M/S.

GLENMARK PHARMACEUTICALS LIMITED

ENVIRONMENTAL IMPACT & RISK ASSESSMENT REPORT

CHAPTER – 10:
Risk Assessment & Disaster Management Plan
10.1BACKGROUND
Identification analysis and assessment of hazards and risks provide vital information to the
risk management, that what should be the type & capacity of any on-site and off-site
emergency plan & what type of safety measures and maintenance is required. Risk and
consequence analysis has been carried out considering storage and handling of various
hazardous raw materials, intermediates and product as well as manufacturing process.

10.2 METHODOLOGY
Hazard Identification and Risk assessment is type of Quantitative risk assessment (QRA) is
mean of making a systematic analysis of the risks from hazardous activities, and forming a
rational evaluation of their significance, in order to provide input to a decision-making
process. The term ‘quantitative risk analysis’ is widely used, but strictly this refers to the
purely numerical analysis of risks without any evaluation of their significance. The study has
been conducted based on the premises of a traditional Quantitative Risk Assessment. The
key components of a QRA are explained below, and illustrated in Figure 10.1.
 M/S. GLENMARK PHARMACEUTICALS LIMITED
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FIGURE – 10.1
QRA METHODOLOGY

The purpose of Risk Assessment & HAZOP is to develop mitigation measures for
unacceptable generators of risk, as well as to reduce the overall level of risk to As Low as
Reasonably Practical.
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FIGURE – 10.2
ALARP PRINCIPLE

In order to help assess the viability of Risk Reduction Measures (RRM), the economic costs
of the measures can be compared with their risk benefits using Cost Benefit Analysis (CBA).

10.3STORAGE AND HANDLING OF HAZARDOUS CHEMICALS

The details of storage of Hazardous chemicals along with measures taken during storage are
given in Table 10-1.
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TABLE-10.1
STORAGE DETAILS OF HAZARDOUS CHEMICALS

Sr. Name of the Material Type of Kind of Max. Storage Tank Dyke
No. Hazard Storage Quantity to Condition Dimensions Dimensions
be stored i.e. Temp., in (m)
(MT) Pressure
1 Fire and OH Tanks 156 Ambient As per PESO As per PESO
PETROLEUM [Class- A in bulk] Explosion
License License
2 Fire and OH Tanks 125 Ambient As per PESO As per PESO
PETROLEUM [Class- B & C] Explosion License
License
3 Fire and OH Tanks 60 Ambient As per PESO As per PESO
PETROLEUM [Class- B] Explosion License
License
4 Fire and UG Tanks 124.5 Ambient As per PESO As per PESO
PETROLEUM [Class- A in bulk
Explosion License
& otherwise then in bulk] License
5 STOREGE OF COMPRESSED Fire and OH Tanks 3 Vessels Ambient As per SMPV As per SMPV
GAS IN PRESSURE VESSEL – Explosion License License
Liquid N2
6 Fire and OH Yard Diff Types of Ambient As per SMPV As per SMPV
STOREGE OF COMPRESSED
Explosion License License
GAS IN CYLINDER Cylinders
7 Acid Storage Area Corrosive AG Yard Diff Types of Ambient - -
Containers
8 Hazardous & Flammable Fire and AG Yard Diff Types of Ambient - -
Chemicals
Explosion Containers
and Toxic
9 Fire and AG Yard Diff Types of Ambient - -
Recovered Solvent Storage
Yard Explosion Containers
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Table -10.2
Properties of Chemicals

SR. NAME OF HAZARD FLASH BP LEL % UEL SP.GR. VD SOLUBILITY NFPA HAZARDOUS TLV IDLH LC50 CARCINO ANTIDOTE
0 0
CHEMICAL POINT C % 20 C WITH H F R COMBUSTIO PPM PPM mg/m3 GENIC
0
C WATER at 20 N PRODUCT TWA CHARACT
0
C ERISTIC
1. Toluene F 4.0 111 1.1 7.1 0.87 3.2 Insoluble 2 3 0 Irritating 50 2000 400 ppm No Diazem –
CAS # 108-88-3 Vapour for 24Hr mg/Kg.(Intraveno
generated Rat us), Epinephina,
Efidrine
2. Sulfuric Acid C -- 340 -- -- 1.84 -- Water 3 0 2 Non 1 15 510 mg/m3 No Sodium Hydro
3
CAS # 7664-93-9 reactive combustible mg/m3 mg/m for 2H Rat Carbonate (4
Conc.), Milk, Li
Juice, Milk of
Megnesia
3. Hydrochloric Acid C/T NF 108 NF NF 1.12 - 1.267 Soluble 3 0 1 NA 5 ppm 50 ppm 3124 ppm No Sodium Hydro
HCL 1.19 for 1h rat Carbonate (4%
Conc.), Milk, Lim
Juice, Milk of
Megnesia
4. Nitric Acid C -- 121 -- -- 1.408 2.5 Soluble 3 0 0 - 4 67 ppm 260 Yes Sodium Hydro
CAS # 7697-37-2 (NO2)/4 mg/m3/30 Carbonate (4%
H. M Rat Conc.), Milk, Lim
Juice, Milk of
Megnesia
5. Ethylene F/T 13 83 6.2 15.9 1.253 3.4 0.87 %0 2 3 1 HCl, 10 50 ppm 1414 Yes N.A.
Dichloride (EDC) Phosgene
CAS #107-06-2
6. Xylene F 25 140 1.7 7.5 0.878 4.5 Insoluble 2 3 0 Fire will - - 4550 ppm 4 Yes Diazem – 1
CAS No.1330-20-7 produce hour(s) mg/Kg.(Intraven
irritating, ous), Epinephina
corrosive
and/or toxic
gases
7. Methanol F 11 64.5 6 36.5 0.793 1.11 Very soluble 1 3 0 Fire will 200 - 64000 Yes 10 mg diazepam
CAS No. 67-56-1 produce ppm/4h through
irritating, injection

10-5
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corrosive
and/or toxic
gases
8. Hydrogen F -18 -252.8 4 76 - 0.07 0.17 mg 3 4 0 Heating may - - - No No specific
CAS No.1333-74-0 100 ml cause violent Antidote
combustion or
explosion
9. Liq. Ammonia T 11 -33.34 15 30 0.9 0.597 54 g/100 ml 3 1 0 Hock-sensitive 50 300 2000 No Wash with Lactic
CAS No.7664-41-7 compounds ppm/4-hr Acid, Apply
are formed soframycin
with mercury, Smelling Ethanol
silver and gold or Ether
oxides.
10. Dimethyl Formamide F 57.8 153 2.2 15.2 0.949 2.51 Easily soluble in 2 2 0 These 10 - 2800 mg/kg Yes Calcium
CAS No.68-12-2 cold water, hot products are Gluconate
water carbon oxides 10 ml
(CO, CO2), in 10% solution
nitrogen through injection
oxides (NO,
NO2)
11. Dichloromethane T -4 39.8 13 22 1.325 2.9 10-50 mg/ml 2 1 0 Dissociation 50 2300 14400 Yes Hydrocortisone
CAS No.75-09-2 products ppm/7H (200 mg at every
generated in a 4 hrs.) Aspirin
fire may be and if pneumonia
irritating or gives antibiotics
toxic
12. MIBK F 14 115.9 1.4 7.5 0.802 3.45 Insoluble 2 3 0 -- 50 ppm 300 ppm 8000 ppm Yes Not available
CAS # 108-10-1 for 4 hr
(Rat)
13. Sodium Hydroxide C -- 142 -- -- 2.12 -- Soluble 200 -- 2 -- -- No --
CAS No. 67-56-1
14. Sodium Nitrite T -- 120 -- -- 1.28 -- Miscible 102 -- 0.1 -- 88 mg/kg No --
CAS No. 67-56-1
15. Acetic anhydride Flammab 51 139.9 3.52 2.7 1.09 3.52 Not Soluble -- -- 10.3 5 ppm 200 ppm Yes Hydrocortisone
le/Toxic (200 mg at every
4 hrs.) Aspirin
and if pneumonia
gives antibiotics
16. Phosphoric Acid Toxic -- 108 -- -- 1.685 3.4 Easily 3 0 2 -- 3 -- 1530 No Sodium Hydro
soluble in (mg/m3 mg/kg Carbonate (4
hot water. ) [Rat]. Conc.), Milk, Lim

10-6
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Soluble in Juice, Milk
cold water. Megnesia
17. Tri Ethyl Amine F,T -8.3 89.7 1.2 8 0.73 3.48 Soluble 2 2 0 -- 10 1.2 8 NO --

18. Thionyl Chloride T -- 76 -- -- 1.638 4.1 Insoluble 3 0 0 -- 1 4.87 500 ppm NO Sodium Hydro
1Hr Rat Carbonate (4
Conc.), Milk, Lim
Juice, Milk
Megnesia
19. Butanol Flammabl 35 117.6 1.4 11.2 0.8100 2.55 Soluble 1 3 0 -- 1 -- 790 mg/kg, No 10 mg diazepam
e rat through
injection
20. Formaldehyde F/T 50 98 3 36.5 1.08 1.03 Soluble 1 3 0 -- 2 200 64000 ppm No --
4 hours
[Rat]

F = FIRE T = TOXIC
E = Explosive R = REACTIVE
BP = BOILING POINT LEL = LOWER EXPLOSIVE LIMIT
UEL = UPPER EXPLOSIVE LIMIT SP.GR = SPECIFIC GRAVITY
VD = VAPOUR DENSITY ER = EVAPORATION RATE
H = HEALTH HAZARD CLASS F = FIRE HAZARD CLASS
R = REACTIVE HAZARD BR = BURNING RATE
TLV = THRESHOLD LIMIT VALUE PPM = PARTS PER MILLION
STEL = SHORT TERM EXPOSURE LIMIT NFPA = NATIONAL FIRE PROTECTION ASSOCIATION-USA

10-7
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FIGURE –10.3
SITE PLAN

Tank Farm
Area
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10.4 Facilities / System for process safety, Storage, transportation, fire fighting
system and emergency capabilities to be adopted.

10.4.1 PROCESS SAFETY:

Flameproof equipment’s and fittings will be provided for handling of hazardous chemicals.
1. Safety measures will be adopted from the design stage.
2. The reaction will be carried by heating, here the heat energy will be conducted vide steam
through Jackets/Limpet Coils. Low Pressure Steam Line will be connected to these vessels
with jackets /Limpet coils appropriately insulated. The vessels will also be fitted with safety
valve, pressure indicator for visual periodic checks.
3. Safety Valve and pressure gauge will be provided on reactor jacket.
4. PRV will be provided from steam boiler high pressure line to control required pressure in
reactor jacket.
5. Utility like Chilling, cooling, vacuum, steaming and its alternative will be provided to
control reaction parameters in a safe manner.
6. Control of addition of reactants in to reactor by gravity from day tank or by manual
addition in continuous watching temperature and other critical reaction parameters.
7. Free Fall of any flammable material in the vessel/ reactor will be avoided.
8. Powder charging through man hole will be avoided and safe hoper with slotting
arrangement will be adopted.
9. Static earthing provision will be made at design stage to all solvent handling equipments,
reactors, vessels & powder handling equipments.
10. Any reaction upsets will be confined to the reaction vessel itself as defined quantity of
charges of raw materials is issued to the reaction vessel/Day tank by metering pumps, or
manual charging by drums.
11. Stirrer On- Off position indicators will be provided.
12. Reactor vent line will be connected with reflux unit or condenser in case of VOC or with
scrubber in case of toxic gas generation in reaction.
13. All emergency valves and switches will be easily assessable.
14. Distillations will be carried out under vacuum distillations wherever required. Hence the
pressure development within the unit will not occur. However since the distillations will be
carried out well above the flash point of the mass.
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15. Further all the vessels will be examined periodically by a recognized competent person
under the Gujarat Factory Rules 1963-Rule 61(1).
16. All the vessels and equipment’s will be well earthed appropriately and well protected
against Static Electricity. Also for draining in drums proper earthing facilities will be
provided.
17. Materials will be transferred by pumping through pipeline or by vacuum from drums.
18. Temperature indicators are provided near all reactor and distillation process.
19. Caution note, safety posters, stickers, periodic training & Updation in safety and
emergency preparedness plan will be displayed and conducted.
20. Flame proof light fittings will be installed in the plant.
21. All the Plant Personnel will be provided with Personal Protection Equipments to protect
against any adverse health effect during operations, leakage, spillages or splash. PPE like
Helmets, Safety Shoes, Safety Glasses, Acid-Alkali Proof Gloves etc. will be provided to the
employees. All employees will be given and updated in Safety aspects through periodic
training in safety.
22. Material Safety Data Sheets of Raw Materials & Products will be readily available for
shop floor People.
23. Full fledge ETP plant followed by RO plants and MEE will be available and it will take
care of liquid effluent of the plant and final discharge parameter will be maintained as per
GPCB norms.
24. Scrubbers system will be provided on all process vents wherever required and air
monitoring will be carried out and parameters will be maintained as per GPCB norms.
25. Safety permit for hazardous material loading/unloading will be prepared and
implemented.
26. Oxygen Analyzer is compulsory for the entry of confined space for monitoring oxygen
level throughout the work and warning of low oxygen level if any deviation occurred.

For Underground and above ground storage tank farm:

1. Class A petroleum products will be received through road tanker and stored in storage
tank as per petroleum rules.
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2. Tank farm will be constructed as per explosive department requirement and separation
distance will be maintained.
3. Static earthing provision will be made for road tanker as well as storage tank.
4. Flame arrestor with breather valve will be provided on vent line.
5. Road tanker unloading procedure will be prepared and implemented.
6. Fire load calculation will be done and as per fire load Hydrant System will be provided as
per NFPA std. and Fire extinguishers will be provided as per fire load calculation.
7. Spark arrestor will be provided to all vehicles in side premises.
8. Flame proof type equipment and lighting will be provided.
9. Lightening arrestor will be provided on the top of chimney.
10. Trained and experience operator will be employed for tank farm area.
11. NFPA label (hazard identification) capacity and content will be displayed on storage tank.
12. Solvents will be transferred by pump and through drum dispensing in plant area and day
tank will be provided wherever required. Overflow line will be return to the storage tank or
Pump On-Off switch will be provided near day tank in plant.
13. Jumpers are be provided on solvent handling pipe line flanges.
14. Flexible SS hose will be used for road tanker unloading purpose and other temp.
Connection.
15. Tanker unloading activity will be proceeding through Unloading/loading of flammable /
hazardous chemical work permit.

For Drum Storage area:

Some chemicals will be received at plant in drums by road truck and stored in a separate
drum storage area.
• FLP type light fittings will be provided.
• Proper ventilation will be provided in godown.
• Proper label and identification board /stickers will be provided in the storage area.
• Drum handling trolley / stackers/fork lift will be used for drum handling.
• Separate dispensing room with local exhaust and static earthing provision will be made.
• Materials will be stored as per its compatibility study and separate area will be made for
flammable, corrosive and toxic chemical drums storage.
• Smoking and other spark, flame generating item will be banned from the Gate.
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Transportation
1. Class A petroleum products will be received through road tanker and stored in storage
tank as per petroleum Act & Rules.
2. Road tanker unloading procedure will be in place and will be implemented for safe
unloading of road tanker.
3. Static earthing provision will be made for tanker unloading.
4. Earthed Flexible Steel hose will be used for solvent unloading from the road tanker.
5. Fixed pipelines with pumps will be provided for solvent transfer up to Day tanks/reactors.
6. Mechanical seal type pumps will be installed.

Safety Measures for Acid storage tank area:

• Storage tank will be stored away from the process plant.
• Tanker unloading procedure will be prepared and implemented.
• Caution note and emergency handling procedure will be displayed at unloading area and
trained all operators.
• NFPA label will be provided.
• Required PPEs like full body protection PVC apron, Hand gloves, gumboot, Respiratory
mask etc. will be provided to operator.
• Neutralizing agent will be kept ready for tackle any emergency spillage.
• Acid scrubber will be installed to scrub acid fumes generated in acid storage area.
• Safety shower, eye wash with quenching unit will be provided in acid storage area.
• Material will be handled in close condition in pipe line.
• Dyke wall will be provided to all storage tanks, collection pit with valve provision.
• Double drain valve will provided.
• Level gauge will be provided on all storage tanks.
• Safety permit for loading unloading of hazardous material will be prepared and
implemented.
• TREM CARD will be provided to all transporters and will be trained for transportation
Emergency of Hazardous waste.
• Fire hydrant system with jockey pump as per TAC norms will be installed.
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10.4.2SAFE DESIGN AND MAINTENANCE

After studying the properties of the material to be stored, proper selection of the material
of construction, metal thickness, design, nozzles, connections, pipe lines, fittings, valves,
pumps, lining, coating, jacketing, insulation, cladding etc. and colour coding are necessary.

10.4.3HANDLING OF CORROSIVE CHEMICALS

Important corrosive substances are: Acids and alkalis

When in contact with human tissues, most corrosive substances will produce chemical burns,
while certain other substances produce deep ulceration. Many corrosive substances have a
defeating action on the skin and may cause dermatitis.

The safeguards against these hazards will:

Preventing or minimizing contact between corrosive substances and skin, mucous

membranes and eyes.

Corrosive substances will be not allowed to come in contact with materials that may
react.

All the containers, pipes, apparatus, installations and structures used for the
manufacture, storage, transport or use of these substances will be protected by
suitable coatings, impervious to and unaffected by corrosives.

All containers or receptacles are clearly labeled to indicate their contents and should
bear the danger symbol for corrosives.

A high standard of maintenance and good housekeeping will essential.

Adequate ventilation and exhaust arrangement whether general or local, should be

provided whenever corrosive toxic gases or dust are present.

Personal protective devices will be used depending upon the nature of work viz.
o Corrosion-resistant and impervious suits, or hand-gloves, aprons etc.
o Respirator, gas mask or self contained breathing apparatus,
o Barrier cream when exposure is not severe.

First aid treatment facilities are provided and all concerned will be instructed to
follow safe practices such as
o Prolonged washing with water
o Removing contaminated clothing
o Seeking immediate medical help
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Safety showers and eye washers will be provided.

10.4.4 FIRE FIGHTING SYSTEM

Fire Detection System:
Automatic detection of fire is essential especially for hazard, sensitive and unmanned area.
Unit shall provide automatic fire detection system which includes heat, smoke detector to
give audio / visual alarm / signal locally as well as in the permanently manned area. This in
turn helps in early detection of the fire and to start fire-fighting activity at early stage.

Fire Alarm
150 V AC operated fire alarm, with manual call points shall be provided in plant call points
location to start, activate alarm, siren shall be indicated in site plant provided in ECC, control
rooms and OHC. Zone indication is received at main gate. To identify problem area and
communicate to main gate security officer, coordinate with OHC / fire station, to organize
help to respective zones with ambulance and fire tender.
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Fire hydrant Pump Details:-
Technical Details of
Electrical Pump Diesel pump Jockey pump
Hydrant Pumps
Mather & Platt pump
Make Kirloskar Kirloskar
Ltd
Capacity 75.83 L/S 273 M3/Hr 14.97 L/S
167 HP
Motor Power 110 KW 22 KW
(DG Rating)
Motor RPM 2900 1800 2900
Head 88 M 88 M 88 M

Hydrant Points and other details:-

• Single Hydrant stand points - 67 No
• Double Hydrant stand points - 05 No
• Fire Escape Hydrant points - 37 No
• Foam-water monitors - 15 No
• Total Hydrant points – 124 No
• Location of fire water tanks & capacity- 550 Kl underground storage
Tank near engineering office.
Details of qualified and trained fire personnel & their job specifications:-
List of Trained Fire Fighter
Sr. Sr.
Name of Fire Fighter Department Name of Fire Fighter Department
No. No.
1 Mr. Yatin Patel EHS 20 Mr. Viraj Shah Plant-08
2 Mr. Hiren Gandhi Engineering 21 Mr. ChandrabhanSrivastav Plant-08
3 Mr. Jatin Patel Engineering 22 Mr. Laxman D Chaudhary Plant-09
4 Mr. Subhash Bhatiya Plant-01 23 Mr. Prakash Modhvadiya Plant-10 M-I
5 Mr. MayurHirkani Plant-01 24 Mr. Naresh Parmar Plant-10
6 Mr. Suresh Sharma Plant-01 25 Mr. JigarBhatiya Plant-12
7 Mr. Mayur Dave Plant-02 26 Mr. Krunal Patel Plant 13
8 Mr. Jaykishan Patel Plant-02 27 Mr. Vikas Chavan Plant-14
9 Mr. Ashvani.Pandey Plant-03 28 Mr. Rahul vala Plant-15
10 Mr. Dharmik.Dixit Plant-03 29 Mr. Gulab Mali. Plant-15
11 Mr. Tanajisomavansi Plant-03 30 Mr. Dharmesh.Baldha Plant-15
12 Mr. Avneendr Singh Plant-04 31 Mr. Gajanan.Bhomre PRD
13 Mr. Akhilesh Sharma Plant-05 32 Mr. Ramneti Prasad Q.C
14 Mr. DenishGheewala Plant-05 33 Mr. Rakesh Jhungare Q.C
15 Mr. Birendra Singh Plant-05 34 Mr. Dhaval Patel Q.C
16 Mr. Praveen Singh Plant-06 35 Mr. Dara.Ansari T.T
17 Mr. Himaxu Modi Plant-06 36 Mr. Adarsh Dubey Warehouse
Mr. Ashik Mohd.
Plant-06 Mr. Krunal Marfatia
18 Shaikh 37 Warehouse
19 Mr. Nilesh Sable Plant-07
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Roles and Responsibilities

1. You are required to maintain fire control equipment in good working condition and
measures at your department / section.
2. You are required to regularly impart awareness to fire wardens on fire prevention,
protection & emergency preparedness.
3. You are required to inform the FPPC through Monthly Report for your department /
section highlighting the following:
a. Status on fire control measures
b. Operational status of Fire Extinguishers and other Fire Fighting Equipment
c. Operational status of Emergency Exits and Escape / Emergency Lighting
d. Operational condition of fire proof doors if applicable

Mutual Aid facility:

Nearest fire station is DPMC which is away around 2.5 Km from the organization &
maximum five minute time required to reach at the site.

Details of detector installation:

List of Safety Equipment No of Items Remark
1. Warehouse
2. Admin block
3.Engg store
4. PCC area
Smoke detector 122
5. DG house
6.PRD lab
7. Utility area
8. BSR store
Heat Detector 20 1. Solvent Store
2.PRD lab dryer room
3. PCC-2 battery room

TABLE 10.3
Details of Fire fighting installation:

Sr No List of Safety Equipment’s No of Items Remark

1 ABC Type Fire Extinguisher 164
2 CO2 type fire extinguisher 185
Total-682 fire extinguisher
3 DCP type fire extinguisher 244
4 Foam type fire extinguisher 89
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5 Fire Bucket 96 18 location
6 Safety Shower 45 All Plant
Plant-8
Plant-3
Plant-5
Opp. Engg office
Solvent Store
Gate No. 4
ECC-1
ECC-1
7 SCBA Set 16
Fire Tender
Plant-10
Gas Cylinder Storage
Plant-06
Plant-15
Plant-15 M-2
Plant No-2 Intermediate
First Floor passage, QC
Hose Box available at hydrant
8 Hose Box 99
point
9 Hose Pipe in hose Box 198 Available in all Hose box
1. Plant-8
Hose pipe in Emergency Utensil 2. PRD lab
10 4
Box 3. Plant-10
4. Opp Plant-11
1. Near Plant-11
11 Portable foam Trolley 2
2. Near Utility-3 (PESO Side)
1. Plant-8
2. Plant-6
12 Hose Reel 10
3. Plant-14
4. Plant-15
1. Plant-8
2. PRD lab
13 Emergency Utensil Box 4
3. Plant-10
4. Opp Plant-11
14 Manual Call Point 74 Near All Plant area
1.Main Gate
2. Plant-8
3. Plant-5
15 Wind Shock 6
4. MEE
5. Plant-11
6. Plant-15
1. Main Gate
16 Emergency Siren 4
2. Plant-2
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3. Plant-6
4. Plant-15
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10.5 HAZARD IDENTIFICATION
The major hazards in the M/s. Glenmark Pharmaceuticals Limited are described below...
Fire and Explosive hazard due to leakage of chemicals Toluene, DMF, methanol and
petroleum Class chemicals etc.
Corrosive hazard due to leakage of chemicals like HCl, H2SO4, etc.
Toxic hazard due to leakage of chemicals like MDC, EDC, bromine, ammonia etc.
Electrical hazards due to the electrical major equipment/ machinery, operations,
welding, motors, and heavy lift devices, cabling, human intervention (short circuit
possibility), maintenance work (due to machinery breakdown etc.), plant lighting
related electrical hazards.
Possibility of human injury due to working with mechanical machines, manual
handling etc.
Possibility of injury during chemicals handled, during operations and due to
intoxication.
Major dropped objects hazard due to large number of physical handling steps /
operations involved with crane/ overhead lifting/ hoisting equipment.
Fires in any part of the plant working areas – there is a possibility of rapid escalation
if it is not brought under control quickly.
Possibilities of fire hazards at transformers, switchgear and other electrical
equipment etc.
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10.5.1Hazard Control measures
A) Hazard Control Measures:

1) Fire Hazard 2) Others Hazard 3) Chemical / Solvent leakage

Flameproof electrical WH & Solvent Building Handling of chemicals

apparatus installed at located away from other with confined
probable fire hazard area. plants. containers / drums
Well maintained Fire Online flammable gas only.
Fighting Apparatus (fire detection meters with Availability of spillage
extinguisher, fire hydrant audible alarm / hooter. control kit & sand
system) in sufficient Explosion proof wall & buckets on specific
quantity. doors of process area locations.
Well defined storage where such hazards are Regular monitoring of
facility for fire hazard apparent. VOC level of plant by
substances. Copper Jumpers are internally and
Copper Jumpers are provided on solvent externally agency and
provided on solvent transferring lines. precaution are taken to
transferring lines. Earthing/Bonding system avoid exposure.
Earthing/Bonding system is provided at designated PPEs like organic
is provided at designated areas. cartridge mask , air
areas. Process operated by bubbler and full body
Smoke detectors and fire competent person only. pressure suit with
alarm system installed at Regular testing / breathing air provision
site. inspection of pressure are provided as and
Process / operation vessels by competent when required.
handling by competent person as per GFR (form People in vicinity of
person only. no. 11). area are trained to use
Permit to work system. Installation of safety spillage control kit.
Round the clock valve on probable SCBA set is readily
availability of qualified explosion hazards available at designated
Safety Officer & vessels. locations for
Paramedic. Gas cylinders are stored emergency scenario.
Mutual aid with nearby at separate area with
industries and Disaster safety care.
Preventive Management Permit to work system.
Centre.
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10.6 OCCUPATIONAL HEALTH HAZARD AND SAFETY PROGRAM FOR THE PROJECT

Occupational Health is eventually a branch of preventive medicine which examines the

relationship between work and health and effects of work on the health of the worker.
Occupational health service is operated to achieve the statutory declared aim of
occupational health by medical and technical measures. Its role is mainly preventive and to
give first aid and emergency treatment. It is certainly useful in early detection of any
occupational or non-occupational disease or any man-adjustment of the man-job
relationship.

OCCUPATIONAL HEALTH AND SAFETY PROGRAM:

Pre-employment & Periodic Medical check for all the workers.
Induction Training is emphasis on workplace safety and hygiene.
Workplace safety and Hygiene provisions are included with fresh cleaned uniform /
gowning etc.
Provision of OHC, Rest Room and Canteen.
Well ventilated workplaces / area.
Adequate sanitation facility.
Adequate illumination is provided.
Periodic Noise level Monitoring to take measures for the noise level reduction.
Promotional Programs on Personnel and workplace hygiene. (swatch Bharat Campaign
, NSW and WED celebrations)
Effective Machine Guarding is provided at Pumps, compressors, utilities and other
concern machineries.
Workers are wearing all the required PPE’s as per respective operation OR Material
Handling.
Organization is OHSAS: 18001 and ISO 14001 certified, and maintaining systems
accordingly.
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The working personnel shall be given the following appropriate personnel protective
equipment’s.
• Industrial Safety Helmet;
• Face shield
• Welders equipment for eye and face protection;
• Ear muffs;
• Self contained breathing apparatus;
• Leather apron;
• Aluminized fiber glass fix proximity suit with hood and gloves;
• Boiler suit;
• Safety belt/line man's safety belt;
• Leather hand gloves;
• Acid/Alkali proof rubberized hand gloves;
• Canvas cum leather hand gloves with leather palm;
• Electrically tested electrical resistance hand gloves; and
• Industrial safety shoes with steel toe.
Expected Occupational Health Hazards & Safety
• Physical Hazards: Noise, Heat, Dust
• Chemical Hazards: Corrosive, Toxic Substances, Irritants, Carcinogens, Chemical
emissions
• Psychological hazards resulting from stress and strain
• Hazards associated with the non-application of ergonomic principles, for example
badly designed machinery, mechanical devices and tools used by workers, improper
seating and workstation design, or poorly designed work practices

Expected chemical hazards in work environment

Name of Chemical Health Hazard due to exposure to these chemicals
Acids Corrosive, Irritant. Causes severe eye burns.
Causes skin burns. May cause deep, penetrating ulcers of the skin.
Solvents Hazardous in case of skin contact (irritant, permeator), of eye contact
(irritant), of ingestion, of inhalation.
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Mitigation Measures for the Occupational Safety & Health hazards so that such exposure
can be kept within permissible exposure level (PEL)/Threshold Level value (TLV) so as to
protect health of workers.

Mitigation Measures for OSH: It is proposed to formulate and implement a structure for
Occupational Safety and Health with following aims…
• To keep air-borne concentration of toxic and hazardous chemicals below PEL and TLV.
• Protect general health of workers likely to be exposed to such chemicals
• Providing training, guidelines, resources and facilities to concerned department for
occupational health hazards.
• It is proposed that this EMP be formulated on the guidelines issued by Bureau of Indian
Standards on OH&S Management Systems: IS 18001:2000 Occupational Health and Safety
Management Systems
• Proposed EMP will be incorporated in Standard Operating Procedure also.

The proposed EMP will also include measure to keep air-born concentration of toxic and
hazardous chemicals below its PEL and TLV, like…
– Leak Surveys
– Separate storage for toxic chemicals
– Exhaust Ventilation
– Proper illumination
– Close processes to avoid spills and exposures
– Atomization of process operations to hazards of manual handling of chemicals
– Supply of proper PPEs like Air mask, Berating canisters, SCBA sets, On-line breathing
apparatus at the places where there is possibility of presence of toxic chemicals
– Decontamination procedure for empty drums and carboys.
– Regular maintenance program for pumps, equipment, instruments handling toxic and
corrosive chemicals
– Training to persons handling toxic and corrosive chemicals
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Workplace Monitoring Plan

• It is proposed that a Workplace Monitoring Plan to be prepared & implemented in

consultation with FMO and industrial hygienists.
• Each workplace must be evaluated to identify potential hazards from toxic substances
or harmful physical agents. Air-borne concentration of toxic chemicals will be
measured and record will be kept.
• The current state-of-the-art exposure measurement model is as follows: For purposes
of measuring worker exposure across a single shift it is sufficient t o place a reasonably
accurate exposure measuring device on the worker, within the worker’s breathing
zone, and have it operate for nearly the full shift. Client will propose to study the
exposure data when the plant is operative.
• Permanent changes to workplace procedures or work location to be done if it is found
necessary on the basis of findings from workplace Monitoring Plan.

Health Evaluation of Workers

It is proposed that management will devise a plan to check and evaluate the exposure
specific health status evaluation of workers.
Workers will be checked for physical fitness with special reference to the possible health
hazards likely to be presented where he/she is being expected to work before being
employed for that purpose. Basic examinations like Liver Function tests, chest x ray,
Audiometry, Spirometry Vision testing (Far & Near vision, color vision and any other ocular
defect) ECG, etc. will be carried out. However, the parameters and frequency of such
examination will be decided in consultation with Factory Medical Officer and Industrial
Hygienists.
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10.7 Risk Management
M/s. Glenmark Pharmaceuticals Limited will be managed the economical and social aspects
of risk. Improvement in scientific and factual basis for risk assessment is necessary for better
risk management decisions and public creditability of those decisions. However, M/s.
Glenmark Pharmaceuticals Limited will do the QRA to be undertaken prior to risk
management decisions.

M/s. Glenmark Pharmaceuticals Limited will consider the Risk management strategies
including all the specific activities. First step involves taking a decision about the weather
any actions are necessary and if so, what nature of the action should it be. Industries’ risk
management decision shall be based not only computed risk in terms of fatality probability
(fatality/year), but also on judging the acceptability of the risk – a matter of personal and
social value judgement. The risk management includes implementing the actions, decided
upon and evaluating their effects.

The fatality probability is function of:

• Probability of occurrence of hazardous events
• Probability of weather condition, wind direction
• Probability of number of persons exposed which depends on the severity of the
consequences
• Lethality factor
• Probability of ignition source

Any potentially hazardous installation or operation in individual member industries could be

made safer through enhances implementation of safeguards, diverse control systems,
multiple containment barriers and redundant structures.
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10.8 Quantitative Risk Assessment
FIG. 10.4

Start Identify Risk Areas

Select a Risk Area

Identify Failure Cases

Select a Failure Cases

Identify Consequence

Select Consequence Outcomes

Next Next
Determine Frequency

Estimate

Record Frequency and Consequence in a summary

Have all Consequence outcomes been studied?

Have all failure cases been studied?

Have all risk areas been studied?

Define Possible Risk Finish

Yes
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Identification of Hazardous Areas

The procedure for QRA starts with identification of major risk areas in the installation.
Operation carried out in chemical Industry usually come under certain board, general
categories.

• Bulk storage of liquids (e.g. Solvent) area in M/s. Glenmark Pharmaceuticals Limited at
ambient temperature and atmospheric pressure.
• Hydrogenation area ( High Pressure reactions)
• Process Plant involving Piping, pumping, transportation, reactors, distillation, heating,
cooling, electricity etc.
• Drum Storage Area.

Identification of Failure cases for Hazardous areas

• Release due to catastrophic failure of drum or process vessels.

• Rupture of connected pipe with process vessels.
• Continuous release at significant rates for long durations transfer pipelines caused by
sudden, major break of the pipeline.
• Continuous release at low rate through small holes or cracks in piping and vessels, flange
leaks, and leakage from pump glands and similar seals.
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10.9CONSEQUENCE ANALYSIS
In a plant handling hazardous chemicals, the main hazard arises due to storage, handling &
use of these chemicals. If these chemicals are released into the atmosphere, they may cause
damage due to resulting fires or vapour clouds. Blast Overpressures depend upon the
reactivity class of material and the amount of gas between two explosive limits.

Operating Parameters
Potential vapour release for the same material depends significantly on the operating
conditions. Especially for any liquefied gas, the operating conditions are very critical to
assess the damage potential.

Inventory
Inventory Analysis is commonly used in understanding the relative hazards and short listing
of release scenarios. Inventory plays an important role in regard to the potential hazard.
Larger the inventory of a vessel or a system, larger the quantity of potential release.
The potential vapour release (source strength) depends upon the quantity of liquid release,
the properties of the materials and the operating conditions (pressure, temperature). If all
these influencing parameters are combined into a matrix and vapour source strength
estimated for each release case, a ranking should become a credible exercise.

Loss of Containment
Plant inventory can get discharged to Environment due to Loss of Containment. Certain
features of materials to be handled at the plant need to the clearly understood to firstly list
out all significant release cases and then to short list release scenarios for a detailed
examination. Liquid release can be either instantaneous or continuous. Failure of a vessel
leading to an instantaneous outflow assumes the sudden appearance of such a major crack
that practically all of the contents above the crack shall be released in a very short time. The
more likely event is the case of liquid release from a hole in a pipe connected to the vessel.
The flow rate will depend on the size of the hole as well as on the pressure, which was
present, in front of the hole, prior to the accident. Such pressure is basically dependent on
the pressure in the vessel. The vaporisation of released liquid depends on the vapour
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pressure and weather conditions. Such consideration and others have been kept in mind
both during the initial listing as well as during the short-listing procedure. In the study,
Maximum Credible Loss accident methodology is to be used, therefore, the largest potential
hazard inventories have been considered for consequence estimation.

Damage criteria
In consequence analysis, use is made of a number of calculation models to estimate the
physical effects of an accident (spill of hazardous material) and to predict the damage
(lethality, injury, material destruction) of the effects. The calculations can roughly be divided
in three major groups:
a) Determination of the source strength parameters;
b) Determination of the consequential effects;
c) Determination of the damage or damage distances.
The basic physical effect models consist of the following.

Source strength parameters

Calculation of the outflow of liquid, vapour or gas out of a vessel or a pipe, in case of
rupture. Also two-phase outflow can be calculated.
Calculation, in case of liquid outflow, of the instantaneous flash evaporation and of
the dimensions of the remaining liquid pool.
Calculation of the evaporation rate, as a function of volatility of the material, pool
dimensions and wind velocity.
Source strength equals pump capacities, etc. in some cases.

Consequential effects
Dispersion of gaseous material in the atmosphere as a function of source strength,
relative density of the gas, weather conditions and topographical situation of the
surrounding area.
Intensity of heat radiation [in kW/ m2] due to a fire or a BLEVE, as a function of the
distance to the source.
Energy of vapour cloud explosions [in N/m2], as a function of the distance to the
distance of the exploding cloud.
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Concentration of gaseous material in the atmosphere, due to the dispersion of
evaporated chemical. The latter can be either explosive or toxic.
Selection of Damage Criteria
The damage criteria give the relation between extent of the physical effects (exposure) and
the percentage of the people that will be killed or injured due to those effects. The
knowledge about these relations depends strongly on the nature of the exposure. For
instance, much more is known about the damage caused by heat radiation, than about the
damage due to toxic exposure, and for these toxic effects, the knowledge differs strongly
between different materials.

In Consequence Analysis studies, in principle three types of exposure to hazardous effects

are distinguished:
- Heat radiation, from a jet, pool fire, a flash fire or a BLEVE.
- Explosion
- Toxic effects, from toxic materials or toxic combustion products.
In the next three paragraphs, the chosen damage criteria are given and explained.

MAXIMUM CREDIBLE LOSS ACCIDENT SCENARIOS

A Maximum Credible Accident (MCA) can be characterised as the worst credible accident. In
other words: an accident in an activity, resulting in the maximum consequence distance that
is still believed to be possible. A MCA-analysis does not include a quantification of the
probability of occurrence of the accident. Another aspect, in which the pessimistic approach
of MCA studies appears, is the atmospheric condition that is used for dispersion calculations.
As per the reference of the study, weather conditions having an average wind speed of
2.0m/s have been chosen.

The Maximum Credible Loss (MCL) scenarios have been developed for the Facility. The MCL
cases considered, attempt to include the worst “Credible” incidents- what constitutes a
credible incident is always subjective. Nevertheless, guidelines have evolved over the years
and based on basic engineering judgement, the cases have been found to be credible and
modelling for assessing vulnerability zones is prepared accordingly. Only catastrophic cases
have been considered and not partial or small failures (as is the case in Quantitative Risk
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Assessment where contributions from low frequency - high outcome effect as well as high
frequency - low outcome events are distinguished). The objective of the study is emergency
planning; hence only holistic & conservative assumptions are used for obvious reasons.
Hence though the outcomes may look pessimistic, the planning for emergency concept
should be borne in mind whilst interpreting the results.

CONSEQUENCE ANALYSIS CALCULATIONS

The Consequence Analysis has been done for selected scenarios. This has been done for
weather conditions having wind speed 2.14 m/s. In Consequence Analysis, geographical
location of the source of potential release plays an important role. Consideration of a large
number of scenarios in the same geographical location serves little purpose if the dominant
scenario has been identified and duly considered.

SOFTWARE USED FOR CALCULATIONS

Phast Micro:
Phast is the most comprehensive software available for performing Process Hazard Analysis
(PHA), Quantitative Risk Assessment (QRA) and Financial Risk Analysis (FRA). Our
extensively validated software for consequence and risk analysis is used by governments
and industry helping them to comply with local safety regulation and their own corporate
best practice. Phast contains all the discharge, dispersion, effects and risk models you will
need to accurately assess all your major hazards and associated risks. Phast Consequence
provides you with comprehensive hazard analysis facilities to examine the progress of a
potential incident from the initial release to its far-field effects.

Toxic and Flammable Impact

It calculates the initial discharge, as the material expands from its storage conditions to
atmospheric, through dispersion, as the material mixes with air and dilutes, and the
subsequent toxic or flammable effects. Phast includes a wide range of models for discharge
and dispersion as well as flammable, explosive and toxic effects.
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Discharge
• Phast requires basic information about storage or process conditions and material
properties in order to perform discharge calculations
• The software comes with an integrated material property database containing more
than 1,600 pre-defined pure component chemicals
• Various discharge scenario options have been implemented to represent common
process failures, and model their behavior. These include:
Leaks and line ruptures from long & short pipelines
Catastrophic ruptures
Relief valve and disc ruptures
Vent from vapour spaces
In building release effects

Dispersion
The dispersion models within Phast are able to model the following phenomena
• Dispersion of gas, liquid and two-phase releases
• Liquid droplet thermo dynamics calculations and liquid droplet rainout
• Pool spreading and vaporization
• Building wake dispersion effects for vapor releases

Flammable Effects
For releases of flammable material Phast calculates
• Radiation profiles and contours from a range of fire scenarios including pool fires,
flash fires, jet fires and fire balls, including cross-wind effects on a jet fire
• Vapor Cloud Explosion modeling using industry standards models including the TNO
Multi-energy, Baker Strahler Tang and TNT Equivalence models
• Overpressure contours from Boiling Liquid Expanding Vapour Explosions

Toxic Effects
• Graphs of toxic concentration profile
• Indoor and outdoor toxic dose prediction
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• Reporting of distance to specific dose and concentration
• Calculated exposure time and use as “averaging time” for passive dispersion effects

Phast Risk
Phast Risk allows you to combine the flammable and toxic consequences from each
scenario in your QRA model with their likelihood to quantify the risk of fatalities. Phast Risk
allows you to take account of local population distribution, sources of ignition, land usage
and local prevailing weather conditions. It is designed to perform all the analysis, data
handling and results presentation elements of a QRA within a structured framework.

Phast Risk allows you to quickly identify major risk contributors so that time and efforts can
be directed to mitigating these highest risk activities. Based on effects calculations and
population vulnerabilities, Phast Risk can integrate over all scenarios and weather
conditions to estimate the total risk. The established individual and societal risk indicators
are predicted by Phast Risk across your facility and surrounding area using the classical QRA
methodology. Risk ranking reports can be produced at points of strategic importance to
show the relative influence of the various failure scenarios and their contribution to both
the individual and societal risk metrics.

A key benefit of Phast Risk is the ability to identify major risk contributors and differentiate
these from incidents with worst case consequences which might otherwise dominate the
safety reviews. Whilst medium scale incidents have lesser consequences, they may have a
higher frequency, which, when combined with their hazardous effects, generate a higher
level of risk. Time and effort directed to mitigating high consequence but often low
frequency events may not be well spent. Phast Risk helps you direct this effort more
effectively.

Phast Risk also provides facilities to help you manage large quantities of input data,
including scenarios, parameters, wind roses, ignition and population, and combine these in
many ways. This is critical when looking at sensitivity analyses and assessing the merits of a
range of risk reduction measures.
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Benefits
• Facilitates cost reduction in terms of losses and insurance
• Allows optimization of plant and process design
• Assist in compliance with safety regulators
• Enables quicker response to hazardous incidents
• Improve engineer’s understanding of potential hazards
• Regular software upgrades incorporate industry experience and expertise, and
advances in consequence modeling technology

Financial Extension
The Financial Consequence extension is used to assess situations which present potential
hazards not only to life but also to the environment, property and business and help
quantifying their severity in financial terms. Phast Financial helps you to estimate the cost
of a particular release of a given material under specified conditions. The Financial Risk
extension helps you to calculate the broader financial risks associated with accidents and
can be used to help manage your business risk and assess appropriate levels of insurance.

Blast Extension for Explosion Risk

The Blast extension permits more accurate explosion modeling and thus better risk
predictions. It provides all the extra functionality required to assess overall risks taking
account of protection provided by different types of structure and areas of congestion on
your plant. Models supported include the Multi Energy and Baker Strehlow Tang explosion
models and a number of industry standard vulnerability models

Multi-Component Extension
The multi-component extension to Phast provides greater accuracy for liquid or two-phase
mixture releases compared to the standard pseudo-component approach. The composition
of each component of the mixture is calculated throughout the discharge and dispersion
phases of the release.
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10.9SCENARIOS
TABLE –10.4
_______________________________________________________________________
POSSIBLE ACCIDENT SCENARIOS

Scenario MCL Scenario Quantity Failure Mode

1 Release of Acid 20 KL Catastrophic failure,
over filling, outlet-
drain line 100 %
failure
2 Catastrophic failure
Release of Hydrogen gas 7 m3
3 Petroleum class chemicals 20 KL Catastrophic failure
storage tank catastrophic
failure
4 Unconfined Pool Fire 20 KL Drum failure
Simulations for Drum Storage
Area

Conséquence Analysis
Introduction
In this, the source terms for each defined failure cases are presented, including calculated
release rate, release duration and total released mass of fluid. Subsequently consequence
results from selected failure cases are also presented in order to give overview on the
extent of impact from potential major accident scenarios. Five types of consequences are
presented, i.e. jet fire, pool fire, flash fire, explosion and toxic impact.

CONSEQUENCE DISTANCES
Pool Fire, Fire ball, Flash Fire
The extent of the consequence of a Pool fire is represented by the thermal radiation
envelope. Three levels of radiation are presented in this report, i.e.:
· 4 kW/m2; this level is sufficient to cause personnel if unable to reach cover within
20s;however blistering of the skin (second degree burn) is likely; 0: lethality.
· 12.5 kW/m2; this level will cause extreme pain within 20 seconds and movement to a safer
place is instinctive. This level indicates around 6% fatality for 20 seconds exposure.
· 37.5 kW/m2; this level of radiation is assumed to give 100% fatality as outlined above.
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10.9.1 DETAILED SUMMARY OF RESULTS:
Detailed Results of the consequence analysis of above-mentioned scenarios have been given
below:
Scenario-1Release of Acid (Sulphuric Acid)

Spill pool evaporation module for Acid due to Catastrophic Rupture of 20 MT Storage Tank
Input Data
Stored quantity - 20 KL
Failure Mode: Catastrophic failure
Release rate: 1000 g/s
Results indicate
LC50 – 510 ppm 42.00 meter
IDLH – 3 ppm 560.00 meter
TLV –1 ppm 880.80 meter

Results:-

• LC50 HUMAN (510 ppm) area is up to 42.00 meter,

• IDLH (3 ppm) concentration area is up to 560.0 meter and
• TLV (1 ppm) area is up to 880.80meter.

Therefore, 560.00 meter area in wind direction is considered as evacuation area.

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MITIGATION MEASURES FOR ACID LEAKAGE:

Isolate the source if possible without risk.

If leakage is small, dilute with water and mop up, or absorb with an inert dry material
and place in an appropriate waste disposal container. If necessary: Neutralize the
residue with a dilute solution of sodium carbonate.
Absorb with DRY earth, sand or other non-combustible material.
Do not get water inside container. Do not touch spilled material. Use water spray
curtain to divert vapor drift.
Use water spray to reduce vapors.
Prevent entry into sewers, basements or confined areas.
Neutralize the residue with a dilute solution of sodium carbonate.

PREVENTIVE MEASURES TO AVOID ACID LEAKAGE:

A dike will be provided to accommodate the full quantity in tank.

Periodic testing of storage tank will be done by competent person.
Provide exhaust ventilation or other engineering controls to keep the airborne
concentrations of vapors below their respective TLVs. Storage tank vent is connected
to scrubber system.
Flange guard provided to prevent splash of material.
Level interlock
Keep container dry. Never add water to this product.
In case of insufficient ventilation, wear suitable respiratory equipment. If ingested,
seek medical advice immediately and show the container or the label.
Avoid contact with skin and eyes. Keep away from incompatibles such as oxidizing
agents, organic materials, metals, alkalis, moisture.
Storage: Keep container tightly closed. Keep container in a cool, well-ventilated area.
While handling always use face shield. Full suit. Vapor respirator. Be sure to use an
approved/certified respirator or equivalent.
Ensure that eyewash stations and safety showers are proximal to the work-station
location.
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Scenario – 1Release of Hydrogen
This scenario considers release of Hydrogen from Storage Tank:

Results indicate:

Scenario: Diffusion Jet Fire Simulation for 1.0 cm copper connecting pipe to PRV station
In put Data Results of Computations
Stored quantity 100 Cylinder Max. IHR at flame center height 52.49 Kw/m2
Gas Jet diameter 1 (cm) Flame center height 63 meter
Gas velocity in the 143463 m/s Maximum Flame width 12 meter
leakage hole/ pipe
Wind speed 2.31 m/s Heat Flux 8.5 KW/ m2
Gas Density 0.067 kg/m3 Flame Surface Area 3778 m2

Incident Intensity of IHR- Isopleth Effect if IHR at Height of Simulation

Heat Radiation ( IHR) Distance
at ground level KW ( Meters )
/m 2
37.5 21.5 Damage to process equipment. 100 % Fatal in 1 Min. 1 %
fatal in 10 sec.
12.5 32.8 Min. to ignite wood (with flame contact). 1 % fatal in 1
min. 1st deg. burn in 10 sec.
4.0 51.6 Pain after 20 secs. Blistering unlikely.

Results
♦ In the 21.5 meter radius area is considered as 100% fatality in 1 min.
♦ In the 32.8 meter radius first degree burn in 10 sec.
♦ In the 51.6 meter radius area will give pain after 20 seconds. Blistering unlikely.
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Over pressure / explosion for rupture of 1.0 cm copper pipe line of Hydrogen cylinder to
PRV station

Results indicate:
In put Data Results of Computations
Stored quantity 7 m3 Visible Flash Fire Height 0.52 m
Mass of Gas 1 kgs Visible Flash Fire Width 0.26 m
Heat of combustion 42267 KJ/Kg Duration of Flash-Fire in Sec. 2 sec
Fuel-Air volume ratio in 0.600 Radius of fuel-air cloud mixture 4.19 m
Flash fire cloud
Stoichiometric Fuel-Air 00:29 Total energy release 283720 KJ
Mixture
Wind speed 2.31 m/s Max. Heat Radiation from 1 m from Flash 750 KW/ m2
Fire
Gas Density 0.067 kg/m3 Combustion efficiency 0.5

Incident Intensity of Heat IHR- Isopleth Effect if IHR at Height of Simulation

Radiation ( IHR) at ground Distance
level KW /m 2
( Meters )
37.5 23 Damage to process equipment. 100 % Fatal in 1 Min. 1 % fatal in
10 sec.
12.5 36 Min. to ignite wood (with flame contact). 1 % fatal in 1 min. 1st
deg. burn in 10 sec.
4.0 62 Pain after 20 secs. Blistering unlikely.

Results
♦ In the 23 meter radius area is considered as 100% fatality in 1 min.
♦ In the 36 meter radius first degree burn in 10 sec.
♦ In the 62 meter radius area will give pain after 20 seconds. Blistering unlikely.
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Scenario: Over pressure / explosion for rupture

♦ In the 23 meter radius ♦ In the 36 meter radius ♦ In the 662 meter radius
area is considered as first degree burn in 10 area will give pain
100% fatality in 1 min. sec. after 20 seconds.
Blistering unlikely.
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Scenario-4 Tank on Fire for 18 KL Class A petroleum storage tank
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Pool Fire for Class A petroleum storage tank catastrophic failure
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Fire Ball simulation for Class A petroleum storage tank catastrophic failure:
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Scenario:

♦ In the 28 meter radius ♦ In the 54 meter radius ♦ In the 92 meter radius

area is considered as first degree burn in 10 area will give pain
100% fatality in 1 min. sec. after 20 seconds.
Blistering unlikely.
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Flash Fire simulation for Class A petroleum storage tank catastrophic failure:
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Unconfined Vapour cloud Explosion ( UVCE ) for Class A petroleum storage tank:
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Scenario-5Unconfined Pool Fire Simulations for Drum Storage Area
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Pool Fire Scenario:

♦ In the 23.1 meter ♦ In the 40 meter radius ♦ In the

radius area is first degree burn in 10 radius area will give
considered as 100% sec. pain after 20 seconds.
fatality in 1 min. Blistering unlikely.
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ENVIRONMENTAL IMPACT & RISK ASSESSMENT REPORT
BLEVE simulation for Drums Storage
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ENVIRONMENTAL IMPACT & RISK ASSESSMENT REPORT
BLEVE Scenario:

♦ In the 25 meter radius ♦ In the 42.5 meter ♦ In the

area is considered as radius first degree area will give pain
100% fatality in 1 min. burn in 10 sec. after 20 seconds.
Blistering unlikely.
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Measures to control and mitigate Emergency of fire & explosion:
Measures to be taken to prevent such accident:
• Security person will check License, TREM CARD, Fire extinguisher condition, Antidote Kit,
required PPEs as per SOP laid down.
• Officer will take sample as per sampling SOP from sampling point.
• After approval of QC department unloading procedure will be allowed be started.

Following precautions will be adopted during unloading

• Wheel stopper will be provided to Tanker at unloading platform.

• Static earthing will be provided to road tanker.
• Tanker unloading procedure will be followed according to check list and implemented.
• Flexible SS hose connection will be done at Tanker outlet line.
• Finally earthing connection and wheel stopper will be removed.
• Only day time unloading will be permitted.

Following precautions will be adopted Storage of such chemicals

• Tanker unloading procedure will be prepared and implemented.
• Caution note and emergency handling procedure will be displayed at unloading area and
trained all operators.
• NFPA label will be provided.
• Required PPEs like full body protection PVC apron, Hand gloves, gumboot, and
Respiratory mask Breathing Appratus etc. will be provided to operator.
• Neutralizing agent will be kept ready for tackle any emergency spillage.
• Safety shower, eye wash with quenching unit will be provided in acid storage area.
• Material will be handled in close condition in pipe line.
• Double drain valve will provided.
• Safety permit for loading unloading of hazardous material will be prepared and
implemented.
• TREM CARD will be provided to all transporters and will be trained for transportation
Emergency of Hazardous chemicals.
• Fire hydrant system with jockey pump as per TAC norms will be installed.
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Mitigation measures to control Emergency:

♦ Hydrant system & sprinkler system will be provided as per requirements.

♦ Emergency organization and team will be prepared as per On site-Off site emergency
planning
♦ Solvent transportation safety SOP will be prepared and trained employees.
♦ Emergency siren and wind sock will be provided.
♦ Scenario base Off Site emergency Plan will be prepared.
♦ Tele Communication system and mobile phone will be used in case of emergency
situations for communication.
♦ First Aid Boxes and Occupational health centre will be made at site.
♦ Full body protection suite and other PPEs will be kept ready in ECC at site.
♦ Emergency team will be prepared and trained for scenario base emergency. Like Toxic
control team, Fire control team, First aid team, Communication and general
administration team, Medical team etc.

EMERGENCY RESPONSE
DO NOT EXTINGUISH A LEAKING GAS FIRE UNLESS LEAK CAN BE STOPPED.
Small Fire
Dry chemical or CO2.
Large Fire
Water spray or fog.
Move containers from fire area if you can do it without risk.
Fire involving Tanks
· Fight fire from maximum distance or use unmanned hose holders or monitor nozzles.
· Cool containers with flooding quantities of water until well after fire is out.
· Do not direct water at source of leak or safety devices; icing may occur.
· Withdraw immediately in case of rising sound from venting safety devices or discoloration
of tank.
· ALWAYS stay away from tanks engulfed in fire.
· For massive fire, use unmanned hose holders or monitor nozzles; if this is impossible,
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withdraw from area and let fire burn.

SPILL OR LEAK
· ELIMINATE all ignition sources (no smoking, flares, sparks or flames in immediate area).
· All equipment used when handling the product must be grounded.
· Do not touch or walk through spilled material.
· Stop leak if you can do it without risk.
· If possible, turn leaking containers so that gas escapes rather than liquid.
· Use water spray to reduce vapors or divert vapor cloud drift. Avoid allowing water runoff
to contact spilled material.
· Do not direct water at spill or source of leak.
· Prevent spreading of vapors through sewers, ventilation systems and confined areas.
· Isolate area until gas has dispersed.

10.10HAZARDOUS MATERIALS TRANSPORTATION SAFETY GUIDELINES

Introduction
Transportation typically involves carrying of small amounts of materials over short distances
transportation does, however, pose significant risks from the frequency of the activity and
the lack of observance of prescribed regulations. The hazardous materials should be
packaged, based on the composition in a manner suitable for handling, storage and
transport. Labeling and packaging is required to be easily visible and be able to withstand
physical conditions and climatic factors. These guidelines are issued to facilitate safe
transportation of the hazardous material in compliance of the regulations. In view of the
stringent product quality requirement, various complex processes are introduced involving
the handling of hazardous chemicals. These chemicals pose various types of hazards like
flammability, toxicity, explosives, corrosives etc. Inadequate awareness about the hazardous
properties of these chemicals may lead to serious accidents which will affect the men at
work and the environment.
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Scope
This document applies to the vehicular transportation, within geographically contiguous, of
hazardous materials, substances, and wastes. Hazardous materials include chemical
materials, substances or wastes. Transportation shall be performed in a manner which
minimizes risk to the health and safety of employees, the public and the environment.

Guidelines for Transportation

General
It will be ensured that during the transportation contents are not spilled, packaging is not
damaged and personnel are properly trained to generate, transport and receive such
materials. In general, the traffic control program at M/s. Glenmark Pharmaceuticals Limited
requires that an onsite driver possess a valid driver’s license. TREM (Transport Emergency)
cards are to be provided to the drivers.

Packing
The containers must be able to withstand normal handling and retain integrity for a
minimum period of six months. In general, packaging for hazardous substances must meet
the following requirements:

- All packaging materials including containers shall be of such strength, construction

and type as not to break open or become defective during transportation.
- All packaging materials including containers shall be so packaged and sealed those
spillages of hazardous materials / substances are prevented during transportation
due to jerks and vibrations caused by uneven road surface.
- Re-packaging materials including that used for fastening must not be affected by the
contents or form a dangerous combination with them.
- Packaging material should be such that there will be no significant chemical or
galvanicaction among any of the material in the package.
- Ensure that any cushioning or absorbent material used for packaging is also
compatible with the hazardous material.
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The containers when used for packaging of the hazardous Material shall meet the
following requirements:
- Modes of packaging, like collection in 200-litre plastic drums, cardboard cartons, PP
and HDPE/LDPE containers etc., also work for variety of materials. However, all such
container should be amenable to mechanical handling.
- It should be leak proof.
- Use drums that are in good condition and free of rust and major dents.
- Ensure that drums are not leaking or overfilled before transporting them.
- Ensure that drum bungs are tight.
- Carefully inspect pallets before they are loaded.
- Do not use pallets with cracked or broken slats.
- Use a drum dolly to place drums on pallets.
- Secure all drums to the pallet with appropriate strapping material.
- In general, the containers for liquid HM should be completely closed, in fact sealed.
There should be no gas generation due to any chemical reaction within the container,
and, hence, there should not be any need for air vents; expansion due to increase
/decrease in temperature normally does not need air vents.
- Container should be covered with a solid lid or a canvas to avoid emissions of any
sort including spillage, dust etc. and to minimize odour generation both at the point
of loading as well as during transportation.
- Container used for transportation of Material should be able to withstand the shock
loads due to vibration effect/undulations of pavements etc.
- Container should be easy to handle during transportation and emptying.
- As far as possible, manual handling of containers should be minimized. Appropriate
material handling equipment is to be used to load, transport and unload containers.
This equipment includes drum, dollies, and forklifts, drum handling equipment, lift
gates and pallets. Drums should not be rolled on or off vehicles.
- Where two-tier or three-tier storage is envisaged, the frame should have adequate
strength to hold the containers.
- One-way containers are also allowed. The multi-use containers should be re-usable
provided it should be cleaned and free from deterioration or defects.
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- Loads are to be properly placed on vehicles. HM containers are not to overhang,
perch, lean or be placed in other unstable base. Load should be secured with straps,
clamps, braces or other measures to prevent movement and loss. Design of the
container should be such that it can be safely accommodated on the transport
vehicle.
- Dissimilar materials shall not be transported in the same container.

Labeling
There are two types of labeling requirements:
i. Labeling of individual transport containers and
ii. Labeling of transport vehicles.
- All hazardous Material containers must be clearly marked with current contents. The
markings must be waterproof and firmly attached so that they cannot be removed.
Previous content labels shall be obliterated when the contents are different. Proper
marking of containers is essential.
- Color code is to be provided to the tanker to indicate the type of material present in
that.
- Containers that contain HM shall be labeled with the words "HAZARDOUS
MATERIAL" in Vernacular language, Hindi / English. The information on the label
must include the code number of the Material, the Material type, the origin (name,
address, telephone number of the supplier and receiver), hazardous property (e.g.
flammable, corrosive), and the symbol for the hazardous property.
- The label must withstand the effects of rain and sun. Labeling of containers is
important.

The following are the requirements for labeling:

Emergency contact phone numbers shall be prominently displayed viz. the phone number of
concerned Regional Officer of the SPCB, Fire Station, Police Station and other agencies
concerned.
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Unloading of Drums / Containers
- Manual handling of drums / containers should be minimized. It is preferable fork-
lifters and suitable cradles are used to handle drums.
- Carboys containing hazardous chemicals should not be subjected to impact.
- Suitable protective clothing should be used while handling drums / containers and
the operators should position him such that he is in the upwind direction so that
even in case of accidental release of chemical, he is safe.

10.11 RECOMMENDATIONS
From the Risk Analysis studies conducted, it would be observed that by and large, the risks
are confined within the factory boundary walls in case of fire & explosion, except in the
event of a catastrophic failure. In case of catastrophic failure of toxic chemical storage tanks,
it will also create OFF site emergency situations and required more attention and
emergency preparedness for combat such situations. To minimize the consequential effects
of the risk scenarios, following steps are recommended.

1. Plant should meet provisions of the Manufacture, storage & Import of Hazardous
Chemicals Rules, 1986 & the factories Act, 1948.
2. Sprinkler system is installed in tank farm area.
3. Air line respirator provision to be made in respective area
4. For bromine emergency details are provided in report to be implemented.
5. Fire hydrant system for proposed plant to be installed as per TAC/NFPA Norms in
each plant and buildings.
6. Dyke wall and collection pit with drain valve needs to be provided in acid storage
area
7. Tanker unloading procedure needs to be displayed at tanker unloading area.
8. Periodic On Site Emergency Mock Drills and occasional Off Site Emergency Mock
Drills to be conducted, so those staffs are trained and are in a state of preparedness
to tackle any emergency.
9. Emergency handling facilities to be maintained in updated condition at all time.
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10. Safe operating procedure to be prepared for hazardous process and material
handling process.
11. Safety devices and control instruments to be calibrated once in a year.
12. Permit to work system to be implemented 100 % for hazardous work in the plant.
13. The details of emergency equipments are given in on site emergency Plan along with
its quantity. As per our site visit, these was found in order & working condition and
sufficient for existing production Activates.
14. Manual call points for fire location identification to be installed in plant premises.
15. Fog type Pressure sprinkler to be installed at storage tank farm.
16. For proposed plant Fire & Safety organization setup to be replanted for better plant
process safety.
17. All Acid vents to be connected with scrubber system.
18. Induction safety program to be prepared and trained all new employees before
starting duties in plant.
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10.12DISASTER MANAGEMENT PLAN -ON-SITE /OFF-SITE EMERGENCY PLAN

Glenmark Pharmaceuticals Limited has prepared the Disaster Management Plan to minimize
human, property and economic losses.
The purpose of this plan is to provide M/s. Glenmark Pharmaceuticals Limited with the
means to effectively utilize all the resources at its disposal for the protection of life,
environment and property. The same DMP shall be updated after installation of plants or
facilities. The details of the same are discussed in the following sections.

DEFINING THE NATURE/LEVEL OF EMERGENCY

THE LEVEL OF EMERGENCY CAN BE CLASSIFIED IN THREE CATEGORIES:
LEVEL - 1:
The leakage or emergency, which is confinable within the plant/area. It may be due to:
a) Small pipe/valve rupture or similar leakages that do not affect outside premises
b) Release of toxic chemicals for short duration.
c) Small fire in the plant
LEVEL - 2:
The emergency, which is confinable within the factory premises. It may arise due to -
a) Medium scale leakage of toxic chemicals for long duration
b) Medium scale explosion confined to the factory premises.
c) Medium scale fire inside the factory premises.

LEVEL - 3:
The emergency, which is not confinable within the factory premises and general public in
the vicinity likely to be affected. It may arise due to -
a) Heavy / Profuse leakage of toxic / flammable gases for a long duration
b) Explosion of high magnitude affecting the adjacent area
c) Major fire inside the factory premises.
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STRUCTURE OF EMERGENCY MANAGEMENT SYSTEM
Glenmark Pharmaceuticals Limited will develop an emergency management team. The
management structure includes the Following personnel’s;
• Site Main Controllers
• Incident Controllers and Deputy Incident Controllers
• Key Personnel’s
• Essential Workers
The other elements of Disaster Management Plan are:
• Assembly points
• Emergency control center
• Fire control arrangements
• Medical arrangements
• Other arrangements
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SITE MAIN CONTROLLER
Plant head will be the Site Main Controller. In absence of Plant Head, Safety in Charge will
act as a SMC. His task will be to co-ordinate all internal and external activities from the
Emergency Control Centre at Main Security Gate from where all operations will be directed.
He shall…
• Immediately on being informed of the emergency and its location, will arrive at the
site, review the situation and control further actions.
• Direct all Emergency Operations within the approved area with the following
priorities:
a) Personnel Safety,
b) Plant, Property and Environment Safety and
c) Minimum loss of production.
• Co-ordinate to avail services from external agencies like fire brigade, hospitals etc, if
called for, following the declaration of major emergency. If necessary, major
installations in the vicinity may also be informed of the situation.
• Exercise direct operational control of the unaffected section of the plant.
• In consultation with the advisory team, expedite the shutting down of loading /
unloading operations of tankers and if necessary, instruct the supervisor / security
personnel to evacuate tankers.
• Ensure that all employees are evacuated from the affected area and the casualties, if
any, are given necessary medical attention. Instruct P & A Assistant / Security for
rushing casualties to hospitals if required.
• Liaise with fire and police officials, pollution control board officials and other
statutory bodies and advise them of all possible consequence effects outside the
premises.
• Arrange for relief of personnel when emergency is prolonged.
• Issue authorized statement or press release to the news – media.
• Ensure preservation of evidence for enquiries to be conducted by statutory
authorities.
• Authorize the sounding of “All Clear” and “Evacuation Siren”.
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• Arrange for obtaining the head – count of all personnel within the premises and
cross-checking with the data from records available for no. of persons within the
premises.
• Nominate a person from advisory team, to maintain chronological log of event
during the entire period of emergency.
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ON SITE EMERGENCY PLAN

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