M/s. Solisom Healthcare LLP Environmental Impact ...Environmental Impact Assessment Report M/s. Solisom Healthcare LLP. Survey No.: 99/P1, Rajpar – Nashitpar Road, Village: Nashitpar,

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


–2 Instability -0

1.52 kPa @

20 °C

3. Toluene TWA:

20 ppm

NA 1390

°C -

Toxic


–0 Reactivity – 1

29 mbar @

20 °C

4. Isopropyl Alcohol

5. Triethylamine TWA: 1 ppm

40 °C

117 - 118 °C

B Highly Toxic Flammable


–2 Instability -0

69 mbar @

20 °C

6. Acetone TWA: 250 ppm

-20 °C

56 °C A Toxic

Highly Flammable


–3 Instability - 0

247 mbar @ 20 °C

7. Ethyl

Carbamate NA

92 °C

182 – 184 °C

C Toxic

Flammable


–1 Instability – 0

10 mm Hg @ 77.8°C





Morbi Gujarat


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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



160 mbar @ 20 °C

9. Acetonitrile

TWA: 20

ppm Skin

12.8 °C

81 - 82 °C

A Toxic

Highly Flammable



97 mbar @

20 °C

10. Methanol TWA: 200 ppm

12 °C

64.7 °C

A Highly

Flammable



128 hPa @

20 °C

11. n-Butanol TWA:

20 ppm

35 °C

117.6 °C

B Toxic

Highly Flammable



6.7 mbar @

20 °C

12. Chloroform TWA:

10 ppm

NA 61 -

61 °C - Toxic



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.





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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





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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


M/s. Solisom Healthcare LLP.

Survey No.: 99/P1, Rajpar – Nashitpar Road, Village:

Nashitpar, Taluka: Tankara, District: Morbi, Gujarat.


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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






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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.






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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






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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




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





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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:





Morbi, Gujarat.



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.





Morbi, Gujarat.



Figure 10.1: Environmental Management Cell

Director

Plant Manager

EHS Officer

Plant Technician





Morbi, Gujarat.



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





Morbi, Gujarat.



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





Morbi, Gujarat.




Pollution Potential


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.





Morbi, Gujarat.




Pollution Potential


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





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Pollution Potential


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





Morbi, Gujarat.




Pollution Potential


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.





Morbi, Gujarat.



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





Morbi, Gujarat.



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





Morbi, Gujarat.



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.





Morbi, Gujarat.



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





Morbi, Gujarat.



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





Morbi, Gujarat.



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).





Morbi, Gujarat.



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





Morbi, Gujarat.



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.





Morbi, Gujarat.



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.





Morbi, Gujarat.



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.





Morbi, Gujarat.



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





Morbi, Gujarat.


NABET Accredited

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





Morbi, Gujarat.


NABET Accredited


11.2

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





Morbi, Gujarat.


NABET Accredited


11.3

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.





Morbi, Gujarat.


NABET Accredited


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






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:


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

[email protected];

Current Status NABET Accredited vide their Certificate No.

NABET/EIA/1619/RA 0033 issued on 14.02.2017

(Refer Annexure – 7)

mailto:[email protected]






NABET Accredited


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

[email protected];

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

mailto:[email protected]






NABET Accredited


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:

Admin

Text Box

Annexure-1

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.


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.


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


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


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.


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


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


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



Ethyl Acetate

Annexures


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



Stage I

Stage II

Annexures


3. Esomeprazole Magnesium Trihydrate


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.




Annexures


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


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


12 Water 3950 Aqueous waste with


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



STAGE I

STAGE II

Isopropyl alcohol

Loss 40


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


5 Water 150

Aqueous waste with

organic and

inorganic traces

410 To ETP

Total 1660 1660

Recover Methanol

Methanol

Triethylamine

DCM

Methanol

Annexures


STAGE III

STAGE IV-A

STAGE IV-B

IPA

Annexures


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.




Annexures


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



STAGE I

STAGE II

STAGE III

5. Levocetirizine Dihydrochloride


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


MDC

Methanol

Annexures


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



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



Total 777 777

Annexures



Stage I

Stage II

Toluene

MDC

Acetone

Annexures


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).


Nos. of Batch: 30 No./month


Annexures



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


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

Annexures


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

Annexures


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.


Nos. of Batch: 20 Nos. / Month


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