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Environmental Impact Assessment Report
M/s. Solisom Healthcare LLP
Survey No.: 99/P1, Rajpar – Nashitpar Road,
Village: Nashitpar, Ta. Tankara & District:
Morbi Gujarat
T. R. Associates (Ahmedabad)
NABET Accredited
Chapter-7: Additional Studies
7.59
Sr.
No.
Action required to be taken to
mitigate disaster by aid giving
agency
Responsible
agencies for
taking action
Equipment/material
facilities required at site
to mitigate emergency
2 All other functions as
mentioned for local crisis group
7.10 LDAR (Leak Detection and Repair)
[Answer to TOR no. 7 (xiii)]
It is known that leaking equipment, such as valves, pumps, and connectors, are the largest
source of emissions of volatile organic compounds (VOCs) and volatile hazardous air
pollutants (VHAPs) from chemical manufacturing units.
Table 7.15- List of Volatile organic compounds (VOCs)
Sr. No.
Chemicals /Solvent
TLV/ TWA
Flammable Limit Chemical Class
(As per MSIHC Rules)
NFPA Ratting
Vapour Pressure
FP 0C
BP 0C
Class (As per
Petroleum Classification)
1. Ethyl Acetate TWA: 400 ppm
-20 °C
56 °C A Flammable
Health – 2 Flammability
–3 Reactivity - 0
103 mbar @ 20°C
2. Acetic Acid TWA:
10 ppm
40 °C
117 - 118 °C
B Highly Toxic Flammable
Health – 3 Flammability
–2 Instability -0
1.52 kPa @
20 °C
3. Toluene TWA:
20 ppm
NA 1390
°C -
Toxic
Health – 3 Flammability
–0 Reactivity – 1
29 mbar @
20 °C
4. Isopropyl Alcohol
5. Triethylamine TWA: 1 ppm
40 °C
117 - 118 °C
B Highly Toxic Flammable
Health – 3 Flammability
–2 Instability -0
69 mbar @
20 °C
6. Acetone TWA: 250 ppm
-20 °C
56 °C A Toxic
Highly Flammable
Health – 2 Flammability
–3 Instability - 0
247 mbar @ 20 °C
7. Ethyl
Carbamate NA
92 °C
182 – 184 °C
C Toxic
Flammable
Health – 1 Flammability
–1 Instability – 0
10 mm Hg @ 77.8°C
Environmental Impact Assessment Report
M/s. Solisom Healthcare LLP
Survey No.: 99/P1, Rajpar – Nashitpar Road,
Village: Nashitpar, Ta. Tankara & District:
Morbi Gujarat
T. R. Associates (Ahmedabad)
NABET Accredited
Chapter-7: Additional Studies
7.60
Sr. No.
Chemicals /Solvent
TLV/ TWA
Flammable Limit Chemical Class
(As per MSIHC Rules)
NFPA Ratting
Vapour Pressure
FP 0C
BP 0C
Class (As per
Petroleum Classification)
8. N-Hexane
TWA: 50
ppm Skin
-22 °C
69 °C A Toxic
Highly Flammable
Health – 2 Flammability
–3 Instability - 0
160 mbar @ 20 °C
9. Acetonitrile
TWA: 20
ppm Skin
12.8 °C
81 - 82 °C
A Toxic
Highly Flammable
Health – 2 Flammability
–3 Instability - 0
97 mbar @
20 °C
10. Methanol TWA: 200 ppm
12 °C
64.7 °C
A Highly
Flammable
Health – 1 Flammability
–3 Instability - 0
128 hPa @
20 °C
11. n-Butanol TWA:
20 ppm
35 °C
117.6 °C
B Toxic
Highly Flammable
Health – 2 Flammability
–3 Instability - 0
6.7 mbar @
20 °C
12. Chloroform TWA:
10 ppm
NA 61 -
61 °C - Toxic
Health – 2 Flammability
–0 Instability - 0
213 mbar @ 20 °C
Leak detection and repair (LDAR) programme will be applicable to list of solvents given
in table 7.13 & their related components from which chances of VOC generation as per
CPCB guidelines are as follows :
a. Block valves;
b. Control valves;
c. Pump seals;
d. Pressure relief valves;
e. Flanges – Heat Exchangers;
f. Flanges – Piping;
g. Connectors – Piping;
h. Open ended lines;
i. Sampling connections. Equipment and line sizes more than 2.54 cm are
to be covered.
LDAR programme would be applicable to components (given in Above table) for
following products/compounds: (i) hydrocarbon gases; (ii) Light liquid with vapour
pressure @ 20°C > 1.0 kPa; and (iii) Heavy liquid with vapour pressure @ 20°C between
0.3 to 1.0 kPa.
Environmental Impact Assessment Report
M/s. Solisom Healthcare LLP
Survey No.: 99/P1, Rajpar – Nashitpar Road,
Village: Nashitpar, Ta. Tankara & District:
Morbi Gujarat
T. R. Associates (Ahmedabad)
NABET Accredited
Chapter-7: Additional Studies
7.61
LDAR programme would not be applicable for,
(i) heavy liquids with vapour pressure < 0.3 kPa, it will be desirable to check for
liquid dripping as indication of leak
(ii) Equipment and line sizes less than 2.54 cm, less than 300 hr service and in
vacuum service.
(iii) Equipment and piping during start up and shut down.
(iv) Pumps (canned, diaphragm, magnetic), Valves (Diaphragm, bellow) and close
loop Sampling points; and
(v) Non accessible points to the extent of 5% of total plant.
Following frequency of monitoring of leaks and schedule for repair of leaks shall be
followed:
Component Frequency of
monitoring
Repair
schedule
Responsibility
1 Valves/ Flanges Quarterly
Repair will be
started within
5 working
days and shall
be completed
within 15
working days
after
detection of
leak for
solvents.
Environment
Health & Safety
Officer
2 Pump seals Quarterly
3 Pressure relief
devices
Quarterly
4 Pressure relief
devices (after
venting)
Within 24
hours
5 Heat Exchangers Quarterly
6 Process drains Annually
7 Pump seals with
visible liquid
dripping
Weekly Immediately
8 Any component
with visible leaks
Weekly Immediately
9 Any component
after repair /
replacement
Within a week -
Following types of monitoring methods may be judiciously employed for detection of
leaks:
1. Photo ionization detector (PID) or flame ionization detector
Environmental Impact Assessment Report
M/s. Solisom Healthcare LLP
Survey No.: 99/P1, Rajpar – Nashitpar Road,
Village: Nashitpar, Ta. Tankara & District:
Morbi Gujarat
T. R. Associates (Ahmedabad)
NABET Accredited
Chapter-7: Additional Studies
7.62
(FID) Instrumental method of measurement of leaks;
2. Audio, visual and olfactory (AVO) leak detection; and
3. Soap bubble method.
Data on time of measurement & concentration value for leak detection; time of repair of
leak; and time of measurement & concentration value after repair of leak should be
documented for all the components.
Bibliography
[1] M. o. E. a. Forests, "Manufacture, Storage and Import of Hazardous Chemical
(Ammendment) Rules," New Delhi, 2000.
[2] L. Technica, "Techniques for Assessing Industrial Hazards - A manual," World Bank
Technical Paper, vol. 55, 1988.
[3] V. Marshall, "How lethal are explosions and toxic escapes," Chem. Eng. (London), vol. 8,
no. 24, pp. 573 - 577, 1977.
[4] d. P. U. d. Haag, Guideline for Quantitative Risk Assessment - Purple Book, 2005.
[5] I. A. o. O. &. G. Producers, "Storage Incident Frequencies," in Risk Assessment Data
Directory, OGP Publications, 2010.
CHAPTER – 8
PROJECT BENEFITS
Environmental Impact Assessment Report
M/s. Solisom Healthcare LLP.
Survey No.: 99/P1, Rajpar – Nashitpar Road, Village:
Nashitpar, Taluka: Tankara, District: Morbi, Gujarat.
T. R. Associates (Ahmedabad)
NABET Accredited
Chapter-8: Project Benefits
8.1
CHAPTER - 8
PROJECT BENEFITS
8.1 Introduction
Project benefit focus on those points which will become beneficial to the
surrounding area or community in terms of infrastructural development, social
development, employment and other tangible benefits due to project. Proposed
project has a potential for employment of skilled, semi-skilled and unskilled
employees during construction phase as well as operational phase.
8.2 Employment Potential
Approximately 30 persons will get employment potential for skilled & unskilled,
for the operation and maintenance in efficient way. In addition, during
construction phase, adequate manpower will be required for various
construction activities. Preference will be given to the local people from nearby
villages according to their skills as well as project requirements which will
increase employment opportunity in the surrounding area. Secondary jobs and
indirect employment are also bound to be generated to provide day-to-day needs
and services to the work force and industrial activity. Employed people will be
benefited financially as this financial growth will fulfil their economic
requirements, which in turn will increase their standard of living.
8.3 Improvement In Physical & Social Infrastructure
Physical infrastructure includes infrastructural & technological facilities of the
project, necessary for the operation. Unit is proposing to manufacture API (active
Pharmaceuticals Ingredients) at Survey No.: 99/P1, Rajpar-Nashitpar Road,
Village: Nashitpar, Taluka: Tankara, District: Morbi, Gujarat. Unit will use
modernized technologies and infrastructural facilities. So, that nearby public or
workers will become aware to new technology launched or running in the
present market and thereby it will also helpful in increasing knowledge of
employee and surrounding people.
Following will be other improvements in the physical infrastructure:
Adoption of new technology
Awareness in local educated people for new technology
Improvement in local amenities facilities
Environmental Impact Assessment Report
M/s. Solisom Healthcare LLP.
Survey No.: 99/P1, Rajpar – Nashitpar Road, Village:
Nashitpar, Taluka: Tankara, District: Morbi, Gujarat.
T. R. Associates (Ahmedabad)
NABET Accredited
Chapter-8: Project Benefits
8.2
Improvement in road link facilities as transportation through truck and
other vehicles will increased due to proposed project
Improvement in local civilization
Increase income of local population
Increase requirement of man power
Due to proposed project activity, social infrastructure will be improved by means
of civilization, vocational training and basic amenities.
Civilization: Due to the project, employment and other infrastructural facilities
will boost up income of surrounding people and improve quality of life. This will
indirectly boost up the civilization of the surrounding people.
Vocational Training: Moreover, unit will provide vocational training
opportunity to the surrounding people and greed for employment will motivate
the education activities that will lead the change in life style of the surrounding
and affected people hence social infrastructure will be improved.
Basic Amenities: Better education facilities, proper healthcare, road
infrastructure and drinking water facilities are basic social amenities for better
living standard of any human being which will further increase the above
amenities directly/indirectly either by providing or by improving the facilities in
the area, which will help in uplifting the living standards of local communities.
8.4 Other Tangible Benefits
Employment & trade opportunities will be generated with the starting of the
construction activities. Thus, these considerable employment & trade
opportunities will eventually result in appreciable economic benefits to the local
people & businesses/contractors.
The proposed project will contribute revenue to the Central & State exchequer in
the form of applicable taxes. Indirect contribution to the Central & State
exchequer will be there due to Income by way of registration of trucks, payment
of road tax, income tax from individual as well as taxes from associated units.
Thus, the proposed project will help the Government by paying different taxes
from time to time, which is a part of revenue and thus, will help in developing the
area. The country shall also benefit from increase in excise and vat revenues.
Environmental Impact Assessment Report
M/s. Solisom Healthcare LLP.
Survey No.: 99/P1, Rajpar – Nashitpar Road, Village:
Nashitpar, Taluka: Tankara, District: Morbi, Gujarat.
T. R. Associates (Ahmedabad)
NABET Accredited
Chapter-8: Project Benefits
8.3
8.5 Corporate Environment Responsibility (CER) [Answer to TOR no. 11]
As per MoEF&CC Office Memorandum F.No.22-65/2017- IA.III dated 1st May,
2018 project proponent will earmark 2 % of total capital investment, i.e. Rs. 8
Lakhs, towards the Corporate Environment Responsibility. Socio-economic
development activities have been planned based on the suggestions received
during public hearing as well as general necessity in surrounding villages. Details
of proposed Corporate Environment Responsibility (CER) activities are given as
below:
Table 8.1: Action Plan for Corporate Environment Responsibility Activities
Type of Activities
Yearly amount to be spent in CER activities (Rs. in Lakhs)
Total amount to be spent
(Rs. in Lakhs) 1st
Year 2nd
Year 3rd
Year
Donation in schools of nearby villages for education aids
1.0 1.5 1.5 4.0
Drinking & sanitation facilities in schools of nearby villages
1.0 1.5 1.5 4.0
Total 2.0 3.0 3.0 8.0
The CER activities proposed by the company are considerably beneficial for
social upliftment of surrounding villages. These all together with the economic
benefits of the proposed project will result in further benefits to surrounding
communities.
CHAPTER – 9
ENVIRONMENTAL COST
BENEFIT ANALYSIS
Environmental Impact Assessment Report
M/s. Solisom Healthcare LLP.
Survey No.: 99/P1, Rajpar – Nashitpar Road, Village:
Nashitpar, Taluka: Tankara, District: Morbi, Gujarat.
T. R. Associates (Ahmedabad)
NABET Accredited
Chapter-9: Environmental Cost Benefit Analysis
9.1
CHAPTER - 9
ENVIRONMENTAL COST BENEFIT ANALYSIS
9.1 Environmental Cost Benefit Analysis
As per EIA Notification 2006, this Chapter of the ‘Environmental Cost Benefit
Analysis’ is applicable only if it is recommended at the Scoping stage. Please note
that as per the TOR issued by MOEF&CC, New Delhi vide File No. IA-J-
11011/28/2019-IA.II.(I) dated 26th February, 2019, the Environmental Cost Benefit
Analysis is not applicable and hence it has not been prepared.
CHAPTER – 10
ENVIRONMENTAL
MANAGEMENT PLAN
Environmental Impact Assessment Report
M/s. Solisom Healthcare LLP.
Survey No.: 99/P1, Rajpar – Nashitpar Road,
Village: Nashitpar, Taluka: Tankara, District:
Morbi, Gujarat.
T. R. Associates (Ahmedabad) NABET Accredited
Chapter-10: Environmental Management Plan 10.1
CHAPTER - 10
ENVIRONMENTAL MANAGEMENT PLAN
10.1 Introduction
To formulate and monitor Environmental Protection measures during and after
commissioning of project, preparation of Environmental Management Plan
(EMP) is required. The development of sound Environment Management Plan is
important to mitigate any adverse impacts of the proposed project. The plan
should indicate the details as to how various measures have been or are being
proposed to be taken including cost components as may be required. Cost of
measures for environmental safe guards should be treated as an integral
component of the project cost and environmental aspects should be taken in to
account at various stages of the project.
Conceptualization: Preliminary environmental assessment
Planning: Detailed studies of environmental impacts and design of safe
guards
Execution: Implementation of environmental safety measures
Operation: Monitoring of effectiveness of built in safe guards
The maximum amount of pollution load that can be discharged in the
environment without affecting the designated use and is governed by dilution,
dispersion and removal due to natural physico-chemical and biological processes
is the assimilative capacity of the study area. The main objective of
Environmental Management Plan is to warrant that the industrial development
in an identified particular study area needs to be entangled with judicious
utilization of non-renewable resources and to ensure that the stress/load on the
ecosystem is within its permissible assimilative capacity i.e. its carrying capacity.
The Environment Management Plan (EMP) is required to ensure sustainable
development in the area of the proposed plant. Hence, it needs to be an all
encompass plan for which the proposed industry, government, regulating
agencies like Pollution Control Board working in the region and more
importantly the affected population of the study area need to extend their co-
operation and contribution. The identification and quantification of impacts
based on scientific and mathematical modelling.
The Environmental Management Action Plan aims at controlling pollution at the
source level to the possible extent with the best available technology followed by
treatment measures before they are discharged. The recycling and re-use of
Environmental Impact Assessment Report
M/s. Solisom Healthcare LLP.
Survey No.: 99/P1, Rajpar – Nashitpar Road,
Village: Nashitpar, Taluka: Tankara, District:
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T. R. Associates (Ahmedabad) NABET Accredited
Chapter-10: Environmental Management Plan 10.2
industrial waste not only reduces the waste generated but can be an economic
gain to the industry.
10.2 Objective of Environmental Management Plan
The objective of the Environmental Management Plan is summarized as under: To limit/reduce the degree, extent, magnitude or duration of adverse impacts.
To treat all the pollutants i.e. liquid effluent, air emissions and hazardous
waste with adoption of adequate and efficient technology.
To comply with all the norms and standards stipulated by Gujarat Pollution
Control Board/Central Pollution Control Board.
To create good working conditions.
To reduce any risk hazards and design the disaster management plan.
Continuous development and search for innovative technologies for a cleaner
and better environment.
10.3 Components of Environmental Management Plan
EMP for the proposed project covers following aspects:
Description of mitigation measures which are proposed for proposed
operation phase only
Description of monitoring program
Institutional arrangements
Implementation schedule and reporting procedures
All above aspects and objectives are kept in the view and considering the same
EMP is prepared for two major fields,
10.3.1 Environmental Management Systems (EMS)
Unit is well aware of environmental requirements for planning and
implementation of the project and set up a department with trained
personnel headed under the qualified EHS officer. As indicated in the
impact and mitigation chapter of this report, the environmental impact due
to the proposed activity is very marginal release of pollutants due to
proposed activity.
10.3.2 Environmental, Health and Safety (EHS)
Chemical industries prefer an integrated approach and make
environmental management a part of overall Environment, Health and
Safety (EHS) Management system. This model EHS system suggests and
addresses EMS issues such as:
Environmental Impact Assessment Report
M/s. Solisom Healthcare LLP.
Survey No.: 99/P1, Rajpar – Nashitpar Road,
Village: Nashitpar, Taluka: Tankara, District:
Morbi, Gujarat.
T. R. Associates (Ahmedabad) NABET Accredited
Chapter-10: Environmental Management Plan 10.3
Management system expectation
Management leadership, responsibilities and accountability
Risk assessment and management
Compliance and other requirements
Personnel, training and contractor services
Documentation and communications
Facilities design and construction
Operation, maintenance and management
Community awareness and emergency response
EHS performance monitoring and measurement
Incident investigation reporting and analysis
EHS management system audit
Management review and audit
10.3.3 Environmental Management Cell (EMC)
[Answer to TOR no. 9 (iii)]
For effective implementation of the monitoring program, it is necessary to
have a permanent organizational set-up. Thus, unit will set-up permanent
Environmental Management Cell (EMC) for the effective implementation
and monitoring of environmental management system as given below.
EMC will monitor all project activities to ensure the appropriate
implementation of all environmental mitigation activities and to identify
areas where environmental management plan compliance is not satisfied.
Responsibilities will be assigned to officer from various disciplines to
perform and co-ordinate the activities concerned with management and
implementation of environmental control measures. Director of the
company will be responsible for overall environmental management. EHS
officer will inform all the matter regarding environmental management
including reporting of non compliances / violations of environmental
norms.
Environmental Impact Assessment Report
M/s. Solisom Healthcare LLP.
Survey No.: 99/P1, Rajpar – Nashitpar Road,
Village: Nashitpar, Taluka: Tankara, District:
Morbi, Gujarat.
T. R. Associates (Ahmedabad) NABET Accredited
Chapter-10: Environmental Management Plan 10.4
Figure 10.1: Environmental Management Cell
Director
Plant Manager
EHS Officer
Plant Technician
Environmental Impact Assessment Report
M/s. Solisom Healthcare LLP.
Survey No.: 99/P1, Rajpar – Nashitpar Road,
Village: Nashitpar, Taluka: Tankara, District:
Morbi, Gujarat.
T. R. Associates (Ahmedabad) NABET Accredited
Chapter-10: Environmental Management Plan 10.5
10.4 Environmental Management Plan for the Proposed Project
EMP is given below for both construction phase as well as operational phase.
10.4.1 Environment management during Construction Phase
Description Source Type of Pollutant Control Measures Responsibility
Various
Environmental
Parameters such
as
air, water, noise,
land/soil,
flora, fauna,
socio-economic,
health & safety
Project Construction activities such as site
cleaning, excavation, building construction,
installation of equipment’s, transportation
of construction material and construction
material handling etc.
Particulate matter,
fugitive emissions,
domestic and industrial
wastewater, noise,
municipal waste,
hazardous waste etc.
Regular sprinkling of the
water will be
recommended during
the construction phase.
Tarpaulin sheet will be
used to cover the
materials during
transportation.
Preventing maintenance
of machinery and
transportation vehicles
should be carried out
regularly.
Regular use of PPE like
nose masks, gum-boots
& hand gloves while
working.
Plant
Supervisor
Environmental Impact Assessment Report
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Chapter-10: Environmental Management Plan 10.6
10.4.2 Environment management during Operation Phase [Answer to TOR no. 7 (viii) & Specific TOR no. 6]
Description Source Type of Pollutant/
Pollution Potential
Control Measures Responsibility
Air
Environment
Stack attached to
Boiler, Rectors, Dryers
and D.G. Sets (Stand By)
SPM, SO2, NO2 and
Ammonia, VOC
Cyclone Separator followed by Bag Filter will be
provided to the stack attached to Boiler as an Air
Pollution Control System
Coal/ Briquettes should only be used as fuel for
Boiler.
Diesel should only be used as fuel for D.G. Set.
Water scrubber followed by activated carbon
column will be provided to the stack attached to
reactors as an Air Pollution Control System
Activated carbon column will be provided to the
stack attached to Dryer as an Air Pollution
Control System
Adequate stack height will be provided to
control & disperse the air pollutants within the
stipulated norms.
Peripheral greenbelt should be developed as per
CPCB guidelines and maintained adequately.
EHS
Manager
Fugitive emissions due
to raw material
handling and
transportation,
manufacturing activity
etc.
Odour/VOC All the raw materials will be stored in isolated storage
area and containers will be kept tightly closed.
Entire manufacturing activity will be carried out in
closed reactors / vessels and regular checking and
maintenance of the same will be carried out to avoid
any leakages.
EHS manager
Environmental Impact Assessment Report
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Survey No.: 99/P1, Rajpar – Nashitpar Road,
Village: Nashitpar, Taluka: Tankara, District:
Morbi, Gujarat.
T. R. Associates (Ahmedabad) NABET Accredited
Chapter-10: Environmental Management Plan 10.7
Description Source Type of Pollutant/
Pollution Potential
Control Measures Responsibility
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.
The 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.
The spillages / leakages of specific chemical will be
collected and use or it will be drained to effluent
treatment plant.
Precautionary measures will be taken while handling
various hazardous chemicals.
There will also provision of adequate ventilation
system such as turbo ventilators in process plant and
hazardous chemical storage area.
A regular preventive maintenance will be planned to
replace or rectify all gaskets, joints etc.
Transporters will be instructed to cover the trucks by
tarpaulin sheets.
TREM card will be provided to the driver during the
transportation of Hazardous raw materials/products.
Sufficient information and training regarding
characteristics and immediate actions in case of any
spillage or accident during transportation of
hazardous chemical will be provided to the driver.
Environmental Impact Assessment Report
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Chapter-10: Environmental Management Plan 10.8
Description Source Type of Pollutant/
Pollution Potential
Control Measures Responsibility
The unit will also develop green belt area within the
factory premises to control the fugitive emissions
from spreading into surrounding environment.
Unit will install portable detection system VOCs in the
process area.
Moreover, unit will carry out regular work place
monitoring (LDAR).
Water
Environment
Domestic Wastewater Low Pollution Potential The domestic wastewater generated will be
disposed off through septic tank/soak pit
system.
ETP
Operator
Industrial Wastewater Slightly High Pollution
Potential W/W generation from industrial activities will be
110.5 KLD.
14 KLD W/W streams containing Ammoniacal
Nitrogen will be treated in ammonia stripper and
then it will be sent to ETP.
44 KLD high COD w/w from process, 1 KLD w/w
from washings and 6 KLD w/w from scrubber
will be passed through solvent stripper and w/w
coming from solvent stripper will be sent to MEE.
Condensate water from MEE followed by ATFD
along with 44 KLD w/w rejected from RO, 0.5
Environmental Impact Assessment Report
M/s. Solisom Healthcare LLP.
Survey No.: 99/P1, Rajpar – Nashitpar Road,
Village: Nashitpar, Taluka: Tankara, District:
Morbi, Gujarat.
T. R. Associates (Ahmedabad) NABET Accredited
Chapter-10: Environmental Management Plan 10.9
Description Source Type of Pollutant/
Pollution Potential
Control Measures Responsibility
KLD boiler blow-down and 1 KLD cooling tower
blow down will be taken to ETP.
Solid/
Hazardous
Waste
Management
Manufacturing
Activity, Wastewater
Treatment
ETP Sludge + MEE Salt,
Process Residue, Spent
carbon spent solvent,
Distillation residue, Off
specification drug, Date
expiry product, Used
Oil, Discarded Plastic
Bags/Drums.
ETP Sludge + MEE Salt will be disposed off at
approved TSDF site. Used Oil will be reused
within premises as a lubricant or sold to
registered recycler. Discarded Plastic
Bags/Drums will be sold to authorized vendor.
Process Residue, Spent carbon, spent solvent,
Distillation residue, off specification drug, Date
expiry product will be disposed off at approved
CHWIF.
Separate storage area should be provided for
hazardous waste proposed to be generated from
the unit. The hazardous waste storage area will
have RCC flooring and asbestos roof covering on
the top so as to avoid rainwater mixing with the
same. The leachate if any, will be discharged to
collection tank of Effluent Treatment Plant
EHS
Manager
Burning of Fuel in
Boiler
Fly Ash Fly ash (Coal/briquettes will be used) will be
generated as solid waste; which will be sold to
cement/ RMC/ paver blocks/ building bricks
manufacturer units and also will be supplied to
the other companies for land levelling,
conditioning, road construction, etc.
EHS
Manager
Environmental Impact Assessment Report
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Survey No.: 99/P1, Rajpar – Nashitpar Road,
Village: Nashitpar, Taluka: Tankara, District:
Morbi, Gujarat.
T. R. Associates (Ahmedabad) NABET Accredited
Chapter-10: Environmental Management Plan 10.10
Description Source Type of Pollutant/
Pollution Potential
Control Measures Responsibility
Noise
Environment
Plant Equipments and
various Machinery
Low Pollution Potential Noise suppression measures such as enclosures,
buffers and/or protective measures should be
provided, if required (wherever noise level is
more than 90 dB (A)).
Employees should be provided with ear
protection measures like earplugs or earmuffs.
Earplug should be provided to all workers where
exposure is 85 dB (A) or more.
The transportation contractor shall be informed
to avoid unnecessary speeding of the vehicles
inside the premises.
Extensive oiling, lubrication and preventive
maintenance will be carried out for the
machineries and equipments to reduce noise
generation.
The selection of plant equipment will be made
with specification of low noise levels.
Areas with high noise levels will be identified
and segregated where possible and will include
prominently displayed caution boards.
The greenbelt area will be developed within
industrial premises and around the periphery (if
possible) to prevent the noise pollution in
surrounding area.
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10.5 Biological Conservation Plan for Indian Peafowl (Peacock)
An Indian Peafowl or Peacock (Pavo Cristatus) is a large pheasant justifiably
declared as the National Bird of India in 1963 due to its flagship value founded
on its glorious position in mythology and its widespread distribution and
grandeur. In India, it is given the utmost protection by inclusion in Schedule 1 of
Indian Wildlife Act, 1972 (2002). Being a wide spread species, apart from the
various urban habitats, it is also found in agriculture field, along stream with
good vegetation and close to human habitation in semi –feral conditions. In the
present study area this species have been confirmed from various habitats
located near the village periphery.
Appearance:-
Male peacock has a spectacular glossy green long tail feathers that may be more
than 60% of the total body length. These feathers have blue, golden green and
copper colored eyes. The long tail feathers are used for mating rituals like
courtship displays. The feathers are arched into a magnificent fan shaped from
across the back of the bird and almost touching the found on both sides. Female
do not have these graceful tail feathers. They have to fan like crest with whites
face and throat, chestnut brown crown and hind neck, metallic green upper
breast and mantle, white belly and brown back rump and tail. Their primaries
are dark brown.
Study Approach: -
Since the buffer zone of the proposed synthetic organic chemical mfg. unit
reported with Schedule 1 Species named as Pavo cristatus commonly known as
peacock, a systematic study was conducted to assess their status in terms of
movement and habitat use of the species. At first, a detailed biological survey of
the core & buffer zone was carried out to understand the status distribution of
the species in the study area. Also, questionnaire survey was carried out to
understand the recent status of peacock sighting and their movements. Villagers
from Lavad, Lihoda, Kadjodra, Devkaran Na muvada, Vasana Rathod, Dahegam
and Sanoda interviewed randomly. The conclusion of the survey discussed the
potential sighting & habitat use, and movement and food habitats of peacock in
the study area.
Sighting and Habitat Use:- From the Core Zone no peacock were sighted. However, direct sighting of the
peacock were located near the human dominated and associated surround
habitats like agriculture fields and near water bodies. This species is well
adapted to natural village environment setting. According to the villagers
(interview), during day time that temporally move towards the surrounding
areas like agricultural fields or water bodies for feeding while during night time
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roosts on the trees present in vicinity of the human settlement and also road side
trees. Some villages emphasized that, sometime peacock roosts on the roof of the
houses.
Food and Feeding Habitats:- Peafowls are omnivores, eating plant parts, flower petals, seed heads, insects,
and other arthropods, reptiles and amphibians. In the study area dense tree
canopy cover supports good insect diversity which is very common food for
peafowls.
Habitat Improvement Action Plan:- Habitat improvement program will include plantation of various plant species
like Acacia leucophloea (Roxb.) Willd (Harmo Bavar), Butea monosperma (Lam.) Taub
(Kesudo, Khakharo), Diospyros cordifolia Roxb (Makrodu, Makrodi), Madhuca indica J. F.
Gmel (Mahudo), Prosopis cineraria (L.) Druce (Khijado, Hangar) and other species
reported from the study area should be taken into priority. In order to improve
vegetation cover, it is suggested to carry out extensive afforestation program in
different phases. These species will help to provide habitat for faunal diversity,
and also increases the species diversity and maintain the naturalness of the
surrounding area.
Seed Distribution among the Villagers:- During this habitat improvement programme the seed of Butea monosperma (Lam.)
Taub (Kesudo, Khakharo), Diospyros cordifolia Roxb (Makrodu, Makrodi), and other
seeds will be distributed in the various villages of the study area. Compost
packets will be also provided at the intervals of the every six months by the
proponent (in consultation of forest department).
Water Filing in the existing Water Bodies during Summer:- Water will be filled in the existing (selected by forest department) water bodies
by water tankers (five number in each water body).
Inference – Buffer Zone as Peacock Habitat:- Presented survey of the peacock in the buffer zone of the project site shows that,
peafowl is well adapted to the existing rural setting of the study area. However,
the following points can give an insight on the overall status of peafowl in the
study area and thereby plan for better management strategies related to
proposed activities.
Local resident of the study area well aware of the movement pattern of
peafowl in their surrounding habitats.
Peafowl uses agriculture and various rural habitats as a feeding ground
during day time while during night time they take shelter on the trees as
well as on the roof of the houses. It clearly indicates peafowl normally
uses ecosystem or habitats adjacent to village.
From the above said facts, it can be inferred that, some villages of the buffer zone
provide roosting and feeding ground for peafowl, while core zone do not have
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potential habitat for roosting or feeding ground for peafowl. Therefore, it has
been visualized that, the proposed project will not have any significant impact on
peacock in terms of their normal movements and other activities. However, it is
necessity to take some management option like habitat improvement in the
villages located in the immediate vicinity of the project site. So, habitat
improvement programme (Plantation of recommended and local plant species)
will be under taken in (in consultation of forest department) different villages
located in the close vicinity of the project area. Under this programme sampling
will be distributed in the nearby villages with the consultation of the local forest
department.
In consultation of the forest department, following conservation measures will
be adapted for peacock conservation:
1. Habitat improvement programme in the different villages will be
undertaken in the buffer zone area for shelter and roosting of peacocks.
This will be achieved by plantation of local varieties of the tree species
near villages in buffer area. Plantation will also be carried in some forest
patches identified by local forest department.
2. School level awareness programme will be conducted for conservation of
peacock by organizing competition during “Wildlife Week” and “Van
Mahotsav” celebration.
Further suggestion/ recommendation:- Restricted uses of pollutants in their habitat.
Stopping the increased vehicle pollution, wildlife road fatalities and damaged
to precious habitat by people to start movement towards these areas.
To carry annual census research project to ecology and habitat use by
peacock.
By making provision of veterinary care and cages for injurious or sick
deformed birds.
Table 10.1: Conservation plan for Peacock for five years
Conservation plan Sr. No.
Work or Activity 1 to 5 years Location
1 Plantation 100 trees per year plant of local plant species for five years in
villages.
Villages covered in 10 km study area
2 Water filling 5 number in water hole filing during summer.
Ponds covered in 10 km study area
3 Awareness
In school of nearby villages for peacock conservation as Drawing Competition. (Peacock Picture)
& Essay Writing on Peacock.
Villages covered in 5 km study area
** All above activity will be carried out with the consultation of local forest department.
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Plant Species will be suggested by the local forest department and plant
saplings will be distributed in project villages as per the above mentioned
schedule (year wise).
10.6 Greenbelt Development Plan [Answer to TOR no. 7 (x)]
The main objective of the greenbelt is to provide a barrier between the plant and
the surrounding areas. The greenbelt helps to halt soil erosion, make the eco-
system more sustainable, make the climate more conductive and restore water
balance. The greenbelt helps to capture the fugitive emissions and to attenuate
the noise generated in the plant apart from improving the aesthetics of the plant
site.
The unit proposes to create the peripheral greenbelt within the project site as
well as outside the project premises considering the CPCB guidelines.
Out of total plant area 7689 m2, Unit will develop thick greenbelt in 2545 m2 area
(about 33.1 %). Considering the environmental status of project area four main
parameters like salinity, draught, fire resistance, native species with faster
growth rate and ever green nature have been considered while selecting the
species. Facts considered during selection of plant species for greenbelt
development are:
Agro climatic zone (arid to semi-arid climate) of the project area
Evergreen species to mitigate cumulative impacts due to other industries.
Type of pollutant (mainly air) likely to disperse from project activities.
Biological–filter Efficiency: Absorption of gases, Dust capturing and Noise
control.
The green belt development program will go simultaneously in phased manner
along with the civil activities. It may be noted that this activity demands expert
advice and guidance. Details of the selected plant species for development of
greenbelt are given in the Table 10.2.
Table 10.2: Details of Plant Species in Greenbelt
Common Name of Trees Scientific Name Number of Species
Deshi Baval, Bavar Acacia nilotica (L.) Del. subsp. indica(Bth.) Brenan
30
Karo Sirish Albizia lebbeck (L.) Bth. 25
Limbdo, Neem Azadirachta indica A. Juss. 35
Kasid Cassia siamea Lam. 30
Gundi Cordia gharaf (Forsk.) E.&.A. 27
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Common Name of Trees Scientific Name Number of Species
Gulmohor Delonix regia (Boj.) Raf. 27
Karanj Derris indica (Lam.) Bennet 28
Vad Ficus benghalensis L. 28
Kanaji Holoptelea integrifolia (Roxb.) Planch.
27
Liso Bavar Leucaena latisiliqua (L.) Wt. & Arn.
28
Keri Mangifera indica L. 24
Tamrafali Peltophorum pterocarpum (DC.) Backer ex Heyne
24
Asopalav Polyalthia longifolia (Sonn.) Thw.
23
Mota Bor Zizyphus mauritiana Lam. 24
Total Species 380
Proposed Three Years Program for Greenbelt Development
Plantation Details 1st Year 2nd Year 3rd Year Total
No. of plants 130 130 120 380
10.7 Rain Water Harvesting Scheme
Rainwater Harvesting is generally recharging rainwater in to the underground
formation, where it will be stored in underground reservoirs (Aquifer) so that we
can draw it whenever we need it.
Rain water harvesting means “Arresting rainwater during monsoon and storing
it in natural reservoirs (aquifers) or artificial/manmade reservoir (tanks)”. It
rains everywhere in India and the end user can store this water at marginal cost.
The harvested rainwater can be used for flushing, washing, gardening, irrigation,
fire fighting and even consumption with necessary treatment. Rainwater is the
purest form of water available. Experts opine that the major source of water, rain
must be saved to solve the problem of water scarcity.
Need for Rainwater Harvesting
To reduce ground water pollution
To augment the ground water storage and decline of water level
To improve the quality of ground water
To reduce the soil erosion
To avoid flooding on roads
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Advantages of Rainwater Harvesting
Provides self sufficiency at least reduces load on water supply
Reduces the cost of pumping of ground water as it raises ground water table
Improves quality of ground water through dilution when recharge to ground
water
Reduces soil erosion in alluvium area
Rainwater harvesting systems are simple which can be adopted by individuals
Available Technology
Storage in artificial above or underground tanks.
Recharging aquifer directly through tube wells with necessary treatment.
Recharging aquifer by percolation / Soakage in the ground.
Method of Rain Water Harvesting
In arid and semiarid areas rain water forms the only source of domestic water
supply. This is an ideal solution to water problem where there is no ground
water (Saline ground water) and surface sources are very far. This is ideally
suited from the economical point of view. Rain water is bacteriologically pure,
free from, organic water and soft in nature. To meet drinking water demand
during the critical dry period of 90-120 days roof top water harvesting is very
useful. Ground water recharge or storage from house of 100 m2 of roof top will
be 55,000 liters in one year, sufficient for a period of four months for a family of
five members.
In roof top rain water harvesting the rain water is collected from roof of the
buildings and stored in water tank for beneficial use in future. The size of the
catchment area and tank should be enough to supply sufficient water for the
users during this period.
Volume
Volume of tank can be calculated by the following formula.
V= (T X N X A) TAT
Where,
V= Volume of tank (litters)
T= Length of the dry season (days)
N= Number of people using the tank
A= Consumption per capita per days (litters)
ET= Evaporation loss during the dry period
Since evaporation from a closed storage tank is negligible the evaporation
loss (ET) can be ignored (=Zero).
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Essential Components of the system
Roof Catchment
Gutters for collection of roof water
Down pipe to convey rain water from gutter to storage tank
“Foul Flush” to divert the contaminated run-off from roof (for initial
wash out before taking to storage tank
Filter/Mesh
Storage tank under ground
Water withdrawal arrangement (Hand Pump)
Dis-infection arrangement
Design Consideration
In the design system, the main criterion is the most economical combination of
the storage tank volume, systematic analysis of rainfall records and construction
costs.
Selection of Site
Site should be close to the house to reduce the cost of down pipe
Site should have good drainage and should be away from the cattle
shed and soak pits etc. for cleanliness and hygiene surrounding the
tank
Site should be away from tress to prevent litters falling on the roof
and structural disturbance to the tank by roof propagation
Site should be easily accessible for tapping water
Runoff Calculation & Provision of Rainwater Tanks
The area under investigation for M/s. Solisom Healthcare Pvt. Ltd. at Village:
Nashitpar, Taluka: Tankara, District: Morbi is 7689 m2. The dependable rainfall
of the project area is 660 mm i.e. 0.660 m. Calculation of rain water to be
harvested based on yearly rainfall and runoff is given in Table 10.3.
Table 10.3: Details of Rain Water Harvesting
Particular
Details
Roof
Top
Area
Open
Area
Road Area Green Belt
Area
Annual Rainfall (mm) 660
No. of rainy days per year 30
Catchment area Available (m2) 2921 1073 1150 2545
Coefficient of runoff (as per
CGWB Guideline)
0.8 0.2 0.5 0.2
Area wise volume of rain water
can be harvested (KL/Year)
1542 141 380 335
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Total volume of rain water can
be harvested (Kl/Year) 2400
Average volume of rain water
can be harvested (kl/day) during
30 rainy days
80
Volume of storage tank to be
provided by unit for rain water
storage (kl)
50 kl X 2 no.
Based on the above table, unit will provide rain water storage tank of about 50
Kilo Litres (2 nos.) and stored rainwater will be used for purposes like cooling,
washing & domestic etc. as per the requirement.
Tips for Maintenance of the R R H S
Always keep the surroundings of the tank clean and hygienic
Remove Algae from the roof tiles and asbestos sheets before the
monsoon
Drain the tank completely and clean from inside thoroughly before
the monsoon
Clean the water channels (Gutters) often during rainy season and
definitely before the first monsoon rain
Avoid first 15 or 20 minutes of rain fall depending on the intensity of
rain. Use the first flush arrangement to drain off this first rain water
Change the filter media every rainy season
In coastal area the tank may be painted outside by corrosion resistant
paint once in 3 years and in other areas lime (Calcium Carbonate)
based white wash may be applied not only for beauty but also for
cleanliness
Withdraw water from the system at the rate of 5 lits/head/day. This
will ensure availability of water throughout the water scarcity period.
Cover all inlet and outlet pipes with closely knife nylon net or fine
cloth or cap during non-rainy season to avoid entry of insects, worms
and mosquitoes.
The substances that go into the making of the roof should be non-
toxic in nature
10.8 Occupational Health Management Plan
All precautionary methods will be adopted by the company to reduce the risk of
exposure of hazards to employees, specifically:
Pre-employment and periodical medical examinations will be carried out to
assess the health status of the workers and medical records for the same will
be maintained for each employee.
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A qualified doctor will be appointed on casual basis and required medicines,
antidotes and first-aid box will be procured under the guidance of appointed
doctor as per guidelines of Factory Act.
Personal Protective Equipment’s (PPEs) like helmet, goggles, hand gloves,
safety shoes, nose masks and ear protecting devices like ear plugs/ear muffs
will be provided to all the workers.
Adequate numbers of fire fighting equipments and extinguishers will be
installed as per requirement of the fire risk in the proposed plant.
Proper training will be imparted to employees for use of safety appliances &
first aid.
All workers will be trained on respective Standard Operating Procedure (SOP)
so as to enable them to prevent any possible mishaps.
All loading/unloading will be carried out under technical guidance as per the
Standard Operating Procedure (SOP) generated for the particular raw
material/product.
All pollution control equipments are periodically checked and maintained.
The work place area monitoring will be carried out for Particulate Matters
(PM), VOCs & Noise on regular basis.
Good housekeeping, proper and adequate ventilation and lighting will be
arranged for better workplace area as per guidelines of Factory Act.
Water purification and water cooler will be provided for safe drinking water.
10.9 Fire & Safety Management Plan
The company will provide sufficient fire extinguishers and fire hydrant systems
for protection of the plant building against fire due to electrical spark and short
circuit. Automatic type fire extinguishing system will be provided to protect the
control and computer rooms areas from fire hazards.
Qualified and trained EHS officer will manage the environment and safety
department. All persons in operation and maintenance of the plant will be given
basic fire fighting training.
To avoid short-circuiting an earthing system will be designed and installed for a
ground fault short circuit. Grid resistance will be decided based on soil resistively
and allowance for corrosion. Electrical equipments will be flame proof. To avoid
road accident due to spillage of fuels and blockages of road, proper parking and
road safety signs both inside and outside the plant will be displayed.
Good housekeeping, proper and adequate ventilation and lighting will be
arranged for better workplace area as per guidelines of Factory Act.
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10.10 Cleaner Production Technologies [Answer to TOR no. 7 (vii)]
Cleaner production is a preventive, company-specific environmental protection
initiative. It is intended to minimize waste and emissions and maximize product
output. Unit will adopt cleaner production techniques in water conservation,
waste minimization, housekeeping, reuse/recycle, energy saving etc. wherever
possible by the following practices;
Adopting latest and best process technology to achieve maximum yield with
minimum waste generation.
Adopting good housekeeping practices by maintaining cleanliness in
premises and providing regular training and giving instructions for the same.
Carrying out energy audit at regular time interval.
Installing flow meter at water intake and at inlet of effluent treatment plant.
Installation and efficient use of rain water harvesting system.
Reusing spent/waste oil for lubrication in machineries and equipments
within the premises.
10.11 Budget for Environment Protection Measures [Answer to TOR no. 7 (xi) & 8(i)] Capital investment for the protection of environment will be about Rs. 118 Lakhs.
Unit will regularly and efficiently operate environmental management systems
and keep provision for fund for meeting expenses for the same. The budgetary
allocation towards Environmental Management for the proposed project is
presented in the Table 10.4
Table 10.4: Budgetary allocation towards Environmental Management
Aspect of
Environmental
Management
Cost in
Lakh
[Rs.]
Recurring
Cost (Lakh
/Annum) [Rs.]
Remarks
Air Pollution 15 1.50 Capital cost would include air pollution
control devices and the recurring cost
would include operation and maintenance
of pollution control devices and stack
emission/AAQ monitoring & sample
analysis charges.
Water Pollution 90 443 Capital cost would include cost of septic
tank/soak pit system, ETP, evaporator etc.
and recurring cost would include
maintenance charges, manpower salary,
sample analysis charges etc.
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Aspect of
Environmental
Management
Cost in
Lakh
[Rs.]
Recurring
Cost (Lakh
/Annum) [Rs.]
Remarks
Noise Pollution 1.0 0.3 Capital cost would include providing
adequate sound enclosures and recurring
cost would include monitoring of noise
level.
Hazardous /
Solid Waste
Management
1.0 0.6 Capital cost would include expense for
providing storage area for hazardous waste
and recurring cost would be for solid/
hazardous waste packing & its disposal and
for the membership of TSDF site.
Green Belt 2.0 0.7 Capital cost would include development of
green belt within and outside the project
premises and recurring cost would include
maintenance charges, manpower salary
etc.
Occupational
Health & Safety
2.0 1.0 Capital cost would include cost of OHS
center, PPEs and recurring cost would
include maintenance charges
Miscellaneous 7.0 2.9 Miscellaneous activity such as
development of rain water harvesting
system, cost of fire and safety equipment
and recurring cost would include
maintenance charges
Total 118.00 450
CHAPTER – 11
SUMMARY &
CONCLUSION
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Chapter-11: Summary & Conclusion
11.1
CHAPTER - 11
SUMMARY & CONCLUSION
11.1 Introduction
Generally any project or action includes various impacts, which vary in
magnitude as their beneficial or adverse classification. At the same time it is very
important to conclude that the “overall” or “collective” impact of the proposed
project is beneficial or detrimental.
In case of the proposed project, impacts are evaluated with respect to various
activities during construction and operational phase.
11.2 Air Environment
The general meteorological data collected during the study period confirms that
climatic status of the study area is consistent with the regional meteorology.
Baseline AAQ data indicates that 98th percentile concentration of PM10, PM2.5,
SO2, NO2, CO, Ammonia & VOCs in the study area are well within the permissible
limits as prescribed in the National Ambient Air Quality (NAAQ) standards.
Based on the ground level concentration evaluated by Dispersion Modelling, it is
found that due to the operation of proposed project incremental values of
various parameters are well within the permission limits as prescribed in the
National Ambient Air Quality (NAAQ) standards.
Hence, it may be concluded that there would not be any adverse impacts on
surrounding air environment within the study area due to the proposed project.
11.3 Water Environment
Baseline data reveal that as per drinking water quality standards IS 10500
overall quality of both surface & ground water is suitable for domestic activity
including agricultural activity after appropriate Treatment. Ground water quality
in the area meets the Water Quality Standards (IS 10500) for drinking water
except for parameters like TDS, Total Hardness & Magnesium ion concentration
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whereas surface water quality in the area meets the Water Quality Standards (IS
10500) for drinking water except for parameters like pH and Turbidity.
The total water requirement for the proposed project activity will be 119 kl/day
out of which 31 kl/day is Fresh Water required & 88 kl/day Recycled water from
ETP is reused for proposed project. Water will be obtained through bore-well to
fulfil such requirements. However, industry proposed to install rainwater
harvesting system to recharge the ground water to the tune of 2400 kl/year.
Therefore, there will be no significant impact on groundwater.
Domestic wastewater will be disposed off through a septic tank/soak pit system
and industrial w/w streams containing Ammoniacal Nitrogen will be treated in
ammonia stripper and then it will be sent to ETP. High COD w/w from process,
washings and scrubber will be passed through solvent stripper and w/w coming
from solvent stripper will be sent to MEE. Condensate water from MEE followed
by ATFD along with w/w rejected from RO, boiler blow-down and cooling tower
blow down will be taken to ETP. The ETP will be consisting of collection cum
neutralization tank, primary clariflocculator, aeration tank, secondary
clariflocculator, PSF & ACF. Sludge generated from ETP and MEE salt will be sent
to TSDF site.
Thus, it can be concluded that there would not be any significant adverse impact
on the water environment due to the proposed project.
11.4 Noise Environment
Noise level in the project premises will be controlled at the source itself by
appropriate use of noise suppressing systems. Noise level in the surrounding
study area is well within the permissible limits (as prescribed in the National
Noise Quality Standards) at all locations.
Thus, noise generated due to the project activity shall create negligible impact in
surrounding environments. This shall further be attenuated by a barrier of
plantation at the periphery of the plant.
11.5 Land/Soil Environment
The soil pollution is generally due to wastewater and solid waste. There will be
no industrial wastewater discharge outside the Project Premises & treated water
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will be reused into the Industrial activities. Hazardous waste will be properly
collected, stored & ultimately disposed to secured landfill/TSDF site.
All the solid/hazardous wastes generated due to the proposed project will be
properly collected, stored & ultimately disposed off as per the applicable
Act/Rules prescribed by statutory authority and as per consent and/or
authorization.
Therefore, there would be no adverse impact on the land environment due to the
proposed project.
11.6 Ecology & Biodiversity
The flora and fauna of the study area indicate that species diversification is
decent in the study area. Study reported a total of 133 plant species, 7 species of
herpetofauna, 38 species of birds and 6 species of mammalian fauna from the
buffer zone of project site. However, no threatened biodiversity reported with
highest density or richness from the core and buffer zone of the study area.
Since the project associated activities do not require any additional land, the
terrestrial ecosystem is considerably free from the project related impacts.
11.7 Socio-Economic Environment
The proposed project will generate employment during construction & operation
phase. The indirect employment will also be generated by way of transportation,
shopkeepers and other casual employment for many people during operation
phase as well as construction phase. Industrial growth will improve economic
status of the people either directly or indirectly
Local people will be given preference for the jobs in the proposed project.
Economic status of the local people will improve due to the increased business
opportunities, thereby making a positive impact. Educational, medical and
housing facilities in the study area will considerably improve.
Thus, the proposed project will have significant positive impact on the
employment pattern of the study area.
11.8 Conclusion
Negligible impacts will occur on air quality. However, all the necessary air
pollution control measures will be provided.
No ecological damage will occur.
No adverse impacts will occur on water environment.
Environmental Impact Assessment Report
M/s. Solisom Healthcare LLP.
Survey No.: 99/P1, Rajpar – Nashitpar Road,
Village: Nashitpar, Taluka: Tankara, District:
Morbi, Gujarat.
T. R. Associates (Ahmedabad)
NABET Accredited
Chapter-11: Summary & Conclusion
11.4
Local employment opportunities will increase.
Various other environment parameters like Forest/ National Park/ Sanctuary
and Religious / Historical Places will not be affected.
Environment Management Plan has been formulated to control all the
pollutant parameters and Environment Management Cell has been set-up to
ensure that these parameters do not exceed the norms set out by the
concerned authorities.
After commissioning of the proposed project the Environmental Management
Cell will take care of all the pollution control measures.
It can be concluded on a positive note that after the implementation of the
mitigation measures and environmental management plan during the construction
& operational phase, there will be negligible impact on the environment.
CHAPTER – 12
DISCLOSURE OF CONSULTANT ENGAGED
Environmental Impact Assessment Report
M/s. Solisom Healthcare LLP.
Survey No.: 99/P1, Rajpar – Nashitpar Road, Village:
Nashitpar, Taluka: Tankara, District: Morbi, Gujarat.
T. R. Associates (Ahmedabad)
NABET Accredited
Chapter-12: Disclosure of Consultant Organization
12.1
CHAPTER - 12
DISCLOSURE OF CONSULTANT ORGANIZATION
[Answer to TOR no. 2 (i)]
12.1 Declaration for Involvement in the EIA Study
DECLARATION BY ORGANIZATION
Project Details
Name & address M/s. Solisom Healthcare LLP.
Survey No.: 99/P1, Rajpar-Nashitpar Road, Village:
Nashitpar, Taluka: Tankara, District: Morbi, Gujarat.
Project Type Manufacturing of Active Pharmaceutical Ingredients
(API)
Category as per EIA Notification 5(f) ‘A’
NABET sector 21
EIA Consultant Details
Name & address T. R. Associates
A-401, S G Business hub, B/w Sola Bhagwat and Gota
Overbridged, Near Umiya Campus, S.G. Highway,
Ahmedabad- 380060. Gujarat.
Contact No.: 98253 71099
Current Status NABET Accredited vide their Certificate No.
NABET/EIA/1619/RA 0033 issued on 14.02.2017
(Refer Annexure – 7)
Environmental Impact Assessment Report
M/s. Solisom Healthcare LLP.
Survey No.: 99/P1, Rajpar – Nashitpar Road, Village:
Nashitpar, Taluka: Tankara, District: Morbi, Gujarat.
T. R. Associates (Ahmedabad)
NABET Accredited
Chapter-12: Disclosure of Consultant Organization
12.2
Details of Laboratory engaged in the EIA Study
Name & Address T. R. Associates
A-401, S G Buisnesshub, B/w Sola Bhagwat and Gota
Overbridged, Near Umiya Campus, S.G.Highway,
Ahmedabad- 380060. Gujarat.
Contact No.: 98253 71099
Current Status NABL Accredited vides Certificate No. TC-7896 dated
14-11-2018 valid upto 13-11-2020 (Refer Annexure
– 8)
Name & Address Gujarat Laboratory
F /16,17, Madhavpura Market,
Shahibaug, Ahmedabad – 380004
Current Status NABL Accredited vide Certificate No. TC-5961 valid
upto 17-01-2020
12.2 Company Profile
T. R. ASSOCIATES is an organization working towards providing techno-economical
solutions through innovative ideas and indigenous technologies, in the field of Pollution
Control and Management. Having in-house facilities for Design, Execution, Erection and
Commissioning; T. R. Associates undertakes project from Concept to Commissioning.
T. R. ASSOCIATES is enlisted as Environmental Consultant and is recognized as
Schedule-II Environmental Auditors by Gujarat Pollution Control Board.
SERVICES
T. R. Associates provides services in the areas,
Research & Development
Environment & Safety Consultation: Environmental Quality Monitoring
Engineering Designs
Environment & Safety Assessment: Environmental Impact Assessment
Environmental Audit
Environmental Impact Assessment Report
M/s. Solisom Healthcare LLP.
Survey No.: 99/P1, Rajpar – Nashitpar Road, Village:
Nashitpar, Taluka: Tankara, District: Morbi, Gujarat.
T. R. Associates (Ahmedabad)
NABET Accredited
Chapter-12: Disclosure of Consultant Organization
12.3
Safety Audit
Risk Assessment
Engineering Procurement & Commissioning: Effluent Treatment Plants
Sewage Treatment Plants
Laboratory work: Ambient air and Noise monitoring &
analysis, source monitoring, water, waste
water & soil analysis
INFRASTRUCTURAL FACILITIES
Office Premises: Office area of around 1995 sq. ft. is located in commercial area on S. G.
Highway, B/w Sola Bhagwat & Gota Over Bridge, near Umiya Campus. The office and the
laboratory are located very near, which help in maintaining the authenticity of the
methodologies used for the analysis thus helping in arriving at the quality solution
timely.
Laboratory Facilities: Laboratory is a heart for any organization dealing in the
environmental field. T. R. Associates has a NABL accredited Laboratory with a team of
experience personnel who are trained in sampling for air, water and wastewater and for
conducting Analysis, Treatability and Feasibility studies at its own well-equipped
laboratory.
Analytical Capability: The laboratory can undertake the qualitative and timely analysis
of all the environmental parameters concerning Air, Water & Waste Water and
Hazardous / Solid Waste.
R&D Facilities: Has established bench scale models for process development,
performance evaluation and process optimization.
Communication Facilities: Main facilities like office and laboratory are located very
near thus aiding faster communication between the personnel’s thus helping at arriving
to a solution faster. The infrastructure is adequately equipped with Telephone
connections, Wi-Fi connection, Internet connection, Courier services etc. to have faster
communication with the outer world.
ANNEXURES
No.IA-J-11011/28/2019-IA-II(I)
Goverment of India
Minister of Enviroment,Forest and Climate Change
Impact Assessment Division
***
Indira Paryavaran Bhavan,
Vayu Wing,3rd Floor,Aliganj,
Jor Bagh Road,New Delhi-110003
26 Feb 2019
To,
M/s M/S. SOLISOM HEALTHCARE LLP
Jai Dipal Ma Marketing, Shop No. 33, Swagat Chamber, Trajpar Char Rasta, Old Ghuntu,
Morbi - 363642.,
Morbi-363642
Gujarat
Tel.No.079-27450694; Email:[email protected]
Sir/Madam,
This has reference to the proposal submitted in the Ministry of Environment, Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification, 2006. For this purpose, the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report. The details of the proposal are
given below:
1. Proposal No.: IA/GJ/IND2/92443/2019
2. Name of the Proposal: Synthetic Organic Chemicals (Active
Pharmaceutical Ingredients)
3. Category of the Proposal: Industrial Projects - 2
4. Project/Activity applied for: 5(f) Synthetic organic chemicals industry (dyes
& dye intermediates; bulk
5. Date of submission for TOR: 22 Jan 2019
In this regard, under the provisions of the EIA Notification 2006 as amended, the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows:
STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FOR PROJECTS/ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f):STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES & DYEINTERMEDIATES; BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS; SYNTHETIC RUBBERS;BASIC ORGANIC CHEMICALS, OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIA/EMP REPORT
A. STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i. Details of the EIA Consultant including NABET accreditation
ii. Information about the project proponent
iii. Importance and benefits of the project
3) Project Description
i. Cost of project and time of completion.
ii. Products with capacities for the proposed project.
iii. If expansion project, details of existing products with capacities and whether adequate landis available for expansion, reference of earlier EC if any.
iv. List of raw materials required and their source along with mode of transportation.
v. Other chemicals and materials required with quantities and storage capacities
vi. Details of Emission, effluents, hazardous waste generation and their management.
vii. Requirement of water, power, with source of supply, status of approval, water balance diagram,man-power requirement (regular and contract)
viii. Process description along with major equipments and machineries, process flow sheet(quantative) from raw material to products to be provided
ix. Hazard identification and details of proposed safety systems.
x. Expansion/modernization proposals:
c. Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEF/SEIAA shall be attached as an Annexure. A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May, 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided. In
STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FORPROJECTS/ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition, status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report.
d. In case the existing project has not obtained environmental clearance, reasons for nottaking EC under the provisions of the EIA Notification 1994 and/or EIA Notification2006 shall be provided. Copies of Consent to Establish/No Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006, CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted. Further, compliancereport to the conditions of consents from the SPCB shall be submitted.
4) Site Details
i. Location of the project site covering village, Taluka/Tehsil, District and State, Justificationfor selecting the site, whether other sites were considered.
ii. A toposheet of the study area of radius of 10km and site location on 1:50,000/1:25,000 scaleon an A3/A2 sheet. (including all eco-sensitive areas and environmentally sensitive places)
iii. Details w.r.t. option analysis for selection of site
iv. Co-ordinates (lat-long) of all four corners of the site.
v. Google map-Earth downloaded of the project site.
vi. Layout maps indicating existing unit as well as proposed unit indicating storage area, plantarea, greenbelt area, utilities etc. If located within an Industrial area/Estate/Complex, layoutof Industrial Area indicating location of unit within the Industrial area/Estate.
vii. Photographs of the proposed and existing (if applicable) plant site. If existing, showphotographs of plantation/greenbelt, in particular.
viii. Landuse break-up of total land of the project site (identified and acquired), government/private - agricultural, forest, wasteland, water bodies, settlements, etc shall be included. (notrequired for industrial area)
ix. A list of major industries with name and type within study area (10km radius) shall beincorporated. Land use details of the study area
x. Geological features and Geo-hydrological status of the study area shall be included.
xi. Details of Drainage of the project upto 5km radius of study area. If the site is within 1 kmradius of any major river, peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years. Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided. (mega green fieldprojects)
xii. Status of acquisition of land. If acquisition is not complete, stage of the acquisition processand expected time of complete possession of the land.
xiii. R&R details in respect of land in line with state Government policy.
STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FOR PROJECTS/ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable):
i. Permission and approval for the use of forest land (forestry clearance), if any, andrecommendations of the State Forest Department. (if applicable)
ii. Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii. Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted.
iv. The projects to be located within 10 km of the National Parks, Sanctuaries, Biosphere Reserves,Migratory Corridors of Wild Animals, the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-à-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon.
v. Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna, if any exists in the study area.
vi. Copy of application submitted for clearance under the Wildlife (Protection) Act, 1972, to theStanding Committee of the National Board for Wildlife.
6) Environmental Status
i. Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature, relative humidity, hourly wind speed and directionand rainfall.
ii. AAQ data (except monsoon) at 8 locations for PM10, PM2.5, SO2, NOX, CO and otherparameters relevant to the project shall be collected. The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction, population zoneand sensitive receptors including reserved forests.
iii. Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov. 2009 along with - min., max., average and 98% values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report.
iv. Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCB/MoEF&CC guidelines.
v. Whether the site falls near to polluted stretch of river identified by the CPCB/MoEF&CC, ifyes give details.
vi. Ground water monitoring at minimum at 8 locations shall be included.
vii. Noise levels monitoring at 8 locations within the study area.
viii. Soil Characteristic as per CPCB guidelines.
ix. Traffic study of the area, type of vehicles, frequency of vehicles for transportation of materials,additional traffic due to proposed project, parking arrangement etc.
STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FORPROJECTS/ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x. Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare, endemic and endangered species. If Schedule-I fauna are found within the study area, a Wildlife Conservation Plan shall be prepared andfurnished.
xi. Socio-economic status of the study area.
7) Impact and Environment Management Plan
i. Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features. In case the project is located on a hilly terrain, theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ. Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed. Details ofthe model used and the input data used for modelling shall also be provided. The air qualitycontours shall be plotted on a location map showing the location of project site, habitationnearby, sensitive receptors, if any.
ii. Water Quality modelling - in case of discharge in water body
iii. Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided. In this regard, options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined.
iv. A note on treatment of wastewater from different plant operations, extent recycled and reusedfor different purposes shall be included. Complete scheme of effluent treatment. Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules.
v. Details of stack emission and action plan for control of emissions to meet standards.
vi. Measures for fugitive emission control
vii. Details of hazardous waste generation and their storage, utilization and management. Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded. EMP shall include the concept of waste-minimization, recycle/reuse/recovertechniques, Energy conservation, and natural resource conservation.
viii. Proper utilization of fly ash shall be ensured as per Fly Ash Notification, 2009. A detailedplan of action shall be provided.
ix. Action plan for the green belt development plan in 33 % area i.e. land with not less than1,500 trees per ha. Giving details of species, width of plantation, planning schedule etc. shallbe included. The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated.
x. Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FOR PROJECTS/ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources.
xi. Total capital cost and recurring cost/annum for environmental pollution control measuresshall be included.
xii. Action plan for post-project environmental monitoring shall be submitted.
xiii. Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control. Disaster management plan should belinked with District Disaster Management Plan.
8) Occupational health
i. Plan and fund allocation to ensure the occupational health & safety of all contract and casualworkers
ii. Details of exposure specific health status evaluation of worker. If the workers' health is beingevaluated by pre designed format, chest x rays, Audiometry, Spirometry, Vision testing (Far& Near vision, colour vision and any other ocular defect) ECG, during pre placement andperiodical examinations give the details of the same. Details regarding last month analyzeddata of above mentioned parameters as per age, sex, duration of exposure and departmentwise.
iii. Details of existing Occupational & Safety Hazards. What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL). If these are not within PEL,what measures the company has adopted to keep them within PEL so that health of the workerscan be preserved,
iv. Annual report of heath status of workers with special reference to Occupational Health andSafety.
9) Corporate Environment Policy
i. Does the company have a well laid down Environment Policy approved by its Board ofDirectors? If so, it may be detailed in the EIA report.
ii. Does the Environment Policy prescribe for standard operating process / procedures to bringinto focus any infringement / deviation / violation of the environmental or forest norms /conditions? If so, it may be detailed in the EIA.
iii. What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions? Details of this system may be given.
iv. Does the company have system of reporting of non compliances / violations of environmentalnorms to the Board of Directors of the company and / or shareholders or stakeholders atlarge? This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FORPROJECTS/ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation, fuel, restroom etc. to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase.
11) Enterprise Social Commitment (ESC)
i. Adequate funds (at least 2.5 % of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included. Socio-economic development activities need to beelaborated upon.
12) Any litigation pending against the project and/or any direction/order passed by any Court of Lawagainst the project, if so, details thereof shall also be included. Has the unit received any noticeunder the Section 5 of Environment (Protection) Act, 1986 or relevant Sections of Air and WaterActs? If so, details thereof and compliance/ATR to the notice(s) and present status of the case.
13) 'A tabular chart with index for point wise compliance of above TOR.
B. SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES & DYE INTERMEDIATES;BULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS; SYNTHETIC RUBBERS; BASIC ORGANICCHEMICALS, OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1. Detailsonsolvents to be used,measuresfor solventrecovery and for emissions control.
2. Details of process emissions from the proposed unit and its arrangement to control.
3. Ambient air quality data should include VOC, otherprocess-specificpollutants* like NH3*, chlorine*,HCl*, HBr*, H2S*, HF*,etc.,(*-asapplicable)
4. Work zone monitoring arrangements for hazardous chemicals.
5. Detailed effluent treatment scheme including ssegregation of effluent streams for units adopting'Zero' liquid discharge.
6. Action plan for odour control to be submitted.
7. A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solid/hazardous waste generated.
8. Authorization/Membership for the disposal of liquid effluent in CETP and solid/hazardous waste inTSDF, if any.
9. Action plan for utilization of MEE/dryers salts.
10. Material Safety Data Sheet for all the Chemicals are being used/will be used.
11. Authorization/Membership for the disposal of solid/hazardous waste in TSDF.
STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FOR PROJECTS/ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12. Details of incinerator if to be installed.
13. Risk assessment for storage and handling of hazardous chemicals/solvents. Action plan for handling& safety system to be incorporated.
14. Arrangements for ensuring health and safety of workers engaged in handling of toxic materials.
***
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Annexures
Solisom Healthcare LLP Page 1
ANNEXURE – 3
MANUFACTURING PROCESS
Manufacturing process of various products comprises of brief process of synthesis, mass balance,
stage wise process flow diagrams and route of synthesis. It is described below for each API
product.
1. Deferasirox
A. Brief Process of Synthesis 2-(2-hydroxyphenyl)-4H-benzo[e][1,3]oxazin-4-one is reacted with 4-hydrazinyl benzoic acid
which is then purified with ethyl acetate to give Deferasirox.
B. Mass Balance Batch size: 100 kg
No. of Batch: 40 no. /month
Total Production: 4 MT/month
Annexures
Solisom Healthcare LLP Page 2
Sr. No.
Input Quantity
(Kg) Output
Quantity (Kg)
Remark
STAGE 1
1 2-(2-hydroxyphenyl)-4H-
benzo[e][1,3]oxazin-4-one
86
Stage I 100
2 4-hydrazinylbenzoic acid 60
3 Ethyl acetate 310
Recovered Ethyl acetate
290
Ethyl acetate Loss
10
4 Activated Carbon 4 Spent carbon 4 To TSDF
5 Water 1430 Aqueous waste 1466 To ETP
6 Distillation
residue 20 To CHWIF
Total 1890 1890
Annexures
Solisom Healthcare LLP Page 3
C. Route of Synthesis
2. Duloxetine Hydrochloride
A. Brief Process of Synthesis Stage I
S-(-)N-Methyl-N-benzyl-3-Hydroxy-3-(2-Thienyl)Propanamine on condensation with 1-Flouro
naphthalene in presence of sodium hydroxide to give stage I.
Stage II
Stage I on condensation with hydrogen and salt formation with hydrochloric acid in presence of
Isopropyl Alcohol gives Duloxetine Hydrochloride.
B. Mass Balance
Batch size: 100 kg
No. of Batch: 30 no. /month
Total Production: 3 MT/month
Ethyl Acetate
Annexures
Solisom Healthcare LLP Page 4
Sr. No.
Input Quantity
(kg) Output
Quantity (kg)
Remarks
Stage I
1 S-(-)N-Methyl-N-benzyl-3-
hydroxy-3- (2-thienyl)propanamine
100 Stage I 150
2 1-Fluoronaphthalene 60
3 Sodium hydroxide 100 Sodium fluoride 15
4 Water 1500 Aqueous water
with organic traces 1595 To ETP
Total 1760 1760
Stage II
1 Stage I 150 Final Product 100
2 Hydrogen 5
3 Toluene 1200 Toluene recovered 1164
Toluene loss 25
4 Isopropyl alcohol 500
Recovered Isopropyl alcohol
465
Isopropyl alcohol loss
24
5 Distillation residue 47 To CHWIF
6 Water 2000 Aqueous waste
with organic traces 2030 To ETP
Total 3855 3855
Annexures
Solisom Healthcare LLP Page 5
C. Route of Synthesis
Stage I
Stage II
Annexures
Solisom Healthcare LLP Page 6
3. Esomeprazole Magnesium Trihydrate
A. Brief Process of Synthesis Stage I
2-chloromethyl-4-methoxy 3,5-dimethylpyridine Hydrochloride is condensed with 5-methoxy-
1H-benzimidazole-2-thiol in presence of caustic solution using methanol and water mixture to
get sulphide compound (5-Methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl)sulfanyl]-
1H benzimidazole).
Stage II
Sulfide compound is oxidized by using diluted hydrogen peroxide in presence of Ammonium
molybdate tetrahydrate as catalyst in methanol to give 5-methoxy-2-{[(4-methoxy-3,5-
dimethylpyridin2-yl)methyl]sulfinyl}-1H-benzimidazole.
Stage III
Resolution of 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin2-yl)methyl]sulfinyl}-1H-
benzimidazole is carried out using S-Binol in Toluene & Cyclohexane solvent mixture to give
Stage III product (S-(-)-Binol complex of 5-methoxy-2-{[(4-methoxy3,5-dimethylpyridin-
2yl)methyl]sulfinyl}-1-H-benzimidazole).
Stage IV
Stage III product is made free from binol by using potassium hydroxide in methanol, and then
isolated as a magnesium salt using Magnesium acetate tetrahydrate in methanol water mixture.
B. Mass Balance Batch size: 100 kg
No. of Batch: 40 no. /month
Total Production: 4 MT/month
Annexures
Solisom Healthcare LLP Page 7
Sr. No. Input Quantity
(kg) Output
Quantity (kg)
Remarks
Stage I
1
2-chloromethyl-4-methoxy
3,5-dimethylpyridine
Hydrochloride
300
Stage I 410
2 5-Methoxy-1H-
benzimidazole-2-thiol 260
3 Sodium hydroxide 170
4 Methanol 1200
Recovered Methanol 1140
Methanol Loss 40
5 Distillation residue 30 To CHWIF
6 Water 6130 Aqueous waste with
organic traces 6440 To ETP
Total 8060 8060
Stage II
1 Stage I 410
Stage II 350
2 Hydrogen peroxide 100
3 Ammonium.Molybdate
tetrahydrate 15
4 Sodium carbonate 21
5 Sodium hydroxide 60
6 Acetic acid 85
7 Triethylamine 17
8 Dichloromethane (DCM) 2770 Recovered DCM 2710
DCM Loss 50
9 Methanol 3400 Recovered Methanol 3310
Methanol Loss 70
10 Triethylamine Loss 17
11 Distillation residue 48 To CHWIF
12 Water 3950 Aqueous waste with
organic traces 4273 To ETP
Total 10828 10828
Stage III
1 Stage II 350 Stage III 285
2 S- Binol 430 S- Binol (unreacted) 300 Reused
3 Toluene 6032 Recovered Toluene 5775
Toluene Loss 230
4 Cyclohexane 1360
Recovered
Cyclohexane 1290
Cyclohexane Loss 50
5 Isopropyl alcohol 1780 Recovered
Isopropyl alcohol 1720
Annexures
Solisom Healthcare LLP Page 8
C. Route of Synthesis
STAGE I
STAGE II
Isopropyl alcohol
Loss 40
6 Distillation residue 67 To CHWIF
7 Organic waste 195 To TSDF
Total 9952 9952
Stage IV
1 Stage III 285
Final Product 100
2 Magnesium acetate
tetrahydrate 85
3 Methanol 1140 Recovered Methanol 1090
Methanol Loss 40
4 Distillation residue 20 To CHWIF
5 Water 150
Aqueous waste with
organic and
inorganic traces
410 To ETP
Total 1660 1660
Recover Methanol
Methanol
Triethylamine
DCM
Methanol
Annexures
Solisom Healthcare LLP Page 9
STAGE III
STAGE IV-A
STAGE IV-B
IPA
Annexures
Solisom Healthcare LLP Page 10
4. Gabapentin A. Brief Process of Synthesis Stage I
1-Carbomoylmethyl cyclohexyl-acetic acid undergoes Hoffman reduction with Sodium
Hypochloride in MDC followed by cyclisation to give stage-I.
Stage II
Stage-I is converted into its Hydrochloride Salt with concentrated HCl. The product (Stage-II) is
isolated by cooling the reaction mixture.
Stage III
Hydrochloride salt of stage-II is converted into Gabapentin Monohydrate by treatment with
Caustic solution. The product crystallises during caustic addition. Gabapentin Monohydrate is
dehydrated with Methanol to get clear solution. It is treated with activated carbon and filtered.
Gabapentin is isolated by concentrating followed by cooling of reaction mixture. Product is
filtered, washed and dried.
B. Mass Balance Batch size: 250 kg
No. of Batch: 20 no. /month
Total Production: 5 MT/month
Annexures
Solisom Healthcare LLP Page 11
Sr. No.
Input Quantity
(kg) Output
Quantity (kg)
Remark
STAGE I
1 1-Carbomoylmethyl
cyclohexyl- acetic acid
400
Stage I 275
2 Sodium hypochlorite 3750
3 Methylene Dichloride 2500 MDC Recovered 2445
MDC Loss 40
4 Water 1500
Distillation Residue
90 To CHWIF
Effluent water 5213 To ETP
5 Carbon dioxide 87
TOTAL 8150 8150
STAGE II
1 Stage I 275 Stage II 337
2 Hydrochloric acid 75 Effluent water 1478 To ETP
3 Water 1500 Process residue 35 To TSDF
Total 1850 1850
STAGE III
1 Stage II 337 Gabapentin 250
2 Methanol 1400
Methanol Recover
1382
Methanol loss 10
3 Sodium Hydroxide 75 Effluent water 2626 To ETP
4 Activated carbon 40 Spent Carbon 40 To TSDF
5 Water 2500 Process Residue
26 To TSDF
6 Distillation
Residue 18 To CHWIF
TOTAL 4352 4352
Annexures
Solisom Healthcare LLP Page 12
C. Route of Synthesis
STAGE I
STAGE II
STAGE III
5. Levocetirizine Dihydrochloride
A. Brief Process of Synthesis Stage I
1-[(4-Chloro-phenyl)-phenyl -methyl]-piperazine reacts with Chloro ethanol in presence of
Triethyl amine and Toluene to give stage I product.
Stage II
Stage I product undergoes condensation with Sodium monochloro acetate in presence of DMF,
Acetone and HCl to give Levocetrizine Dihydrochloride.
B. Mass Balance Batch Size: 100 kg
No. of Batch: 30 no./month
Total Production: 3 MT/month
MDC
Methanol
Annexures
Solisom Healthcare LLP Page 13
Sr. No.
Input Quantity
(kg) Output
Quantity (kg)
Remark
STAGE I
1 1-[(4-Chloro-phenyl)-
phenyl -methyl]-piperazine
65
Stage I 74
2 Chloro ethanol 20
3 Triethyl amine 25 Triethyl amine
hydrogen chloride 32
Process Residue
4 Toluene 400 Toluene recovered 375
Toluene Loss 10
5 Water 300 Effluent water with
organic traces 304 To ETP
6 Distillation residue 15 To CHWIF
Total 810 810
STAGE II
1 Stage I 74
Final product 100 2 Sodium mono chloro
acetate 26
3 Hydrochloric acid 17
4 Di methyl formamide 100 DMF recovered 92
DMF Loss 4
5 MDC 250 MDC recovered 235
MDC loss 10
6 Activated Carbon 10 Spent carbon 10 To TSDF
7 Acetone 100 Acetone recovered 94
Acetone loss 5
8 Water 200 Effluent water with
organic traces 207 To ETP
9 Distillation residue 20 To CHWIF
Total 777 777
Annexures
Solisom Healthcare LLP Page 14
C. Route of Synthesis
Stage I
Stage II
Toluene
MDC
Acetone
Annexures
Solisom Healthcare LLP Page 15
6. Metaxalone A. Brief Process of Synthesis Stage I
Preparation of 2-[(3,5-Dimethylphenoxy)methyl]oxirane:
A mixture of 3,5-Dimethyl Phenol and Epichlorohydrine is stirred with aqueous Potassium
hydroxide at 40 °C. Water is distilled out under vacuum after the reaction. The liquid crude
product 2-[(3,5-Dimethylphenoxy)methyl]oxirane obtained is taken as such for the next reaction.
Stage II
Preparation of 5-[(3,5-dimethylphenoxy)methyl]-1,3-oxazolidin-2-one (Metaxalone):
To a solution of 2-[(3,5-Dimethylphenoxy)methyl]oxirane; N,N-Dimethylformamide, is added.
Ethyl carbamate and catalytic amount of Triethylamine are also added. The reaction mixture is
heated at 120 – 125 °C till the completion of the reaction. After the reaction, isolated solid is
filtered once, which is purified by stirring with isopropyl alcohol to get 5-[(3,5-
dimethylphenoxy)methyl]-1,3-oxazolidin-2-one (Metaxalone).
B. Mass Balance Batch Size: 200 kg
Nos. of Batch: 30 No./month
Total Production: 6 MT/month
Annexures
Solisom Healthcare LLP Page 16
C. Route of Synthesis
STAGE I
Sr. No.
Input
Quantity (Kg)
Output Quantity
(Kg) Remark
STAGE I
01 3,5 – Dimethyl Phenol 368 Stage I 320
02 Epichlorohydrine 280
03 Aqueous Potassium
hydroxide 204 Aqueous effluent 532 To ETP
Total 852 852
STAGE II
01 Stage I 320 Metaxalone 200
02 Isopropyl Alcohol 1280 IPA Recover 1252
Loss IPA 20
03 DMF 32 Organic residue 40 To TSDF
04 Ethyl carbamate 160 Ethanol 84
05 Triethyl Amine 34 Aqueous effluent 230 To ETP
Total 1826 1826
Annexures
Solisom Healthcare LLP Page 17
STAGE II
7. Pregabalin A. Brief Process of Synthesis Stage I
Charge L n-hexane, Ethyl cynoacetate and Isovaleraldehyde. Start stirring and cool the
reaction mass up to 10C to 15C. Add Di-N-Propyl amine and N-Hexane and stir the
reaction mass. Separate aqueous layer and distil out the organic layer. Degas the reaction
at 70C to 75C and cool the reaction mass upto 10C to 15C.
Charge Di-Ethylmalonate in it, add Di-N-propyl amine from addition pot and stir the
reaction mass. Charge hydrochloric acid in reaction mixture. Stir and maintain the
reaction mass and cool the reaction mixture up to 85C to 90C.
Decrease the temperature up to 70C to 75C and add toluene into reaction mass and stir.
Separate out aqueous and organic layer and collect aqueous layer. Charge collected
toluene layer and distilled out toluene. Degas the content under high vacuum for 1 hour.
Charge this collected glutaric acid and Urea. Increase the temperature up to 80C to 90C
and add NaOH solution. Add charcoal in reaction mass and filter the reaction mass and
cool it up to 30C to 35°C.
Charge hydrochloric acid and after addition of HCl cool it up to 10C to 12C. Centrifuge
the product and wash with water. Unload the wet cake. Charge ethyl acetate and dry
crude material and heat the reaction mass and cool up to 25°C to 30°C. Further chill it up
to 5°C to 10°C and maintain for 1 hour.
Centrifuge the product and wash with ethyl acetate. Dry the product at 80°C to 85°C for 2
hours.
Stage II
Charge Chloroform, Methanol and Charge (±)-3-(carbamoymethyl)-5-methyl hexanoic
acid into reactor. Raise the temperature of the reaction mass to 50 - 55°C. Add R-(+)-1-
phenyl ethyl amine to the above slurry slowly at 50 - 55°C. Maintain for 15 min at 50 -
55°C. Maintain mass for 30 min at 50 - 55°C. Stop heating and charge (3R)-(-)-3-
(carbamoyl methyl)-5-methyl-hexanoic acid as a seeding for crystallization under
stirring. Cool the mass slowly to 30-35°C.
IPA
DMF Triethylamine
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Maintain under stirring for 30 min at 30 -35°C. Centrifuge the material and wash with
chloroform. The wet cake is ready for next stage. ML is sent to step II-A for raw material
recovery.
Stage III
Charge water and (3R)-3-(Carbamoyl methyl)-5-methyl-hexanoic acid, phenylethyl
amine salt into reactor. Cool the reaction mass up to 10 to 15°C. Adjust the mass pH to 10-
11 using sodium hydroxide solution. (Dissolve sodium hydroxide in water (Lot-2)).
Maintain the mass for 30 min under stirring. Solution should be clear.
Charge chloroform into the reactor. Maintain reaction for 30 min under stirring. Settle the
mass for 30 min. Separate the lower chloroform layer. Slowly adjust the pH to 2-3 using
con. HCl. Maintain the mass at 10-15°C for 1 hr. Centrifuge the material. Wash the
material with water (lot-3).
The wet cake is ready for next stage. ML generated goes to ETP for Evaporation.
Chloroform is recovered.
Stage IV
Charge D.M. Water and NaOH into the reactor. Cool the mass to 0 to 5°C. Add chlorine gas
in to the reactor at 0 to 10°C. After addition of gas, charge (3R)-3-(Carbamoyl methyl)-5-
methylhexanoic acid into reactor from Stage-2 slowly at 0 to 15 °C (exothermic reaction).
Maintain the mass for 30 min. After addition, maintain mass for 2 hrs at 15 to 20°C. Raise
the temperature to 50 -55°C. Maintain the reaction mass at 50 -55°C for 30-45 mins. Cool
the mass to 30 - 35°C.
Filter the mass through hiflow bed (sparkler filter). Now, put the mass into a mixing
vessel to adjust the mass pH 3.5 by adding 50% H2SO4 solution at 30-35°C. Adjust the
mass pH 7-7.5 using 50 % NaOH solution at 25-30°C. Maintain the mass at 20-25°C for 1
hr. Centrifuge the material. ML generated goes to ETP for Evaporation. CO2 emission will
be there in this stage.
Stage V
Charge n-Butanol, tech- pregabalin and water into reactor. Heat the mass to 80 to 85°C.
Maintain for 30 min at 80 - 85°C. Cool the mass slowly to 8 -12°C. Add methanol into the
Mass. Maintain mass at 8-12°C for 1 hr. Filter the material. Dry the material at 45 -
50°C.ML generated goes to ETP for Evaporation. Butanol layer is sent to Butanol recovery
system.
Stage II-A
Charge ML and sodium hydroxide solution in to the reactor. Maintain the mass for 1 hr
under stirring. Settle the mass for 30 mins. Separate the lower chloroform layer. Slowly
adjust pH 2-3 using Con. Hydrochloric acid. Maintain the mass at 10 to 15°C for 1 hr.
Centrifuge the material. The wet cake is ready for next stage. ML generated goes to ETP
for Evaporation. Chloroform layer is sent to Chloroform recovery system.
Stage II-B
Charge toluene, unwanted isomer and PTSA into reactor. Heat the mass to reflux
temperature (110-115°C) for 10 hrs. Cool the mass to 60-65°C. Slowly charge sodium
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hydroxide solution. Maintain the reaction at 60-65°C for 2-3 hrs. Cool the mass to 20-
30°C. Separate the layers. Take aq. layer in to the reactor. Adjust the pH to 2-2.5 using
Con. HCl. Cool the mass to 10-15 °C. Maintain mass for 1 hr at 10-15°C. Filter the material
through a centrifuge. Wash the material with water (Lot-2) at 10-15°C. Dry the material
at 50-60°C till moisture content is less than 1.0%. The material is ready to be recycled to
Stage 1. ML generated goes to ETP for Evaporation. Toluene layer is sent to Toluene
recovery system.
B. Mass Balance Batch Size: 300 kg
Nos. of Batch: 20 Nos. / Month
Total Production: 6 MT/month