AURABINDO Pencilin Plant

Aurobindo Antibiotics Pvt. Ltd.
Environmental Management Plan
1.0 INTRODUCTION
M/s. Aurobindo Anitibiotics Pvt. Ltd. a subsidiary of Aurobindo Pharma Ltd. proposed
to establish an API manufacturing unit at Sy. no. 350, 351, 353, 354 to 358, 361 to 375 and
380 to 382, A.V. Nagaram village, Kakinada SEZ area, Tondangi mandal, East Godavari
district, Andhra Pradesh in an area of 230 acres. The proposed products of unit
essentially are active pharmaceutical ingredients and intermediates based on
fermentation and enzymatic routes of synthesis. Capital cost of proposed unit is 3000
crores towards production blocks, co-generation power plant, effluent treatment facility,
SRS system and utility proposed. The cost estimate of environment management is
220.42 crores with annual recurring expenditure of 370.78 crores/annum.
1.1 Location of the Project

The site is located at the intersection of 17°11'31.20"N latitude and 82°24'35.74"E
longitude. The plant site is surrounded by open lands in all directions. The main
approach road is A V Nagaram to Perumallapuram road passing at a distance of 10 m
in West direction. The nearest human settlement is A V Nagaram village at a distance of
1.0 km in NW direction. The nearest town Tuni is at a distance of 23 km in NE direction.
The nearest railway station of Ravikampadu railway station is at a distance of 6.0 km in
NW direction and the nearest airport at Visakhapatnam is located at a distance of 104
km in NE direction. Irrigation Upputeru Canal is passing at a distance of 10m in North
direction. Seasonal Nakkala Khandi stream is passing at a distance of 9.0 in SW
direction. Bay of Bengal is at a distance of 3.5 km in southeast direction. There are no
reserve forests, inter-state boundary, national park, sanctuary, biosphere reserves,
ecologically sensitive area and critically polluted area within 10 km from the site. The
location map and site layout are as shown in Fig 1.1 and Fig 1.2.
1.2 Regulation
Prior environmental clearance is mandated by Ministry of Environment and Forests,
vide SO 1533, dated September 14, 2006, for synthetic organic chemicals manufacturing
activity. The MoEFCC vide SO 1223 (E) dt. 27.3.2020 issued a notification that, all
proposals or activities in respect of Active Pharma Ingredients (API’s) (bulk drug and
intermediates) manufacturing facilities or expansion of such facilities are categorized as
1-1 Team Labs and consultants

Aurobindo Antibiotics Pvt. Ltd. Environmental Management Plan
B2 and will be appraised at SEIAA. Accordingly this proposal is submitted to SEIAA for
appraisal to obtain prior environmental clearance for the proposed project.
1.3 Product Profile

The list of proposed products with manufacturing capacity is presented in Table 1.1
Table 1.1 Manufacturing Capacity
S.No Name of Product Capacity
TPM TPA
Regular Products
1 7-Amino- Cephalosporanic Acid (7-ACA) 166.66 2000
2 Penicillin G (Pen G) 1250 15000
3 Glucose 16500 198000
4 6-Aminopenicillanic Acid (6-APA) 350 4200
Total - I 18267 219200
Campaign Products
1 Amoxycillin Trihydrate (Enzymatic) 150 1800
2 Ampicillin Trihydrate (Enzymatic) 150 1800
Total – II – Worst Case One Product 150 1800
Grand Total (I + II) 18417 221000
Co-Generation Power Plant 100 MW
1-2 Team Labs and consultants

Fig 1.1 Location of M/s. Aurobindo Antibiotics Pvt. Ltd
1-3 Team Labs and Consultants

E
S
Entr
y
Security
20x20 M
400 Sq.M Admin & Canteen
50x 100m
5000 Sq.M
Parking Area
Space for Future Expansion Space for Future Expansion

Space for Future Expansion
48400Sq.M
18925 Sq.M 47943Sq.M 62443 Sq.M
Production Block -1 Production Block -3 Space for Future Expansion

200 x 112m 200 x 112m
22400 Sq.M 22400 Sq.M 33053 Sq.M
Space for ETP

22 Acres
Utility Utility
200 x 70m 200 x 70m
14000 Sq.M 14000 Sq.M
Cogen / Boiler Area

100 x 200m
Production Block -2 Production Block -4

200 x 112m 200 x 112m Space for Future Expansion
22400 Sq.M 22400 Sq.M 33453 Sq.M
Legend:
Total Site Area - 230 Acres (930769.8 Sq.M)
Plingth Area - 30.39 Acres (123000 Sq.M) 13% of Total Area
Space for Future Expansion Area - 60 Acres (244217 Sq.M) 26% of Total Area
Green Belt Area - 75 Acres (303809 Sq.M) 33% of Total Area
Roads Area - 19.51 Acres (78964 Sq.M) 8% of Total Area
Fig 1.2 Layout of M/s. Aurobindo Antibiotics Pvt. Ltd

1.4Project Benefits
1.4.1 Employment Potential
The proposed project will provide employment to 3500 people. It will be spending
approximately Rs. 4.5 lakhs of rupees every month on salaries providing bread and
succour to 3500 families. The proposed project will also generate indirect employment
to the locals during construction phase in the order of 1500 people for a period of 20-36
months. The employers will contribute to the provident fund, ESI and provide facilities
as per the relevant labour act.
1.4.2 Corporate Environment Responsibility

The ministry of Environment, Forest and Climate Change issued an office
memorandum mandating corporate environment responsibility expenditure contingent
on the capital cost of the project, in addition to the expenditure on environmental
management. The office memorandum prescribed a CER expenditure of 0.5 % for
green field projects of less than Rs. 10000 crores. The capital cost of the proposed
project is Rs. 3000 crores and hence must spend Rs. 15 crores towards corporate
environment responsibility. The programs identified by the ministry are drinking water
supply, sanitation, health, education, skill development, roads, cross drains,
electrification including solar power, solid waste management facilities, scientific
support and awareness to local farmers to increase yield of crop and fodder, rain water
harvesting, soil moisture conservation works, avenue plantation, plantation in
community areas etc.
1.5 Scope of Report

The MoEFCC mandated prior environmental clearance process under B2 category for
establishing and expanding API manufacturing facilities to facilitate self-sufficiency and
to encourage indigenization of manufacturing to avoid imports of these chemicals
considering supply chain disruption induced by Covid 19. It is mandated in the EIA
notification and its amendments that prefeasibility report, form I and environment
management plan should be submitted for appraisal to issue prior environmental

clearance. Accordingly, this report presents the environment management plan of the
proposed proposal. The environment management plan follows a brief environmental
impact statement, as management plans have to address the identified impacts.

2.0 PROCESS DESCRIPTION
M/s. Aurobindo Anitibiotics Pvt. Ltd. a subsidiary of Aurobindo Pharma Ltd.

proposed to establish an API manufacturing unit at Sy. no. 350, 351, 353, 354 to 358, 361
to 375 and 380 to 382, A.V. Nagaram village, Kakinada SEZ area, Tondangi mandal,
East Godavari district, Andhra Pradesh in an area of 230 acres. The proposed products
of unit essentially are active pharmaceutical ingredients and intermediates based on
fermentation and enzymatic routes of synthesis. The list of proposed products with
manufacturing capacity is presented in Table 2.1
Table 2.1 Manufacturing Capacity
TPM TPA
Regular Products
3 Glucose 16500 198000
Total - I 18267 219200
Campaign Products
Grand Total (I + II) 18417 221000
2.1 Process Description

The proposed products of unit essentially are active pharmaceutical ingredients and
intermediates based on fermentation and enzymatic routes of synthesis. The
manufacturing process of each product, reaction scheme, material balance and flow
diagram are presented separate Annexure.
2.1.18 Process Description of C-generation Power Plant

Power will be generated using steam turbines in cogeneration plant. Boilers of capacity 4
x 150 TPH @ 87 bar (a) pressure will be installed to cater to the steam requirement of the
turbines. Steam at 15 to 20 bar(a) will be extracted from the turbines for process use and

generation of chilled water by VAMs. The electricity generated in the cogeneration

plants will be used for captive consumption for plant operations.
The fuel requirement of the imported coal is approx. 21.3 T/hr at 100% MCR. Fuel will be
brought by covered trucks and unloaded at site in covered shed. The fuel will be control
and conveyed to the boiler by conveyor system and fed to the boiler by Rotary feeders.
AFBC Atmospheric Fluidized Bed Combustion type boiler is chosen considering
imported coal and good combustion efficiency. The boiler operates with low bed
Temperature of 900 °C. Water is heated in the boiler to generate high pressure super-
heated steam at 67 and 87 bar (a). The boilers shall have standard accessories such as
Feed water pumps, Soot blowers, Dosing system, safety valves and cut offs.
Fresh air for fuel combustion will be supplied by FD fans. Pre heated hot air will be
supplied at combustion zone as secondary air through PA fans. ID fan will be used to
exhaust the waste flue gasses through a stack of adequate height as per PCB norms.
Turbine will have Turbovisory, safety devices, instrumentation, controls and interlocks
as per standard engineering practice. The Generator is driven by the Turbine at 1500 rpm
through reduction gear box. The generator will have brushless Excitation system and
closed-circuit indirect water-cooling system. Power will be generated at 11 kV, 3phase,
50cps frequency. The Generator will be provided with HT breaker, LASCPT, NGR, AVR,
Metering & Synchronization panels as per standard engineering practices and protective
measures. The power produced at 11 kV will be taken to plant's HT yard through
cabling. All necessary protections are incorporated such that power plant is protected
from any electrical faults.
II. Steam turbine generator

Steam generated in boiler will enter a multi-stage turbine and will cause the turbine shaft to
rotate. In this process, the steam will lose its temperature and pressure. Steam at 15 to 20 bar
(a) will be extracted from turbine for process use. As the pressure is coming down volume
will increase, thereby increasing velocity of flow in the turbine. This thermal energy getting

converted to mechanical energy will rotate the turbine shaft which is rigidly coupled to
generator. An electrical generator coupled to the steam turbine shaft will rotate in a magnetic
field and generate electrical power of 4 x 25 MW at voltage of 11 KV. A small percentage of
electrical power thus produced will be used in the power plant itself to energies the rotating
equipment like the FD fan and ID fan of boiler, the feed water pumps, lighting etc.
2.2 Utilities
It is proposed to establish coal fired boilers of capacity 4 x 150 meet the steam
requirement for process, SRS and effluent treatment system. It is proposed to establish
4 x 4 Lakh k. Cal/hr thermic fluid heater for process requirement. The total power
requirement estimated as 100 MW. The DG sets required for emergency power
during load shut down is estimated at 15150 kVA and accordingly 15 x 1010 kVA
capacity DG sets are proposed. The list of utilities is presented in Table 2.2.
Table 2.2 List of Utilities
S.No Utility Unit Capacity
1 Coal Fired Boilers TPH 4 x 150
2 Thermic Fluid Heaters k.cal/hr 4 x 4 Lac
3 DG Sets* kVA 15 x 1010
*DG sets kept as standby.
2.3 Water Requirement

Total water required is 23.5 MLD. Th water requirement shall be met from Indira sagar
canal and samarlakot canal or it is proposed to establish desalination plant of capacity
47 MLD to meet water requirement of 23.5 MLD. Water from Bay of Bengal will be
used as feed water for Desalination Plant. The RO reject from desalination plant shall
be disposed to sea, using marine outfall facility.
Table 2.3 Total Water Balance
S. Water Input Quantity Output Quantity
No. (MLD) (MLD)
1 Process Applications Process Wastewater
Pen G 8.00 Pen G 8.00
7-ACA 5.10 7-ACA 5.00
6-APA 0.61 6-APA 0.63
Glucose 1.00 Glucose 1.36
Penicillin Products 0.28 Penicillin Products 0.28

2 Boiler Make-up 3.50 Boiler Blow Down 1.00

3 CT make Up 3.00 CT Blow Down 1.50
4 QC, R&D & Garment Washing 0.25 QC, R&D and Garment 0.25
Washing
5 Miscellaneous (SRP, ETP, 1.00 Miscellaneous (ETP, SRP, 1.00
Manufacturing Blocks Manufacturing Blocks &
Operations Areas cleaning, etc) Operations Areas cleaning,
contaminated steam
condensate, etc)
6 Domestic 0.25 Domestic 0.25
7 Gardening 0.50 Gardening 0.00
Total 23.49 Total 19.27
2.4 Pollution Control Facilities

Liquid Effluents, air emissions and solid wastes are the major pollutants from the
process operations of bulk drug manufacturing activity. The pollution control measures
proposed to treat/mitigate the emissions and effluents are described as follows.
2.4.1 Water Pollution

The effluents generated in the process, separation techniques and during purification
contain organic residues and inorganic raw materials, solvents, and products. Hence
the effluents contain both organic and inorganic salts in various quantities leading to
high COD and TDS concentrations respectively. Effluents from process, washings,
scrubbing media, and utility blow downs will be sent to the effluent treatment system.
The treated effluent will be disposed to sea by using marine outfall system. The total
effluent generated is Blocks Operations presented in Table 2.4.
Table 2.5 Total Effluent Generated and Mode of Treatment
Description Quantity Mode of Treatment and Disposal
(MLD)
Process Wastewater Sent to effluent treatment system and
Pen G 8.00 treated effluents are sent to marine
7-ACA 5.00 outfall system.
6-APA 0.63
It is proposed to send treated effluents
Glucose 1.36
from co-located units namely;
Penicillin Products 0.28
Aurobindo Antibiotics Pvt. Ltd. and
Boiler Blow Down 1.00
Auroactive Pharma Pvt. Ltd. to
CT Blow Down 1.50
common marine outfall system (line
QC, R&D and Garment Washing 0.25
and outfall) will be used in
Miscellaneous (ETP, SRP, 1.00

Manufacturing Blocks & Operations compliance with APCZMA

Areas cleaning, contaminated steam recommendations and CRZ
condensate, etc) regulations
Domestic 0.25
RO Rejects from Desalination Plant 23.5 Disposed to the sea through marine
out fall facility.
Total 42.77
2.4.2 Air Pollution

The manufacturing process consists of reaction, separation and purification. The
reaction is conducted in closed reactors, while the separation is conducted in centrifuge,
filtration equipment etc. The purification would be conducted in reactors or filtration
equipment. The transfer of materials will be through closed pipelines. Various sources
of emissions are identified from process operations. The usage of boiler for steam
generation and DG sets for emergency power also release emissions.
2.4.2.1 Emissions from Utilities

The sources of air pollution are proposed 4 x 150 TPH coal fired boilers, 4 x 4 Lac. k.
Cal/hr thermic fluid heater and standby DG sets of 15 x 1010 capacity. The proposed
air pollution control equipment for 4 x 150 TPH coal fired boilers is electro static
precipitators (ESP). Thermic fluid heaters and standby DG sets shall be provided with
effective stack height based on the CPCB formula. The emission rates of SO2, NOx and
PM from each stack are presented in Table 2.5. Technical specification of ESP coal fired
boiler is presented in Table 2.6
Table 2.5 Emission Details of Pollutants from Stack
S. Stack Connected to Stack Dia of Temp. of Exit Pollutant Emission
No Ht stack at exhaust Velocity Rate (g/sec)
(m) top(m) gases (0C) (m/sec) PM SO2 NOx
1 4 x 150 TPH coal fired 70 4.5 190 25 6.8 16.5 18.7
boiler
2 4 x 4 Lakh Kcal 30 0.4 160 9 -- 0.16 0.24
Thermic Fluid Heaters
3 15 X 1010 kVA DG set* 10 0.4 170 10 0.04 0.012 0.18
* DG sets will be used during load shutdown

Table 2.6 Technical Specifications of ESP

Boiler Capacity Units 150 TPH
Chamber design Single
No of gas passages Nos 19
Spacing between electrodes mm 400
Height of collecting plate Feet 36
No of fields Nos 4
Length of each field Feet 16
Hopper arrangement 1.4P (3)
Hopper valley angle Deg 55 deg
Fuel Indian coal and Imported coal
Gas Flow Am3/hr 165000
Temperature Deg C 160
Maximum Inlet Dust load gm/Nm3 Indian coal: 50
Imported Coal: 10
Outlet Emission (All field working at Wet basis) mg/Nm3 115
Plate Area m2 7689
Specific Collection area m2/m3/s 109.23
Velocity through ESP m/s 0.83
Treatment time Sec 25
Migration Velocity cm/s 7
No of Electrical fields Nos. 4
No of Mechanical fields Nos. 4
Height of panel M 10
Material CRCA sheet (IS 513 grade - "D")
Thickness SWG 18
Panel width mm 450
EMITTING ELECTRODE SPECIFICATIONS:
Height of electrode m 12
Type e - Tube
Clearance between two Collectors mm 400
Spacing between Emitter & Collector electrode mm 200
MATERIAL SPECIFICATIONS:
Thickness/Specification/Sizes
Casing 3 mm 5 mm
Hopper 4 mm 5 mm
Inlet/Outlet Nozzles 3 mm 5 mm
Cladding thickness 24 SWG 24 SWG
ELECTRICAL SPECIFICATIONS
TR Sets Qty 4 nos
RAPPING SYSTEM SPECIFICATIONS
Collecting plate rappers 4 Sets
e- Tube rappers 34Sets
Gas distribution plate rappers 1 Set
Type TIGI

DESIGN PRESSURE
Maximum/ Minimum mm WG ±200 mm WC
Maximum pressure drop flange to flange mm WG 25
Casing Mechanical Design Temperature 0C 200
2.4.2.2 Diffuse Emissions

Emissions are also released from various operations of manufacturing like drying,
distillation, extraction etc. These emissions mainly contain volatile contents of the
material sent for processing. The emissions are normally passed through vent scrubber
before releasing into atmosphere to mitigate odor. The emissions from distillation are
passed through condensers, which mitigate odor. Vent condensers in series to reactors,
distillation columns, driers and centrifuge etc. are provided to mitigate VOC emissions
release. Other vents are connected to common headers and scrubbers. The transfer
pumps shall be provided with double mechanical seals. The transfer of solvents will be
mainly by closed pipeline systems, while drum transfer is by using air operated
diaphragm pumps in closed hoods. Safety relief valves rupture disc, Breather provided
to reactors, thermal insulation, vent condenser and nitrogen blanketing provide for
bulk storage tanks. Thermal insulation and condensers will be provided for storage
tanks of low boiling point solvents. The reactor or solvent storage tank vents when not
use shall be kept closed.
2.4.2.4 Fugitive Emissions

Fugitive emissions are anticipated from equipment leakage and transfer spills. The
periodic maintenance program shall ensure integrity of equipment mitigating the
equipment leakage. The spills however shall be managed by adopting the spill
management scheme as mentioned in the respective MSDS. The fugitive emissions
shall be reduced by closed transfer and handling of all hazardous solvents and
chemicals. The ventilation system provided will reduce the health impact on
employees by way of dilution of work room air and also dispersion of contaminated
air.

2.2.2.5 Odour Management

Odour is caused mainly by diffuse and fugitive emissions of low boiling organic
chemicals/ compounds releasing volatile organic compounds. The above-mentioned
measures for mitigation and control of diffuse and fugitive emissions shall reduce
release of VOC’s into atmosphere and the resultant odour.
2.4.4 Solid Waste

Solid wastes are generated from process, solvent distillation, wastewater treatment and
utilities. Process residue contains mainly unreacted raw materials and byproducts. These
are collected from the reactors and other process equipment and stored in drums. Solvent
residue is generated from distillation units, the residues are tarry substances with good
calorific value, and are stored in drums. These salts are stored in HDPE lined bags. All
solid waste storage containers/drums/bags are labeled showing the source, nature of
hazard and type of wastes. All the hazardous wastes are stored in a closed shed with fire
safety measures, and the shed is provided with a leachate collection facility connected to
effluent conveyance lines. The stripper distillate, process residue and solvent residue are
sent to cement plants for co-incineration based on acceptability. If these wastes are not
suitable for co-incineration, the same is sent to TSDF facility. Mixed solvents shall be sent
to authorized recyclers /cement plant for co-incineration while spent solvents are
recovered within plant premises. The evaporation salts are sent to TSDF. Filter media,
activated carbon and catalysts are sent to TSDF. Waste oil and used batteries from the DG
sets are sent to authorized recyclers. The sludge from effluent treatment plant is
considered hazardous and the same is sent to TSDF. The other solid wastes expected from
the unit are containers, empty drums which are returned to the product seller or sold to
authorize buyers after detoxification. The quantity of solid waste generated in the plant
and the disposal practice is presented in Table 2.7.

Table 2.17 Total Solid Waste Generated and Mode of Disposal

S. Name of Hazardous Waste Unit Quantity Mode of Disposal
No.
DISPOSAL OPTION
1 Forced Evaporation Salts TPD 75 Sent to TSDF
2 Process Inorganic Waste/Salts TPD 2 Sent to TSDF
3 ETP Sludge TPD 45 Sent to TSDF
4 Spent Carbon TPD 3.35 Sent to TSDF/ Cement
Plants for Co-incineration
5 Mixed Spent Solvents KLD 2.5 Sent to authorized
recovery units or Cement
Plants for Co-incineration
6 Process Liquid Organic Waste, KLD 2.50 Sent to Cement Plants for
Solvents from QC and R&D Co-incineration
Laboratory
7 Distillation Bottom Residue and TPD 64.64
Process Organic Wastes
8 Off specification raw materials/ TPM 5.6
products
9 Date Expired Products TPM 18 Sent to Cement Plants for
Co-incineration/TSDF
10 Contaminated cotton rags or other TPM 0.2 TSDF / Cement Industry
cleaning materials / Authorized recyclers
11 Waste Resin Kg/ 1200
Month
RECYCLING/REUSE OPTION
1 Mycelium (dry basis) TPM 3000 Agencies authorized by
PCB/CPCB
2 Used Oil/Waste Lubricating Oil KLD 0.5 Agencies authorized by
PCB/CPCB
3 Used Lead Acid Batteries Nos/ 600 Returned back to dealer or
Anum supplier
4 Detoxified Containers and TPM 10 Sold to recyclers after
Container Liners detoxification
Other Waste -Disposal or Recycle
1 Asbestos TPA 5 Disposed to TSDF
2 Gypsum Boards TPA 5 Sent to Cement Plants for
Co-incineration /TSDF
3 Electrical & Electronic Waste TPA 15 Sent to authorized
recyclers
4 Hard Rubber (Electrical Panel TPA 1 Sent to Cement Plants for
Rooms) Co-incineration /TSDF
5 Hardened Latex Paints/Varnishes, TPA 1
adhesives/glues/resins/Plasticizers
7 Packing Material TPM 20 Sale to recycler
8 Discarded PPE (Helmets, goggles, TPM 1 Recyclers/TSDF, HWMP

aprons, etc.)
10 Reagent Bottles: Glass/PP Bottles TPM 2 Sale to recycler
(Small Volume – up to 2.5 L
capacity)
11 Insulation wastes TPM 2.5 To outside agencies, after
complete detoxification
for re-use/ recycle
12 Miscellaneous Wastes--Sparkler TPM 1.67 TSDF and/ Cement Plants
Filter Pads, Centrifuge Bags, FBD for Co-incineration
Bags.
13 Miscellaneous Wastes--Discarded TPM 1 Sent to TSDF
Molecular Sieves/Ion-exchange
resin, etc
2.4.5 Noise Pollution

The noise levels may increase due to motors, compressors, turbine, DG set and other
activities. The major source of noise generation is turbine which emit noise levels of
above 100 dB (A) at a reference distance of 1m from the source. The steam generator and
auxiliaries will perform continuously within noise limits as per relevant standard
specification but not more than 85 dB (A) at 1 meter from any equipment or sub-
equipment. The machines and equipment shall have noise arresting system / low noise
levels to limit noise level. Further, all noise generating equipment shall be housed within
acoustic enclosure (where ever possible), to ensure attenuation of noise. The employees
shall be trained in the mitigation measures and personal protection measures to be taken
to prevent noise related health impacts. Hearing conservation program is adopted to
ensure that employee's hearing is not affected during his working life to an extent
greater than that usually occurring with age and to preserve it at a level sufficient for
normal speed perception.

CHAPTER 3.0ENVIRONMENT MANAGEMENT PLAN
3.1 Identification of Impacts

Identification of impacts is one of the basic analytical steps for subsequent preparation
of management measures to address the significant negative impacts. Impact is a
change in baseline due to interaction of a development activity with environment, or
interaction of environment with development activity, or change in baseline due to a
manmade emergency. The environment management plan relied on secondary data for
baseline, and accordingly assessed the impacts for construction stage, operation stage,
emergency scenarios and decommissioning stage for the proposed Aurobindo
Antibiotics Pvt. Ltd. The conceptual site model of API manufacturing activity is
presented in Fig 3.1 and typical effects of manufacturing activity is presented in Fig 3.2.
The interaction of proposed project activity on the environment was assessed by posing
questions related to each aspect of project activity envisaged to identify valued eco
components. After broad identification of impacts, an interaction table enumerating the
activity vs factors of various environmental components was prepared for various
stages of project implementation considering the entire life cycle of construction,
operation and decommissioning. The operational stage was considered for both regular
operation and for incidents and emergencies caused by both human errors and extreme
weather phenomena.

Fig 3.1 Conceptual Model of Pharmaceutical Activity

Fig 3.2Conceptual Model of Impacts Effects due to Manufacturing Activity

3.1.1. Impact Networks

The purpose of identifying the impacts is that it aids in making appropriate decision to
mitigate the adverse consequences if any. The degree of extensiveness and scale of
impacts and the consequences based on value judgments are generalized while
identifying impacts; as it is imperative that the impact will normally lead to a chain of
reactions. The construction of network charts brings out to certain extent the
appropriate levels of risks that may occur due to the interventions while interacting
with hydrological, biological and social systems due to the proposed unit during its life
time of construction, operation and decommission including emergency scenarios both
natural and manmade. Fig 3.3 to 3.7 presents the identified impacts for various
components of environment viz. air, noise, water, land and socio-economic aspects. The
impact identification matrix indicating the environmental factors anticipated having an
impact due to the proposed project and impacts due to environment on the proposed
project are presented in Table 3.1 to 3.4.

Fig 3.3 Impacts on Air Environment

Fig 3.4 Impacts on Water Environment

Fig 3.5 Impacts on Solid waste and Soil Quality

Fig 3.6 Noise Impact on Surrounding Environment

Fig 3.7 Impacts on Socio-Economic on Environment

Table 3.1 Activity and Environmental Impact (Impact Identification Matrix) - Construction Stage
Environment Abiotic Biotic Socio Others
Component Climate Atmosphere Land Water Economic
Factors
Occupational health
Noise and vibration
Waste Management
Micrometeorology
Climate Change
Socio Economic
Ground Water
Surface Water
Air quality
Fire Safety
and safety
Geology
Fauna
Flora
Soil
Activity
Construction Stage √
Clearing and Grubbing √ √ √ √ √ √ √
Leveling by way of cut and √ √ √ √ √ √ √ √ √
fill
Foundation excavation √ √ √ √ √ √ √ √
Civil Construction √ √ √ √ √ √
Equipment and machinery √ √ √ √ √
erection
Electrical installation √ √ √ √ √
plumbing and piping √ √ √ √ √
painting works √ √ √ √ √
√ Indicates Impact

Table 3.2 Activity and Environmental Impact (Impact Identification Matrix) - Regular Operation Stage
Environment Abiotic Socio
Biotic
Component Climate Atmosphere Land Water Economic Others
Micrometeoro
Surface Water
Occupational
Management
Air quality
Factors
Fire Safety
health and
Noise and
Economic
vibration
Geology
Ground
Climate
Change
Waste
Fauna
Water
safety
Socio
Flora
logy
Soil
Activity
Operation Stage
Regular Operation √
Raw material and finished product transport √ √ √ √ √
Raw material and finished product storage √ √ √
Transfer of raw materials and products √ √ √ √
Water use √ √
Effluent generation √ √ √ √
Domestic Wastewater generation √ √ √ √
Utility emissions √ √ √ √ √ √ √ √ √ √
Process emissions √ √ √ √ √ √ √ √ √
Diffuse emissions √ √ √ √ √ √ √ √ √
Wastewater storage √ √ √ √
Solid waste transfer and storage √ √ √ √ √ √
Solvent storage and use √ √ √ √
Waste transport √ √ √ √
Effluent transfer and Treatment √ √ √ √ √ √
Wastewater Transfer and Treatment √ √ √ √ √
Emissions control √ √ √ √ √ √ √ √
Machine and Equipment Operation √ √
Solvent Recycle √ √ √ √
Table 3.3 Activity and Environmental Impact (Impact Identification Matrix) - Incidents and Accidents


Factors
Occupational health
Noise and vibration
Waste Management
Micrometeorology
Climate Change
Socio Economic
Ground Water
Surface Water
Air quality
Fire Safety
and safety
Geology
Fauna
Flora
Soil
Activity
Operation Stage
Incidents and Accidents
Spillage √ √ √ √ √ √ √ √ √ √
Fugitive emissions √ √ √ √ √ √ √
Equipment Failures √ √
Batch failures √ √
Containment failure √ √ √ √ √ √ √ √ √
Fire accidents √ √ √ √ √ √
Accidents during transport of √ √ √ √ √ √ √ √ √ √
Raw materials and products
Accidents during transport of √ √ √ √ √ √ √ √ √ √
wastes
Arson and Vandalism √ √ √ √ √ √ √ √ √
Extreme Weather phenomenon √ √ √ √ √ √ √ √ √ √ √

Table 3.4 Activity and Environmental Impact (Impact Identification Matrix) – Decommissioning
Factors
Occupational health
Noise and vibration
Waste Management
Micrometeorology
Climate Change
Socio Economic
Ground Water
Surface Water
Air quality
Fire Safety
and safety
Geology
Fauna
Flora
Soil
Activity
Plant Decommissioning √
Inventory preparation √
Transfer and disposal of chemicals √ √ √ √ √ √ √ √ √ √
Transfer and disposal of wastes √ √ √ √ √ √ √ √ √ √
Decontamination of equipment and containers √ √ √ √ √ √ √ √ √
Disposal of Equipment √ √
Dismantling of facility √ √ √ √ √ √
Demolition Waste √ √ √ √ √
Site cleanup √ √ √ √ √ √ √ √
Capping drains and locking water sources √ √ √ √ √

3.2 Environment Management Plan

3.2.1 Construction Phase
The potential of pollution during construction phase due to transport of construction
materials will be less compared to operational stage. However, industry will ensure
that pollution potential in the construction phase is at a minimum. Wherever
applicable, detailed procedures will be developed for control of pollution during
project execution phase. The following measures (Table 3.5) will be adopted to
mitigate pollution during construction phase.
Table 3.5 Impacts and Mitigation –Construction Stage
Impacts Mitigation Measures
Urban Heat Island Effect  Vegetation: Avenue plantation, green area
 Pathways and parking areas: Paver blocks
Emission from transportation of PUC certification of transport vehicles
materials
Sediment load on drainage  Schedule excavation during non-monsoon season,
 Cover disturbed soils as quickly as possible.
 Stabilized entry and exit point
Contour Disturbance Maintain the levels as far as possible
Loss of Productive soil from Reuse for Horticulture
excavation
Noise from Construction Proactive maintenance and avoidance of high noise
Equipment generating construction activity during night time
Noise & Emissions from DG sets Acoustic enclosure and effective Stack height
Energy Solar panels on roof tops wherever possible, and Fly
ash bricks
Occupational safety Personal protective equipment, First Aid Room
Construction Wastes  Recyclables like paper, Steel, Plastics to recyclers
 Concrete wastes for road construction
 Containers to authorized buyers.
 Lubricants and batteries to authorized recyclers
3.2.2 Operation Phase

During operation stage the major pollution is from liquid effluents from process,
utilities and domestic facilities, and air pollution from utilities and or combustion of
fuels/wastes. The effluent treatment system will convert most of the liquid effluents
to solids by way of evaporation salts and ETP sludge. The environment management
plan is drawn in consultation with the project authorities, R&D experts of Aurobindo
Antibiotics Pvt. Ltd. and other technical consultants involved in preparing the project
plan. The management, mitigation and enhancement measures identified for
significant impact sources are presented as follows;

3.2.3 Sources of Pollution from Manufacturing Process:

The major contributions of pollution are effluent generation from process, utilities
and domestic sources and gaseous emission from process and utilities. The water
pollution is due to the effluent generated from process, washings, scrubbing, utility
blow downs and domestic sources. The air pollution is caused due to process
operation and combustion of both fuels and solid/gaseous wastes. The treatment of
effluents and recovery operations of solvents generate salts and residues
respectively, in addition to residues from process operations, which are considered
hazardous wastes. The quantities and quality of effluents, emissions and solid
wastes are identified and quantified in the environmental impact assessment study.
Salient features of environmental management measures proposed to be adopted to
avoid, control, mitigate or minimize the impacts are presented in Table 3.6. The
environment management measures proposed are described as follows;
Table 3.6 Impacts and Mitigation – Operational Stage
Impacts due to Mitigation Measures
AIR
Emissions from fuel ESP – 4 x 150 TPH
combustion Effective Stack height: 4 x 4 Lac K.cal/hr THF
Effective stack height
Low ash and sulfur content fuel usage
Process emissions Double stage scrubbing system
Water Columns
Diffuse emissions Closed transfer of raw materials/solvents
Dual condensing system
Vacuum Pumps
Vent Scrubber
Vent Condenser for low vapor pressure solvents
Nitrogen blanketing to storage tanks
Automatic Powder Transferring system
Personal Protective Equipment (PPE)
Fugitive Emissions Spill control
Periodic proactive maintenance
Ventilation
Odor Nuisance Closed transfer
Good House-keeping
Spill control
WATER
Abstraction of ground water Rain water harvesting and roof run off storage
Process effluents Segregation of effluents,
Washings Treatment in effluent treatment system. The treated
Scrubber effluents effluent will be disposed to sea by using marine outfall

Utility blow downs system.

R & D wastewater
Domestic washings
wastewater
NOISE AND VIBRATION
Compressors and DG sets Acoustic enclosure
Equipment, motors, pumps Casings and guard
Transport Limited vehicle movement in plant boundary
SOLID WASTE
I. Hazardous Waste
Process residue, solvent Designated covered storage
residue, stripper distillate, Labeled containers
Spent carbon Garland drain to storage facility
Disposal to Cement plants for co-incineration
ETP sludge, MEE salts Designated covered storage
Labeled containers
Garland drain to storage facility
Disposal to TSDF
II. Non-Hazardous Waste
Coal Ash Storage silo with ash conditioning facility
Disposal to brick manufacturers
OTHERS
Storage of raw materials and Tank farm with vent condenser facility for low vapor
solvents pressure solvents
Designated covered storage
Closed transfer system for all liquids
Dedicated day tanks at production blocks
Employee exposure to Occupational Health Centre
chemicals Self-contained breathing apparatus
Standard operating procedure
Health checkup on recruitment
Periodic health checkup during employment
Engineering controls like closed transfer, hoods etc.
Employee rotation
Personal protective equipment
Education, training and periodic mock drill
Transport of raw materials TREM cards
and finished products Driver training and briefing

3.2.3.1 Water Pollution

contain organic residues and inorganic salts, residues of raw materials, solvents, and
by-products. Hence the effluents contain both organic and inorganic compounds
resulting high COD and TDS concentrations respectively. Effluents from process,
washings, scrubbing, QC and R&D, utility blow downs, RO rejects and domestic
wastewater will be sent to the effluent treatment system followed by Maine outfall
system.
3.2.3.2 Air Pollution

The manufacturing process consists of reaction, separation and purification. The
reaction is conducted in closed reactors, while the separation is conducted in
centrifuge, filtration equipment etc. The purification would be conducted in reactors
or filtration equipment. The transfer of materials will be through closed pipelines.
Various sources of emissions are identified from process operations. The usage of
boiler for steam generation and DG sets for emergency power also release emissions
Utility Emissions
The sources of air pollution are proposed 4 x 150 TPH coal fired oilers, 4 x 4 Lac. k.
Cal/hr thermic fluid heater and standby DG sets of 8 x 1010 kVA capacity. The
proposed air pollution control equipment for 4 x 150 TPH coal fired boilers is electro
static precipitators. Thermic fluid heaters and standby DG sets shall be provided with
effective stack height based on the CPCB formula.
Diffuse Emissions: Emissions are also released from various operations of

manufacturing like drying, distillation, extraction etc. These emissions mainly contain
volatile contents of the material sent for processing. The emissions are normally
passed through vent scrubber before releasing into atmosphere to mitigate odor. The
emissions from distillation are passed through condensers, which mitigate odor. Vent
condensers in series to reactors, distillation columns, driers and centrifuge etc. are
provided to mitigate VOC emissions release. Other vents are connected to common
headers and scrubbers. The transfer pumps shall be provided with double
mechanical seals. The transfer of solvents will be mainly by closed pipeline systems,

while drum transfer is by using air operated diaphragm pumps in closed hoods. The
charging of solid raw materials shall be by powder transfer system to avoid dust
emissions, safety and hazard of static electricity. Safety relief valves rupture disc,
Breather provided to reactors, thermal insulation, vent condenser and nitrogen
blanketing provide for bulk storage tanks. Thermal insulation and condensers will be
provided for storage tanks of low boiling point solvents. The reactor or solvent
storage tank vents when not use shall be kept closed.
Fugitive Emissions: Fugitive emissions are anticipated from equipment leakage and
transfer spills. The periodic maintenance program shall ensure integrity of
equipment mitigating the equipment leakage. The spills however shall be managed
by adopting the spill management scheme as mentioned in the respective MSDS. The
fugitive emissions shall be reduced by closed transfer and handling of all hazardous
solvents and chemicals. The ventilation system provided will reduce the health
impact on employees by way of dilution of work room air and also dispersion of
contaminated air.
Odour Management: Odour is caused mainly by diffuse and fugitive emissions of

low boiling organic chemicals/ compounds releasing volatile organic compounds.
The above-mentioned measures for mitigation and control of diffuse and fugitive
emissions shall reduce release of VOC’s into atmosphere and the resultant odour.
3.2.3.3 Solid Waste

Solid wastes are generated from process, solvent distillation, wastewater treatment
and utilities. Process residue contains mainly unreacted raw materials and
byproducts. These are collected from the reactors and other process equipment and
stored in drums. Solvent residue is generated from distillation units, the residues are
tarry substances with good calorific value, and are stored in drums. The other major
waste is salts from multiple effect evaporator and agitated thin film dryer section of
effluent treatment system. These salts are stored in HDPE lined bags. All solid waste
storage containers/drums/bags are labeled showing the source, nature of hazard and
type of wastes. All the hazardous wastes are stored in a closed shed with fire safety
measures, and the shed is provided with a leachate collection facility connected to

effluent conveyance lines. The stripper distillate, process residue and solvent residue
are sent to cement plants for co-incineration based on acceptability. If these wastes
are not suitable for co-incineration, the same is sent to TSDF facility. Mixed solvents
shall be sent to authorized recyclers /cement plant for co-incineration while spent
solvents are recovered within plant premises. The evaporation salts are sent to TSDF.
Filter media, activated carbon and catalysts are sent to TSDF. Waste oil and used
batteries from the DG sets are sent to authorized recyclers. The sludge from effluent
treatment plant is considered hazardous and the same is sent to TSDF. The other
solid wastes expected from the unit are containers, empty drums which are returned
to the product seller or sold to authorize buyers after detoxification.
3.2.3.4 Noise Pollution

The noise levels may increase due to motors, compressors, turbine, DG set and other
activities. The major source of noise generation is turbine which emit noise levels of
above 100 dB (A) at a reference distance of 1m from the source. The steam generator
and auxiliaries will perform continuously within noise limits as per relevant standard
specification but not more than 85 dB (A) at 1 meter from any equipment or sub-
equipment. The machines and equipment shall have noise arresting system / low
noise levels to limit noise level. Further, all noise generating equipment shall be
housed within acoustic enclosure (where ever possible), to ensure attenuation of
noise. The employees shall be trained in the mitigation measures and personal
protection measures to be taken to prevent noise related health impacts. Hearing
conservation program is adopted to ensure that employee's hearing is not affected
during his working life to an extent greater than that usually occurring with age and
to preserve it at a level sufficient for normal speed perception.
4.0 Rainwater Harvesting

Rain water harvesting shall be adopted by providing rain water harvesting structures
along the drains, storm water storage sump and tanks. Storm water drains are
provided with rain water harvesting structures which will act as flow dissipaters and
also as infiltration trenches. Filtration points shall ensure percolation of water and
enhance the ground water table. The site area will be provided with 15 nos. of rain

water harvesting structures. The roof water shall be collected in 4 x 100 KL capacity
sump connected to down spouts of the roofs, and the collected water shall be reused
for process and green belt development.
5.0 Occupational Health and Safety

Many worker health and safety hazards are posed by synthesis operations. They
include safety hazards from moving machine parts, pressurized equipment and pipes,
heavy manual handling of materials and equipment, steam, hot liquids, heated
surfaces and hot workplace environments, confined spaces and hazardous energy
sources (Steam, electricity etc., and high noise levels.
Acute and chronic health risks may result from worker exposures to hazardous
chemicals during synthesis operations. Chemicals with acute health effects can
damage the eyes and skin, be corrosive or irritating to body tissues, cause
sensitization or allergic reactions or be asphyxiants, causing suffocation or oxygen
deficiency. Chemicals with chronic health effects may cause cancer, or damage the
liver, kidneys or lungs or affect the nervous, endocrine, reproductive or other organ
systems. Worker exposure to chemicals can occur during manufacturing when
chemicals spill, leak, or discharge from the process system and contaminate areas
where workers are present. The most frequently reported industrial exposure occurs
during the transfer of materials. The entry of workers into systems, equipment, or
enclosures that are contaminated may occur inadvertently, but routine servicing,
nonscheduled maintenance, and process monitoring appear to be the kind of activities
with potential for significant exposure. Health and safety hazards may be controlled
by implementing appropriate control measures (e.g., process modifications,
engineering controls, administrative practices, personal and respiratory protective
equipment).
The process modification shall be a constant exercise of the Research and

development wing of the organization, resulting in reduced pollution loads, and
increased yields. The measures proposed are selection of alternative solvents/routes

of synthesis, avoidance of hazardous chemicals usage, and application of green

chemistry principles.
The engineering controls for reducing occupational hazards are provision of

scrubbers, condenser systems for process equipment, piping systems, insulation to
reactors, usage of transfer pumps with mechanical seals, AOD pumps, trolleys for
transfer of drums or bags, closed hoods for charging raw materials, dip pipe
provision for solvent and liquid raw material charging, level indicators, pressure and
temperature indicators, barrier guards on moving machine parts, optimization of
chemical inventory, control switches and emergency stop devices to mitigate and
avoid physical, chemical, electrical and mechanical hazards.
Work practices proposed for improving occupational safety are induction training
programs, safety training programs, rotation of workers, implementation of proactive
maintenance schedule, provision of standard operating procedures for all plant
operations, access to MSDS for all employees, access to emergency numbers of
contact, and avoidance of crowded work place, and provision of occupational safety
centre.
Personal protective equipment shall be provided to all the employees including

contract employees. All the employees shall be provided with gumshoe, helmet,
masks, and goggles. The other equipment like ear muffs, gloves, respirators, aprons
etc., will be provided to employees depending on the work area allocated to them.
The PPE selection shall strictly follow the prescribed guidelines of MSDS. The budget
allocated for personal protective equipment is Rs. 250 lakh and Rs. 50 lakhs for health
checkup.
5.1 Raw Material/Solvent Storage and Control Measures

Ware Houses:
The plant shall have sufficient storage facility for safe handling of raw materials. All
solid raw materials shall be stored in marked areas with proper identification. Liquid
raw materials and solvents like which are available in drums will be stored according

to material compatibilities and flammability. Adequate firefighting facilities shall be

provided as per NFPA norms.
Table 3.10 Raw Material/Solvent Control Measures

Significant Risks Control Measures
Solvent Tank Farm and Chemical Tank Farm
Fire/ Explosion  Solvent Tank Farm licensed by PESO.
 Restrict inventory to licensed quantities in Solvent Tank
Farm.
 Fenced Solvent Tank Farm.
 Fenced Solvent Tank Farm capable of being locked when not
in use.
 Access Control and control of visitors
 Control of ignition sources.
 All electrical equipment and fittings to be flameproof as per
area classification.
 Provision of foam cover to cover the largest dyke area
 Water spray cooling arrangements for all tanks
 Fire hydrants and fire monitors
 Solvent Storage Tanks to have N2 blanketing
 Earthrite system for earthing of tankers carrying solvents.
 Spark arresters on vehicles
 Wetting of road and tyres before unloading
 NO dry grass inside the fenced area
 No parking inside/ near the tank farm.
 No obstruction on the road for free movement of fire tender.
 No solvent pumping in night shift – Daytime operations
only.
Loss of Containment and  Dykes for all tanks (Dyke capacity to be min. 110% of tank
Spillage capacity and dyke distance from tank to be min half the tank
height).
 Tanker unloading area (road) to be dyked.
 Availability of the Spill control kit.
Injury at the time of  Provision of PPE to stores personnel.
loading/ unloading  Operations by trained stores personnel only.
Bulk Materials Store (liquid chemicals) Drum Yard and Special Chemicals Store
Fire/ Explosion  Fenced area, Access Control and control of visitors
 Building capable of being locked when not in use.
 Control of inventory to minimum possible
 Segregation of materials.
 Smoke/ Heat detection system (non-electricity based)
 No water based firefighting setup around the store.
 Adequate CAUTION displays
 Fire hydrants and fire monitors
 Provision of foam
 No electrical installation inside the Store
 Adequate natural light and ventilation.

Significant Risks Control Measures

 Daily night inspection by Shift Manager.
 No dry grass inside the fenced area
 Emergency exit.
Loss of Containment  Arrangements of drums in rows of two (two levels max) and
Spillage a gap of at least 2 feet between rows and from the walls all
around.
 Storage in open area on hard impervious floor surrounded
by a dyke/ sill. (For Bulk Materials Store and New Solvent
Drum Shed)
 Availability of the Spill control kit
Ergonomics – Poor  Provision of PPE to stores personnel.
posture leading to  Loading/ unloading only by trained stores personnel.
illness/ injury.
Injury at the time of
loading/ unloading
Raw Materials Warehouse, Finished Goods Warehouse, Packing Materials Warehouse,
and Engineering Store
Fire  Access Control and control of visitors
 Fenced area
 Building capable of being locked when not in use.
 Control of inventory to optimal levels
 Segregation of flammable materials.
 Segregation of materials.
 Battery charging not to be done inside the warehouse except
for penicillin warehouse, that too during daytime only.
 Installation of Smoke/ Heat detectors
 Adequate hydrant points outside/around the building
 NO dry grass in open areas.
 Daily night inspection by Shift Manager.
 Emergency exit.
 Availability of DCP, Foam and CO2 fire extinguishers, Spill
Control kit.
Spillage  Availability of the Spill control kit
Falling Objects  Mandatory head and foot protection when inside the
warehouse.
5.2 Hazard in Unit Operations and Control Measures

The various unit operations often involve hazardous material handling under
hazardous operating conditions, adopting hazardous reactions. The general safety
considerations for such unit operations have to be taken into consideration of phase
changes, catalysts used, reaction kinetics, and equilibrium and heat effects. Hazards
associated with unit operations are presented in Table 3.11.

Table 3.11 Hazards associated in Unit Operations

S. Unit Operation Hazards
No.
1. Transfer of flammable Spills during transfer, Containment failure, Fires
solvents-pumping, vacuum due to static charges & ingress of air, exposure
Transfer or pump transfer to toxic & harmful vapors.
or manual transfer to
reactors or containers
2. Extraction of layer with Solvent evaporation, leaking of vapor and
flammable solvents or Toxic igniting
solvents Air entry with flammable mixture may result in
explosions
Exposure to Toxic vapor during extraction &
layer separation
3. Heat Transfer during If the temperature increases beyond the set limit,
Reaction then the Hot reaction mass may bump through
the reactor openings or vents, resulting in loss of
material confinement
Runaway reaction due to exothermicity
4. Distillation Ingress of air while breaking vacuum, resulting
in fire & explosion
Impurity/ un reacted raw material/ by product
getting decomposed at higher temperature than
the set point resulting in explosion
Static charges generation during collection and
transfer of distilled solvent, resulting into fire
Cooling failure may result into loss of solvent
and may cause fire
5. Filtration Choking of filter resulting in over pressurization
and loss of containment of filtrate
Vibration due to uneven cake settling in
centrifuge- may result into fire and accident
Fire due to static charges& flammable vapor-air
mixture over open Nutch filter
Fire due to static charges & ingress of air
6. Drying Overheating during drying may result into fire
and explosion
Air ingress and static charges during Fluid Bed
Drying may result in explosion
Fire & explosion due to static charges due to low
ignition energy & thermal decomposition
7. Milling, Pulverization & Potential explosion hazard if the powder has
Sifting very low minimum ignition energy &Kst value
and prone to generate static charges
8. Blending Fall hazard & caught in Hazard during Blending
operation
9. Micronization Potential explosion hazard if the powder has
very low minimum ignition energy &Kst value
and prone to generate static charges

Control Measures:
Safety training classes are conducted to all the employees periodically to educate and
train them with regard to proper operation and steps to be taken during emergencies.
Work permit system is being strictly implemented. Dedicated ambulance is provided
round the clock. The industry has an arrangement with hospitals for referral cases.
5.3 Maximum Credible Accident and Consequence Analysis (MCACA)

The potential hazards due to flammable and toxic nature of the raw materials,
process streams and products can be quantified. However, it is necessary to carry out
a hazard analysis study to visualize the consequences of an unexpected release from
chemical plant, which consists of a number of process units and tank farm facilities.
The present study provides quantified picture of the potential hazards and their
consequences.
5.3.1 Release Models and Source strength

This depends on the nature of failure of the unit and the content of the unit and
operating temperature and pressure of the unit. The release may be instantaneous
due to total failure of storage unit or continuous due to leakage or rupture of some
component of the storage facility. The material discharged may be gas or liquid or the
discharge could be manifested through two phase flow. Steps in consequence
calculations are presented in Fig 3.9.

Fig 3.8 Steps in Consequence Calculations

5.3.2 Heat Radiation Damage Distances – Pool Fire
When a non-boiling liquid spills, it spreads into a pool. The size of the pool depends
on the availability of the bund and obstacles. The heat load on objects outside a
burning pool of liquid is calculated with the heat radiation model. The average heat
radiation intensity, the diameter-to-height ratio dependent on the burning liquid,
geometric view, distance from the fire, relative humidity of air, horizontal or vertical
orientation of the object radiated with respect to fire are factored. All storage tanks in
tank-farm area are provided with dykes. Heat radiation damage distances for most of
the scenarios are not occurring in the case of release from 50 mm holes at a height of

0.1 m from the bottom of the tank for one hour, in the storage tanks. Heat radiation
damage distance (Pool Fire) for tank farm is presented in Table 3.12.
Table 3.12 Heat Radiation Damage Distances – Pool Fir (Solvent Tank Farm)
S.No Name of Solvent MOC Tank Dimensions (m) Tank
Capacity Height Diameter Volume
(KL) in KL
1 Acetone MS 2 x 100 6.50 4.85 120
2 Dichloromethane SS 1 x 100 6.00 5.20 127
3 Dichloromethane SS 1 x 30 4.50 3.08 34
4 Isopropyl Alcohol MS 2 x 50 5.00 3.60 51
5 Isopropyl Alcohol MS 1 x 30 4.40 3.00 31
6 Methanol MS 5 x 100 6.00 5.25 130
7 Caustic Soda Lye (48%) MS 2 x 30 5.00 3.62 51
8 Dil. Hydrochloric Acid PPFRP 2 x 30 4.40 3.00 31
5.4 Medical Check-Up

M/s Aurobindo Antibiotics Pvt. Ltd. has a medical program of pre-employment
screening, periodic medical examination, emergency treatment, non-emergency
treatment, and record keeping and review. The pre-employment screening and
periodic medical examination shall follow the guidelines of factories act. The pre-
employment screening shall obtain medical history, occupational history followed by
physical examination and baseline monitoring for specific exposures. The frequency
of periodic medical examination and type of evaluation is presented in Table 3.13.
Table 3.13 Frequency of Health Monitoring

Occupation Type of evaluation Frequency
Process area Dermatology examination, ophthalmic examination, ENT Annually
examination, physical examination, complete blood
picture, complete urine examination, ECG, Random blood
sugar, Lipid profile, Liver function test, kidney function
test, Anemia profile, thyroid stimulating hormone,
abdomen ultra sound scanning, thread mill test,
Spirometry test.
Noise prone areas Audiometry Annually
The plant has occupational health center providing emergency and non-emergency
treatment, by way of emergency first aid on site, liaison with local hospitals and
specialists, arranging decontamination of victims, arranging transport of victims to
hospitals, and to transfer medical records, and to provide details of incident and
medical history to next care provider. The occupational health center is under

supervision by a qualified physician. The occupational health center maintains the

health records and analyze the records for any common symptoms and common
health problems which may be due to exposure to chemicals, and or due to other
occupational hazards.
5.5 Handling of Toxic Chemicals/Materials

The engineering controls proposed for reducing occupational hazards in handling of
toxic chemicals are as follows;
 Separate Storage area with environmental controls
 Dispensing of material in isolated dispensing booth with cross ventilation
 Transfer of toxic powders by Power Transfer System (PTS)
 Level Indicators, sensors, pressure & Temperature indicators provision to reactors
 Transfer by dedicated pipe line
 Dump tank system in case of overflow
 Transfer by using AOD pumps in case of Drum transfer and
 Vents connected to common scrubbers.
Administration Controls for handling of toxic chemicals are as follows;
 All chemicals are stored based on respective MSDS
 Periodic health check-up tuned to Toxic chemicals handled.
 All employees are provided with respiratory protection ranging from nose mask
to full body suit to prevent toxic chemicals impacting respiratory system of
employees.
 Personal Protective Equipment (PPE) based on requirement and suitability
5.6 Treatment of Workers affected by Accidental Spillage of Chemicals

The following standard procedure is proposed for adoption in case of causality
during accidental spillage;
 On receiving message of casualty at ECC, Ambulance is sent to the plant /

location of occurrence.

 Give topmost priority to the “personal Safety of employees”. Prevention of life is

the number priority and people must be removed from the danger area and
shifted for medical treatment as early as possible.
 The casualty is rendered first aid by trained first aiders.
 The casualty then shifted to OHC in Ambulance for further treatment.
 Medical aid is administered by FMO / Manager-OHC at OHCS.
 On the instruction of Company Manager – Occupational Health assessment, the
casualty is transported in Ambulance to defined hospitals for further treatment
Toxic release gas;

 Check wind direction of wind sack installed at highest point.
 Wear appropriate / necessary PPE if moving near gas leakage area.
 Rescue operators must wear SCBA set before entering the affected section.
 Monitoring of the emission levels in the immediate vicinity by on-duty
Environment Protection Manager (Dragger Tubes / PID instrument / Gas detector
tubes)
 Water curtains to be started immediately to control drift of gases away from leak
spot.
6.0 Prevention, maintenance and operation of Environment Control System

The pollution control equipment, and the effluent treatment systems and effluents will
be monitored periodically and will be checked for its performance and pro-active
maintenance will be adopted. The environmental monitoring results will be evaluated
to identify the problems/under performance of the equipment. Necessary steps will be
taken to rectify the identified problems/defects. The management agrees that the
evaluation of the performance of pollution control measures and occupational safety
measures to arrive at their efficiency and proposes to adopt new measures for efficient
pollution control which will be a regular exercise.
All pollution control equipment’s are adequately designed and operating staff of the
pollution control equipment have good experience in the operation and maintenance
of the equipment. Standby equipment provided for all critical equipment to ensure
continuous operation of pollution control equipment and preventive maintenance is
done as per the schedule to avoid breakdown. Characteristics of influent and effluent
are monitored on daily basis by the industry and air emissions and effluent
characteristics on monthly basis by third party.
7.0 House Keeping

Good house-keeping practices will be adopted. Floor washing is avoided and wet
mopping will be adopted to minimize liquid waste generation. Paper waste is
minimized by adopting intra office network. Sufficient workspace and proper lighting
will be provided.
8.0 Corporate Environment Responsibility

The proposed project provides an opportunity for the local people to get employment
directly or indirectly and helps in the up-liftment of the socioeconomic status of the
area. The project proponents propose to involve in social activities of the
stakeholders/surrounding community by planning the betterment of neighboring
social conditions through awareness and welfare programs will ensure an improved
relation, useful in the long run. Many of the beneficiaries of such programs shall
include own employees as well. The goodwill of the local populace can never be
ignored. Another important facet of social environment identified by the project
proponents is a green appearance, hence the management will develop a green belt
towards aesthetic beautification as the same is necessary to be considered as a
responsible, social neighbor. The budget allocated for funding corporate social
responsibility activity is as follows;
1. Corporate Environment Responsibility: The ministry of Environment, Forest

and Climate Change issued an office memorandum mandating corporate
environment responsibility expenditure contingent on the capital cost of the
project, in addition to the expenditure on environmental management. The
office memorandum prescribed a CER expenditure of 0.5 % for green field
projects of less than Rs. 10000 crores. The capital cost of the proposed project is
Rs. 3000 crores and hence must spend Rs. 15 crores towards corporate
environment responsibility.

2. Local Content: About 3500 no. of employees are from the surrounding villages.
Local produce like rice, vegetables, milk etc. is procured from surrounding
villagers by the canteen.
3. Capacity building: Skill development, and provision of infrastructural
facilities for drinking water, education and health.
4. Payment of Taxes: The proposed industry will be paying about Rs. 5 crore per
year towards various central and state taxes.
The following activities are identified to be implemented by the project proponent in

consultation with local public representatives and revenue authorities. The list of
activities village wise is presented in Table 3.14.
Table 3.14 Activity Wise CER – Budget (2020-21 to 2024-25)
S. Description TOTAL COST (Rs. IN LAKHS)
No 2020-21 2021-22 2022-23 2023-24 2024-25
1 Socio-economic Development & 95 95 95 63 63
Enriching Livelihood
Includes activities relating to income
generation like skill development
programs, Roads, Drinking water facility,
sanitation to nearby villages.
2 Value addition and necessary 65 65 65 45 45
improvements in Government Schools
Includes construction of toilet blocks,
carrier counseling, special educational
and employment enhancing vocation
skills for students, etc.
3 Care for the Needy 55 55 55 50 50
Eradicating hunger, poverty and
malnutrition. Identification of old age
homes, orphanage, differently abled
persons, etc. Take care of their
requirements.
4 Health & Environment 60 60 60 50 50
Conducting general health camps in the
nearby villages, government schools,
creating environmental awareness,
display of materials, sapling of trees, etc.
5 Infrastructure 55 55 60 45 45
Take care of the local community by
providing facilities in the Government
Primary Health Centers, Government
Hospitals.
Total 330 330 335 253 253

9.0 Transport systems

All the raw materials and finished products are transported by road. Dedicated
parking facility is provided for transport vehicles. The plant is located in an industrial
area, and there will not be any unauthorized shop or settlements along the road
connecting the plant site. There will be 10-15 truck trips per day to the factory. Traffic
signs are placed in the battery limit. The drivers of the vehicles will be provided with
TREM cards and will be explained the measure to be adopted during various
emergencies.
10.0 Reduce, Recovery and Reuse

It is the endeavor of the project authorities to increase yields of the products through
constant research and development activity. The development activity shall
concentrate on increasing the yields, using less quantity of raw material, using
alternative solvents with low hazards by adopting green chemistry principles. The
solvents shall be recycled for reuse in the process by distillation. The mother liquors
from the first crop shall be reused for process. It is proposed to use third and fourth
washing water for first and second washing of the reactor and centrifuges. The steam
condensate shall be reused for boiler feed. The treated effluent will be disposed to sea
by using marine outfall system. A cross functional team shall constantly evaluate
various options of reduce, reuse and recycle for water conservation, reduction in
wastewater generation, effluent segregation, reuse of wastes, alternate treatment
methods, leakage/spillage control, avoidance of overflow and contamination.
11.0 Energy Conservation

It is proposed to use screw compressors (Air/Refrigeration) for energy efficiency (10 –
12% saving), evaporative condensers in the chilling circuit to reduce overall power,
Cooling tower fan control to switch off at times not required (Low temp), energy
efficient pumps to conserve energy.
12.0 Green Belt Development

The management will develop green belt in a total area of 80 acres covering the
boundary of the site as part of environment management plan to enhance

environmental quality through mitigation of fugitive emissions, attenuation of noise

levels, balancing eco-environment, prevention of soil erosion, and creation of aesthetic
environment.
13.0 Environment Management Cell

The Environment Management Cell of the project is headed by the Pant head.
Maintenance manager, Environment manager will report to plant head. Electrical
engineer and mechanical engineer will be reporting to maintenance manager.
Safety& health, ETP, HWA and house-keeping supervisors will be reporting to
environment manager and he will be guided by general manager – EHS. Schematic
diagram of Environment Management cell is presented in Fig 3.11.
Fig 3.9 Organogram of the Environment Management Cell
Records shall be maintained for the analysis of raw effluents and treated effluents,
ambient air quality data, stack emissions monitoring results, micro- meteorological
data and noise levels. These records are not only required for the perusal of the
pollution control board authorities but also to derive at the efficiencies of the
pollution control equipment as the objective of the project proponent is not only

compliance with statutory regulations, but also a serious commitment towards clean
environment.
14.0 EHS Cell & Post Project Monitoring

The industry will maintain records as per the hazardous waste regulations and EPA
regulations and apply for the annual consents for air and water, and renewal of
authorization for the storage of hazardous waste as per Hazardous Waste (Handling
& Management) Rules, 1989 and subsequent amendments. The records of hazardous
waste manifest will be maintained.
The industry shall obtain the consent for operation (CFO) as required under section
25/26 of the Water Act, 1974 and under section 21/22 of Air Act, 1981 before trial
production and commissioning from the State Pollution Control Board. The CFO will
be renewed each year by the industry. The industry will obtain the necessary
permissions under Hazardous Waste (Management and Handling) Rules 1989, and
Manufacture, Storage and Import of Hazardous Chemicals Rules, 1989, issued by the
Ministry of Environment and Forests, New Delhi. The industry will submit
environmental statement every year before September 30, and monthly water cess
returns. The management ensures that it will comply with all the directions and
regulations issued by the Ministry of Environment and Forests, New Delhi, State and
Central Pollution Control Boards. The Consent for Establishment, Consent for
Operation will be displayed in a conspicuous location for the information of the
inspecting authorities of different departments. The post project monitoring plan
along with environmental parameters and the time frame is presented in the Table
3.15.
Table 3.15 Environmental Monitoring Plan
S. Particulars Monitoring Standards Duration Important monitoring
No Frequency of parameters
Sampling
Ambient Air Quality Monitoring
1 Inside Industry Quarterly Air (Prevention 24 hrs PM10, PM2.5, SO2, NOx, &
Main Gate, solvent tank and Control of VOC
farm and nearby two Pollution) Rules,
CPCB, 1994
villages

2 Work Place Monitoring: Quarterly 8 hr SPM, VOC

Production blocks 5
locations, Solvent Tank
farm, and ETP area
Stack Emissions Monitoring
1 Utility Stacks :3 nos. Coal Quarterly Air (Prevention -- PM, SO2, NOx ,
fired boilers, and 8 no. s DG and Control of recommended methods
sets. Thermic fluid heater– Pollution) of CPCB.
CPCB, 1994
4nos
Water Quality Monitoring
1 Process water Daily Water Quality Grab pH, TDS, SS, BOD, COD
standards by and Oil & Grease
CPCB Hardness, , chlorides,
using APHA or BIS
analytical methods.
2 Effluents Stream wise Quarterly Grab pH, TDS, SS, BOD,
CODusing APHA or BIS
analytical methods.
3 Treated effluent after ZLD Daily Grab pH, TDS, TSS, COD,
system BOD and Oil and Grease
using APHA or BIS
analytical methods.
Noise Quality Monitoring
1 Noise Levels at 3 Locations Quarterly Noise standards 24hrs Equivalent Noise levels
within plant site and 2 by CPCB in dB(A)
locations outside the plant
site, Posinavaripalem village
Soil Quality Monitoring
1 Soil - 3 locations within the Once a year pH, EC, CEC, Lead,
site; storage area, near Moisture, Texture, Bulk
production blocks (5 no. s) Density etc.
and ETP area.
14.1 Environmental Monitoring Budget

The environmental monitoring budget for monitoring air, water, soil, and noise levels
is presented in Table 3.16. It may be noted that the annual expenditure for
environmental monitoring is Rs. 11.6 Lakhs.
Table 3.16 Environmental Monitoring Budget
Particulars Monitoring Unit Cost Annual Cost
Frequency Rs. Rs.
Ambient Air Quality Monitoring Monthly 7500 270000
Work Place Monitoring Monthly 2000 240000
Stack Emissions Monitoring Monthly 2700 162000
DG Set Stack Emissions Monitoring Quarterly 2700 86400
Process water Daily 500 165000
Effluents - Stream wise Quarterly 600 4800
Treated effluent (ETP water) Daily 600 198000
Noise Level Monitoring Quarterly 1000 20000
Soil Quality Once a year 2000 14000
Total (Rs.) 1160200

15.0 Cost Estimate for Environment Management Plan

It is estimated that the total capital cost for implementing the Environment
Management plan is Rs. 220 crores, while the recurring costs for the same is Rs. 370
crores/year. The cost estimate is presented in Table 3.17. The item wise tentative
capital cost estimate for environment management measures is presented in Table
3.18.
Table 3.17 Environmental Management Cost estimate
S.No Description Capital Recurring Cost
1 Air pollution Control 2760 150
2 Water pollution Control 18025 32544
3 Noise pollution Control 178 15
4 Environment Monitoring and Management 229 10
5 Occupational Health 740 60
6 Green Belt 45 8
7 Others (S. Waste) 65 4281
Total (Lakhs) 22042 37068
Note: Value in Rs. Lakhs
Table 3.18Item Wise Tentative Capital Cost Estimate for Environment Management
S.No Description Cost
(Rs. Lakhs)
I Air pollution
Electrostatic Precipitators (ESP) 540
Bag Filter 40
Scrubbers 450
Condensers 1000
Vacuum pumps 300
Closed Hoods and AOD pumps 45
Dust Collectors 50
Coal handling system 160
Ash handling system 175
Total - I 2760.0
II Process Safety
Breather Valves 16
Rupture disks 20
Trolleys 16
Safety relief valves 80
Fire extinguishers 48
Fire buckets 10
Total - II 190
III Occupational safety
Occupational safety and health centre with facilities 20
Self-contained breathing apparatus 400
Personal protective equipment 100

Eye wash and body wash showers 30

Total - III 550
IV Water
Effluent treatment system 17500
Storm water drains 175
Effluent and sewage transfer lines 350
Total - IV 18025
V Noise
Acoustic enclosures 87.5
Guards, casing, attenuating screens 45
Turbine Room 35
Vibration control pads 10
Total - V 177.5
VI Solid waste
Storage area for hazardous waste 45
Detoxification area 20
Total - VI 65
VII Green Belt 45
Total - VIII 45
VIII Environmental monitoring
On-line TOC on marine discharge 40
Online pH and TSS meters 20
Flow meters 60
Continuous ambient air quality station 50
Work place monitoring 9
On line stack analysers 50
Total - VIII 229
Total (I+II+III+IV+V+VI+VII+VIII) 22042

MANUFACTURING PROCESS OF 7-Amino- CEPHALOSPORANIC ACID (7 ACA)
Brief introduction of production process:
7-ACA is prepared by chemical or enzymatic hydrolysis of cephalosporin C.

Cephalosporin C is the metabolite of cephalosporin C. the fermentation period is 130-
150 h and the current fermentation level is more than 30000 uuml. The concentrated
liquid of cephalosporin C sodium salt is obtained through membrane ultrafiltration,
resin separation and concentration. The concentrated solution is enzymolysis by D-
amino acid oxidase and GL-7ACA acylase. After crystallization, 7-ACA product is
obtained
Fermentation process: cephalosporin C is produced by biological fermentation, which
is batch fermentation. In the medium containing carbon source, nitrogen source,
inorganic salt and trace elements, deep culture is carried out under certain
temperature and aeration stirring conditions. During the cultivation process, nutrients
such as carbon source and nitrogen source need to be continuously added. At the
same time, strict sterility test and analysis of fermentation intermediates were carried
out
Extraction process: after fermentation of cephalosporin C, 7-ACA was obtained by
acidification, membrane filtration, adsorption and desorption of adsorption column,
oxidation of oxidase, acylase acylation and crystallization

7-ACA process flow Chart:
Cryogenic Isolation single Preparation of first Preparation of second

tube colonies generation ramp generation
Primary seed Secondary Tertiary seed Fermentation tank

seed
Zymotic fluid Acidification Ceramic Pretreatment

membrane column
Decarbonization Decolorizing Column

Nanofiltration
column
Oxidation Intermediate
Concentrate CPC concentrate
reaction reaction
Acylation Nanofiltration Crystal Centrifuge washing

reaction and drying
7 -ACA
7-ACA - Material Balance
Capacity (TPM) = 166.66 Batches per day = 4.00

Batches per month = 119.99 Yield per batch = 1389.00
Stage I
S.No Input kgs/ batch Output kgs/ batch
1 Corn Syrup (40% w/w) 6251 7-ACA 1389
2 Granulated Sugar 208
3 Peanut Cake Powder 2778
4 Glucose 417 Wastewater
5 Soybean cake powder 139 Water 1250789
6 Dextrin 4167 Inorganic Salts 62265
2778 Water soluble Organic 14584
7 Corn flour
solids+solvents+other organics
8 Gluten 4862
9 Soybean oil 22224
10 DL Methionine 1111
11 Ammonium sulphate 2500
12 Calcium sulfate 2084
7 Water Loss (in recovery of 90000
13 Ferrous sulfate
Mycelium)
14 Manganese sulfate 7
15 Copper sulphate 3
16 Zinc sulfate 3 Organic
17 Antifoam agent 4 Recovery Residue 1318
18 Liquid alkali(Aq. NaOH 30%) 1389
19 Liquid sugar (55%) 13196
20 Aq. Ammonia (20%) 10418
21 Sulphuric acid 2084
22 Ammonium oxalate 1 Inorganic
23 Calcium carbonate 1111 Process Inorganic Salt 0
24 Hydrochloric acid (35%) 5278
25 Liquid alkali (Aq. NaOH 30%) 48615
26 Concentrated sulfuric acid 8334
27 Glacial acetic acid 3667
28 Aq. Ammonia (20%) 1667
29 Sodium bicarbonate 3334
Carbon
30 Activated Carbon 125
31 Hiflow 25
Resin 400 Spent Carbon 150
Process Emissions
Carbondioxide 1964
Catalyst 0
Solvents
Isopropanol 2361 Fugitive (Solvent) Losses
Acetone 1000 Isopropanol 43
Acetone 18
Water
DM Water 1283000
Spent Catalyst 0
Sub-total 1435545
Recoveries(-):
Mycelium 10000
Isopropanol 2125
Acetone 900
Total 1422520 Total 1422520

Water & Wastes Generation
Water & Wastewater Other Process Wastes

Water In-put 1283000 Organic Waste (Kg) 1318.1
Wastewater Generation 1250789 Inorganic Waste (Kg) 0.0
TDS (Kg) 128342 Spent Carbon (Kg) 150.0
TDS (mg/L) 102608 Process Emissions (Kg) 1964.3
COD (Kg) 72922 Fugitive Emissions (Kg) 60.5
COD (mg/L) 58301 Spent Catalyst (Kg) 0.0
Waste Generation Details
Proposed Product - 7-ACA

Waste Generation Per Batch

Organic Inorganic
Spent Process Fugitive Spent
Water Input Waste water TDS TDS COD COD solid/semisol solid/semisol
Stage Carbon Emissions Losses Catalyst
id id
Kg Kg Kg mg/L Kg mg/L Kg Kg Kg Kg Kg Kg
I 1283000 1250789 128342 102608 72922 58301 1318 0 150 1964 61 0
1283000 1250789 128342 102608 72922 58301 1318 0 150 1964 61 0
Waste generation per day
5131384 5002557 513305 102608 291652 58301 5272 0 600 7856 242 0
Effluent sent for Evaporation (per day)
5131384 5002557 513305 102608 291652 58301 5272 0 600 7856 242 0
Effluent sent for ETP (per day)
0 0 0 0 0 0 0
MANUFACTRING PROCESS OF GLUCOSE
Process Of Glucose :
The enzymatic method is a production process for hydrolyzing starch into glucose using a highly specific
amylase and saccharification enzyme as a catalyst. Starch hydrolysis is carried out in two steps: in the first
step, liquefaction is carried out with a high temperature resistant a-amylase; in the second step, the
liquefaction liquid is further hydrolyzed to glucose with a starch saccharification enzyme to achieve a DE value
of 98% or more. In summary, the production process of glucose syrup mainly includes seven steps of pulping,
liquefaction, saccharification, deproteinization, decolorization, ion exchange, and concentrated evaporation.
1. Mixing:
Adjust the specific gravity of starch to 17-18.5Be with water below 42 °C, pump the adjusted starch milk into
the mixing tank, and add a certain amount of 10% dilute alkali solution to the starch under constant stirring
conditions, PH value of 5.5-5.8
Add a certain amount of high temperature resistant a-amylase for liquefaction. The amount of enzyme added
is determined by the DE value of the liquefied liquid, and the DE value is required to be between 13% and
17%.
2. Liquefaction:
A certain concentration and pH of the starch is continuously pumped into the liquefaction tank for
liquefaction.
The liquefaction temperature of one spray is controlled at 106-110 °C, the liquefaction temperature of the
second spray is controlled at 135-145 °C, the discharge speed is controlled, and the iodine color of the
liquefied liquid is brownish red.
The indicators required for the enzymatic spray liquefaction process are:
Concentration: 30%-34%
рH value: 5.4~6.0 (preferably 5.5~5.8)
Enzyme amount: 0.035%~0.07% (for solids)
3. Saccharification:
After cooling the liquefied liquid, adjust the pH value and add glucoamylase
Saccharification under certain temperature conditions for a certain time to make the DE value of 98% or
more.
The indicators required for the enzymatic saccharification process are as follows: pH: 4.1~4.5
Add enzyme amount: 100~150u/g(depending on enzyme activity plus 0.6~0.9kg/T dry starch)
Maintain temperature: 58 ° C -62 ° C
Saccharification time: 48h (normal control in 45~56h) The final value of saccharification is DE: ≥98.5% (in most
cases close to or exceed 99%)
5. Decolorization:
After the protein pretreatment feed liquid flows into the decolorization tank, after remove enzyme then
through first decolorization, second decolorization, adsorbed with activated carbon, and filtered through a
plate and frame filter to obtain a clear, transparent, colorless refined sugar liquid.
The decolorization temperature is about 80 °C, and the amount of carbon added can be determined according
to the required amount of discharge color.
When the plate frame pressure is high and the filtration speed is slow, open the plate frame filter to remove
the excess actived carbon.
6. Ion exchange:
Import the required sugar liquid into the ion exchanger for ion exchange
At first into first column, cation resin exchange, then enter the second column anion resin exchange, then
enter the third column for cation resin exchange, then enter the fourth column for anion resin exchange, then
by adjusting the flow rate of the liquid entering the fifth column cationic resin, a sugar liquid meeting the
quality standard is obtained for evaporation.
7. Evaporation and concentration:
The ion exchanged sugar liquid is pumped into a three-effect evaporator to obtain a suitable concentration of
syrup, which is the final product glucose syrup, which can then be sent to a storage tank and packaged.
Flow Chart of Glucose:

Glucose - Material Balance

Batches per month = 300.00 Yield per batch = 55000
Stage I
1 Corn 93500 Glucose 55000
2 Caustic Lye 275
3 Enzyme 65
4 Wastewater 136465
Organic
Recovery Residue 2750.0
5 Carbon 275
Inorganic 0.0
Catalyst 0
Solvents
Spent Carbon 275.0
Water Process Emissions 0.0

DM Water 100100
Sub-total 194215 Fugitive (Solvent) Losses
Recoveries(-):
Spent Catalyst 0.0
Total 194215 Total 194490


Proposed Product - Glucose


Organic Inorganic
id id
I 100100 136465 0 0 0 0 2750 0 275 0 0 0
100100 136465 0 0 0 0 2750 0 275 0 0 0
1001000.0 1364654.5 0.0 0.0 0.0 0.0 27500.0 0.0 2750.0 0.0 0.0 0.0
1001000.0 1364654.5 0.0 0.0 0.0 0.0
0.0 0.0 0.0 0.0 0.0 0.0

BRIEF PROCESS DESCRIPTION OF 6-APA
Dissolved and filtered solution of penicillin G.K was reacted with Wet penicillin G Amidase
enzyme by maintaining an optimum pH with liquor ammonia, obtained enzymatic hydrolysis
solution is mixed with MDC by lowering the pH. Then Methylene Chloride layer with phenyl
acetic acid (PAA) is removed.
From the above layer 6APA is crystallized at an optimum pH and centrifuged to remove
the mother liquor. Obtained wet cake is washed with Methanol or Acetone and Dried to get
6APA.
PROCESS FLOW CHART OF 6-APA
Penicillin G
Potassium
6-APA HCL
solution
Enzyme
Liq. Ammonia
Stage-I
HCL
MDC
DM Water
6 APA Hcl
Mother Liquor
6 APA
Effluents generated
Liq. Ammonia with salts
Stage-II
Methanol
REACTION SCHEME OF 6-APA
6-APA - Material Balance

Stage I
1 Penicillin G Potassium 3889 6 APA HCl solution in mother liquor 111055
2 Enzyme 3889
3 Liquid Ammonia (20%) 4667
Hydrochloric Acid 3500 Wastewater 0
Organic 972
Recovery Residue (Phenyl Acetic Acid)
Catalyst
Inorganic 0
Solvents
4 MDC 10305
Spent Carbon 0
Water Process Emissions 0

DM Water 99972
Recoveries(-): Fugitive (Solvent) Losses

MDC 8167 MDC 2139
Enzyme 3889
Spent Catalyst 0


Stage II
1 6 APA HCl mother liquor 111055 6 APA 1944
2 Liquid Ammonia (20%) 972
Wastewater
Water 105611
Ammonium Chloride 3403
Unreacted Organics 875
Activated Carbon 0
Hyflo 0
Catalyst 0
Organic
Recovery Residue 0
Solvents
Methanol 778
Inorganic 0
Water Spent Carbon 0

DM Water 0
Process Emissions 0
Sub-total 112805
Recoveries(-): Fugitive (Solvent) Losses

Methanol 389 Methanol 583
Spent Catalyst 0


Proposed Product - 6-APA


Organic Inorganic
id id
I 972 0 0 0 0 0 0 0 0 0 3403 875
II 99972 105611 0 0 4278 40505 0 0 0 0 583 0
100944 105611 0 0 4278 40505 0 0 0 0 3986 875

605668 633668 0 0 25667 40505 0 0 0 0 23917 5250
605668.4 633668.4 0.0 0.0 25666.7 40504.9
0.0 0.0 0.0 0.0 0.0 0.0

AMOXYCILLIN TRI HYDRATE
1. PROCESS DESCRIPTION
PREPARATION OF (2S,5R,6R)-6-[[(2R)-2-Amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-di Methyl -7-

oxo-4-thia-1-azabicyclo[3.2.0] heptane-2-carboxylic acid Trihydrate (AMOXYCILLIN TRI HYDRATE).
(2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4- thia-1-azabicyclo[3.2.0]heptane-2- carboxylic acid (6-APA) is

going condense with D-(-)-alpha-p-Hydroxy-phenyl glycine methyl ester (HOPG Ester) in presence of
Pencillin-G-Acylaze enzyme to yield (2S,5R,6R)-6-[[(2R)-2-Amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-di
Methyl -7-oxo-4-thia-1-azabicyclo[3.2.0] heptane-2-carboxylic acid Trihydrate (AMOXYCILLIN TRI
HYDRATE).
2. CHEMISTRY
PREPARATION OF (2S,5R,6R)-6-[[(2R)-2-Amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-di Methyl -7-

oxo-4-thia-1-azabicyclo[3.2.0] heptane-2-carboxylic acid Trihydrate (AMOXYCILLIN TRI HYDRATE).
OH
O S
NH2
O N
O
NH2
D-4-Hydroxyphenyl O OH
glycine methyl ester 6-APA
H2O + HCl
NaOH
OH
O
S
NH
NH2 N NaCl H2O
O
O OH 3H2O
Amoxicillin Try hydrate

3. Balanced Chemical Equations (Condensed chemical equations/stoichiometric
equation)
D-4-Hydroxyphenyl 6-APA Hydrochloric Sodium

glycine methyl ester hydroxide Water
acid
C8H12N2O3S 2H2O
C9H11NO3 HCl NaOH
(216.25) (36.5) : 36.0
181.19 (40)
PGA enzyme
Amoxicillin Try hydrate NaCl CH3OH

C16H25N3O8S (58.6) Methanol
Sodium chloride (32)
(419.4)
4. Flow chart
6-Amino Pencillanic acid Product
4-Hydroxy phenyl glycine Dane salt Water
Ammonia NH4Cl
Hydrochloric Acid Dimethyl acetamide
Pivolyl chloride HOPG base
Pivolic acid Iso Propl alcohol
Fugitive (Solvent)
Pyridine Amoxycillin Trihydrate Losses
Tri ethyl amine
Dimethyl Acetamide
Methylene Chloride
Iso Propyl Alcohol
Butyl Acetate
Purified Water
AMPICILLIN TRI HYDRATE ENZYAMNATIC
1. PROCESS DESCRIPTION
PREPARATION OF (2S,5R,6R)-6-[[(2R)-2-Amino-2-phenyl acetyl]amino]-3,3-di Methyl -7-oxo-4-thia-

1-azabicyclo[3.2.0] heptane-2-carboxylic acid Trihydrate (AMPICILLIN TRI HYDRATE).
(2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4- thia-1-azabicyclo[3.2.0]heptane-2- carboxylic acid (6-APA) is

going condense with D-(-)-alpha-Phenyl glycine methyl ester (PG Ester HCl) in presence of Pencillin-G-
Acylaze enzyme to yield (2S,5R,6R)-6-[[(2R)-2-Amino-2-phenyl acetyl]amino]-3,3-di Methyl -7-oxo-4-
thia-1-azabicyclo[3.2.0] heptane-2-carboxylic acid Trihydrate (AMPICILLIN TRI HYDRATE).
2. CHEMISTRY
PREPARATION OF (2S,5R,6R)-6-[[(2R)-2-Amino-2-phenyl acetyl]amino]-3,3-di Methyl -7-oxo-4-thia-

1-azabicyclo[3.2.0] heptane-2-carboxylic acid Trihydrate (AMPICILLIN TRI HYDRATE).
O
S
NH2
O N
NH2 HCl O
D - P h e n y l g ly c in e m e th y l e s te r - +
O O NH3
H y d r o c h lo r id e 6 - A P A a m m o n iu m s a lt
A m m o n ia
S
NH
NH2 N
O
O OH 3H 2O
A m p y c illin T r y h y d r a te
3. Balanced Chemical Equations (Condensed chemical equations/stoichiometric
equation)
C9H12NO2Cl + C8H12N2O3S + 3H2O + NH3

Phenyl glycine 6-Aminp Water Ammonia
methyl ester HCl Pencillanic
acid
(201.65) (216.29) (54) (17)
Pencillin G
Acylage Enzyme,
C16H25N3O7S + CH3OH + NH4Cl
Isopropyl alcohol
Ampycillin Try Methanol Ammonium

Hydrate Chloride
(403.46) (32) (53.5)
4. Flow chart
6-Aminp Pencillanic acid Ampicillin TH Enzymatic

Phenyl glycine methyl ester
Waste Water
HCl
Ammonia Solution Ammonium Chloride
Hydrochloric Acid AMPICILLIN TRI Methanol
HYDRATE Phenyl glycine methyl
Pencillin G Acylage Enzyme
ENZYAMNATIC ester HCl
Isopropyl alcohol Ammonia Solution
Purified Water Hydrochloric Acid
Other organics
Spent Catalyst
Pen G - Material Balance

Stage I
1 Liquid Glucose 72825 Pen G 10417
2 Solid Glucose 10600
3 PAA 3300
4 Maize Oil 1050 Wastewater
5 Sucrose 1650 Water 2000000
6 Potassium Phosphate 1100 Butyl Acetate 310
7 Ammonium Sulphate 4425 Inorganic Salts 15425
8 Liquid Ammonia 2650 Organic Salts 68044
9 Citric Acid 650
10 Mono Ammonium Phosphate 850
11 PAAN 1700
12 Caustic Soda (Liquid) 4975
13 Caustic Soda (Solid) 650
14 Sodium Sulfate 3975
15 Defoamer 75
16 CSL 1100
17 Demulsifier 400
18 Potassium Carbonate 1325
19 Sulfuric Acid 4425
20 Liquid Caustic Soda 5525
Catalyst 0
Organic
Residue 4047
Solvents
Inorganic 0
21 Butyl Acetate 1550
Spent Carbon 0
Water
22 DM Water 2000000
Sub-total 2124800
Process Emissions 0
Recoveries(-):
Butyl Acetate 1480 Fugitive (Solvent) Losses

Mycelium 25000 Butyl Acetate 78
Spent Catalyst 0
Total 2098320 Total 2098320


Proposed Product - Pen G


Organic Inorganic
Water Input Waste water TDS TDS COD COD solid/semisoli solid/semisoli
d d
I 2000000 2000000 83469 41735 102531 51266 4047 0 0 0 78 0
2000000 2000000 83469 41735 102531 51266 4047 0 0 0 78 0
8000128 8000128 333882 41735 410132 51266 16186 0 0 0 310 0
0.0 0.0 0.0 0.0 0.0 0.0
8000128.0 8000128.0 333882.1 41734.6 410131.8 51265.7

Aurobindo Antibiotics Pvt. Ltd. Form-I
APPENDIX – I
(See Paragraph – 6)
FORM I
I) Basic Information
S.No. Item Details
1 Name of the Project/s Establishment of Active Pharma Ingredients
manufacturing unit by M/s Aurobindo Antibiotics Pvt.
Ltd
2 S. No in the Schedule 5 f – B category - Active Pharma Ingredients
(Bulk Drugs and Intermediates)
3 Proposed capacity/area/length/tonnage to Proposed Production Capacity: 18417 TPM
be handled/command area/lease Co-Generation Power Plant: 100 MW
area/number of wells to be drilled Total Site Area: 230 acres
Project Cost: 3000 Crores
4 New/Expansion/Modernization New
5 Existing Capacity/Area etc. Not Applicable
6 Category of Project i.e 'A' or 'B' “B2”
7 Does it attract the general condition? If yes, NA
please specify
8 Does it attract the Specific condition? If yes, No
please specify.
9 Location Sy. no. 350, 351, 353, 354 to 358, 361 to 375 and 380 to
Plot/Survey/Khasra No. 382, A.V. Nagaram village, Kakinada SEZ area, Tondangi
Village mandal, East Godavari district, Andhra Pradesh
Tehsil
District
State
10 Nearest railway station/airport along with Railway Station: Ravikampadu Railway Station – 6.0 Km
distance in km. Airport: Visakhapatnam Airport – 104 Km
11 Nearest Town, City, District Headquarters Town: Tuni –23 Km

along with distance in kms.
12 Village Panchayats, Zilla Parishad, Municipal A.V. Nagaram –Village Panchayat
Corporation, Local body (complete postal
address with telephone nos. to be given)
13 Name of the Applicant J.V.N. Reddy
14 Registered Address Aurobindo Anitibiotics Pvt. Ltd.
Sy. Nos. 350, 351, 353, 354 to 358, 361 to 375 and 380 to
382, A.V. Nagaram village, Kakinada SEZ area, Tondangi
mandal, East Godavari District, Andhra Pradesh.
15 Address for Correspondence:
Name J.V.N. Reddy
Designation (Owner/Partner/CEO) Sr. Vice President – EHS
Address Aurobindo Pharma Limited,
Plot No. 11, Survey No.9, The Water Mark Building,
Kondapur, Hitech City, Hyderabad, Telangana State.
Pin Code 500 084
E-mail [email protected]
Form I Page 1
Telephone Number Phone: +91 40 66725000 Mobile: +91-98480 50898

Fax No. +91 40 67074044/23746833
16 Details of alternative Sites examined, if any. Not Applicable
Location of these sites should be shown on a
topo sheet.
17 Interlinked Projects Not applicable
18 Whether separate application of interlinked -NA-
project has been submitted?
19 If yes, date of submission -NA-
20 If no, reason
21 Whether the proposal involves -NA-
approval/clearance under: if yes, details of
the same and their status to be given.
(a) The Forest (Conservation) Act, 1980?
(b) The Wildlife (Protection) Act, 1972?
(c) The C.R.Z Notification, 1991?
22 Whether there is any Government No
Order/Policy relevant/relating to the site?
23 Forest land involved (hectares) No
24 Whether there is any location pending No
against the project and /or land in which the
project is propose to be set up?
(a) Name of the Court
(b) Case No
(c) Orders/directions of the Court, if any and
its relevance with the proposed project.
Form I Page 2
(II) Activity
1. Construction, operation or decommissioning of the Project involving actions, which will cause physical
changes in the locality (topography, land use, changes in water bodies, etc.)
S.No. Information/Checklist confirmation Yes/ Details thereof (with approximate quantities /rates,
No wherever possible) with source of information data
1.1 Permanent or temporary change in land Yes The proposal is for a green field project. The land use
use, land cover or topography including presently is barren. The land is plain and does not
increase in intensity of land use (with involve much of leveling/ excavation. The land use
respect to local land use plan) shall change to industrial and may change the
topography by way of extensive greening and
industrial construction.
1.2 Clearance of existing land, vegetation and Yes The land is barren and no major vegetation need to
buildings? be cleared and no buildings etc., in the site area.
1.3 Creation of new land uses? Yes Barren land/Single crop rain fed agricultural land
shall be converted to industrial use.
1.4 Pre-construction investigations e.g. bore YES Soil test done and soil load bearing capacity
houses, soil testing? established
1.5 Construction works? YES Construction activity involves creation of new
additional utilities like Boiler, DG set, Chilling Plant,
Effluent treatment system and SRS system.
1.6 Demolition works? NO Not Applicable. The proposal is a green field project.
1.7 Temporary sites used for construction NO Construction labor from local villages shall be
works or housing of construction employed.
workers?
1.8 Above ground buildings, structures or YES Manufacturing blocks, land scaping for greenery and
earthworks including linear structures, cut roads. Effluent treatment plant, Solvent storage
and fill or excavations facility shall be constructed. No major cut and fill or
excavation is anticipated.
1.9 Underground works including mining or NO No underground works like mining and tunneling.
tunneling?
1.10 Reclamation works? NO No reclamations works are anticipated.
1.11 Dredging? NO No dredging works are anticipated.
1.12 Offshore structures? NO No offshore structures are anticipated.
1.13 Production and manufacturing processes? YES Enclosed in Annexure – I
1.14 Facilities for storage of goods or NO Raw materials and solvents shall be stored with in
materials? factory premises. Materials in bags and drums will be
stored in flame proof ware houses. Bulk quantities of
raw materials will be stored in tank farms with
retention dykes.
1.15 Facilities for treatment or disposal of solid YES High TDS and low TDS effluents are treated in
waste or liquid effluents? effluent treatment plant and treated effluent will be
disposed to sea by using marine outfall system. The
domestic effluent Sent to biological treatment plant
followed by Marine Outfall system.
Organic waste is sent to cement plants for co-
processing or to TSDF. Solid waste generated from
Multiple Effect evaporators sent to secure land
Details of waste treatment facilities presented in
Form I Page 3
Annexure II
1.16 Facilities for long term housing of NO No long-term housing envisaged.
operational workers?
1.17 New road, rail or sea traffic during YES Construction materials shall be transported to the
construction or operation? site. The traffic density of the existing connecting
road is negligible.
1.18 New road, rail, air waterborne or other NO Only upgradation of existing connecting roads to the
transport infrastructure including new or project site.
altered routes and stations, ports, airports
etc?
1.19 Closure or diversion of existing transport NO The proposed connectivity shall not attract any
routes or infrastructure leading to closure or diversion of the existing transport routes.
changes in traffic movements?
1.20 New or diverted transmission lines or NO New Power transmission for the proposed project
pipelines?
1.21 Impoundment, damming, culverting, NO Storm water management plan shall ensure
realignment or other changes to the minimum disturbance of drainage within the site,
hydrology of watercourses or aquifers? without disturbing the inlet and outlet points of
storm water drainage.
1.22 Stream crossings? NO
1.23 Abstraction or transfers of water form YES Total water required shall be 23.5 MLD. Th water
ground or surface waters? requirement shall be met from Indira sagar canal and
samarlakot canal or it is proposed to establish
desalination plant of capacity 47 MLD to meet water
requirement of 23.5 MLD
1.24 Changes in water bodies or the land NO There are no natural water bodies or major drainage
surface affecting drainage or run-off? channels within the site. However, the drainage shall
be planned by considering intensity of rain fall of the
area.
1.25 Transport of personnel or materials for YES The construction material shall be drawn from local
construction, operation or sources within 10 km. There is no transport of
decommissioning? personnel, as the construction workers shall be
drawn from local villages.
1.26 Long-term dismantling or NO No Long-term dismantling or decommissioning or
decommissioning or restoration works? restoration works is envisaged.
1.27 Ongoing activity during decommissioning NO No ongoing activity is envisaged.
which could have an impact on the
environment?
1.28 Influx of people to an area in either YES During construction phase local people will be hired
temporarily or permanently? from local villages on temporary bases. The proposed
green field project shall increase employment
potential.
1.29 Introduction of alien species? NO No introduction of alien species is envisaged.
1.30 Loss of native species or genetic diversity? NO
1.31 Any other actions? NO
Form I Page 4
2. Use of Natural resources for construction or operation of the Project (such as land, water, materials or
energy, especially any resources which are non-renewable or in short supply):
S.No. Information/checklist confirmation Yes/ Details thereof (with approximate quantities
No /rates, wherever possible) with source of
information data
2.1 Land especially undeveloped or YES The land use is barren/rained single dry crop
agricultural land (ha) agricultural land and there is no double crop
agricultural land. The proposed area for land
development is 230 acres.
2.2 Water (expected source & competing YES Total water required shall be 23.5 MLD. Th water
users) unit: KLD requirement shall be met from Indira sagar canal
and samarlakot canal or it is proposed to establish
desalination plant of capacity 47 MLD to meet
water requirement of 23.5 MLD. (Water Balance
Enclosed in Annexure III)
2.3 Minerals (MT) NA
2.4 Construction material – stone, aggregates, YES Shall be sourced from the local villages.
sand / soil (expected source – MT)
2.5 Forests and timber (source – MT) NO
2.6 Energy including electricity and fuels YES The required energy shall be drawn from AP
(source, competing users) Unit: fuel (T), Transco. Standby DG sets of 15 x 1010 kVA. It is
energy (MW) proposed to establish 4 X 150 TPH coal fired boilers
to meet the steam requirement for process, SRS
and effluent treatment system.
2.7 Any other natural resources (use NA
appropriate standard units)
Form I Page 5
3. Use, storage, transport, handling or production of substances or materials, which could be harmful to
human health or the environment or raise concerns about actual or perceived risks to human health.
S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates,
wherever possible) with source of information data
3.1 Use of substances or materials, which YES Hazardous chemicals shall be used for manufacturing
are hazardous (as per MSIHC rules) to of Synthetic Organic Chemicals and intermediates.
human health or the environment MSIHC rules shall be followed during storage,
(flora, fauna, and water supplies) transportation and handling of raw materials.
Hazardous chemicals and solvent shall be stored and
handled in closed systems.
3.2 Changes in occurrence of disease or NO
affect disease vectors (e.g. insect or
water borne diseases).
3.3 Affect the welfare of people e.g. by YES There will be a positive impact on the welfare of the
changing living conditions? people. The estimated employment generation
potential of the project is 3500 including direct
employment generation of 1000. Direct and Indirect
employment during construction and operation
phases of the project.
3.4 Vulnerable groups of people who could NO No sensitive receptors are present in the immediate
be affected by the project e.g. hospital vicinity of the site. The project shall not have any
patients, children, the elderly etc., significant impact on vulnerable groups of people.
3.5 Any other causes NO
4. Production of solid wastes during construction or operation or decommissioning (MT/month)

4.1 Spoil, overburden or mine wastes NO No soil, overburden and mine waste are envisaged.
4.2 Municipal waste (domestic and or NO Wastes from canteen, other commercial wastes like
commercial wastes) paper, empty containers etc. The canteen wastes
shall be in the range of 20 kg/day during operation.
4.3 Hazardous wastes (as per Hazardous YES Hazardous waste generation during construction shall
Waste Management Rules) be limited to waste oils, batteries and containers of
paints etc. The quantity of hazardous wastes
generated during operation contain salts from
evaporators, process residue, and solvent residues,
ETP sludge and filtration media etc. Detail of solid
waste and disposal is enclosed in Annexure – IV
4.4 Other industrial process wastes YES Enclosed at Annexure IV
4.5 Surplus product NO Not Applicable
4.6 Sewage sludge or other sludge from YES Sludge from Effluent treatment plant and evaporation
effluent treatment salts shall be sent to TSDF.
4.7 Construction or demolition wastes YES Disposed as per C&D Rules and guidelines
4.8 Redundant machinery or equipment YES Disposed to recyclers
4.9 Contaminated soils or other materials NO All pipe lines including pipe lines of waste streams are
above ground level to eliminate the possibility of any
contamination due to seepage and for ease of
maintenance.
Form I Page 6
4.10 Agricultural wastes NO No Agricultural wastes are used or generated.

4.11 Other solid wastes YES Hazardous waste and packing material
5. Release of pollutants or any hazardous, toxic or noxious substances to air (Kg/hr)

5.1 Emissions from combustion of fossil YES Coal Shall be used as fuel for boiler. Diesel is for DG
fuels from stationary or mobile sources set. Quantity of fuel and emissions details are
enclosed in Annexure V
5.2 Emissions from production processes NO No Process emissions generation anticipated.
5.3 Emissions from materials handling NO Material transfer takes place in closed pipeline
including storage or transport systems using pumps with mechanical seals.
5.4 Emissions from construction activities YES Dust may rise during transport of material and
including plant and equipment construction activity. The dust emissions shall be
mitigated by water spraying on the roads within the
premises.
5.5 Dust or odors from handling of Yes Dust may rise during transport of material and
materials including construction construction activity. The dust emissions shall be
materials, sewage and waste mitigated by water spraying on the roads within the
premises.
5.6 Emissions from incineration of waste NO Organic waste streams are sent to cement plants for
co-incineration. Incinerators are not proposed.
5.7 Emissions from burning of waste in NO There will not be any burning of wastes.
open air (e.g. slash materials,
construction debris)
5.8 Emissions from any other sources Yes Accidental release/spillage of chemicals may result in
fugitive emission.
Form I Page 7
6. Generation of Noise and Vibration, and Emissions of Light and Heat:

with source of information data
6.1 From operation of equipment e.g. YES Material transport and construction equipment shall be
engines, ventilation plant, crushers source of noise, while transfer pumps, vacuum
systems, DG sets are the sources of noise during
operation.
6.2 From industrial or similar processes YES From Turbine and DG sets. Turbine room will be
covered by special type of walls. Acoustic Enclosures
will be provided for D.G. sets to mitigate noise levels.
6.3 From construction or demolition YES Noise during construction shall be due to construction
equipment and emergency DG sets.
6.4 From blasting or piling NO No blasting activity is envisaged but there will be piling
activity during the construction stage. Personal
Protecting Equipment will be provided to the work
force. Central Pollution Control Board (CPCB) standards
will be adhered at the plant batter limit.
6.5 From construction or operational NO The increased traffic shall not have any significant
traffic impact.
6.6 From lighting or cooling systems Yes May result in marginal increase in the baseline at the
boundary of the site due to noise levels from cooling
towers.
6.7 From any other sources NO No
7.Risks of contamination of land or water from releases of pollutants into the ground or into sewers, surface
waters, groundwater, coastal waters or the sea:
7.1 From handling, storage, use or Yes All the hazardous materials are stored on elevated
spillage of hazardous materials platform and stored in closed storage tanks and
containers (Liner/MS/GI/HDPE) are stored in a closed
shed and contamination of soil is anticipated in case of
spillages and accidental releases.
7.2 From discharge of sewage or other Yes All the waste from domestic operations sent to Effluent
effluents to water or the land Treatment Plant. Treated waste will be disposed to sea
(expected mode and place of through marine outfall facility.
discharge)
7.3 By deposition of pollutants emitted NO All the emissions from process are controlled by
to air into the land or into water providing control equipment like scrubbers, Bag filters.
7.4 From any other sources NO
7.5 Is there a risk of long term build up NO There is no risk of accumulation of long-term
of pollutants in environment from pollutants. Advanced treatment facilities are being
these sources? used to treat the pollutants. Readings of on line TOC
meter and Continuous Ambient Air monitoring stations
will be installed to monitor the pollutants regularly.
Form I Page 8
8.Risk of accidents during construction or operation of the Project, which could affect human health or the
environment
S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate
quantities/rates, wherever possible)
8.1 From explosions, spillages, fires etc from YES All Inbuilt Safety precautions will be
storage, handling, use or production of adopted and there will not be any
hazardous substances damage to environment or human
health
8.2 From any other causes NA
8.3 Could the project be affected by natural disasters NO
causing environmental damage (e.g. Floods,
earthquakes, landslides, cloudburst etc)?
9.Factors which should be considered (such as consequential development) which could lead to environmental
effects or the potential for cumulative impacts with other existing or planned activities in the locality
S. No. Information/Checklist confirmation Yes/No Details thereof (with approximate
quantities/rates, wherever possible)
9.1 Lead to development of supporting. YES The project shall enhance the socio
facilities, ancillary development or development economic status of the area by
stimulated by the project which could have impact increasing the demand for housing,
on the environment e.g.: improving the employment. There are
• Supporting infrastructure (roads, power supply, no major support industries required
waste or waste water treatment, etc.) for this plant.
• housing development
• extractive industries
• supply industries
• other
9.2 Lead to after-use of the site, which could haven NO
impact on the environment
9.3 Set a precedent for later developments NO
9.4 Have cumulative effects due to proximity to other NO The baseline environmental status of
existing or planned projects with similar effects the surrounding areas is within the
prescribed limits as observed from the
Secondary data.
Form I Page 9
(III) Environmental Sensitivity

S. Areas Name/ Aerial distance (within 15 km.)
No. Identity Proposed project location boundary
1 Areas protected under international conventions, NA
national or local legislation for their ecological
landscape, cultural or other related value
2 Areas which are important or sensitive for ecological YES Irrigation Upputeru Canal - 10m - N.
reasons - Wetlands, watercourses or other water Seasonal Nakkala Khandi - 9.0 - SW
bodies, coastal zone, biospheres, mountains, forests Bay of Bengal - 3.5 km - SE
3 Areas used by protected, important or sensitive NA There is no record of any sensitive
species of flora or fauna for breeding, nesting, species of flora and fauna, the same
foraging, resting, over wintering, migration shall be confirmed during EMP study.
4 Inland, coastal, marine or underground waters YES Bay of Bengal – 3.5 km – SE direction
5 State, National boundaries NO
6 Routes or facilities used by the public for access to NO
recreation or other tourist, pilgrim areas
7 Defense installations NO
8 Densely populated or built-up area YES A V Nagaram village- 1.0 km in NW.
9 Areas occupied by sensitive man-made land uses NA
(hospitals, schools, places of worship, community
facilities)
10 Areas containing important, high quality or scarce NO
resources (ground water resources, surface resources,
forestry, agriculture, fisheries, tourism, minerals)
11 Areas already subjected to pollution or NO No record of exceedance.
environmental damage. (those where existing legal
environmental standards are exceeded)
12 Areas susceptible to natural hazard which could NO The project area falls under seismic
cause the project to present environmental problems zone II as per the Seismic Zoning Map
(earthquakes, subsidence, landslides, erosion, flooding of India (BIS: 1893-2002), which means
or extreme or adverse climatic conditions) that the area is under Low risk of
earthquakes.
I hereby give the undertaking that data and information given in the application and enclosures are true to the
best of my knowledge and belief and I am aware that if any part of the data and information submitted is found to
be false or misleading at any stage, the project will be rejected and clearance given, if any to the project will be
revoked at our risk and cost.
J.V.N. Reddy
Head - EHS
Aurobindo Anitibiotics Pvt. Ltd.
Plot No. 11, Survey No.9,
The Water Mark Building,
Kondapur, Hitech City,
Hyderabad – Telangana - 500084
Phone: +91 4066725000.
Form I Page 10
Aurobindo Antibiotics Form I Annexures
Fig A.1 Location Map of M / s. Aurobindo Antibiotics Pvt. Ltd
Page 1
E
S
En
try
Security
20x20 M
400 Sq.M Admin & Canteen
50x 100m
5000 Sq.M
Parking Area
Space for Future Expansion Space for Future Expansion

Space for Future Expansion
48400Sq.M
18925 Sq.M 47943Sq.M 62443 Sq.M
Production Block -1 Production Block -3 Space for Future Expansion

200 x 112m 200 x 112m
22400 Sq.M 33053 Sq.M
22400 Sq.M
Space for ETP

22 Acres
Utility Utility
200 x 70m 200 x 70m
14000 Sq.M 14000 Sq.M
Cogen / Boiler Area

100 x 200m
Production Block -2 Production Block -4

200 x 112m 200 x 112m Space for Future Expansion
22400 Sq.M 22400 Sq.M 33453 Sq.M
Legend:
Total Site Area - 230 Acres (930769.8 Sq.M)
Plingth Area - 30.39 Acres (123000 Sq.M) 13% of Total Area
Space for Future Expansion Area - 60 Acres (244217 Sq.M) 26% of Total Area
Green Belt Area - 75 Acres (303809 Sq.M) 33% of Total Area
Roads Area - 19.51 Acres (78964 Sq.M) 8% of Total Area
Fig A.2 Plant Layout of M/s. Aurobindo Antibiotics Pvt. Ltd.
Page 2
ANNEXURE - I
M/s. Aurobindo Anitibiotics Pvt. Ltd. a subsidiary of Aurobindo Pharma Ltd. proposed to
establish an API manufacturing unit at Sy. no. 350, 351, 353, 354 to 358, 361 to 375 and 380 to
382, A.V. Nagaram village, Kakinada SEZ area, Tondangi mandal, East Godavari district,
Andhra Pradesh in an area of 230 acres. The proposed products of unit essentially are active
pharmaceutical ingredients and intermediates based on fermentation and enzymatic routes of
synthesis. Capital cost of proposed unit is 3000 crores towards production blocks, co-
generation power plant, effluent treatment facility, SRS system and utility proposed. The cost
estimate of environment management is 220.42 crores with annual recurring expenditure of
370.78 crores/annum. The proposed list of products and manufacturing capacity is presented
in Table A-1
Table A-1 Manufacturing Capacity
TPM TPA
Regular Products
3 Glucose 16500 198000
Total - I 18267 219200
Campaign Products
Grand Total (I + II) 18417 221000
Page 3
ANNEXURE – II: Wastewater Treatment Facilities
contain organic residues and inorganic raw materials, solvents, and products. Hence the
effluents contain both organic and inorganic salts in various quantities leading to high COD
and TDS concentrations respectively. Effluents from process, washings, scrubbing media,
and utility blow downs will be sent to the effluent treatment system. The treated effluent
will be disposed to sea by using marine outfall system. Total Effluent generated and mode
of treatment is presented in Table A-2.
Table A-2 Quantity of Effluent Generated and Mode of Treatment
Description Quantity Mode of Treatment and Disposal
(MLD)
Process Wastewater Sent to effluent treatment system and
Pen G 8.00 treated effluents are sent to marine
7-ACA 5.00 outfall system.
6-APA 0.63
Glucose 1.36 It is proposed to send treated effluents
Penicillin Products 0.28 from co-located units namely;
Boiler Blow Down 1.00 Aurobindo Antibiotics Pvt. Ltd. and
CT Blow Down 1.50 Auroactive Pharma Pvt. Ltd. to
QC, R&D and Garment Washing 0.25 common marine outfall system (line
Miscellaneous (ETP, SRP, 1.00 and outfall) will be used in
Manufacturing Blocks & Operations compliance with APCZMA
Areas cleaning, contaminated steam recommendations and CRZ
condensate, etc) regulations
Domestic 0.25
RO Rejects from Desalination Plant 23.5 Disposed to the sea through marine
out fall facility.
Total 42.77
Page 4
ANNEXURE – III: Water Balance
Total water required is 23.5 MLD. Th water requirement shall be met from Indira sagar
canal and samarlakot canal or it is proposed to establish desalination plant of capacity 47
MLD to meet water requirement of 23.5 MLD. Water from Bay of Bengal will be used as
feed water for Desalination Plant. Total water balance is presented in Table A-3.
Table A-3 Total Water Balance
S. Water Input Quantity Output Quantity
No. (MLD) (MLD)
1 Process Applications Process Wastewater
Pen G 8.00 Pen G 8.00
7-ACA 5.10 7-ACA 5.00
6-APA 0.61 6-APA 0.63
Glucose 1.00 Glucose 1.36
Penicillin Products 0.28 Penicillin Products 0.28
2 Boiler Make-up 3.50 Boiler Blow Down 1.00
3 CT make Up 3.00 CT Blow Down 1.50
4 QC, R&D & Garment 0.25 QC, R&D and Garment 0.25
Washing Washing
5 Miscellaneous (SRP, ETP, 1.00 Miscellaneous (ETP, SRP, 1.00
Manufacturing Blocks Manufacturing Blocks &
Operations Areas cleaning, Operations Areas
etc) cleaning, contaminated
steam condensate, etc)
6 Domestic 0.25 Domestic 0.25
7 Gardening 0.50 Gardening 0.00
Total 23.49 Total 19.27
ANNEXURE – IV: Solid Waste
Solid wastes are generated from the process, solvent distillation, wastewater treatment and
utilities. The effluent treatment system generates stripper distillate, ATFD salts and ETP
sludge. The process operations generate process residue, filter media, used catalysts,
activated carbon and inorganic residue. The recycling operation of distillation generates
solvent residue and spent mixed solvents. The utilities i.e., coal fired boiler generates ash
while DG sets generate waste oil and used batteries. All the wastes except coal ash are
considered hazardous. The other non-hazardous wastes are container, packing material,
Page 5
empty drums etc. The containers and drums are detoxified before disposing to authorized
buyers. The hazardous wastes of process residue, stripper distillate, solvent residue, and
activated carbon are sent to cement plants for co-incineration, thereby reducing the load on
TSDF facility and reducing consumption of non-renewable resource of coal in cement plant
kilns. Mixed solvents shall be sent to authorized recyclers/cement plant for co-incineration
while spent solvents are recovered within plant premises. The inorganic wastes, filter media,
used catalysts, salts from ATFD, and ETP sludge are sent to TSDF facility. The waste oil and
used batteries are sold to authorized recyclers. Coal ash is sold to brick manufacturers in the
local area. The total solid waste generated and mode of disposal is presented in Table A-4.
Table A-4 Total Solid Waste Generated and Mode of Disposal

S. Name of Hazardous Waste Unit Quantity Mode of Disposal
No
.
DISPOSAL OPTION
1 Forced Evaporation Salts TPD 75 Sent to TSDF
2 Process Inorganic Waste/Salts TPD 2 Sent to TSDF
3 ETP Sludge TPD 45 Sent to TSDF
4 Spent Carbon TPD 3.35 Sent to TSDF/ Cement Plants
for Co-incineration
5 Mixed Spent Solvents KLD 2.5 Sent to authorized recovery
units or Cement Plants for Co-
incineration
6 Process Liquid Organic Waste, KLD 2.50 Sent to Cement Plants for Co-
Solvents from QC and R&D incineration
Laboratory
7 Distillation Bottom Residue and TPD 64.64
Process Organic Wastes
8 Off specification raw materials/ TPM 5.6
products
9 Date Expired Products TPM 18 Sent to Cement Plants for Co-
incineration/TSDF
10 Contaminated cotton rags or TPM 0.2 TSDF / Cement Industry /
other cleaning materials Authorized recyclers
11 Waste Resin Kg/ 1200
Month
RECYCLING/REUSE OPTION
1 Mycelium (dry basis) TPM 3000 Agencies authorized by
PCB/CPCB
2 Used Oil/Waste Lubricating Oil KLD 0.5 Agencies authorized by
PCB/CPCB
3 Used Lead Acid Batteries Nos/ 600 Returned back to dealer or
Page 6
Anum supplier
4 Detoxified Containers and TPM 10 Sold to recyclers after
Container Liners detoxification
Other Waste -Disposal or Recycle
1 Asbestos TPA 5 Disposed to TSDF
2 Gypsum Boards TPA 5 Sent to Cement Plants for Co-
incineration /TSDF
3 Electrical & Electronic Waste TPA 15 Sent to authorized recyclers
4 Hard Rubber (Electrical Panel TPA 1 Sent to Cement Plants for Co-
Rooms) incineration /TSDF
5 Hardened Latex TPA 1
Paints/Varnishes,
adhesives/glues/resins/Plasticiz
ers
7 Packing Material TPM 20 Sale to recycler
8 Discarded PPE (Helmets, TPM 1 Recyclers/TSDF, HWMP
goggles, aprons, etc.)
10 Reagent Bottles: Glass/PP Bottles TPM 2 Sale to recycler
(Small Volume – up to 2.5 L
capacity)
11 Insulation wastes TPM 2.5 To outside agencies, after
complete detoxification for re-
use/ recycle
12 Miscellaneous Wastes--Sparkler TPM 1.67 TSDF and/ Cement Plants for
Filter Pads, Centrifuge Bags, FBD Co-incineration
Bags.
13 Miscellaneous Wastes--Discarded TPM 1 Sent to TSDF
Molecular Sieves/Ion-exchange
resin, etc
ANNEXURE – V: Stack Emissions Details

The sources of air pollution are proposed 4 x 150 TPH coal fired boilers, 4 x 4 Lac. k. Cal/hr
thermic fluid heater and standby DG sets of 15 x 1010 capacity. The proposed air pollution
control equipment for 4 x 150 TPH coal fired boilers is electro static precipitators (ESP).
Thermic fluid heaters and standby DG sets shall be provided with effective stack height based
on the CPCB formula. The emission rates of PM, SO2, NOx and SPM from each stack are
presented in Table A-5.
Page 7
Table A-5 Stack Emission Details

S. Stack Connected to Stack Dia of Temp. of Exit Pollutant Emission
No Ht (m) stack at exhaust Velocity Rate (g/sec)
top(m) gases (0C) (m/sec) PM SO2 NOx
1 4 x 150 TPH coal 70 4.5 190 25 6.8 16.5 18.7
fired boiler
2 4 x 4 Lakh Kcal 30 0.4 160 9 -- 0.16 0.24
Thermic Fluid
Heaters
3 15 X 1010 kVA DG 10 0.4 170 10 0.04 0.012 0.18
set*
*DG sets kept as standby.
Page 8

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Aurobindo Antibiotics Pvt. Ltd.

Environmental Management Plan

1.1 Location of the Project

1-1 Team Labs and consultants

1.3 Product Profile

1-2 Team Labs and consultants

Fig 1.1 Location of M/s. Aurobindo Antibiotics Pvt. Ltd

1-3 Team Labs and Consultants

Space for Future Expansion Space for Future Expansion

Production Block -1 Production Block -3 Space for Future Expansion

Space for ETP

Cogen / Boiler Area

Production Block -2 Production Block -4

Fig 1.2 Layout of M/s. Aurobindo Antibiotics Pvt. Ltd

1-4 Team Labs and Consultants

1.4.2 Corporate Environment Responsibility

1.5 Scope of Report

1-5 Team Labs and Consultants

1-6 Team Labs and Consultants

2.0 PROCESS DESCRIPTION

M/s. Aurobindo Anitibiotics Pvt. Ltd. a subsidiary of Aurobindo Pharma Ltd.

2.1 Process Description

2.1.18 Process Description of C-generation Power Plant

2-1 Team Labs and Consultants

generation of chilled water by VAMs. The electricity generated in the cogeneration

II. Steam turbine generator

2-2 Team Labs and Consultants

2.3 Water Requirement

2-3 Team Labs and Consultants

2 Boiler Make-up 3.50 Boiler Blow Down 1.00

2.4 Pollution Control Facilities

2.4.1 Water Pollution

2-4 Team Labs and Consultants

Manufacturing Blocks & Operations compliance with APCZMA

2.4.2 Air Pollution

2.4.2.1 Emissions from Utilities

2-5 Team Labs and Consultants

Table 2.6 Technical Specifications of ESP

2-6 Team Labs and Consultants

2.4.2.2 Diffuse Emissions

2.4.2.4 Fugitive Emissions

2-7 Team Labs and Consultants

2.2.2.5 Odour Management

2.4.4 Solid Waste

2-8 Team Labs and Consultants

Table 2.17 Total Solid Waste Generated and Mode of Disposal

2-9 Team Labs and Consultants

2.4.5 Noise Pollution

2-10 Team Labs and Consultants

CHAPTER 3.0ENVIRONMENT MANAGEMENT PLAN

3.1 Identification of Impacts

3-1 Team Labs and Consultants

Fig 3.1 Conceptual Model of Pharmaceutical Activity

3-2 Team Labs and Consultants

Fig 3.2Conceptual Model of Impacts Effects due to Manufacturing Activity

3-3 Team Labs and Consultants

3.1.1. Impact Networks

3-4 Team Labs and Consultants

Fig 3.3 Impacts on Air Environment