion cool the reaction mass and charge zinc
dust. Heat reaction mass at 100 oC. Upon completion cool reaction mass and charge
DM water and toluene. Separate layers. Wash organic layer with 20 % Sodium
hydroxide solution. Acidify aqueous layer with dilute sulfuric acid. Cool reaction
mixture to and filter slurry yield 5-(1-Carboxyethyl)-2-(phenylthio)phenylacetic acid.
Stage-2: Polyphosphoric acid is charged in reactor, followed by 5-(1-Carboxyethyl)-2(phenylthio)phenylacetic acid. Charge Ethylene Dichloride and heat reaction mass to
reflux at 83-85 oC for 30 minutes. Distill out Ethylene Dichloride. Reflux reaction mass
for more 2 hours. After completion of reaction cool reaction mass to room temperature
and quench the reaction mass in water. Heat reaction mass to 68-72 oC for 30
minutes. Separate layers and cool organic layer at 0-5 oC for 2 hours. Filter the
product.
Stage-3: Charge water and Ethanol in reactor and stir for 30 minutes. Charge
Zaltoprofen crude at room temperature. Charge sodium carbonate solution slowly and
stir for 1 hour. Neutralize reaction mass with Acetic acid. Filter the reaction mass and
transfer filtrate to reactor. Charge more acetic acid and stir for 1 hour. Filter product
and wash with DM water.
Page | 28
Stage-1
Reaction
Chemistry
Br
2-(2-(phenylthio)-5Chemical Name propionylphenyl)acet
ic acid
Gram/Mole
300.37
H2O
Zn
Bromine
Zinc Dust
Trimethyl
Orthoformate
Water
159.81
65.38
106.12
16
2-(3(carboxymethyl)-4(phenylthio)phenyl
) propanoic acid
316
Br
Zn
Bromine
Zinc Dust
Trimethyl
Orthoformate
159.81
65.38
106.49
Stage-2
Reaction
Chemistry
Chemical Name
Gram/Mole
2H3PO4
EDC
H2O
2-(3-(carboxymethyl)-4(phenylthio) phenyl)
propanoic acid
Polyphosphoric
acid
Ethylene
Dichloride
Water
316
196
98
18
Stage-3
Reaction
Chemistry
Ethanol
Acetic Acid
Chemical Name
Gram/Mole
Zaltoprofen (Crude)
Zaltoprofen (Pure)
298
298
Page | 29
P2O5
EDC
5H2O
Zaltoprofen
(Crude)
Phosphorus
Pentoxide
Ethelyne
Dichloride
Water
298
142
98
90
2-(2-(phenylthio)-5propionylphenyl) acetic
acid
:
28
Methanol (Fresh)
:
13
Methanol (Recovered)
:
155
Sulfuric acid
:
2.8
Sodium Carbonate
:
Trimethyl Ortho Formate
2-(3-(carboxymethyl)-4(phenylthio)phenyl)
propanoic acid
:
28
5.2
:
155
:
24.4
Methanol Loss
:
13
Zinc Dust
:
1.2
Toluene (Recovered)
:
78
Bromine
:
18.2
Toluene Loss
:
6
Sodium Hydroxide
:
15.4
Effluent
:
280.4
Toluene (Fresh)
:
6
Organic Residue
:
6.6
Toluene (Recovered)
:
78
Water
:
219.8
Total
:
567
Total
:
567
2-(3-(carboxymethyl)-4(phenylthio)phenyl)
propanoic acid
:
28
Zaltoprofen (Crude)
:
23.7
Polyphosphoric acid
:
112
Ethylene Dichloride
(Recovered)
:
67
Ethylene Dichloride
(Fresh)
:
3
Ethylene Dichloride
(Loss)
:
3
Ethylene Dichloride
(Recovered)
:
67
Effluent
:
196
Water
:
82.5
Organic Residue
:
3
Total
:
292.5
Total
:
292.7
Zaltoprofen (Crude)
:
23.7
Zaltoprofen (Pure)
:
19.8
Ethanol (Fresh)
:
2.9
Ethanol (Recovered)
:
53.0
Ethanol (Recovered)
:
53
Ethanol (Loss)
:
2.0
Acetic Acid (Fresh)
:
1.7
Acetic Acid (Recovered)
:
16.0
Stage 1
Stage 2
Stage 3
Acetic Acid (Recovered)
:
16.0
Acetic Acid (Loss)
:
0.7
Sodium Carbonate
:
5.1
Effluent
:
82.2
:
:
Organic Residue
:
6.4
Water
79.4
Process Emission (CO2)
:
1.7
Page | 30
Total
:
181.8
Total
:
181.8
Gross Input
:
1,041.3
Gross Output
:
1,041.5
Capacity, TPM
6.0
Batch size, Kg
19.8
Working Days
26
Stage - 1
Quantity
Sr.
No.
Name of Raw
Material
Kg/Batch
Kg/Kg
of
Product
1.
2-(2-(phenylthio)-5propionylphenyl)acetic
acid
28.0
1.414
8.48 Reactant
2.
Methanol (Fresh)
13.0
0.657
3.94 Solvent
3.
155.0
7.828
4.
Sulfuric acid
2.8
0.141
0.85 Reagent
5.
Sodium Carbonate
5.2
0.263
1.57 Neutralization
6.
Trimethyl Ortho
Formate
24.4
1.232
7.39 Reactant
7.
Zinc Dust
1.2
0.061
0.36 Reactant
8.
Bromine
18.2
0.919
5.51 Reactant
9.
Sodium Hydroxide
15.4
0.778
4.67 Neutralization
10.
Toluene (Fresh)
6.0
0.303
1.82 Solvent
11.
Toluene (Recovered)
78.0
3.939
12.
Water
219.8
11.101
66.61
567.0
28.636
171.82
1.
2-(3-(carboxymethyl)4-(phenylthio)phenyl)
propanoic acid
28.0
1.414
2.
155.0
7.828
Remarks
TPM
Input
Total
Output
Page | 31
3.
Methanol Loss
13.0
0.657
4.
Toluene (Recovered)
78.0
3.939
5.
Toluene Loss
6.0
0.303
6.
Effluent
280.4
14.162
7.
Organic Residue
6.6
0.333
2.00
567.0
28.636
171.82
Total
3.94 Solvent Loss
1.82 Solvent Loss
84.97 To ETP
Organic H/W
(CHWIF)
Stage-2
Quantity
Sr.
No.
Name of Raw
Material
Kg/Batch
Kg/Kg
of
Product
28.0
1.414
8.48 Reactant
112.0
5.657
33.94 Reactant
3.0
0.152
0.91 Solvent
67.0
3.384
82.5
4.167
25.00
292.5
14.774
88.63
23.7
1.197
67.0
3.384
3.0
0.152
195.5
9.874
3.3
0.167
1.00
292.5
14.774
88.63
TPM
Remarks
Input
1.
2-(3-(carboxymethyl)4(phenylthio)phenyl)pro
panoic acid
2.
Polyphosphoric acid
3.
4.
5.
Ethylene Dichloride
(Fresh)
Ethylene Dichloride
(Recovered)
Water
Total
Output
1.
2.
3.
Zaltoprofen (Crude)
Ethylene Dichloride
(Recovered)
Ethylene Dichloride
(Loss)
4.
Effluent
5.
Organic Residue
Total
Page | 32
0.91 Solvent Loss
59.24 To ETP
Organic H/W
(CHWIF)
Stage-3
Quantity
Sr.
No.
Name of Raw
Material
Kg/Batch
Kg/Kg
of
Product
23.7
1.197
7.18 Reactant
2.9
0.146
0.88 Solvent
53.0
2.677
1.7
0.086
0.52 Solvent
16.0
0.808
5.1
0.258
1.55 Reactant
79.4
4.010
24.06
181.8
9.182
55.1
TPM
Remarks
Input
1.
Zaltoprofen (Crude)
2.
Ethanol (Fresh)
3.
Ethanol (Recovered)
4.
Acetic Acid (Fresh)
5.
Acetic Acid
(Recovered)
6.
Sodium Carbonate
7.
Water
Total
Output
1.
Zaltoprofen
19.8
1.000
2.
Ethanol (Recovered)
53.0
2.677
3.
Ethanol (Loss)
2.0
0.101
0.61 Solvent Loss
4.
Acetic Acid
(Recovered)
16.0
0.808
5.
Acetic Acid (Loss)
0.7
0.035
0.21 Solvent Loss
6.
Effluent
82.2
4.153
7.
Organic Residue
6.4
0.322
1.93
8.
Process Emission
(CO2)
1.7
0.086
0.52 Atmospheric Loss
181.8
9.182
55.1
Total
24.92 To ETP
Organic H/W
(CHWIF)
Page | 33
4. CANDESARTAN
Stage-1: Charge Methylene Dichloride and Trityl Amine at 10 oC. Charge solution of
Trityl Chloride in Methylene Dichloride slowly at 10 oC. Stir for 1-2 hours and charge
water to separate organic layer. Concentrate organic layer under vacuum and charge
ethyl acetate. Cool fo 5 oC and filter Trityl Candesartan and dry at 50 oC in dryer.
Reaction Chemistry
Chemical Name
Gram/Mole
Candesartan
Trityl Chloride
Triethyl
amine
440
278
101
Reaction Chemistry
Chemical Name
Gram/Mole
Page | 34
HCl
Trityl Candesartan
Triethyl
amine
Hydro
Chloric Acid
682
101
36
Candesartan :
91
Trityl Chloride :
64
Triethyl amine :
37
:
(Fresh)
15
:
(Recovered)
370
Ethyl Acetate (Fresh) :
40
Ethyl Acetate
:
(Recovered)
Water :
Trityl
Candesartan
Methylene
Dichloride
(Recovered)
Methylene
Dichloride (Loss)
Ethyl
Acetate
(Recovered)
Ethyl Acetate
(Loss)
:
134
:
370
:
15
:
620
:
40
620
Effluent :
154
110
Organic Residue :
14
Stage 1
Total : 1,347
Total : 1,347
Capacity TPM
6.00
Batch size Kg
134
Working Days
26
Sr.
No.
Quantity
Kg/Kg
Kg/Batc
of
h
Produc
t
TPM
Remarks
Input
1.
Candesartan
91.1
0.680
4.08 Reactant
2.
Trityl Chloride
63.8
0.476
2.85 Reactant
3.
37.3
0.279
1.67 Reactant
15.0
0.112
0.67 Solvent
370.0
2.761
6.
Triethyl amine
(Fresh)
(Recovered)
Ethyl Acetate (Fresh)
40.0
0.299
7.
Ethyl Acetate (Recovered)
620.0
4.627
8.
Water
110.0
0.821
1,347.2
10.1
4.
5.
Total
Solvent
Recovered
1.79 Solvent
Solvent
27.76
Recovered
4.92
16.56
60.30
Page | 35
Output
1.
2.
3.
Trityl Candesartan
(Recovered)
(Loss)
4.
5.
Ethyl Acetate (Loss)
6.
Effluent
7.
OrganicResidue
Total
Page | 36
134.0
1.000
370.0
2.761
15.0
0.112
620.0
4.627
40.0
0.299
154.5
1.153
13.6
0.102
1,347.2
10.1
Finished
Product
Solvent
16.56
Recovered
6.00
0.66 Solvent Loss
Solvent
Recovered
1.79 Solvent Loss
27.76
6.92 To ETP
Organic H/W
0.610
(CHWIF)
60.30
5. VALSARTAN
Stage-1: 2-Cyano-4-bromomethyl biphenyl undergoes condensation with L-Valine
methyl ester Hydrochloride in presence of Potassium Carbonate and Hydrochloric
acid in Dimethylformamide solvent medium to yield stage-1 compound.
Stage-2: Stage-1 compound undergoes basification reaction with Sodium Bicarbonate
and on further coupling with Valeryl Chloride in presence of Hydrochloric acid, Sodium
Sulfate and Triethylamine in o-Xylene solvent media.
Stage-3: Charge Stage-2 compound in dil. HCl solution and charge sodium azide
solution in water slowly at room temperature. Stir the reaction mass for 3-4 hours and
upon completion of reaction extract with methylene dichloride and wash organic layer
with dilute sodium hydroxide followed by brine wash and dry organic layer over
sodium sulfate. Concentrate organic layer under vacuum to obtain Valsartan.
Page | 37
Stage - 1
Reaction
Chemistry
K2CO3
2-Cyano-4Chemical
bromomethyl
Name
biphenyl
Gram/Mole
272
L-Valine
Potassium
methyl ester
Carbonate
Hydrochloride
167.5
138
HCl
Hydro
Chloric
Acid
36.5
KCl
Stage-I
Compound
KBr
H2O
Potassium Potassium
Carbon
Water
Chloride
Bromide
Dioxide
358.5
74.5
119
18
Stage - 2
Reaction
Chemistry
Chemical
Name
Gram/Mole
2 NaHCO3
Page | 38
2 NaCl
2 H2O
2 CO2
Stage-I
Compound
Valeryl
Chloride
Sodium
Bicarbonate
Stage-II Compound
Sodium
Chloride
Water
Carbon
Dioxide
358.5
120.5
168
406
117
36
88
CO2
44
Stage - 3
Reaction
Chemistry
Chemical
Name
Gram/Mole
HCl
Stage-II
Compound
406
2 H2O
Hydrochloric
Water
Acid
36.5
36
NaN3
NaCl
H2O
CH3OH
Sodium
Azide
Valsartan
Sodium
Chloride
Water
Methanol
65
435
58.5
18
32
Page | 39
2-Cyano-4bromomethyl :
biphenyl
85
L-Valine methyl
:
ester Hydrochloride
68
Potassium
Carbonate
Hydrochloric acid
(35%)
Dimethyl formamide
(Fresh)
Dimethyl formamide
(Recovered)
Toluene (Fresh)
Toluene
(Recovered)
Water
:
67
:
68
:
30
:
Product (Stage-1) :
Stage 1
Dimethyl
formamide :
(Recovered)
Dimethyl
:
formamide Loss
Toluene
:
(Recovered)
93
470
20
320
Toluene Loss :
14
470
Effluent :
999
:
20
Organic Residue :
41
:
320
21
:
850
Process Emissions
:
(CO2)
Total : 1,978
Total : 1,978
Product (Stage-1) :
93
Sodium Bicarbonate :
60
Product (Stage-2) :
102
Valeryl Chloride :
40
o-Xylene :
(Recovered)
188
Hydrochloric acid
:
(35%)
58
o-Xylene Loss :
22.5
Methylene
Dichloride : 340.5
(Recovered)
Methylene
:
8
Dichloride Loss
Sodium Sulfate :
37
Triethylamide :
33
o-Xylene (Fresh) :
12
Effluent :
823
:
188
Organic Residue :
22
:
29.5
Inorganic Solid
:
Waste
37
Process Emissions
:
(CO2)
28
o-Xylene
(Recovered)
Methylene
Dichloride (Fresh)
Methylene
Dichloride
(Recovered)
Water
: 340.5
:
680
Total : 1,571
Page | 40
Stage 2
Total : 1,571
Product (Stage-2) :
Tri-n-Butyl
:
Tinchloride
Sodium Azide :
102
Sodium Hydroxide :
5
Sodium Chloride :
10
Sodium Sulfate :
20
Hydrochloric acid
:
(35%)
41
o-Xylene (Fresh)
o-Xylene
(Recovered)
Methylene
Dichloride (Fresh)
Methylene
Dichloride
(Recovered)
Water
173
Valsartan :
100
20
:
6
o-Xylene
(Recovered)
o-Xylene Loss
Methylene
Dichloride
(Recovered)
Methylene
Dichloride
Loss
Effluent
:
1329
:
94
Organic Residue :
192
:
32
Inorganic Solid
:
Waste
20
:
368
:
1260
Stage 3
:
94
:
4
:
368
:
24
Total : 2,131
Total : 2,131
Gross Input : 5,680
Gross Output : 5,680
Capacity, TPM
5.00
Batch size, Kg
100
Working Days
26
Stage - 1
Sr.
No.
Quantity
Kg/Kg
Kg/Batch
of
Product
TPM
Remarks
Input
1.
2.
2-Cyano-4-bromomethyl
biphenyl
L-Valine methyl ester
Hydrochloride
85.0
0.850
4.25 Reactant
68.0
0.680
3.40 Reactant
Page | 41
3.
Potassium Carbonate
67.0
0.670
3.35 Reactant
4.
Hydrochloric acid (35%)
Dimethylformamide
(Fresh)
Dimethylformamide
(Recovered)
68.0
0.680
3.40 Reactant
30.0
0.300
1.50 Solvent
470.0
4.700
20.0
0.200
5.
6.
7.
Toluene (Fresh)
8.
Toluene (Recovered)
320.0
3.200
9.
Water
850.0
8.500
42.50
1,978.0
19.780
98.90
93.0
0.930
470.0
4.700
20.0
0.200
320.0
3.200
14.0
0.140
999.1
9.991
40.7
0.407
2.03 Organic HW (CHWIF)
21.2
0.212
1.06 Atmos. Loss
1,978.0
19.780
Total
1.00 Solvent
Output
4.
Product (Stage-1)
Dimethylformamide
(Recovered)
Dimethylformamide
Loss
Toluene (Recovered)
5.
Toluene Loss
6.
Effluent
7.
Organic Residue
Process Emissions
(CO2)
1.
2.
3.
8.
Total
1.00 Solvent Loss
0.70 Solvent Loss
49.96 To ETP
98.90
Stage - 2
Sr.
No.
Quantity
Kg/Kg
Kg/Batch
of
Product
TPM
Remarks
Input
1.
Product (Stage-1)
93.0
0.930
4.65 Reactant
2.
Sodium Bicarbonate
60.0
0.600
3.00 Reactant
3.
Valeryl Chloride
Hydrochloric acid
(35%)
40.0
0.400
2.00 Reactant
58.0
0.580
2.90 Reactant
5.
Sodium Sulfate
37.0
0.370
1.83 To remove water
6.
Triethylamide
33.0
0.330
1.65 Reagent
7.
o-Xylene (Fresh)
12.0
0.120
0.60 Solvent
4.
Page | 42
8.
9.
10.
11.
o-Xylene (Recovered)
(Fresh)
(Recovered)
Water
Total
188.0
1.880
29.5
0.295
1.47 Solvent
340.5
3.405
680.0
6.800
34.00
1,571.0
15.710
78.53
Output
1.
Product (Stage-2)
102.0
1.020
2.
188.0
1.880
3.
22.5
0.225
1.12 Solvent Loss
340.5
3.405
8.0
0.080
6.
o-Xylene Loss
(Recovered)
Loss
Effluent
823.1
8.231
7.
Organic Residue
22.0
0.220
8.
Inorganic Solid Waste
Process Emissions
(CO2)
Total
37.0
0.370
1.85 Inorganic HW (TSDF)
27.9
0.279
1.39 Atmos. Loss
1,571.0
15.710
4.
5.
9.
0.40 Solvent Loss
41.15 To ETP
78.53
Stage - 3
Sr.
No.
Quantity
Kg/Batch
Kg/Kg of
Product
TPM
Remarks
Input
102.0
173.0
20.0
5.0
1.020
1.730
0.200
0.050
5.10
8.65
1.00
0.25
Reactant
Reactant
Reactant
Reagent
For work up
4.
Product (Stage-2)
Tri-n-Butyl Tinchloride
Sodium Azide
Sodium Hydroxide
5.
Sodium Chloride
10.0
0.100
0.50
6.
Sodium Sulfate
20.0
0.200
1.00 To remove water
7.
Hydrochloric acid (35%)
41.0
0.410
2.05 Reactant
8.
o-Xylene (Fresh)
6.0
0.060
0.30 Solvent
9.
(Fresh)
94.0
0.940
32.0
0.320
1.60 Solvent
368.0
3.680
1.
2.
3.
10.
11.
Page | 43
(Recovered)
12.
Water
Total
1,260.0
12.600
63.00
2,131.0
21.310
106.55
100.0
1.000
Output
1.
Valsartan
2.
94.0
0.940
3.
4.0
0.040
0.20 Solvent Loss
368.0
3.680
24.0
0.240
1.20 Solvent Loss
6.
o-Xylene Loss
(Recovered)
Loss
Effluent
1,328.7
13.287
7.
Organic Residue
192.3
1.923
8.
Inorganic Solid Waste
20.0
0.200
66.43 To ETP
Organic HW
9.62
(CHWIF)
Inorganic HW
1.00
(TSDF)
2,131.0
21.310
4.
5.
Total
Page | 44
106.55
6. PRANLUKAST
Stage-1: To a stirred solution of Dimethyl Formamide and Methylene dichloride is
added 4-(4-phenylbutoxy)benzoic acid. Charge dropwisethionyl chloride. After
completion, distill out Methylene Dichloride under vacuum. Charge this reaction mass
to stirred solution of 3-amino 2-hydroxy acetophenone in Methylene dichloride and
pyridine at 0-5 oC. After completion of reaction, charge Hydrochloric acid and
separate layers. Wash with Sodium bicarbonate solution and evaporate organic layer
to yield N-(2-hydroxy-3- (3-oxo-3-(1H-tetrazol-5-yl) propanoyl)phenyl)- 4 - (4phenylbutoxy) benzamide
Stage-2: N-(2-hydroxy- 3- (3-oxo- 3-(1H-tetrazol-5-yl) propanoyl) phenyl)-4-(4phenylbutoxy) benzamide and sulfuric acid were charged in reactor. Reaction mass
was heated at 80 oC for 2-3 hours. After completion, reaction mass was quenched in
ice water to yield crude product.
Stage-3: Pranlukast (crude) and ethyl acetate were charged in reactor and refluxed
for 1 hour. Upon cooling at 10 oC. Solid slurry was filtered to obtain pure product.
Page | 45
Stage - 1
Reaction
Chemistry
Chemical
Name
SOCl2
4-(4-phenylbutoxy)
benzoic acid
1-(3-amino-2hydroxyphenyl)
ethanone
Thionyl
Chloride
271
151
118
Gram/Mole
N-(3-acetyl-2hydroxyphenyl)-4-(4phenylbutoxy)
benzamide
403
HCl
SO2
Hydro
chloric
Acid
Sulphur
Dioxide
73
64
Stage - 2
Reaction
Chemistry
Chemical
Name
Gram/Mole
H2SO4
benzamide
403
Page | 46
H2SO4
H2O
Sulfuric
Acid
Pranlukast (Crude)
Sulfuric
Acid
Water
98
385
98
18
Stage - 3
Reaction
Chemistry
Chemical
Name
Gram/Mole
Pranlukast (Crude)
Pranlukast (Pure)
385
385
Page | 47
4-(4-phenylbutoxy)
:
benzoic acid
1-(3-amino-2hydroxyphenyl) :
ethanone
Methylene
:
Dichloride (Fresh)
Methylene
Dichloride :
(Recovered)
Dimethyl
:
Formamide
Thionyl Chloride :
100
57
N-(3-acetyl-2hydroxyphenyl)-4:
(4-phenylbutoxy)
benzamide
18
125
59
Methylene
Dichloride :
(Recovered)
Methylene
:
Dichloride (Loss)
Effluent :
Pyridine :
90
Organic Residue :
27
Hydrochloric acid :
Sodium
:
Bicarbonate
Water :
300
Process
:
Emissions (SO2)
20
Total :
1,529
Pranlukast (Crude) :
106
Effluent :
1562
1062
Organic Residue :
19
Total : 1,687
Total :
1,687
Pranlukast (Pure) :
100
570
5
Stage 1
30
Sulfuric Acid :
Water :
Intermediate from
:
Stage 2
Ethyl Acetate
:
(Fresh)
18
769
300
Total : 1,529
Intermediate from
:
Stage 1
570
125
500
Stage 2
106
37
Stage 3
Ethyl Acetate
:
(Recovered)
Ethyl Acetate
:
(Loss)
862
22
Effluent :
15
Organic Residue :
6
Total : 1,005
Total :
1,005
Gross Input : 4,221
Gross Output :
4,221
Ethyl Acetate
:
(Recovered)
862
Page | 48
Capacity TPM
5.00
Batch size Kg
100
Working Days
26
Stage - 1
Sr.
No.
Name of Raw
Material
Quantity
Kg/Kg
Kg/Batch
of
Product
TPM
Remarks
Input
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
4-(4-phenylbutoxy)
benzoic acid
ethanone
(Fresh)
(Recovered)
Dimethyl Formamide
Thionyl Chloride
Pyridine
Hydrochloric acid
Sodium Bicarbonate
Water
Total
Output
N-(3-acetyl-2hydroxyphenyl)-4-(41.
phenylbutoxy)benzami
de
2.
(Recovered)
3.
(Loss)
4.
Effluent
5.
6.
OrganicResidue
Process Emissions
(SO2)
Total
100.0
1.000
5.00 Reactant
57.6
0.576
2.88 Reactant
18.0
0.180
0.90 Solvent
570.0
5.700
5.0
0.050
59.0
89.6
300.0
30.0
300.0
0.590
0.896
3.000
0.300
3.000
2.95
4.48
15.00
1.50
15.00
1,529.2
15.3
76.5
125.0
1.250
570.0
5.700
18.0
0.180
769.3
7.693
27.1
0.271
1.35 Organic H/W (CHWIF)
19.8
0.198
0.99 To APCM
1,529.2
15.3
0.25 Catalyst
Reactant
Reagent
For work up
For Neutralization
0.90 Solvent Loss
38.46 To ETP
45.9
Page | 49
Stage 2
Sr.
No.
Name of Raw
Material
Quantity
Kg/Kg
Kg/Batch
of
Product
TPM
Remarks
Input
2.
benzamide
Sulfuric Acid
3.
Water
1.
Total
125.0
1.250
6.25 Reactant
500.0
5.000
25.00 Reactant
1062.0
10.620
53.10
1,687.0
16.870
84.35
106.3
1.063
1562.0
15.620
18.8
0.188
1,687.0
16.870
Output
1.
Pranlukast (Crude)
2.
Effluent
3.
Organic Residue
Total
78.10 To ETP
84.35
Stage 3
Sr.
No.
Name of Raw
Material
Quantity
Kg/Kg
Kg/Batch
of
Product
TPM
Remarks
Input
1.
2.
3.
Pranlukast (Crude)
Ethyl Acetate
(Fresh)
Ethyl Acetate
(Recovered)
Total
106.3
1.063
5.31 Reactant
37.5
0.375
1.87
862.5
8.625
1,006.3
10.063
100.0
1.000
862.5
8.625
22.5
15.0
6.3
1,006.3
0.225
0.150
0.063
10.063
Solvent
50.30
Output
1.
2.
3.
4.
5.
Pranlukast
Ethyl Acetate
(Recovered)
Effluent
Organic Residue
Total
7. TICAGRELOR
Page | 50
1.12 Solvent Loss
0.75 To ETP
50.30
Stage-1: 2 - (((3aR,4S,6R,6aS) - 6 - (7-(((1R,2S) – 2 - (3,4-difluorophenyl)
cyclopropyl) amino) – 5 - (propylthio) - 3H - [1,2,3] triazolo [4,5-d] pyrimidin-3-yl) - 2,2dimethyltetrahydro-3aH-cyclopenta[d][1,3]dioxol-4-yl)oxy)ethanol and methanol were
charged in reactor. 50% solution of Hydrochloric acid was added to reaction mass.
Reaction mass was stirred at Room Temperature for 3-4 hours. After completion,
reaction mass was quenched in water and extracted with Ethyl Acetate, upon
evaporation of which yielded product (Ticagrelor).
Stage-2: Ticagrelor and Ethyl Acetate were charged in reactor and heated at 60 oC for
1 hour. Upon cooling at 50 oC and addition of Heptane to the reaction mass yielded
pure Ticagrelor.
Page | 51
Stage - 1
Reaction
Chemistry
Chemical
Name
Gram/Mole
2-(((3aR,4S,6R,6aS)-6-(7-(((1R,2S)-2-(3,4difulorophenyl)cyclopropyl)amino)-5(propylthio)-3H-[1,2,3]triazolo[4,5d]pyrimidin-3-yl)-2,2-dimethyltetrahydro3aH-cyclopenta[d][1,3]dioxol-4yl)ody)ethanol
562
H2O
HCl
Water
Hydro
Chloric Acid
18
36.5
Reaction
Chemistry
Chemical
Name
Gram/Mole
Page | 52
HCl
Ticagrelor (Crude)
Aceton
522
58
Hydro
Chloric Acid
36.5
Stage – 2
Reaction
Chemistry
Ethyl
Acetate
Heptane
Chemical
Name
Gram/Mole
Ticagrelor (crude)
Ticagrelor
522
522
2-(((3aR,4S,6R,6aS)-6-(7(((1R,2S)-2-(3,4difluorophenyl)cyclopropyl
)
amino)-5-(propylthio)-3H[1,2,3]triazolo[4,5d]pyrimidin-3-yl)-2,2dimethyltetrahydro-3aHcyclopenta[d][1,3]dioxol-4yl)oxy)ethanol
Methanol
:
57
Stage 1
:
283
Hydrochloric Acid
:
141
:
5
:
107
Water
:
254
Total
:
847
Ticagrelor
(Crude)
Ethyl Acetate
(Recovered)
Ethyl Acetate
(Loss)
Effluent
:
51
:
107
:
6
:
679
OrganicResidue :
4
Total :
847
Page | 53
Intermediate from
stage 1
:
51
:
14
Ethyl Acetate
(Recovered)
:
269
Heptane (Fresh)
:
12
Heptane (Recovered)
:
271
Total
:
Gross Input
:
Ticagrelor
:
(Pure)
Ethyl Acetate
:
(Recovered)
Ethyl Acetate
(Loss)
Heptane
(Recovered)
Heptane (Loss)
Organic
Residue
50
269
:
14
:
271
:
12
:
1
617
Total :
617
1,464
Gross Output :
1,464
Stage 2
Capacity, TPM
5.00
Batch size, Kg
50
Working Days
26
Stage 1
Sr.
No.
Quantity
Kg/Kg
Kg/Batch
of
Product
TPM
Remarks
Input
1.
2-(((3aR,4S,6R,6aS)-6-(7(((1R,2S)-2-(3,4difluorophenyl)cyclopropyl
)amino)-5-(propylthio)-3H[1,2,3]triazolo[4,5d]pyrimidin-3-yl)-2,2dimethyltetrahydro-3aHcyclopenta[d][1,3]dioxol-4yl)oxy)ethanol
2.
56.6
1.132
5.66 Reactant
Methanol
282.8
5.656
28.28 Reactant
3.
Hydrochloric Acid
141.4
2.828
14.14 Reactant
4.
5.0
0.100
0.50 Solvent
5.
107.5
2.150
6.
Water
254.5
5.090
25.45
Page | 54
Total
84.78
847.8
16.956
51.5
1.030
107.5
2.150
5.7
0.114
0.57 Solvent Loss
679.3
13.586
3.8
0.076
847.8
16.956
67.93 To ETP
Organic H/W
0.38
(CHWIF)
84.78
Output
1.
Ticagrelor (Crude)
2.
3.
4.
Effluent
5.
Organic Residue
Total
Stage 2
Sr.
No.
Quantity
Kg/Kg
Kg/Batch
of
Product
TPM
Remarks
Input
1.
Ticagrelor (Crude)
51.5
1.029
5.14 Reactant
2.
14.0
0.280
3.
269.0
5.380
4.
Heptane (Fresh)
12.0
0.240
5.
Heptane (Recovered)
271.0
5.420
617.5
12.349
1.40 Solvent
Solvent
26.90
Recovered
1.20 Solvent
Solvent
27.10
Recovered
61.74
50.0
1.000
5.00
269.0
5.380
26.90
14.0
0.280
1.40
271.0
5.420
27.10
12.0
0.240
1.20
1.5
0.029
0.14
617.5
12.349
61.74
Total
Output
1.
Ticagrelor
2.
3.
4.
Heptane (Recovered)
5.
Heptane (Loss)
6.
Organic Residue
Total
Finished
product
Solvent
Recovered
Solvent Loss
Solvent
Recovered
Solvent Loss
Organic HW
(CHWIF)
Page | 55
8. BAZEDOXIFENE ACETATE
Stage-1: Charge Denatured Spirit, Glacial Acetic acid, 4-Benzyloxy Phenyl Hydrazine
Hydrochloride and 4-Benzyloxy propiophenone. Heat to 75-80 oC. After completion
cool reaction mass to 10-15 oC. Filter slurry to obtain 3-Methyl-5-(Phenylmethoxy)-2[(4-Phenylmethoxy] Phenyl]-1H Indole.
Stage-2: Charge 4-Hydroxy Benzyl Chloride, Sodium Hydroxide and water. Stir for 30
minutes and charge toluene. Add 2-Chloro Ethyl Azepan Hydrochloride and Tetra
Butyl Ammonium Bromide and heat to reflux. Upon completion of reaction cool to
room temperature and separate organic layer. Distill out toluene and charge
Methylene Dichloride. Pass Hydrochloride gas for 1.5 hour. Distill out Methylene and
add acetone. Cool reaction mass to 0 oC for 5 hours. Filter slurry to obtain 4-[2-(1Azepanyl)Ethoxy] BenzylAlcohol Hydrochloride.
Stage-3:
Charge
Dimethyl
Formamide,
3-Methyl-5-(Phenylmethoxy)-2-[(4-
Phenylmethoxy] Phenyl]-1H Indoleand Sodium Methoxide. Heat to 50-55 oC for 2
hours and cool to room temperature. Charge 4-[2-(1-Azepanyl)Ethoxy] Benzylchloride
Hydrochlorideand stir. Upon completion of reaction, distill Dimethyl Formamide below
60 oC. Charge water and ethyl acetate to separate layers. Evaporate Organic layer
under vacuum. Charge Ethyl Alcohol to the reaction mass and stir for 1 hour. Filter
solids. Charge Ethyl acetate to the wet cake. Charge Palladium Charcoal. Stir for 4-5
hours at 45-50 oC. Filter reaction mass and distill Ethyl acetate under vacuum. Charge
Ethanol and adjust pH to 2 using Hydrochloric acid. Filter the solids. Charge Ethyl
acetate to the wet cake. Charge Sodium bicarbonate solution and heat to 50 oC.
Separate organic layer and add charcoal. Stir and filter. Distill out Ethyl acetate.
Charge Acetone and L-Ascorbic acid to the reaction mass. Heat 40-45 oC. Charge
Glacial acetic acid and cool to room temperature and filter slurry to obtain
Bazedoxifene Acetate.
Page | 56
Stage - 1
Reaction Chemistry
Chemical Name
Gram/Mole
H2O
NH3
HCl
4-Benzyloxyphenyl Hydrazine
Hydrochloride
1-(4-(benzyloxy)phenyl)
propane-1-one
5-(benzyloxy)-2-(4(benzyloxy)phenyl)-3methyl-1 H-indole
Water
Ammonia
Hydrochloric
Acid
250.72
240.3
419.51
18
17
36.5
Stage - 2
Reaction Chemistry
Chemical Name
Gram/Mole
2NaOH
HCl
2NaCl
2H2O
(4-(chloromethyl)phenyl)
methanol
1-(2-Chloroethyl)
azepane hydrochloride
Sodium
Hydroxide
Hydro
Chloric Acid
1-(2-((4-(chloromethyl)
benzyl)oxy) ethyl) azepane
hydrochloride
Sodium
Chloride
Water
156.61
198.13
80
36.5
318.28
117
36
Stage - 3
Reaction Chemistry
Chemical Name
Gram/Mole
2NaOMe
5-(benzyloxy)-2-(4(benzyloxy)phenyl)-3methyl-1 H-indole
419.51
1-(2-((4Sodium
(chloromethyl)benzyl)oxy)
Methoxide
ethyl)azepanehydrochloride
318.28
108
Page | 57
CH3COOH
2H2
2NaCl
Acetic
Acid
Hydrogen
Benzedoxifene Acetate
Toluene
60
4
530.65
184
2MeOH
Sodium
Methanol
Chloride
117
64
4-Benzyloxyphenyl
Hydrazine
Hydrochloride
1-(4(benzenyloxy)phenyl)
propan-1-one
Denatured Spirit
(Fresh)
Denatured Spirit
(Recovered)
Glacial Acetic acid
:
20
:
19.2
:
8
:
232
:
Water :
Total
(4-(chloromethyl)
phenyl) :
methanol
2-Chloro Ethyl
:
Azipan hydrochloride
5-(benzyloxy)-2-(4(benzyloxy)phenyl)- :
3-methyl-1H-indole
32
0.2
Denatured Spirit
:
(Recovered)
Denatured Spirit
:
(Loss)
Effluent :
105.6
100
OrganicResidue :
1.8
Stage 1
232
8
379.4
Total
379.4
11
1-(2-((4
(chloromethyl)benzyl)
oxy) ethyl) azepane
hydrochloride
23.7
21
:
Sodium Hydroxide :
8
Toluene (Recovered) :
86
Tetra Butyl
:
Ammonium Bromide
0.5
Toluene (Loss) :
4
Toluene (Fresh) :
4
Toluene (Recovered) :
86
Methylene
Dichloride (Fresh)
(Recovered)
Hydrochloric acid
Gas
Acetone (Fresh)
Stage 2
:
(Recovered)
:
(Loss)
245
15
:
15
Acetone (Recovered) :
215
:
245
Acetone (Loss) :
9
:
35
Effluent :
200
:
9
Acetone (Recovered) :
215
Organic Residue :
1.8
Water :
150
Total :
799.5
Total :
799.5
Page | 58
Intermediate from
:
Stage 1
Intermediate from
:
Stage 2
Sodium Methoxide :
23.7
Palladium Carbon :
9
Dimethyl
Formamide (Fresh)
Dimethyl
Formamide
(Recovered)
Ethyl Acetate
(Fresh)
Ethyl Acetate
(Recovered)
Ethyl Alcohol
(Fresh)
Ethyl Alcohol
(Recovered)
L-Ascorbic Acid
32
8.4
:
10
:
440
:
50
:
Bazedoxifene :
Acetate
Dimethyl Formamide
:
(Recovered)
36
440
Dimethyl Formamide
:
(Loss)
10
Ethyl Acetate
:
(Recovered)
550
550
Ethyl Acetate (Loss) :
50
:
15
Ethyl Alcohol
:
(Recovered)
345
:
345
Ethyl Alcohol (Loss) :
15
:
0.3
Effluent :
438.6
Carbon :
3
Organic Residue :
5
Hydrochloric acid :
10
Glacial Acetic acid :
5
Inorganic Residue :
12
Water :
400
Hydrogen Gas :
0.15
Stage 3
Total : 1,901.6
Total : 1,901.6
Gross Input : 3,080.5
Gross Output : 3,080.5
Page | 59
Capacity, TPM
5.00
Batch size, Kg
36
Working Days
26
Stage - 1
Sr.
No.
Name of Raw
Material
Quantity
Kg/Kg
Kg/Batch
of
Product
TPM
Remarks
Input
5.
4-Benzyloxyphenyl
Hydrazine
Hydrochloride
1-(4-(benzenyloxy)
phenyl) propan-1one
Denatured Spirit
(Fresh)
Denatured Spirit
(Recovered)
Glacial Acetic acid
6.
Water
1.
2.
3.
4.
Total
Output
5-(benzyloxy)-2-(41.
(benzyloxy)phenyl)3-methyl-1H-indole
Denatured Spirit
2.
(Recovered)
Denatured Spirit
3.
(Loss)
4.
Effluent
5.
Organic Residue
Total
20.0
0.556
2.78 Reactant
19.2
0.533
2.67 Reactant
8.0
0.222
1.11 Solvent
232.0
6.444
0.2
0.006
100.0
2.778
13.89
379.4
10.539
52.70
32.0
0.889
4.44 Used in 3rd Stage
232.0
6.444
8.0
0.222
105.6
2.934
1.8
0.049
379.4
10.539
0.03 Reactant
1.11 Solvent Loss
14.67 To ETP
0.26 Organic H/W (CHWIF)
52.70
Stage - 2
Sr.
No.
Name of Raw
Material
Quantity
Kg/Kg
Kg/Batch
of
Product
TPM
Remarks
Input
1.
2.
(4-(chloromethyl)
phenyl)methanol
2-Chloro Ethyl
Page | 60
11.4
0.316
1.58 Reactant
20.7
0.576
2.88 Reactant
Azipan
hydrochloride
3.
Sodium Hydroxide
Tetra Butyl
4.
Ammonium Bromide
5.
Toluene (Fresh)
Toluene
6.
(Recovered)
Methylene
7.
Dichloride (Fresh)
Methylene
8.
Dichloride
(Recovered)
Hydrochloric acid
9.
Gas
10. Acetone (Fresh)
Acetone
11.
(Recovered)
12. Water
Total
Output
1-(2-((4(chloromethyl)benzy
1.
l)oxy)ethyl) azepane
hydrochloride
Toluene
2.
(Recovered)
3.
Toluene (Loss)
Methylene
4.
Dichloride
(Recovered)
Methylene
5.
Dichloride (Loss)
Acetone
6.
(Recovered)
7.
Acetone (Loss)
8.
Effluent
9.
Organic Residue
Total
7.7
0.215
1.07 Reactant
0.5
0.014
0.07 Reactant
4.0
0.111
0.56 Solvent
86.0
2.389
15.0
0.417
245.0
6.806
35.0
0.972
4.86
9.0
0.250
1.25 Solvent
215.0
5.972
150.0
4.167
20.83
799.4
2.08 Solvent
22.204 111.01
23.7
0.658
3.29 Used in 3RD Stage
86.0
2.389
4.0
0.111
245.0
6.806
15.0
0.417
215.0
5.972
9.0
0.250
199.9
5.551
1.8
0.051
799.4
0.55 Solvent Loss
2.08 Solvent Loss
1.25 Solvent Loss
27.75 To ETP
22.204 111.01
Page | 61
Stage - 3
Sr.
No.
Quantity
Kg/Kg
Kg/Batch
of
Product
TPM
Remarks
Input
3.
5-(benzyloxy)-2-(4(benzyloxy)phenyl)-3methyl-1H-indole
1-(2-((4(chloromethyl)benzyl)
oxy)ethyl) azepane
hydrochloride
Sodium Methoxide
4.
Glacial Acetic acid
5.
8.
Hydrogen Gas
Dimethyl Formamide
(Fresh)
Dimethyl Formamide
(Recovered)
9.
10.
Ethyl Alcohol (Fresh)
11.
Ethyl Alcohol (Recovered)
12.
Palladium Carbon
9.0
0.250
1.25 Catalyst
13.
L-Ascorbic Acid
0.3
0.008
0.04 Catalyst
14.
Carbon
3.0
0.083
0.42 Decolorize
15.
Hydrochloric acid
10.0
0.278
1.39 Neutralization
16.
Water
400.0
11.111
55.56
1,901.4
52.814
264.08
1.
2.
6.
7.
Total
32.0
0.889
4.44
Intermediate product
from stage- 1
23.7
0.658
3.29
Intermediate product
from stage- 2
8.4
0.233
1.17 Reactant
4.8
0.133
0.67 Reactant
0.15
0.004
0.02 Reactant
10.0
0.278
1.39 Solvent
440.0
12.222
50.0
1.389
550.0
15.278
15.0
0.417
345.0
9.583
6.94 Solvent
2.08 Solvent
Output
36.0
1.000
440.0
12.222
3.
Dimethyl Formamide
(Recovered)
Dimethyl Formamide (Loss)
10.0
0.278
4.
550.0
15.278
5.
50.0
1.389
6.
Ethyl Alcohol (Recovered)
345.0
9.583
7.
Ethyl Alcohol (Loss)
15.0
0.417
8.
Effluent
438.6
12.184
9.
Organic Residue
4.7
0.131
1.
2.
Page | 62
1.39 Solvent Loss
6.94 Solvent Loss
2.08 Solvent Loss
60.92 To ETP
0.66 Organic HW
(CHWIF)
10.
Inorganic Residue
Total
12.0
0.332
1.67
1,901.4
52.814
264.08
Inorganic HW
(TSDF)
Page | 63
4.5
Raw Material Requirements
Various raw materials will be required for manufacturing of proposed products. Details
of raw material requirement for proposed project are given below in Table-8.
Table - 8: Details of Raw Material Requirements
Requirement
Sr.
No.
1
2
3
4
5
6
7
8
9
10
11
Name of Raw
Material
[2(((3aR,4S,6R,6aS)-6(7-(((1R,2S)-2-(3,4difluorophenyl)
cyclopropyl)amino)-5(propylthio)- 3H[1,2,3]triazolo[4,5d]pyrimidin-3-yl)-2,2dimethyltetrahydro3aH-cyclopenta[d]
[1,3]dioxol-4-yl)oxy)
ethanol]
2-(2-(phenylthio)-5propionylphenyl)
acetic acid
2-Chloro Ethyl Azipan
hydrochloride
2-Cyano-4bromomethyl
biphenyl
ethanone
4-(4phenylbutoxy)benzoic
acid
4-(tert-Butyl)benzene1-sulfonamide
1-(4(benzenyloxy)phenyl)
propan-1-one
4-Benzyloxyphenyl
Hydrazine
Hydrochloride
4-chloro benzoyl
chloride
Page | 64
Product
Code
Kg/Kg
of
Product
TPM
Total
Max of Requirement
Group
(TPM)
(TPM)
7
1.131
5.66
5.66
5.66
3
1.414
8.48
8.48
8.48
8
0.576
2.88
2.88
2.88
5
0.850
4.25
4.25
4.25
6
0.576
2.88
2.88
2.88
6
1.000
5.00
5.00
5.00
1
0.510
3.06
3.06
3.06
8
0.533
2.67
2.67
2.67
8
0.556
2.78
2.78
2.78
2
0.764
4.58
4.58
4.58
2
0.575
3.45
3.45
3.45
12
13
(4(chloromethyl)phenyl)
methanol
5-(2Methoxyphenoxy)4,6-dichloro-2(pyrimidin-2-yl)
pyrimidine
8
0.316
5.00
5.00
5.00
1
0.835
5.01
5.01
5.01
2
0.023
0.14
3
0.086
0.52
0.52
0.52
14
Acetic Acid
15
Acetone
8
0.250
1.25
1.25
1.25
16
Bromine
3
0.919
5.52
5.52
5.52
17
Candesartan
4
0.680
4.08
4.08
4.08
18
Carbon
8
0.083
0.42
0.42
0.42
19
Denatured Spirit
Diethyl 2aminomalonate
Hydrochloride
8
0.222
1.11
1.11
1.11
2
0.694
4.16
4.16
4.16
6
0.050
0.25
8
0.278
1.39
1.5
1.5
5
0.300
1.50
3
0.146
0.88
0.88
8
0.417
2.08
2.08
6
0.375
1.88
7
0.380
1.90
8
1.389
6.94
4
0.299
1.79
1.79
20
21
22
23
Dimethyl Formamide
Ethanol
Ethyl Acetate
6.94
2.88
8.74
24
Ethylene Dichloride
3
0.152
0.91
0.91
0.91
25
Ethylene glycol
1
0.150
0.90
0.90
0.90
26
Glacial Acetic acid
8
0.139
0.69
0.69
0.69
27
Heptane
7
0.240
1.20
1.20
1.20
2
0.186
1.12
1.12
7
2.828
14.14
8
0.278
1.39
6
3.000
15.00
5
1.670
8.35
8
0.972
4.86
4.86
4.86
8
0.004
0.02
0.02
0.02
28
29
30
Hydrochloric Acid
Hydrochloric acid
Gas
Hydrogen Gas
15.00
16.12
Page | 65
31
32
33
34
L-Ascorbic Acid
L-Valine methyl ester
Hydrochloride
Methanol
(Fresh)
8
0.008
0.04
0.04
0.04
5
0.680
3.40
3.40
3.40
7
5.656
28.28
28.28
2
0.144
0.87
3
0.657
3.94
1
0.335
2.01
2
0.037
0.22
4
0.112
0.67
5
0.615
3.08
6
0.180
0.90
8
0.417
2.08
3.94
32.22
2.01
5.09
3.08
35
o-Xylene (Fresh)
5
0.180
0.90
0.90
0.90
36
Palladium Carbon
8
0.250
1.25
1.25
1.25
37
Polyphosphoric acid
3
5.657
33.94
33.94
33.94
38
Potassium Carbonate
5
0.670
3.35
3.35
3.35
39
Pyridine
6
0.896
4.48
4.48
4.48
40
Sodium Azide
5
0.200
1.00
1.00
1.00
1
0.205
1.23
1.23
5
0.600
3.00
6
0.300
1.50
41
Sodium Bicarbonate
3.00
4.23
42
Sodium Carbonate
3
0.520
3.12
3.12
3.12
43
Sodium Chloride
5
0.100
0.50
0.50
0.50
2
0.256
1.54
3
0.778
4.67
5
0.050
0.25
8
0.215
1.07
1
0.130
0.78
2
0.356
2.14
8
0.233
1.17
1.17
5
0.570
2.85
2.85
3
0.141
0.85
2
0.698
4.19
6
5.000
25.00
25.00
8
0.014
0.07
0.07
44
45
46
47
48
Sodium hydroxide
Sodium Methoxide
Sodium Sulfate
Sulfuric acid
Tetra Butyl
Ammonium Bromide
Page | 66
4.67
5.74
1.07
2.14
4.19
3.30
2.85
29.19
0.07
49
50
Thionyl Chloride
Toluene
6
0.590
2.95
1
0.500
3.00
3
0.303
1.82
5
0.200
1.00
8
0.111
0.56
2
0.722
4.33
4
0.279
1.67
51
Triethyl Amine
52
5
0.330
3
55
Triethylamide
Trimethyl Ortho
Formate
Tri-n-Butyl
Tinchloride
Trityl Chloride
56
57
53
54
4.6
2.95
2.95
3.00
4.00
1.00
4.33
4.33
1.65
1.65
1.65
1.232
7.39
7.39
7.39
5
1.730
8.65
8.65
8.65
4
0.476
2.86
2.86
2.86
Valeryl Chloride
5
0.400
2.00
2.00
2.00
Zinc Dust
3
0.061
0.36
0.36
0.36
Details of Machineries & Utilities
As the proposed project will have different production segments for the manufacturing
of various products, this requires various plant machineries and also various utilities
will be required. The lists of plant machineries for the proposed project are given in
Table-9. However, the actual requirements of machineries & equipment are not
limited to the basic list below as some minor requirements can also be cited
depending up on necessity noticed during installation & operations.
Table – 9: Details of Proposed Machineries and Utilities
Sr.
No.
Item Name
1.
Glass lined reactor
2.
Glass lined reactor
3.
Glass lined reactor
4.
Glass lined reactor
5.
Stainless steel reactor
6.
7.
8.
Make
Swiss
GlasCoat
Swiss
GlasCoat
Swiss
GlasCoat
Swiss
GlasCoat
Nitin
Engineering
Nitin
Engineering
Nitin
Engineering
Nitin
Engineering
Qty.
Size/
Capacity
2
1
4
2
1
3
1
4
1
1
5
2
2
3
2
4
Page | 67
Sr.
No.
Item Name
9.
Tray Dryer
10.
Tray Dryer
11.
Vacuum Tay Dryer
12.
Fluidized bed dryer
13.
Fluidized bed dryer
14.
Blender
15.
Miller
16.
Centrifuge
17.
Centrifuge
18.
Sparkler filter
Make
Nitin
Engineering
Nitin
Engineering
Nitin
Engineering
Nitin
Engineering
Nitin
Engineering
Nitin
Engineering
Nitin
Engineering
D Parikh
D Parikh
Nitin
Engineering
Qty.
Size/
Capacity
1
48 Tray
2
96 Tray
2
48 Tray
2
200 kg
1
160 kg
2
100 kg
1
50 kg/Hr
1
36’’
7
48’’
2
18’’a
4.7 Solvent Recovery System:
The industry proposes to manufacture synthetic organic chemicals, which require
solvents during various unit processes. The spent solvent generated during the
manufacturing process will be recovered by way of distillation and reused in the
process. The process of the solvent recovery system is described hereunder;
 After the completion of the reaction, the reaction mass is either directly distilled out
through distillation inside the reactor to recover the solvent and separate the
product or the mother liquor/solvent from the reactor will be separated and then
taken for distillation to recover the solvent and separate the impurities.
 Firstly, the mass will be distilled at required temperature where pure solvent will be
distilled out depending on their boiler points and it will be collected in the recovered
solvent storage tank and reused in the process.
 The recovered solvent will be reused in the process and residue will be sent to
TSDF/CHWIF site for the disposal by incineration.
 Vacuum will also be applied during distillation.
 The summary of the solvent consumption and mass balance is given in Table - 10.
Page | 68
Table - 10: Summary of Solvent Consumption and Mass Balance
Sr.
No.
1
2
3
Name of
Solvent
Toluene
Methylene
Dichloride
Dimethyl
Formamide
Product
Code
Solvent Requirement, TPM
Fresh
Recovered
1
3.00
47.10
3
1.82
5
Total
Solvent Requirement,%
Fresh
Recovered
Total
50.10
5.99
94.01
100
23.64
25.46
7.14
92.86
100
1.00
16.00
17.00
5.88
94.12
100
8
0.56
11.94
12.50
4.44
95.56
100
1
2.01
23.04
25.05
8.02
91.98
100
2
0.22
3.13
3.35
6.67
93.33
100
4
0.67
16.57
17.24
3.90
96.10
100
5
3.08
35.43
38.50
7.99
92.01
100
6
0.90
28.50
29.40
3.06
96.94
100
8
2.08
34.03
36.11
5.77
94.23
100
5
1.50
23.50
25.00
6.00
94.00
100
8
1.39
61.11
62.50
2.22
97.78
100
4
O-xylene
5
0.90
14.10
15.00
6.00
94.00
100
5
Methanol
2
0.87
32.65
33.52
2.58
97.42
100
3
3.94
46.97
50.91
7.74
92.26
100
2
0.14
3.21
3.35
4.17
95.83
100
3
0.52
4.85
5.36
9.61
90.40
100
6
Acetic Acid
7
Ethylene
Dichloride
3
0.91
20.30
21.21
4.29
95.71
100
8
Ethanol
3
0.88
16.06
16.94
5.19
94.81
100
9
Ethyl
Acetate
6
1.88
43.13
45.00
4.17
95.83
100
7
1.90
37.65
39.55
4.80
95.20
100
8
6.94
76.39
83.33
8.33
91.67
100
4
1.79
27.76
29.55
6.06
93.94
100
10
Heptane
7
1.20
27.10
28.30
4.24
95.76
100
11
Denatured
Spirit
8
1.11
32.22
33.33
3.33
96.67
100
12
Aceton
8
1.25
29.86
31.11
4.02
95.98
100
13
Ethyl
Alcohol
8
2.08
47.92
50.00
4.17
95.83
100
44.53
784.15
828.68
5.40
94.60
100
Total/Average
Measures for achieving maximum solvent recovery:
 The entire manufacturing activities & distillation process will be carried out in
totally closed system.
Page | 69
 Maintenance of the pipeline, valves & fittings will be carried out regularly to avoid
any leakages.
 Reactor will be connected with two numbers of condensers where cooling water
and chilled water will be used as media and also equipped with vacuum system
as per requirement.
 The condenser will be provided with the sufficient HTA and residence time to
achieve 90- 98% recovery.
Page | 70
5. Pollution Potential and Control Measures
5.1
(a)
Water Pollution
Details of Water Requirement & Wastewater Generation
The water requirement for the proposed project will be met by ground water supply
through own bore well. The total fresh water requirement for various domestic,
gardening & industrial activities will be 8.30 KLD.
Based on the material balance and technical experience of the similar industries, the
water consumption and wastewater generation for all the products as well as for
various categories have been calculated. The fresh water requirement for industrial
activities will be 5.3 KLD, which will be mainly used in the process, cooling, and
washing activities. The water requirement for domestic activity will be 1.5 KLD and for
green belt development will be 1.5 KLD.
The product-wise water requirement & wastewater generation is given in Table –
11(a) and category-wise water requirement and wastewater generation is given in
Table – 11(b). The water balance diagram is given in Drawing-2.
Table – 11(a) Product-wise Water Requirement & Wastewater Generation
Group
Group
A
Group
B
Product
Code
1
2
3
4
5
6
7
8
Water Consumption
Stream
Process
Process
Process
Process
Process
Process
APCE
Process &
APCE
Process
Process
Liter / Kg
of Product
KLD
Wastewater
Generation
Liter / Kg
KLD
of Product
8.35
6.28
19.28
0.82
27.90
13.62
1.05
1.93
1.45
4.45
0.19
5.37
2.62
0.20
8.76
8.85
28.21
1.15
31.51
23.46
0.00
2.02
2.04
6.51
0.27
6.06
4.51
0.00
14.67
2.82
23.46
4.51
5.09
18.06
0.98
3.47
13.59
20.67
2.61
3.97
Maximum of Group A
4.45
6.51
Maximum of Group B
5.37
6.06
Total Water Consumption /
Generation (KLD)
9.82
12.57
Page | 71
Table – 11(b): Category-wise Water Requirement & Wastewater Generation
Sr.
No.
Particulars
Stream
Water
Requirement,
KLD
Waste Water
Generation,
KLD
I
Domestic
Fresh
1.5
1.0
II
Gardening
Fresh
1.5
Nil
III
Industrial
Fresh
1.8
a
Process & APCE
b
Boiler
c
Cooling
d
Washing
Total Industrial Water
Requirement / Generation
Total water Requirement /
Generation (I+ II+ III)
Reused
(from ETP)
Reused
(from ETP)
Fresh
(from WTP)
Fresh
(from WTP)
Fresh+
Reuse
Reuse
from ETP
8.2
13.0
8.0
2.0
2.0
0.1
1.5
1.5
21.5
16.6*
16.2
16.2*
Fresh
5.3
Nil
Fresh
8.3
1.0
*Note: The difference of 0.4 KL/Day between total industrial wastewater generation
(i.e. 16.6 KL/Day) and industrial effluent reuse (i.e. 16.2 KL/Day) is salts generated
from MEE during evaporation and it will be disposed of by land filing to TSDF site.
Page | 72
Drawing – 2: Water Balance Diagram
(1.5)
Fresh Water
(Source: Bore well)
(8.3 = 5.3 + 3.0)
Domestic
(1.0) To soak pit
through
septic tank
Gardening
Nil
(1.5)
Industrial
Fresh: 5.3
Recycled from
ETP: 8.2
WTP: 13.5
RO Reject:
(3.5)
RO
Permeate:
(10.0)
(8.0)
(2.0)
Process&
APCE
Cooling
(13.0)
(1.5)
Washing
(0.1)
(6.0)
(7.0)
High
TDS/COD
Stream
Low
TDS/COD
Stream
(1.5)
(7.0)
Boiler
(2.0)
Industrial
Wastewater
Generation
16.6 KLD
(3.6)
(13.0)
MEE
MEE
Condensate
(12.6)
(0.4)
ETP
(23.2)
Salt to
TSDF
RO
RO
Permeate
(16.2)
RO Reject: 7.0
RO Permeate: 8.2
*All quantities are expressed in KL/Day
Page | 73
(b) Wastewater Management System
Effluent generation from industrial activities will be 16.6 KLD. After treatment in ETP
followed by RO, treated effluent @16.2 KLD will recycled for Process @ 8.2 KLD and
Boiler @ 8.0 KLD purpose. There will be no discharge of treated effluent and
therefore, unit will maintain Zero Liquid Discharge.
The details of proposed effluent treatment scheme are given in Drawing – 3. Stream
wise characteristic of effluent and stage wise characteristic of effluent are given in
Table – 12(a) and Table – 12(b) respectively.
Proposed Effluent Treatment Scheme
Effluent generated from proposed project will be segregated into high concentration
and low concentration streams. High concentrated wastewater stream will be treated
in proposed Multiple Effect Evaporator after giving physico-chemical treatment.
Condensate water from MEE will be sent to ETP along with other waste streams i.e.
Process & APCE, Cooling, Washing and Boiler.
Raw effluent will be collected in collection cum neutralization tank for proper mixing
and neutralization of effluent. Effluent from neutralization tank will be sent to primary
tube settler by pumping. Settled sludge will be sent to sludge sump and supernatant
effluent will be sent to Moving Bed Bio Reactor (MBBR). Air blowers will be provided
for air and oxygen requirement through bubble diffusers. Treated effluent from MBBR
will be then sent to secondary settling tube settler for sludge to settle down. Settled
sludge will be sent to sludge sump and treated effluent collected in collection tank for
further treatment.
Treated effluent from collection tank will pass through Pressure sand filter and
activated carbon filter to remove remaining solid particles, dead micro organisms and
color. Further, treated effluent will be sent to RO unit. RO permeate will be recycled
back for use in process and boiler. RO reject will be sent to MEE for further treatment.
Page | 74
Drawing - 3: Schematic flow diagram of Proposed Effluent Treatment Plant
Page | 75
Table – 12(a): Stream wise Characteristics of Effluent
Sr
No.
W/W Stream
Process &
APCE
Boiler
b.
Hydraulic Flow
13.00
2.00
Rate, KLD
Concentration of Parameters, mg/l
1.
pH
2.
a.
Cooling
Washing
Composite
Ind.
Effluent
0.10
1.50
16.60
4.0 – 5.0
6.0 - 7.0
6.5 - 7.5
7.0 - 8.0
5.0 - 6.0
TDS (Max.), mg/L
7,768
1800.0
2000.0
2000.0
6,493
3.
COD (Max.), mg/L
5,832
30
40
1,000
4,662
4.
BOD (Max.), mg/L
1,868
10.0
15.0
300.0
1,491
Table – 12(b): Stage wise Characteristics of Effluent
Sr.
No.
1.
Parameter
pH
Composite
Influent
5.0 - 6.0
Primary
Outlet
6.5 - 8.5
Secondary
Outlet
6.5 - 8.5
Tertiary
Outlet
6.5 - 8.5
2.
TDS (Max.), mg/L
6,493
5,500
5,500
1,000
3.
COD (Max.), mg/L
4,662
2,400
500
100
4.
BOD (Max.), mg/L
1,491
800
170
30
5.2
Air Pollution
The main sources of air pollution will be flue gas emission & process gas emission
from the proposed project. There will be also chances of fugitive emission due to
manufacturing activities and raw material handling and transportation. Various
sources of air pollution are described hereunder;
(a)
Process Gas Emissions
The source of process gas emission from the proposed manufacturing activity will be
SO2 gas generated from the manufacturing of product Pranlukast. The details of
gaseous pollutants liberated due to proposed manufacturing activities are given in
Table - 13 (a) and details of process gas stack are given in Table – 13 (b). The
adequate scrubbing system consisting of alkali (Caustic) scrubber will be provided for
the control of process gas emission. Output from APCE will be sold as a by-product or
will be sent to ETP along with other waste streams.
Page | 76
Table – 13(a): Details of Process Gas Emissions
Product
Code
6
Expected
Pollutants
Product
SO2
Pranlukast
Pollution Load
Kg/Kg of
Product
MT/Month
MT/Day
0.198
0.99
0.038
Table – 13(b): Details of Process Gas Stack
Stack
Sr.
Height Dia.
Polluant
attached
No.
(m)
(m) Concentration
to
1.
Reactors
10
0.10
SO2 ≤ 40
mg/Nm3
APCM
Output
Mangement
Alkali Scrubber
Sell as a byproduct or send
to ETP for
treatment
(b) Flue Gas Emissions
Main source of flue gas generation will be steam boiler (2 TPH) and Thermic fluid
boiler (2 Lac Kcal/hr) from the proposed unit. Biofuel / Agrowaste will be used as a
fuel in the boilers & Thermic fluid boiler and individual multi cyclone separator will be
provided for the control of emissions. The Unit will also install DG Sets of 250 KVA
capacity as stand-by units. Adequate stack height will be provided to ensure proper
dispersion of pollutant. The details of flue gas emission are given hereunder in Table 14.
Table – 14: Detils of Flue Gas Stacks
Sr.
Stack Attach to
No.
Air Pollution
Control
Mesures
Multi
Cyclone
PM ≤ 150 mg/Nm3 Separator
2.5
Multi
SO2 ≤ 100 ppm
Cyclone
NOx ≤ 50 ppm
Separator
Adequate
1.2
stack height
Fuel
Height Dia. Concentration of
Requirement (m)
(m)
Polluants
1
Steam Boiler
(2 TPH)
2
Thermic Fluid Boiler
(2 Lac Kcal/hr)
(80 TPM)
3
DG Set (250 KVA),
Stand-by
Diesel
(125 Lit/Hr)
(c)
Fugitive Emission
Biofuel /
Agrowaste
4.0
3.2
There will be a chance of fugitive emission from the manufacturing process as well as
due to storage & handling of raw materials and products. The unit will take following
adequate precautions for the control of fugitive emission;
Page | 77
 The entire manufacturing activities will be carried out in the closed reactors and
regular checking and maintenance of reactors will be carried out to avoid any
leakages.
 All the motors of pumps for the handling of hazardous chemicals will be flame
proof and provided with suitable mechanical seal with stand-by arrangement.
 Control of all parameters on a continuous basis will be done by adequate control
valves, pressure release valves and safety valves etc.
 All the flange joints of the pipe lines will be covered with flange guards.
 All the raw materials will be stored in isolated storage area and containers are
tightly closed.
 Precautionary measures will also be taken while handling various hazardous
chemicals.
 There will also be provision of adequate ventilation system in process plant and
hazardous chemical storage area.
 A regular preventive maintenance will be planned to replace or rectify all gaskets,
joints etc.
 The unit will also develop green belt within the factory premises to control the
fugitive emission from spreading into surrounding environment.
5.3
Hazardous Waste Generation and Management
The main sources of hazardous waste generation from proposed unit will be dried
sludge from ETP and various process waste viz. Inorganic Process waste, Organic
Residue, Spent Carbon and Spent Solvent. The ancillary source of hazardous waste
generation will be discarded Containers/bags from storage and handling of raw
materials and spent/used oil generation from plant & machinery. The details of
hazardous waste generation and handling / Management are given in Table-15.
Table –15: Hazardous Waste Generation and Management
Source
ETP
Process
Type of
waste
Quantity Physicalper
Chemical
Annum
Form
ETP
Sludge
34.3
5 MT
Solid &
Inorganic
Inorganic
Waste
28.1
35 MT
Solid &
Inorganic
Organic
Residue
28.1
211 MT
Semisolid
& Organic
Spent
Carbon
28.2
20 MT
Solid &
Inorganic
Page | 78
Category
Method of Disposal
Collection,
Storage,
Transportation, Disposal by
land filling at TSDF
Collection, Storage & disposal
by land filling at TSDF
Collection,
Storage,
Transportation, Disposal by
incineration at CHWIF OR
Disposal by co-processing in
Cement Kiln
Spent
Solvent
Raw
Material
Storage &
Handling
Discarded
Containers/
Bags
Plant and
Spent Oil/
Machineries Used Oil
28.5
275 MT
Liquid &
Organic
Collection, storage & Reuse
after distillation within premises
33.3
100
Nos.
(10
Kg)
Solid &
Inorganic
Collection,
Storage,
Decontamination and Disposal
by selling to scrap vendors
Liquid &
Organic
Collection,
Storage,
Transportation,
sell
to
registered Reprocessor / MoEF
approved recyclers OR Reused
as Lubricant within premises
5.1
50 Lit
The unit will provide an adequate designated storage area for the hazardous waste
storage within premises having impervious floor, roof cover system and leachate
collection system. The hazardous waste will be disposed of through the GPCB
approved TSDF / CHWIF sites after obtaining necessary permission.
5.4
Noise & Vibration Control
The only source of noise generation may be from the DG Set , which will be kept as
stand-by and no other source of noise and vibration in the proposed unit except plant
machineries. However, the following adequate precautions will be taken for control of
noise & vibration;

The unit will install latest technology based low noise DG Set with acoustic
enclosures.

Proper and timely oiling, lubrication and preventive maintenance will be carried out
for the machineries and equipments to reduce noise generation.

The noise generation will be mitigated by installing noise barriers/absorbers
around stationery noise sources. Adequate noise control measures such as antivibration pad for equipment with high vibration will be provided.

All the vibrating parts will be checked periodically and serviced to reduce the noise
generation. The equipment, which generates excessive noise, will be provided with
enclosures etc.

To minimize the adverse effect on the health, ear muffs / earplugs will be provided
to the working under high noise area.

To reduce the noise generation during the transportation activities; the vehicles will
be kept periodically serviced and maintained as per the requirement of latest trend
in automobile industry. Only those vehicles with PUC’s will be allowed for the
transportation.
Page | 79

The transport contractors will be informed to avoid unnecessary speeding of
vehicles inside the premises.

Green belt area will be developed to prevent the noise pollution inside and outside
the factory premises.

Noise monitoring will be carried out regularly at different parts of the plant.
Page | 80
6. PROJECT SCHEDULE & COST ESTIMATES
6.1
Schedule of Approval and Implementation
The proposed project has been planned for the manufacturing of synthetic organic
chemicals. The entire development will take about 1 year for the completion of
proposed project. The construction activities and installation of plant & machineries
will start after obtaining necessary approval from State Level Environment Impact
Assessment Authority (SEIAA) and State Pollution Control Board (SPCB).
6.2
Capital Investment
The proposed unit is a small scale unit with the capital investment of Rs. 800 Lacs
and estimated cost of Rs. 150 Lacs towards Environmental Protection Measures.
Break-up of the capital cost is given in Table - 17.
Table – 17: Capital Cost
Sr.
No.
Capital Cost
(Rs. in Lacs)
Description
1.
Land & Site Development
100
2.
Building
250
3.
Environmental Protection Measures
150
4.
Plant & Machineries & Other Costs
300
Total
800
Page | 81
7. FINAL RECOMMENDATIONS
The unit will provide adequate measures for the prevention and control of pollution.
With the execution and operation of such control measures along with proper
Environmental Management System, there will not be any major potential for negative
impact on the environment due to proposed project.
On the contrary, there will be positive impact on the socio-economic environment
since proposed project will generate some permanent and secondary employment.
The unit will also establish Cordial relation with the nearby villagers and will carry out
social welfare activities according to their needs.
The proposed project will also boosts up ancillary industrial and commercial activity.
Thus, it will improve the economic condition of the area.
Page | 82

Annexure-PFR - Environmental Clearances

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