1 | p a g e · environment management plan human health care 1 | p a g e introduction: eisai co.,...

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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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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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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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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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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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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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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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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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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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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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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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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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