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EISAI PHARMACEUTICALS INDIA PVT LTD.
human health care ENVIRONMENT MANAGEMENT PLAN
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Introduction:
Eisai Co., Ltd. based in Tokyo, Japan is a research-based human health care (hhc)
company that discovers, develops and markets products throughout the world.
Eisai's corporate human health care (hhc) mission is to give first thought to patients
and their families, and to increase the benefits that health care provides.
Eisai Pharmaceuticals India Pvt. Ltd (EIL) a 100% subsidiary of Eisai Co. Ltd , has
set up a state of art Research and Manufacturing facility for Active Pharmaceutical
Ingredients and Formulations at Ramky Pharma City( SEZ) Visakhapatnam –Andhra
Pradesh, for export to global pharmaceutical markets.
EPM is having an integrated complex in Ramky Pharma City (SEZ), Plot
Nos.96,97,98,124 &126, Parawada - 531019, Visakhapatnam, Andhra Pradesh,
having manufacturing facilities of API & Formulations.
Eisai Pharmaceuticals India Pvt. Ltd. has applied for the consent for establishment
to the AP Pollution Control Board for Change of product mix (for inclusion of new
products) and enhancement of the existing production quantities. The details of
which has been attached with this report.
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EISAI PHARMACEUTICALS INDIA PVT LTD.
human health care ENVIRONMENT MANAGEMENT PLAN
2 | P a g e
ENVIRONMENT MANAGEMENT PLAN
Comprehensive Environmental Management Plan is envisaged to minimize pollution
load on air, water, land and socio-economic environment. As a global company, we
understand that impacts of our operations extend beyond the walls of our facilities
and hence all the business operations that are carried out at EIL are examined
continuously considering all the aspects of operations and management takes every
opportunity to reduce their impacts on environment.
To strengthen our environment management system we have designed and
implementing it, in-line with ISO-14001 guidelines.
ISO 14001 standards represents the core set of standards used by organizations for
designing and implementing an effective Environmental Management System
(EMS).
All the functional groups at EIL have performed a painstaking exercise to identify
the aspect of every activity which they perform at department level and its impact
on the environment has been documented and evaluated. Based on the criticality of
the impact, Operational Control Procedures (OCPs) are approved and implemented
to mitigate the impacts.
EIL also took Environment Management Plans (EMPs) to mitigate certain significant
impacts identified during the ISO-14001 implementation exercise and these plans
have been executed.
Our facility has been inspected by an auditing agency of international reputation
‘TUV-SUD’ and ISO-14001:2015 certification has been awarded to us in
Environment Management System.
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EISAI PHARMACEUTICALS INDIA PVT LTD.
human health care ENVIRONMENT MANAGEMENT PLAN
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1 Management Commitment
Management initiative, commitment and involvement are key elements of
Environment Management Program. The management at EIL is committed to adopt
and implement effective Environment Management System by conducting following
activities:
� Employee awareness and participation
� Improved operating procedures
� Adopting clean and efficient technologies
� Employee training
� Improved scheduling of processes
All efforts are made to make sure that manufacturing operations in our plant are
clean and efficient and controls are put in place to minimize air pollution, water
pollution and ground pollution.
These measures are described as below.
2. Air Pollution Control
Clean and efficient technologies have been adopted in our manufacturing plant to
minimize the air pollution like – Closed vacuum transfer system has been adopted
for transfer of wet mass. Pumps with mechanical seals and vacuum transfer system
are used for transfer of solvents to reduce emission of volatile organic compounds
into the atmosphere. All the process operations are carried out under closed
conditions and the entire manufacturing process is closely monitored and controlled
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EISAI PHARMACEUTICALS INDIA PVT LTD.
human health care ENVIRONMENT MANAGEMENT PLAN
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by computer based system (DCS system). The plant is operated by qualified and
experienced staff.
We have selected and installed suitable scrubbers for treating not only the acidic
gases generated during the process but also the fugitive emissions of the solvents.
To assess the quality of ambient air, On-line Volatile Organic Compounds monitor
with sampling ports are installed in up wind and down wind direction in the plant
premises. Periodic monitoring of exhaust from the stacks and ambient air is carried
out to ensure that the parameters are well within the defined norms.
In addition to above, on-line gas detection system has been provided in the process
area to identify the gases in the environment at work place.
The emissions from Boiler and DG set are passed through the adequate height of
stack. Boiler and DG set stack emissions have been monitored by the authorized
agency and reports are submitted to the Regional office – APPCB, on monthly basis.
The monitoring and testing of the air quality is carried out by an authorized agency
(Which is recognized by MoEF, GOI - New Delhi) for Ambient Air Quality, Stack
Emissions, Noise and Fugitive Emissions.
Three Ambient Air Quality monitoring stations have been identified within the
premises (they are - Terrace of R&D building, Terrace of Gate hosue-2, near
production building) and 15 stacks monitoring stations (stack of D.G sets, Boilers
and Scrubbers) are being monitoring once in a month and the reports are
submitted to A.P Pollution Control Board, regional Office Visakhapatnam.
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EISAI PHARMACEUTICALS INDIA PVT LTD.
human health care ENVIRONMENT MANAGEMENT PLAN
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3. Water Pollution Control
Two streams for the waste water from the plant have been designed. The Low TDS
(total dissolved solids) water is segregated from the high TDS water at the source
itself. The high TDS water is conveyed and stored above the ground to completely
rule out the possibility of land contamination. The Low TDS water is also pre-
treated before disposing off to centralized effluent treatment plant of our industrial
area.
The trade effluent from the process, Floor and Equipment washings, Boiler blow
down, cooling tower bleed off and domestic effluents have been pre-treated in the
Effluent treatment plant and fed to the Effluent conveyance lines of the developer of
our industrial area (M/s. Ramky) for further treatment and disposal in the
centralized effluent treatment plant.
The treatment process adopted in our plant is primary treatment only.
The High TDS and Low TDS waste water generated from process are collected
separately into above ground Effluent collection tanks and Effluent pH is adjusted to
6.5 to 8.5 using either Caustic Lye or Hydrochloric Acid. During the process of pH
adjustment in one particular tank, the effluent coming from the process shall be
collected in another tank. After pH adjustment, the waste water sample is collected
by M/s Ramky crew (CETP) for analysis. The approved waste water (Low TDS) is
conveyed to Ramky’s Common effluent treatment facility through the respective
Low TDS pipe line network through a flow meter.
After pre-treatment, HTDS Effluent or the approved waste water (High TDS) is
conveyed to Ramky’s Common effluent treatment facility through the respective
High TDS pipe line network through a flow meter.
The schematic drawing of the pre-treatment facility for LTDS and HTDS effluent
given below.
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EISAI PHARMACEUTICALS INDIA PVT LTD.
human health care ENVIRONMENT MANAGEMENT PLAN
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LTDS ETP SCHEMATIC DIAGRAM
Raw Effluent
Collection tank
Equalization cum
neutralization tanks
Equalization
cum
neutralization
tanks
PRE-TREATED EFFLUENT
HOLDING TANKS
Effluent
Conveyance
Pipeline to
CETP
NaOH HCl Web Camera
F
Flow Meter
(F)
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EISAI PHARMACEUTICALS INDIA PVT LTD.
human health care ENVIRONMENT MANAGEMENT PLAN
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HTDS ETP SCHEMATIC DIAGRAM
Collection Tank-1
Collection Tank-2
1 2 PRE-TREATED EFFLUENT
HOLDING TANKS
Effluent Conveyance
Pipeline to CETP
Chemical
Dosing
tank
Raw Effluent from
Production Blocks
F Flow Meter
(F)
Web Camera
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EISAI PHARMACEUTICALS INDIA PVT LTD.
human health care ENVIRONMENT MANAGEMENT PLAN
8 | P a g e
4. Land Pollution Control
To minimize the land pollution, containment pellets have been provided for storing
process waste. Drum containment pellets, spill kits and catchment trays have been
provided in our Labs and R & D section.
The high TDS water is conveyed and stored above the ground to completely rule
out the possibility of land contamination. Both the high TDS and Low TDS effluent is
stored, treated and conveyed above the ground to avoid land pollution.
A greenbelt in 30 Acres of area has been maintained in the plant premises.
PLANTATION PHOTS
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EISAI PHARMACEUTICALS INDIA PVT LTD.
human health care ENVIRONMENT MANAGEMENT PLAN
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EISAI PHARMACEUTICALS INDIA PVT LTD.
human health care ENVIRONMENT MANAGEMENT PLAN
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EISAI PHARMACEUTICALS INDIA PVT LTD.
human health care ENVIRONMENT MANAGEMENT PLAN
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EISAI PHARMACEUTICALS INDIA PVT LTD.
human health care ENVIRONMENT MANAGEMENT PLAN
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5. Noise Pollution Control
Our all process equipments are well designed with inbuilt safety features to
minimize sound level with in TLV values.
The DG sets are provided with acoustic enclosures and adequate dampening
arrangement and neoprene sleeves/slash pads have been provided for vibration
isolation for diesel generators.
The noise levels are being monitored both in daytime and night time; the reports
are being submitted to Regional office APPCB.
6. Solid Waste Management
The Solid Wastes generated from the plant are segregated in to hazardous and
non-hazardous wastes. Hazardous waste is stored in the Hazardous waste storage
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EISAI PHARMACEUTICALS INDIA PVT LTD.
human health care ENVIRONMENT MANAGEMENT PLAN
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shed. Non-hazardous solid wastes are stored in scrap shed. Details of hazardous
and non-hazardous wastes and their method of disposal are tabulated as below:
Hazardous waste
Waste
Description Waste materials details Disposable Method
Process waste
Rejected/expired raw
materials/intermediate/finished
product, spilled materials, Waste
solid samples, rejected, activated
alumina, activated charcoal, cation
resin, ash dust, Silica gel,
decontaminated media and cultures
etc.
Pack in container / bag
properly and sent to
Hazardous waste storage shed
along with transfer note for
further disposal to CWMP
(Coastal Waste Management
Project – TSDF )
Process waste Spent catalyst
Pack in container and sent to
Hazardous waste storage shed
for further disposal to
approved vendor / CWMP.
Non-process
waste / packing
material waste
Used Poly bags, Used PPEs, plastic
disposable petri plates, used filters
etc., Waste cotton, Oil soaked
cloth/cotton, cloth filters etc., Used
Polythene sample covers, asbestos
waste etc.
All packing material wastes
shall be kept in polythene bag
and sent to Scrap yard shed
for further disposal to CWMP.
Non-process
waste / packing
material waste
Used Poly bags, cable ties, lint free
wipes, worn-out mops, plastic
covers, used labels, rejected blisters,
PVC foils, printed Al. foils, Foil core,
All packing material wastes
shall be kept in polythene bag
and sent to Scrap yard shed
for further disposal to CWMP/
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EISAI PHARMACEUTICALS INDIA PVT LTD.
human health care ENVIRONMENT MANAGEMENT PLAN
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stationery items, rejected leaflets,
primary packing materials, Plastic
disposable lops, secondary packing
materials, treasury packing material,
Waste papers, files, bounded books,
used rubber gaskets, paper gaskets,
metallic gaskets, Waste cotton,
bunion clothes, used paper filters,
cartridge filters, cloth filters etc.,
Packing paper, thermo coal, waste
cardboard pieces etc.
approved Vendor.
E-Waste
Fused lamps, chokes, electronic
ballasts, wires, cables etc., worn out
computer accessories, DVDs, Printers
cartridges, Cell batteries, Lead acid
batteries etc.
E-waste should be collected
separately and sent to Scrap
shed for storage and further
disposal to CWMP/ approved
Vendor.
Non-Hazardous Waste:
Rubber & Plastic
Scrap
Rubber belts, rubber hoses, PVC
hoses, Plastic container, plastic
bottles, plastic spare parts, HDPE
pipes, flanges, other spare parts and
worn-out scrubber spare parts.
Shall be sent to scrap yard for
further disposal to vendor /
CWMP.
Metal scrap Metal pipes, fasteners, nut & bolts,
spare parts etc.
Metal scrap shall be sent to
Scrap yard for further
disposal.
Carton Boxes Carton boxes.
Remove the label on carton
boxes and sent to Scrap yard
for further disposal.
Drums & Barrels MS Drums, HDPE Drums, GI drums, Decontaminated drums
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EISAI PHARMACEUTICALS INDIA PVT LTD.
human health care ENVIRONMENT MANAGEMENT PLAN
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HDPE carboys, MS/GI small drums,
card board drums, plastic/HDPE
canes, paint tins etc.
before send to scrap shed
remove the label on the
containers and sent to scrap
yard for further disposal.
Wooden Waste Wood
Waste wood shall be sent to
scrap yard shed for further
disposal.
Glass Scrap
Broken glassware, empty chemical
bottles, GC glass columns, glass
vials, broken glass pieces,
Toughened glass, Non toughened
glass etc.
Cleaned glass bottles before
send to scrap shed and
remove the labels on the glass
bottles and clean the bottles /
sample vials thoroughly, sent
to scrap yard shed for further
disposal. (Note: If any
samples found in the vials
should empty out and collect
the sample separately, send
these samples to Hazardous
waste storage shed along with
transfer note).
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