Manual

MYLAN LABORATORIES LIMITED, UNIT ‐ 3
PLOT NO.S 35, 36, 38, 39, 40, 49, 50 AND 51
PHASE IV IDA JEEDIMETLA, QUTHBULLAPUR MANDAL,
MEDCHAL DISTRICT, TELANGANA

RISK ASSESSMENT REPORT

Project No. 0317‐21‐01
March 2017
STUDIES AND DOCUMENTATION BY
Mylan Laboratories Limited, Unit ‐ 3 TEAM Labs and Consultants
Plot No.s 35, 36, 38, 39, 40, 49, 50 AND 51 B‐115‐117 & 509, Annapurna Block,
Phase IV IDA Jeedimetla, Quthbullapur Mandal, Aditya Enclave, Ameerpet,
Medchal District‐ 500 055 Hyderabad‐500 038.
Phone: +91 040‐3049 3800, 8008001511 Phone: 040‐23748 555/23748616,
E‐mail ID: srinivas.gangavarapu@mylan.in Telefax: 040‐23748666
SUBMITTED TO
STATE LEVEL ENVIRONMENT IMPACT ASSESSMENT AUTHORITY,
TELANGANA, GOVERNMENT OF INDIA
Mylan Laboratories Limited. Unit – 3 Environmental Impact Assessment Report
6.0 RISK ASSESSMENT AND DAMAGE CONTROL
6.0 INTRODUCTION
This chapter presents the risk assessment study results for the plant operations, transport
and storage of raw materials, and identifies maximum credible accident scenarios to draw
the emergency management plan addressing various credible scenarios identified.
6.1. OBJECTIVES AND SCOPE
The production of Bulk drugs involves usage of many chemicals which are both
hazardous and toxic in nature. The risks associated with the pharmaceutical / chemical
industry are commensurate with their rapid growth and development. Apart from their
utility, chemicals have their own inherent properties and hazards. Some of them can be
flammable, explosive, toxic or corrosive etc. The whole lifecycle of a chemical should be
considered when assessing its dangers and benefits. In order to ensure the health and
safety of persons at or near the facilities, Govt. has approved some regulations. The
regulation requires Employers to consult with employees in relation to:
- Identification of major hazards and potential major accidents
- Risk assessment
- Adoption of control measures
- Establishment and implementation of a safety management system
- Development of the safety report
The involvement of the employees in the identification of hazards and control measures
enhances their awareness of these issues and is critical to the achievement of safe
operation in practice. In order to comply with regulatory authorities, M/s Mylan
Laboratories Limited, Unit – 3 have entrusted Team Labs and Consultants, Hyderabad to
review and prepare Hazard analysis and Risk assessment for their facility along with an
approach to on-site emergency preparedness plan as required under the acts and rules.
(Manual on emergency preparedness for chemical hazards, MOEF&CC, New Delhi). In
this endeavor, the methodology adopted is based on
6-1 Team Labs and Consultants

• visualizing various probable undesirable events which lead to major accidents

• detailed and systematic assessment of the risk associated with each of those
hazards, including the likelihood and consequences of each potential major accident
event; and
• identifying the technical and other control measures that are necessary to reduce
that risk to a level that is as low as reasonably practicable
The strategy to tackle such emergencies, in-depth planning and person(s) or positional
responsibilities of employees for implementation and coordination of timely and effective
response measures are described in onsite detail in Emergency Plan.
6.2 PROJECT DETAILS:
The project site is located at Plot No’s 35, 36, 38, 39, 40, 49, 50 and 51, Phase IV, IDA
Jeedimetla, Quthbullapur Mandal, Medchal District, Telangana State. The site is situated at
17°31'47" (N) latitude and 78°26'8" (E) longitude. The site elevation above mean sea level
(MSL) is 586 m. The site is surrounded by IDA internal road in west direction, Balanagar-
Narsapur road in east direction, Sri Lakshmi Floor Mill Pvt. Ltd in north direction and
Srak Prestek Pvt. Ltd in south direction. The nearest habitation from the site is Jeedimetla
located at a distance of 0.5 Km to the industrial estate premises. The main approach road is
Hyderabad – Narsapur passing at a distance of 0.3 km in southwest direction. The nearest
railway station is Sanath Nagar at a distance of 7.5 km in south direction and Shamshabad
airport is located at a distance of 32 km in southwest direction. Hakimpet Air Force Station
is located at a distance of 7.6 km in northeast direction. Hyderabad town is located at a
distance of 8.2 km in southeast direction. There are no major water bodies within the study
area. There are no National parks, sanctuaries and ecologically sensitive areas within the
impact area of 10 km. There are nine reserve forests in the study area Dulapalli RF is at a
distance of 1 km in northeast direction, Gajularamaram RF is at a distance of 1.2 km in
northwest direction, Suraram RF is at a distance of 3.1 km in north direction, Borampet RF
is at a distance of 4.4 km in northwest direction, Pochampalli RF is at a distance of 6.6 km

in northeast direction, Gaudavalli RF is at a distance of 6.8 km in northeast direction,

Kazipally RF is at a distance of 7.9 km in northwest direction, Dundigil RF is at a distance
of 8.7 km in northwest direction and Kandlakoya RF is at a distance of 9.6 km in northeast
direction. The site is located at a distance of 7.67 Km from the critically polluted area of
Patancheru and Bollaram Industrial estatesThere are no National parks, sanctuaries and
ecologically sensitive areas within the impact area of 10 km. The manufacturing capacity
of the proposed Chemicals and By-products after expansion are presented in Table 6.1 and
6.2. Chemical inventory is presented in Table 6.3
Table 6.1 Manufacturing Capacity – After Expansion
S.No Product Name Capacity
(TPM)
1 Celecoxib 7.00
2 Citalopram hydrobromide 8.00
3 Armodafinil 2.00
4 Modafinil 2.00
5 Emitricitabine 10.00
6 Levofloxacin 6.00
7 Escitalopram 2.00
8 Mirtazapine Hemihydrate 2.40
9 Esomeprazole 3.00
10 Ciprofloxacin HCl base 0.15
11 Ciprofloxacin Lactate 0.15
12 Venlafaxine 0.50
13 Zolpidem 0.05
14 Aripiprazole 0.10
15 Eszopiclone 0.02
16 Itraconazole 0.20
17 Olanzapine 0.15
18 Sibutramine Hydrochloride 0.10
19 Rilpivirine Hydrochloride 0.05
20 Candesartan Cilexetil 0.15
21 Carvedilol 0.35
22 Tadalafil 0.20
23 Telmisartan 0.15
24 Gabapentin 1.00
25 Atorvastatin Calcium 0.20
26 Pantoprazole 0.20
27 Quetiapine 0.50
28 Simvastatin 0.25
29 Irbesartan. 0.32
30 Gatifloxacin 0.10

31 Moxifloxacin 0.10
32 Risperidone 0.10
33 Valsartan 0.05
34 Sertraline 0.40
35 Montelukast 0.60
36 Ciprofloxacin hydrochloride 0.10
37 Rabeprazole 0.05
38 Norfloxacin 0.10
39 Efavirenz 0.10
40 Duloxetine hydrochloride 0.02
41 Paroxetine Hydrochloride 0.01
42 Valganciclovir 0.01
43 Zonisamide 0.05
44 Darifenacin 0.05
45 Rosiglitazone 0.05
46 Latanoprost 0.02
47 Vardenafil 0.05
48 Validation Products 0.85
Total 50.00
Table 6.2 List of By-Products – After Expansion

S.No Name of the Product Stage Name of By Product Quantity
(Kg/day)
1 Escitalopram II Ammonium Phosphate 29.5
2 Quetiapine I Piperazine 240.7
3 Ciprofloxacin HCl II Piperazine 13.6
4 Norfloxacin IV Piperazine 4.2
5 Latonoprost I Spent Phosphosate salts 0.2
6 Citalopram HBr III Spent Phosphosate salts 1584.2

Table 6.3 List of Raw Materials and Inventory (Terms of Reference No. 3(iv) & (v))
S.No Nam of Ram Material Max Physical Type of Mode of Mode of
Storage Form Hazard Storage Transport
Quantity
(Tons)
1 1-(2,3-Dichlorophenyl) 0.6 Liquid Corrosive Drums By Road
Piperzine base
2 1-(Mercapto methyl) 1.59 Solid Non - Bags By Road
cyclopropane acetic acid Flammable
3 1,2 Dimethoxy ethane 0.84 Solid Flammable Bags By Road
(DME)
4 1,4-Dibromo butane 2.13 Liquid Corrosive Drums By Road
5 1-Bromo-4-Flourobenzene 51.78 Liquid Corrosive Drums By Road
6 1-chloroethyl cyclohexyl 0.72 Solid Corrosive Bags By Road
carbonate
7 1-Fluoronaphthalene 1.32 Solid Corrosive Bags By Road
8 1H-Benzimidazole-7- 1.05 Solid Flammable Bags By Road
Carboxylicacid (CBBI)
9 2-(2-Methoxy Phenoxy) 3.45 Liquid Corrosive Drums By Road
Ethyl amine HCL
10 2,2-Dimethylbutyryl 1.86 Liquid Flammable Drums By Road
chloride
11 2,8- Diazabicyclononane 0.42 Liquid Irritant Drums By Road
12 2-Chloromethyl - 4- 23.01 Solid Irritant Bags By Road
methoxy-3,5-dimethyl
pyridine HCl
13 2-mercapto-5-methoxy-1 H 15.3 Solid Flammable Bags By Road
Benzimidazole
14 3- Chloro 4- Fluoro aniline 0.99 Solid Irritant Bags By Road
15 3(2-Chloroethyl)-2 Methyl- 1.2 Solid Corrosive Bags By Road
6,7,8,9-Tetrahydro-4H
Pyrido[1,2-α] Pirimid-4-
One Hydrochloride
16 4- Carboxybutyl triphenyl 1.59 Solid Flammable Bags By Road
phosphonium bromide
(CBTPPB)
17 4- Hydroxy carbozole 1.62 Liquid Corrosive Drums By Road
18 4- Methyl Acetophenone 24.6 Solid Irritant Bags By Road
19 4-(Sulphamoyl Pheny;) 47.01 Solid Flammable Bags By Road
Hydrazine Hcl
20 4-Bromomethyl-2- 2.04 Solid Irritant Bags By Road
Cyanobiphenyl(BMCP)
21 4-Methoxy phenyl 2.34 Solid Irritant Bags By Road
acetonitrile
22 5-(difloro methoxy)-2-[{3,4- 1.05 Liquid Non - Drums By Road
dimethoxy-2-pyridinyl0 Flammable

methyl} sulfinyl]-1II
benzimidazole
23 5-Cyano phthalide 31.44 Liquid Drums By Road
24 Acetonitrile 41.73 Liquid Flammable Drums By Road
25 Activated carbon 285 Solid Flammable Bags By Road
26 Ammonia gas 34.47 Gas Toxic Cylinders By Road
27 Ammonia Solution 743.88 Liquid Toxic Drums By Road
28 Ammonium sulfate 1.74 Crystalline non-Hazard Bags By Road
29 Benzhydrol 53.55 Liquid Flammable Drums By Road
30 Boric acid 0.51 Powder Corrosive Bags By Road
31 Butyl Amine derivative 0.78 Powder Corrosive Bags By Road
32 Cesium carbonate 9.84 Powder Non- Bags By Road
Flammable
33 Chloroacetyl chloride 0.69 Liquid Combustible Drums By Road
34 Ciprofloxacin Hcl 3.12 Solid Irritant Bags By Road
35 Cumene Hydroperoxide 16.17 Liquid Flammable Drums By Road
36 Cyclohexanone 1.89 Liquid Flammable Drums By Road
37 D - Tryptophan 1.05 Powder Irritant Bags By Road
38 Dichloromethane 12.36 Liquid Carcinogenic Drums By Road
39 Diethyl Ethoxy methylene 1.56 Liquid Irritant Drums By Road
manolate
40 Diethyl Fomamide 8.25 Liquid Flammable Drums By Road
41 DiethylSulphate 1.2 Liquid Flammable Drums By Road
42 Diisopropyl ethyl amine 3.48 Liquid Flammable Drums By Road
43 Dimethyl Formamide 154.74 Liquid Flammable Drums By Road
44 Dimethyl Sulphate 32.01 Liquid Flammable Drums By Road
45 Dimethyl Sulfide 53.4 Liquid Flammable Drums By Road
46 Dimethyl Sulfoxide 60 Liquid Flammable Drums By Road
47 Epichlorohydrin 2.85 Liquid Flmmable Drums By Road
48 Ethanol 589.59 Liquid Flammable Drums By Road
49 Fluoroboric acid 25.47 Liquid Corrosive Drums By Road
50 Formaldehide (35 %) 2.55 Liquid Flammable Drums By Road
51 Formaldehyde 0.69 Liquid Flammable Drums By Road
52 Formic acid 0.93 Liquid Flammable Drums By Road
53 Formic acid (98 %) 3.78 Liquid Flammable Drums By Road
54 Hyflo 43.02 Solid Non - Bags By Road
Flammable
55 Hydrobromic Acid 110.94 Liquid Corrosive Drums By Road
56 Hydrobromic acid (48%) 25.17 Liquid Corrosive Drums By Road
57 Hydrogen Peroxide 50% 26.85 Liquid Corrosive Drums By Road
58 Hydrose 0.42 Powder Flammable Bags By Road
59 Imidazole 1.32 Solid Corrosive Bags By Road
60 Isopropyl ether 6.24 Liquid Irritant Drums By Road
61 Liquid Paraffin 3.99 Liquid Irritant Drums By Road
62 L(+) Tartaric Acid 1.11 Crystalline Irritant Bags By Road

63 Lactic acid 0.63 Solid Corrosive Bags By Road

64 Magnesium chloride 10.2 Solid Irritant Bags By Road
hexahydrate
65 Magnesium turnings 14.58 Turnings Flammable Bags By Road
66 Methane sulphonyl 6.09 Liquid Toxic Drums By Road
chloride
67 Methanolic Hcl 4.95 Liquid Corrosive Drums By Road
68 Methyl Isobutyl Ketone 9.45 Liquid Flammable Drums By Road
69 Monochloro acetic acid 30.42 Crystalline Irritant Bags By Road
70 n- Hexane 23.79 Liquid Flammable Drums By Road
71 n- Pentane 30.15 Liquid Flammable Drums By Road
72 N,N Dimethyl acetamide 0.75 Liquid Carcinogenic Drums By Road
73 n-Heptane 194.4 Liquid Flammable Drums By Road
74 N-Methyl Piperzine 28.53 Liquid Corrosive Drums By Road
75 N-Methyl Pyrrolidinone 0.75 Liquid Irritant Drums By Road
76 n-Propanol 0.72 Liquid Flammable Drums By Road
77 Omeprazole 54.99 Solid Irritant Bags By Road
78 Oxalic acid 8.43 Solid Non - Bags By Road
Flammable
79 Phenyl Chloroformate 1.5 Solid Toxic Bags By Road
80 Phosphorous oxychloride 2.1 Liquid Corrosive Drums By Road
81 Piperazine 2.55 Solid Corrosive Bags By Road
82 Piperonal 0.84 Solid Irritant Bags By Road
83 Potassium carbonate 2.34 Crystalline Irritant Bags By Road
84 Potassium hydroxide 6.9 Solid Corrosive Bags By Road
flakes
85 Potassium Tretiary 44.52 Solid Corrosive Bags By Road
Butoxide
86 S-(-)-α-Methyl benzyl 9.57 Liquid Corrosive Drums By Road
amine
87 Silica Gel 19.02 Beads Non- Bags By Road
Flammable
88 Sod. Hypochlorite 0.78 Liquid Non - Drums By Road
Flammable
89 Soda Ash 1.11 Crystalline Irritant Bags By Road
90 Sodium azide 1.71 Crystalline Toxic Bags By Road
91 Sodium Bicarbonate 72.93 Crystalline Irritant Bags By Road
92 Sodium Borohydride 34.05 Powder Flammable Bags By Road
93 Sodium Carbonate 5.61 Crystalline Irritant Bags By Road
94 Sodium hypochlorite 0.42 Liquid Corrosive Drums By Road
95 Sodium iodide 0.48 Crystalline Irritant Bags By Road
96 Sodium Methoxide 17.58 Solid Combustible Bags By Road
97 Sodium Nitrite 0.48 Solid Oxidizing Bags By Road
98 Sodium Sulphate 31.17 Granules Non-Hazard Bags By Road
99 Sulfuric Acid (CP) 189.9 Liquid Corrosive Drums By Road

100 Tri Ethyl Amine 29.7 Liquid Flammable Drums By Road

101 Tertiary butyl dimethyl 1.26 Crystalline Flammable Bags By Road
silyl chloride
102 Thionyl chloride 0.6 Liquid Toxic Drums By Road
103 Thiourea 26.79 Solid Irritant Bags By Road
104 Tri butyl tin chloride 5.91 Liquid Corrosive Drums By Road
105 Tri Ethyl amine 0.96 Liquid Flammable Drums By Road
106 Tri fluro-acetic acid 5.49 Liquid Corrosive Drums By Road
107 Triethylamine 99.27 Liquid Flammable Drums By Road
108 Trifluoro acetic acid 26.28 Liquid Corrosive Drums By Road
109 Triphosgene 0.51 Solid Combustible Bags By Road
110 Trityl Chloride 0.84 Powder Corrosive Bags By Road
111 Vitride 4.02 Liquid Flammable Drums By Road
112 Ethyl acetate 50 Liquid Flammable Storage Tanks By Road
113 Absolute alcohol 25 Liquid Flammable Storage Tanks By Road
114 Acetic Acid 45 Liquid Flammable Storage Tanks By Road
115 Acetone 50 Liquid Flammable Storage Tanks By Road
116 Caustic Lye Solution 8.3 Liquid Corrosive Storage Tank By Road
117 Chloroform 15 Liquid Carcinogenic Storage Tanks By Road
118 Cyclohexane 25 Liquid Flammable Storage Tanks By Road
119 Ethyl Acetate 50 Liquid Flammable Storage Tanks By Road
120 Hexane 15 Liquid Flammable Storage Tanks By Road
121 Hydrochloric acid 12 Liquid Corrosive Storage Tank By Road
122 Isopropyl alcohol 50 Liquid Flammable Storage Tanks By Road
123 Methanol 50 Liquid Flammable Storage Tanks By Road
124 Methylene Dichloride 40 Liquid Carcinogenic Storage Tanks By Road
(MDC)
125 n-Butanol 15 Liquid Flammable Storage Tanks By Road
126 Ortho Phosphoric acid 25 Liquid Irritant Storage Tanks By Road
127 O-Xylene 25 Liquid Flammable Storage Tanks By Road
128 Tetrahydrofuran 30 Liquid Flammable Storage Tanks By Road
129 Toluene 50 Liquid Flammable Storage Tanks By Road
6.3 PROCESS DESCRIPTION

The manufacturing process for all the products is presented in Chapter 2 Of the report.
6.4 PLANT FACILITIES

The manufacturing facility shall be provided with
1) Production blocks 5) Warehouses
2) Utilities 6) Tank farm areas
3) Quality control 7) Administrative Office
4) Effluent treatment plant 8) Solvent recovery area

The production facilities designed for proper handling of materials and machines.
Safety of operators, batch repeatability and process parameter monitoring shall be the
major points of focus in the design of facility. The current Good Manufacturing
Practices (GMP) guidelines shall be incorporated as applicable to pharmaceutical
facilities.
6.4.1 Production Blocks:

The Production blocks will consist of SS and glass lined reactors, storage tanks, shell &
tube heat exchangers, evaporators, packed columns, centrifuges, filter presses,
crystallizers, layer separators etc. The area shall be provided with proper concealed
drainage facility and all process facilities shall be performed under protective
environment.
6.4.2 Utilities:
The proposed expansion requires additional steam. It is proposed to install 3 x 5 TPH
oil fired boilersout of which 1 x 5 TPH oil fired boiler will be kept as standby and
proposed to dismantle existing 1 x 4 TPH oil fired boiler after expansion. The required
steam both for process and ZLD system will be drawn from proposed 2 x 5 TPH oil
fired boilers.The DG sets required for emergency power during load shut down is
estimated at 4750 KVA and accordingly 2 x 1500 KVA DG sets are proposed in addition
to existing 1 x 500 KVA and 3 x 750 KVA for expansion in addition to existing DG sets.
The list of utilities is presented in the following Table 6.4.
Table 6.4 List of Utilities
S.No Utility Permitted Proposed After Expansion
1 Oil Fired Boiler 1 x 4TPH* 3 x 5TPH 3 x 5 TPH#
2 DG Set** 1 x 500 KVA 2 x 1500 KVA 2 x 1500 KVA
3 x 750 KVA 3 x 750 KVA
1 x 500 KVA
*Boilers shall be dismantled after expansion
# 1 x5 TPH shall be kept as standby
**DG sets will be used during load shut down by TSPDCL

6.4.3 Quality Control, R&D Lab:

The QC department comprise of an in-process lab with instruments like HPLC, GC etc.
It will be maintained by highly qualified and trained people. The activities include:
• In-process quality check during manufacturing
• Validation of facilities
• Complaint handling
Also a process development laboratory provided for in-house process development,

initial evaluation of process technology in case of technology transfer, back-up for
production department to address any issues arising during commercial production
6.4.4 ETP and Solid waste storage:

The total effluents segregated into two streams High COD/ TDS and Low COD/ TDS
streams. These effluents are treated in Zero Liquid Discharge system and the treated
effluents are reused for cooling towers make-up.
6.4.5 Ware Houses:

The plant have sufficient storage facility for safe handling of raw materials. All solid
raw materials stored in marked areas with proper identification. Liquid raw materials
and solvents like which are available in drums will be stored according to material
compatibilities and flammability. Adequate firefighting facilities shall be provided as
per NFPA norms.
6.4.6 Tank Farm Area:
A separate tank farm area shall be provided for storing liquid raw materials, especially,
for Solvents with high inventory and also for toxic, corrosive chemicals. Dykes shall be
provided to ensure safety in case of tank failure.
6.4.7 Cylinders storage Area:

Gas cylinders storage should conform to SMPV-Unfired rules-1981. Hydrogen cylinders
used in QC department should be stored in approved Gas Storage pad. Chained and

capped when not in use. Operational cylinder should be firmly secured. Pressure
regulator, metal piping, non-return valve, and safe residue bleed off arrangement
should be incorporated in installation design. Strict hot work control and display of
danger signs should be ensured.
6.4.8 Administrative Office:

An Administrative office shall be provided at the entrance of the factory to ensure the
entry of authorized personnel only into the premises.
6.4.9 Water Sump:

Water sump of 500 m3 capacity shall be provided for firefighting in case of emergencies.
6.4.10 House Keeping:

A regular housekeeping schedule with adequate preventive maintenance shall be
ensured so that the plant is consistently maintained as per GMP standards.
6.4.11 Facility layout and design:

The layout of all the various areas required for the facility, as mentioned above is
considered. In laying out the above areas, isolation of the various process areas from the
utilities and non-process areas is considered in view of both containment and cGMP. A
tentative plant layout is shown in Fig 6.1.

GATE
GATE
Mylan
Mylan Laboratories Limited
SITE LAYOUT
UNIT−3
Fig 6.1 Plant Layout of Mylan Laboratories Limited, Unit -3

6.5 Hazard Analysis and Risk Assessment

6.5.1 Introduction.
Hazard analysis involves the identification and quantification of the various hazards
(unsafe conditions) that exist in the plant. On the other hand, risk analysis deals with the
identification and quantification of risks, the plant equipment and personnel are exposed
to, due to accidents resulting from the hazards present in the plant.
Hazard and risk analysis involves very extensive studies, and requires a very detailed
design and engineering information. The various hazard analysis techniques that may be
applied are hazard and operability studies, fault-tree analysis, event-tree analysis and
failure and effects mode analysis.
Risk analysis follows an extensive hazard analysis. It involves the identification and
assessment of risks; the neighboring populations are exposed to as a result of hazards
present. This requires a thorough knowledge of failure probability, credible accident
scenario, vulnerability of population's etc. Much of this information is difficult to get or
generate. Consequently, the risk analysis is often confined to maximum credible accident
studies.
In the sections below, the identification of various hazards, probable risks, maximum
credible accident analysis, consequence analysis are addressed which gives a broad
identification of risks involved in the plant.
6.5.2 Hazard Identification (Terms of Reference No. 3(ix))

The Hazard identification process must identify hazards that could cause a potential major
accident for the full range of operational modes, including normal operations, start-up,
and shutdown, and also potential upset, emergency or abnormal conditions. Employers
should also reassess their Hazard identification process whenever a significant change in
operations has occurred or a new substance has been introduced. They should also
consider incidents, which have occurred elsewhere at similar facilities including within the
same industry and in other industries.

Hazard identification and risk assessment involves a critical sequence of information

gathering and the application of a decision-making process. These assist in discovering
what could possibly cause a major accident (hazard identification), how likely it is that a
major accident would occur and the potential consequences (risk assessment) and what
options there are for preventing and mitigating a major accident (control measures). These
activities should also assist in improving operations and productivity and reduce the
occurrence of incidents and near misses.
While HAZOP is primarily a tool for hazard identification, the HAZOP process can also
include assessment of the causes of accidents, their likelihood and the consequences that
may arise, so as to decide if the risk is acceptable, unacceptable or requires further study..
Moreover, a formal guidance for applying this technique is available. Collaboration
between management and staff is fundamental to achieving effective and efficient hazard
identification and risk assessment processes.
After identifying hazards through a qualitative process, quantification of potential

consequences of identified hazards using simulation modelling is undertaken. Estimation
of probability of an unexpected event and its consequences form the basis of quantification
of risk in terms of damage to property, environment or personnel. Therefore, the type,
quantity, location and conditions of release of a toxic or flammable substance have to be
identified in order to estimate its damaging effects, the area involved, and the possible
precautionary measures required to be taken.
Considering operating modes of the facility, and based on available resources the following
hazard identification process chosen are:
a) Fire Explosion and Toxicity Index (FETI) Approach;
b) HAZOP studies;
c) Maximum Credible Accident and Consequence Analysis (MCACA);
d) Classification of Major Hazard Substances;
e) Manufacture Storage and Import of Hazardous Chemical Rules, 1989 (GOI Rules,
1989);
f) Identification of Major Hazardous Units.

The physical properties of solvents used in the process are presented in Table 6.2 which
forms the basis for identification of hazards during storage and interpretation of the
Manufacture, Storage and Import of Hazardous Chemical Rules, 1989 (GOI Rules, 1989)
The interpretation of “The Manufacture Storage and Import of Hazardous chemicals”

issued by the Ministry of Environment and Forests, GOI, which guides the preparation of
various reports necessary for safe handling and storage of chemicals shows that the
present project requires preparation of safety reports before commencing operation and
risk assessment is not mandatory. The applicability of various rules is presented in Table
6.5.
Table 6.5 Applicability of GOI Rules to Storage/Pipeline
S. Chemical Inventory Threshold Quantity (T)
No KL For Application of Rules Applicable Rules
5,7-9, 13-15 10-12
1 Acetone 2 x 25 KL 1500 10000 4 (1) (a), (2), 5,15
2 Tetra hydro Furan 30 KL 1500 10000 4 (1) (a), (2), 5,15
3 Cyclohexane 25 KL 1500 10000 4 (1) (a), (2), 5,15
4 Toluene 2 x 25 KL 1500 10000 4 (1) (a), (2), 5,15
5 Absolute Alcohol 2 x 25 KL 1500 10000 4 (1) (a), (2), 5,15
6 Methanol 2 x 25 KL 1500 10000 4 (1) (a), (2), 5,15
7 Ethyl Acetate 2 x 25 KL 1500 10000 4 (1) (a), (2), 5,15
8 Diesel 25 KL 1500 10000 4 (1) (a), (2), 5,15
9 Isopropyl Alcohol (IPA) 2 x 25 KL 1500 10000 4 (1) (a), (2), 5,15
10 n-Butanol 15 KL 1500 10000 4 (1) (a), (2), 5,15
11 Ortho Xylene 15 KL 1500 10000 4 (1) (a), (2), 5,15
12 Chloroform 25 KL 1500 10000 4 (1) (a), (2), 5,15
13 n-Hexane 15 KL 1500 10000 4 (1) (a), (2), 5,15
14 Methylene dichloride 25 KL 1500 10000 4 (1) (a), (2), 5,15
15 Ammonia Solution 10 KL 1500 10000 4 (1) (a), (2), 5,15
16 Caustic Soda Lye 8.3 KL 1500 10000 4 (1) (a), (2), 5,15
17 Hydrochloric Acid 12 KL 1500 10000 4 (1) (a), (2), 5,15
18 Acetic Acid 25 KL 1500 10000 4 (1) (a), (2), 5,15
19 Orthophosphoric Acid 25 KL 1500 10000 4 (1) (a), (2), 5,15
20 Chloroform 25 KL 1500 10000 4 (1) (a), (2), 5,15
21 Cyclohexane 25 KL 1500 10000 4 (1) (a), (2), 5,15

Table 6.6 Physical Properties of Raw Materials and Solvents

Name of Solvent TLV Toxicity Level Flammable Limit Chemical Class
(ppm) LD50 LD50 LC 50 (As per MSIHC
Oral Dermal (mg/1) LEL UEL FP BP Class (As per Rules)
(mg/kg) (mg/kg) (%) (%) (OC) (OC) Petroleum
Classification
Absolute Alcohol 1000 1720 1025 20000 2.1 11.5 .-4 (CC) 77 B Highly Flammable
Acetic acid 10 3310 1060 88 4 19.9 39 (CC) 118 C Flammable
Acetic Anhydride 5 1780 4320 4200 2.0 10.2 49 (C.C) 138 B Corrosive
Acetone 1000 5800 20000 5540 2.6 13.0 <-20 (CC) 56.2 B Highly Flammable
Acetonitrile 40 3800 988 1000 3.0 17.0 2 (CC) 81.6 B Highly Flammable
Chloroform 50 908 20000 47702 ---- 61 --- Not Flammable
Cyclohexane 300 12705 2000 13900 1.2 8.2 .-18 (C.C) 81 B Flammable
Diisopropyl ether 250 8470 14480 162000 1.0 21.0 .-28 (C.C) 67 C Flammable
Dimethyl Amine 10 1000 3900 --- 2.6 12.3 .-18.5 (C.C) 54 B Flammable/Corrosive
Dimethyl Formamide 10 2800 1500 15 2.2 16.0 58 (CC) 153 C Flammable
Dimethyl Sulphoxide 50 14500 5000 40250 1.8 63 95 (CC) 189 B Non-Hazard
Ethyl Acetate 400 5620 18000 2500 2.1 11.5 .-4 (CC) 77 B Highly Flammable
Isopropyl Alcohol 400 5045 12800 100000 2.0 12.7 12 (CC) 82.4 B Highly Flammable
Isopropyl Ether 500 8470 14480 162000 1.0 21.0 .-28 (C.C) 67 C Flammable
Methanol 200 5628 15800 64000 5.5 36.5 11 (CC) 64.5 A Flammable
Methyl isobutyl ketone 100 2080 16000 8.2 1.2 8.0 14 (C.C) 117 B Flammable
Methylene Dichloride 50 670 2800 2270 6.0 11.4 13 (CC) 84.1 B Carcinogenic
n- Hexane 50 28710 2000 >20 1.0 8.1 .-22 (C.C) 69 B Flammable
n-Heptane 400 15000 9750 4900 1.0 7.0 .-4 (CC) 98.4 B Highly Flammable
Ortho Xylene 100 3567 12126 4595 1.0 7.6 30 (C.C) 144.4 B Flammable
Tetrahydrofuran 200 1650 2000 2160 1.5 12.4 .-21.5 (CC) 66 B Highly Flammable
Toluene 200 636 12124 313 1.2 8.0 4 (CC) 110.6 B Highly Flammable
Tert. Butyl alcohol 100 2733 2000 --- 2.3 8.0 14 (C.C) 83 B Flammable
Triethyl Amine 5 730 580 7.1 1.2 9.3 .-11 (C.C) 90 B Flammable

Mylan Laboratories Limited, Unit - 3 Environmental Impact Assessment Report
6.5.3 Fire & Explosion Index (F & EI):

6.5.3.1 Methodology
Dow Chemical Company issued a guideline for hazard determination and protection. By
this method a chemical process unit is rated numerically for hazards. The numerical
value used is the Fire and Explosion Index (F&EI) which is most widely used for hazard
evaluation in chemical process industries.
The guide applies to process unit only and not to auxiliary units such as power
generating stations, plant water systems, control rooms, fired heaters, structural
requirements, corrosive nature of material handled and personal safety equipment. These
are regarded as basic features that do not vary according to the magnitude of the fire and
explosion hazard involved. The guide also does not cover the processing and handling of
explosives such as dynamite, TNT etc.
Computation of F&EI
The F&EI is calculated as a product of Material factor, General process hazard factor, and
special process hazard factor The Material factor is a measure of the intrinsic rate of
potential energy release from fire or explosion of most hazardous material or mixture of
materials present in significant quantity, whether it is raw material, intermediate,
product, solvent etc, by combustion or chemical reaction. “In significant quantity” here
means such quantity that the hazard represented by the material actually exists. The
National Fire Protection Agency of USA (NFPA) have specified standard values for
material factor which should be used for F&EI calculations and are available in Dow’s
Hazard Classification Guide. In case it is not readily available, it can be calculated using
the heat of combustion, flammability indices etc.
General process hazards are factors that play a primary role in determining the
magnitude of loss of incident. It takes into account the nature of the reaction, ventilation
of the unit, accessibility of the unit, drainage facilities etc., special process hazards are
factors that contribute primarily to the probability of a loss of incident. They consist of

specific process conditions that have shown themselves to be major causes of fire and
explosion incidents. It takes into account toxicity of the material, operating pressure,
operation near flammable range, quantity of material, joints and packing, use of hot oil
exchange system etc., The F&EI index is calculated as a product of Material factor,
General process hazard factor, and Special process hazard factor.
Hazard Ranking
The hazard ranking based on F&EI value is presented in Table 6.7.
Table 6.7 Degree of Hazard for F&EI

F&EI Index Range Degree of Hazard
1 – 60 Light
61 – 96 Moderate
97 – 127 Intermediate
128 – 158 Heavy
159 & above Severe
The estimated values of F&EI and hazard ranking are given in the Table 6.8. The radius
of exposure is determined by 0.26 meter x respective F&EI. The estimated values of F&EI
reflect light hazard in view of the low volume of chemicals.
The fire and explosion index evaluation can be very useful in developing plant layouts or
adding equipment and buildings to existing plants. Evaluation of the F&EI calculations
and layout considerations will result a safe, operable, maintainable and cost-effective
arrangement of equipment and buildings.
Table 6.8 Fire & Explosion Index for Tank farm
S. No. Name of the Solvent F& EI Radius of Exposure Degree of
(F1*F2*MF) (m) F&EIx0.26 Hazard
1 Absolute Alcohol 71.62 18.62 Moderate
2 Methanol 76.3 19.84 Moderate
3 Toluene 87.91 22.86 Moderate
4 Acetone 79.18 20.59 Moderate
5 Ethyl Acetate 77.53 20.16 Moderate
6 Methylene Dichloride 98.8 25.69 Moderate
7 Iso Propyl Alcohol 79.81 20.75 Moderate
8 n- Hexane 79.04 20.55 Moderate
9 O-Xylene 85.32 22.18 Moderate
10 Acetic Acid 71.58 18.61 Moderate
11 Tetrahydrofuran 61.83 16.08 Moderate
12 n-Butanol 68.44 17.79 Moderate

13 Chloroform 59.35 15.43 Moderate

14 Cyclohexane 72.01 18.72 Moderate
The storage is a small capacity facility and accordingly the F& E index value is found to be
moderate reflecting the threshold limits as prescribed in MSHC rules. Both MSHC rules
and F & E index indicate that the present facility does not require a detailed risk
assessment.
6.5.4 Hazard and Operability Study (HAZOP)

Hazard and Operability Study (HAZOP) is a highly structured and detailed technique,
developed primarily for application to chemical process systems. A HAZOP can generate
a comprehensive understanding of the possible ‘deviations from design intent’ that may
occur. However, HAZOP is less suitable for identification of hazards not related to
process operations, such as mechanical integrity failures, procedural errors, or external
events. HAZOP also tends to identify hazards specific to the section being assessed, while
hazards related to the interactions between different sections may not be identified.
However, this technique helps to identify hazards in a process plant and the operability
problems. It is performed once the engineering line diagrams of the plant are made
available. It is carried out during or immediately after the design stage. The purpose of
the study is to identify all possible deviations from the way the design/operation is
expected to work and all the hazards associated with these deviations. A multi-
disciplinary team was constituted with chemical, mechanical and instrumentation
engineers, R&D chemist and production manager. It is important to keep the team small
enough to be efficient, while retaining a sufficient spread of skills and disciplines for all
aspects of the study to be covered comprehensively. The group discussion is facilitated
by a Chairman and the results of the discussion are recorded by a Secretary. Every
investigation must be led by Chairman who is familiar with the HAZOP study technique,
which is primarily concerned with applying, controlling the discussions and stimulating
team thinking.

The preparative work for HAZOP studies consisted of four stages i.e., obtaining the data,
converting into usable form, planning the sequence of the study and arranging the
necessary meetings. The documents referred to for the study include process description,
process flow diagrams, P&I diagrams plant layout, operating manuals including startup
& shutdown, safety instructions etc., The parameters such as temperature, pressure, flow,
level were investigated for deviation and hazard situations are identified.
Some basic definitions of terms frequently used in HAZOP studies are deviation, causes,
consequences and guide words etc., Deviations are departures from the design intent
which are discovered by systematically applying the guide words. Causes are the reasons
why deviations might occur. Consequences are the reasons why deviations should they
occur. Guide words are simple words used to understand a particular plant section in
operating condition in order to guide and simulate the creative thinking process and so
discover deviations. NO, less, more, as well as, part of, reverse, other than are guide
words used.
Potential problems as represented by the consequences of the deviation should be

evaluated as they arise and a decision reached on whether they merit further
consideration or action. Except for major risk areas where a fully quantitative assessment
is required this decision is made semi-quantitatively on the consequence (usually scaled
as trivial, important or very probable). Typical HAZOP study for one product is
mentioned as follows;
6.5.5 Hazard Factors

A study of past accident information provides an understanding of failure modes and
mechanisms of process and control equipment and human systems and their likely effects
on the overall plant reliability and safety.

Some of the major contributing factors for accidents in chemical industries are:
S. No Contributing Factor Percent Loss
1 Equipment design faults 41
2 Process design faults 10
3 Operator errors 31
4 Maintenance deficiencies 12
5 Material hazards 6
A study by AIChE (1972) indicates that majority of equipment of component failures

involve compressors, furnaces and heat exchangers as there are lesser opportunities to
take them off for maintenance. The frequency of equipment or component failures is
observed as follows:
S. No Equipment Frequency (%)

1 Compressors 30
2 Furnaces 18
3 Heat Exchangers 17
4 Process Vessels 18
5 Others 17
However, failures of storage vessels and those during transportation have been reported
more frequently than cases of plant failures. The failure rate of various equipment in a
typical power plant is provided in the following table.
Equipment Failure Rates
Failure rate Failures 10-6/h
Electric motors (general) 10
Transformers (<15 kV) 0.6
(132-400k V) 0.7
Circuit breakers (general, <33k V) 2
(400kV) 10
Pressure vessels (general) 3
(High standard) 0.3
Pipes 0.2
Pipe joints 0.5
Ducts 1
Gaskets 0.5
Bellows 5
Diagrams (metal) 5
(Rubber) 8
Unions and junctions 0.4


Hoses (heavily stressed) 40
(Lightly stressed) 4
Ball bearings (heavy duty) 20
(Light duty) 10
Roll bearings 5
Sleeve bearings 5
Shafts (heavily stressed) 0.2
(Lightly stressed) 0.02
Relief valves leakage 2
Blockage 0.5
Hand- operated valves 15
Control valves 30
Ball valves 0.5
Solenoid valves 30
Rotating seals 7
Sliding seals 3
‘O-ring seals 0.2
Couplings 5
Belt drives 40
Spur gears 10
Helical gears 1
Friction clutches 3
Magnetic clutches 6
Fixed orifices 1
Variable orifices 5
Nozzle and flapper assemblies: Blockage 6
Breakage 0.2
Filters: blockage 1
Leakage 1
Rack-and-pinion assembles 2
Knife-edge fulcrum: wear 10
Springs (heavily stressed) 1
(Lightly stressed) 0.2
Hair springs 1
Calibration springs: creep 2
Breakage 0.2
Vibration mounts 9
Mechanical joints 0.2
Grub screws 0.5
Pins 15
Pivots 1
Nuts 0.02
Bolts 0.02
Boilers (all types) 1.1


Boilers feed pumps 2.5
Cranes 7.8
6.5.6 Common Causes of Accidents

Engineering and Instrumental
Based on the analysis of past accident information, common causes of major chemical
plant accidents are identified as:
• Poor house keeping
• Improper use of tools, equipment, facilities
• Unsafe or defective equipment facilities
• Lack of proper procedures
• Improving unsafe procedures
• Failure to follow prescribed procedures
• Jobs not understood
• Lack of awareness of hazards involved
• Lack of proper tools, equipment, facilities
• Lack of guides and safety devices
• Lack of protective equipment and clothing
Failures of Human Systems

An assessment of past chemical accidents reveals human factor to be the cause for over
60% of the accidents while the rest are due to other plant component failures. This
percentage will increase if major accidents alone are considered for analysis. Major
causes of human failures reported are due to:
• Stress induced by poor equipment design, unfavorable environmental conditions,

fatigue, etc.
• Lack of training in safety and loss prevention.
• Indecision in critical situations.
• Inexperienced staff being employed in hazardous situations.

Often, human errors are not analyzed while accident reporting and accident reports only
provide information about equipment or component failures. Hence, a great deal of
uncertainty surrounds analysis of failure of human systems and consequent damages.
The number of persons/materials are potentially exposed to a specific hazard zone is a

function of the population density and distribution near the accident location. The failure
rate data and ignition sources of major fires are presented in the following Tables 6.9 and
6.10.
Table 6.9 Failure Rate Data
S.No Item International S.No Item International
Data Data
1 Process Controllers 2.4 x 10-5 hr-5 4 Leakage at biggest storage 5.0 x 10-5 yr-1
tank
2 Process control valve 2.0 x 10-6 hr-1 5 Leakage of pipe line 1 x 10-7 m-1 yr-1
3 Alarm 2.3 x 10-5 hr-1 6 Human Failure 1 x 10-4
(demand)-1
Table 6.10 Ignition Sources of Major Fires

S.No Ignition Source Percent S.No Ignition Source Percent
1 Electrical (wiring of 23% 9 Exposure (fires jumping into new 3%
motors) areas)
2 Smoking 18% 10 Incendiarism (fires maliciously set) 2%
3 Friction 10% 11 Mechanical sparks 2%
4 Over heated material 8% 12 Molten substances 1%
5 Burner flames 7% 13 Chemical actions 1%
6 Combustion sparks 5% 14 Static sparks 1%
7 Spontaneous ignition 4% 15 Lightening 1%
8 Cutting & welding 4% 16 Miscellaneous 1%
6.6 Maximum Credible Accident and Consequence Analysis (MCACA)

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

6.6.1 Methodology
MCACA aims at identifying the unwanted hazardous events, which can cause maximum
damage to plant and personnel. At the first instance, all probable accident scenarios are
developed. Scenarios are generated based on properties of chemicals, physical conditions
under which reactions occur or raw materials stored, as well as material strength of
vessels and conduits, in-built valves and safety arrangements, etc. Creating a scenario
does not mean that it will occur, only that there is a reasonable probability that it could. A
scenario is neither a specific situation nor a specific event, but a description of a typical
situation that covers a set of possible events or situations.
This is the basis of the risk study; it tells us what may happen so that ways and means of
preventing or minimizing the possibility can be devised. The next step is estimation of
the probability of each accident scenario. A credible accident is one within the realm of
possibility and is likely to be severe enough to cause significant damage. This concept
comprises of two parameters- probable damage caused by an accident and probability of
occurrence of an accident .There may be types of accidents that may occur frequently, but
would cause very little damage. And there may be other types that may cause great
damage, but would have a very low probability of occurrence. Both are important and
need to be considered, even if they are later discarded. A host of probable accident
scenarios are visualized examined and credibility of probable events is established based
on engineering judgment, past accident data and expertise in the field of risk analysis.
The following steps are involved in identifying the maximum credible accident scenarios.
a. A detailed study of the process and plant information including process flow diagrams
and piping & instrumentation diagrams.
b. Hazard classification of chemicals, operations and equipment.
c. Identification of representative failure cases of vessels and pipelines and the resulting
release scenarios
d. Establishment of credibility of visualized scenarios based on past accident data.

6.6.2 Identification of Vulnerable Areas

The unit operations in the process and storage areas involve mass and energy transfer
operations to effect the necessary physical changes. Nature of chemicals and the
operating conditions create special hazardous situations. In the present case the chemicals
handled are flammable and toxic in nature. With these factors in mind a thorough
examination of the process information is carried out and a list of inventories of the
hazardous chemicals is prepared to identify the hazardous situations. Based on the raw
material consumptions determined from the pilot scale studies, experience in handling
commercial scale processes and logistics in procurement of raw materials, the inventories
to be maintained for each of the raw material and its mode of storage is determined. High
inventory liquid raw materials like solvents are usually stored in tank farms, while solids
and other low inventory liquids are stored in ware house based on compatibility,
reactivity, toxicity etc. with appropriate safety and firefighting facilities to handle any
kind of emergencies.
6.6.3 Representative Accident Scenarios

A study of past accidents, which took place in similar process units and the present plant,
provides reasons and course of accidents and there by focusing on most critical areas. A
thorough examination of engineering details indicated many possible scenarios like
gasket leak, pinholes in pipes & vessels apart from rupture of pipelines & vessels and
catastrophic failure of vessels. Heat radiation damage distances for Pool fire was
considered.
Failure Frequency:
The release scenarios considered above can be broadly divided in to two categories
(i) Catastrophic failures which are of low frequency and
(ii) Ruptures and leaks which are of relatively high frequency
Vapor or liquid release from failure of gasket, seal and rupture in pipe lines and vessels
fall in second category whereas catastrophic failure of vessels and full bore rupture of
pipe lines etc., fall in to first category. Typical failure frequencies are given in Table 6.11.

Table 6.11 General Failure Frequencies

Item Mode of failure Failure frequencies
Pressure Vessel Serious leak 1.0*10-5/Year
Catastrophic 3.0*10-6/Year
Pipe lines
=50 mm dia Full bore rupture 8.8*10-7/m.year
Significant leak 8.8*10-6/m.year
>50 mm =150 mm dia Full bore rupture 2.6*10-7/m.year
>150 mm dia Full bore rupture 8.8*10-8/m.year
hose Rapture/Failure 4.0*10-5/hr
Unloading arm Rapture/Failure 3.0*10-8/hr
Check valve Failure on demand 1.0*10-4/on demand
motor operated valve Failure on demand 1.0*10-3/ on demand
Flange Leak 3.0*10-4/ Year
Pump seal Leak 5.0*10-3/ Year
Gasket failure Failure 5.0*10-5/ Year
Process safety valve(PSV) Lifts heavily 4.0*10-3/ Year
Blocked 1.0*10-3/ Year
Lifts lightly 6.0*10-2/ Year
6.7 CONSEQUENCE ANALYSIS

The accidental release of hazardous chemicals leads to subsequent events, which actually
cause the damage. The damages are of three types.
1) Damage due to heat radiation.
2) Damage due to over pressure effects subsequent to explosion
3) Damage due to toxic effects
The type of damage and extent of damage depends on nature of chemical, the conditions
of release, atmospheric conditions and the subsequent events. The sequence of probable
events following the release of a hazardous chemical is schematically shown in Figure
6.2. The best way of understanding and quantifying the physical effects of any accidental
release of chemicals from their normal containment is by means of mathematical
modeling. This is achieved by describing the physical situations by mathematical
equations for idealized conditions and by making corrections for deviation of the

practical situations from ideal conditions. In the present study ALOHA software from
USEPA. These models for various steps are described in the following sub-sections.
6.7.1 Release Models and Source strength

This depends on the nature of failure of the unit and the content of the unit and operating
temperature and pressure of the unit. The release may be instantaneous due to total
failure of storage unit or continuous due to leakage or rupture of some component of the
storage facility. The material discharged may be gas or liquid or the discharge could be
manifested through two phase flow. The models that are used to calculate the quantity of
liquid/vapor released are:
Fig 6.2 Steps in Consequence Calculations
The following criteria tables present heat radiation intensities (Table 6.12), radiation
exposure and lethality (Table 6.13), and damage due to peak over pressure is presented
in Table 6.14.

Table 6.12 Damage Due to Incident Radiation Intensities

S. Incident Type of Damage Intensity
No Radiation Damage to Equipment Damage to the People
(KW/m2)
1 37.5 Damage to process Equipment 100% lethality in 1 min.
1% lethality in 10 sec.
2 25.0 Minimum energy required 50 % lethality in 1min.
to ignite wood at indefinitely long Significant injury in 10 sec.
exposure without a flame
3 19.0 Maximum thermal radiation ---
intensity allowed n thermally
Unprotected adjoining equipment.
4 12.5 Minimum energy to ignite with 1% lethality in 1 min.
a flame, melts plastic tubing
5 4.0 -- Causes pain if duration is longer than 20
sec, howeverblistering is unlikely (1st
degree burns)
6 1.6 -- Causes no discomfort on
Longer exposure
Source: Techniques for Assessing Industrial Hazards by World Bank
Table 6.13 Radiation exposure and lethality
Radiation Intensity Exposure Time 1% Lethality Degree Burns
(KW/m2) (seconds)
1.6 -- 0 No Discomfort even after
longer exposure
4.5 20 0 1st
4.5 50 0 1 st
8.0 20 0 1 st
8.0 50 <1 3 rd
8.0 60 <1 3 rd
12.0 20 <1 2 nd
12.0 50 8 3 rd
12.5 -- 1 --
25.0 -- 50 --
37.5 -- 100 --
Table 6.14 Damage Due to Peak over Pressure

Human Injury Structural Damage
Peak Over Type of Damage Peak over Type of Damage
Pressure (bar) Pressure (bar)
5–8 100% lethality 0.3 Heavy (90%Damage)
3.5 – 5 50% lethality 0.1 Repairable (10%Damage)
2–3 Threshold lethality 0.03 Damage of Glass
1.33 – 2 Severe Lung damage 0.01 Crack of Windows
1 – 11/3 50% Eardrum rupture - -
Source: Marshall, V.C. (1977)’ How lethal are explosives and toxic escapes.

6.7.2 Results of Consequence Analysis

The damages due to the accidental release of chemicals are of three types.
a) Damage due to heat radiation
b) Damage due to over pressure effects subsequent to explosion
c) Damage due to Toxic effects
The consequence analysis for the identified scenarios is carried out using software based
on Yellow book of TNO.
6.7.2.1 Analysis of Hazardous Scenarios

The hazardous chemicals involved are stored within the threshold limits of storage and
hence few representative chemicals mainly solvents were studied.
6.7.2.1.1 Heat radiation effects (Terms of Reference No. B(13))
When a non-boiling liquid spills, it spreads into a pool. The size of the pool depends on
the availability of the bund and obstacles. The heat load on objects outside a burning pool
of liquid is calculated with the heat radiation model. The average heat radiation intensity,
the diameter-to-height ratio dependent on the burning liquid, geometric view, distance
from the fire, relative humidity of air, horizontal or vertical orientation of the object
radiated with respect to fire are factored. All storage tanks in tank-farm area are provided
with dykes. For each of the hazardous chemicals involved various scenarios such as pipe
line leaks of 5mm or pipeline ruptures or catastrophic vessel ruptures of the inventories
as outlined have been considered and damage distances for Lower Flammability Limits
(LFL) and heat radiation effects for the three levels of intensity are calculated and
presented in Table 6.15 . Heat radiation damage distances for most of the scenarios are
not occurring. In case of pipeline leaks, 5 mm leaks are considered for 15 mm and 50 mm
pipe sizes. Very low release rates of material are obtained due to small leaks and cannot
create a major incident hazard. The concentration of the flammable material in the vapor
cloud was found to be below the lower flammability limits.

Table 6.15 Heat Radiation Damage Distances – Tank Farm

S.No Name of Raw Capacity No.s Diameter Height Volume Hole Release Heat radiation damage
material (KL) (m) (m) (m3) Dia Rate distances in m for KW/m2
(mm) (Kg/sec) 37.5 12.5 4.0
1 Absolute Alcohol 25 2 2.8 4.0 25 25 0.38 <10 <10 <10
2 Methanol 25 2 2.8 4.0 25 25 0.38 <10 <10 <10
3 Toluene 25 2 2.8 4.0 25 25 0.40 <10 <10 11
4 Acetone 25 2 2.8 4.0 25 25 0.38 <10 <10 <10
5 Ethyl Acetate 25 2 2.8 4.0 25 25 0.40 <10 <10 <10
6 Methylene dichloride 25 1 2.8 4.0 25 25 2.07 <10 <10 12
7 Isopropyl Alcohol 25 2 2.8 4.0 25 25 0.38 <10 <10 <10
8 n-Hexane 15 1 2.3 3.8 15 25 0.34 <10 <10 11
9 Ortho Xylene 15 1 2.3 3.8 15 25 0.42 <10 <10 12
10 Acetic Acid 25 1 2.8 4.0 25 25 0.43 <10 <10 <10
11 Tetra hydro Furan 30 1 3.1 4.0 30 25 0.40 <10 <10 <10
12 n-Butanol 15 1 2.3 3.8 15 25 0.36 <10 <10 <10
13 Cyclohexane 25 1 2.8 4.0 25 25 0.38 <10 <10 12

6.7.2.1.2 Overpressure effects:
When an unignited gas cloud mixes with air and reaches the flammable range and if the
cloud ignites wither a flash fire or flash fire explosion can occur. Since the burning time is
shorter, instead of heat radiation from a flash fire, peak overpressure as a function of
distance from the center of the cloud is derived. In case of pipeline leaks, damage
distances due to overpressure effects are not observed. The values are found to be similar
as there are no pressurized storage tanks in the tank farm, and the over pressure
distances are contingent on the tank capacity.
6.7.3 Observations:
From the previous incident records published in literature and hydrocarbon release data
bases, it has been observed that pinhole leaks contribute highest percentage whereas the
second cause is small sized leaks of 25 mm diameter in tank farm, and 10 mm for drums.
6.7.4 Recommendations:
The following are the recommendations to minimize the hazards and improve the safety
of the proposed plants. Plants of this nature, which handle a variety of chemicals, face
problems of fire and vapor cloud explosions. It has been observed that for the proposed
plants the damage distances are more or less confined to the plant area only. Taking
precautionary safety measures as outlined below can further minimize these effects.
• In view of hazardous nature of operations, it is recommended to adopt best practices

with respect to design, operation and maintenance.
• It is recommended that all flammable areas and process area be maintained free of
ignition sources. Ensure that sources of ignition, such as pilot lights, electrical
ignition devices etc., at strategic locations like solvent storage areas are avoided.
• All electrical fittings involved in and around the pipeline and operation system
should conform to flame/explosion proof regulations.
• Strict hot work control and display of danger signs should be ensured.

• It is recommended to provide one fire hydrant point in the tank-farm area to take
care of any emergency. Installation of fire water hydrant network is suggested.
• It is suggested to provide fire extinguishers in process plant at solvent storage area
and the vents of solvent tanks to be provided with PESO approved flame arrestors.
• Fire protection equipment should be well maintained so that it is available when
required. They should be located for quick accessibility. Provide carbon dioxide fire
extinguishers and DCP extinguishers for Electrical fires.
• It is suggested to have a periodical review of safety awareness and safety training
requirements of plant employees with respect to hazards present in the plant.
• In general, all pipelines carrying flammable liquids/vapor are periodically checked
for their integrity. Spillages have to be avoided and disposal should be done
quickly.
6.7.5 Transportation (Terms of Reference No. 7(iii))
Transportation of raw materials may result in accidents due to high speed collision, low
speed collision, overturning and non-accident-initiated release. The initiating and
contributing causes are presented in Table 6.16
Table 6.16 Truck Incidents – Initiating and Contributing Causes
Human Errors Equipment Failures System or Procedural External Events
Failures
Driver Non-dedicated trailer Driver incentives Vandalism/
Impairment Sabotage
Speeding RR crossing guard Driver training Rain
Driver Overtired Failure Carrier selection Fog
Contamination Leaking Valve Container Specification Wing
Overfilling Leaking Fitting Route selection Flood/washout
Other Vehicle's Brake Failure Emergency response Fire at rest
Driver training areas/parking
areas
Taking Tight Insulation/Thermal Speed Enforcement Earthquake
Protection Failure
Unsecured Load Relief device failure Driver rest periods Existing accident
Tire failure Maintenance Inspection
Soft shoulder

Overpressure Time of day Restrictions

Material defect
Steering failure
Sloshing
High center of gravity
Corrosion
Bad Weld
Excessive Grade
Poor Intersection design
Suspension system
The scenarios presented for storages are calculated for transport related
incidents/accidents and presented in Table 6.17.
Table 6.17 Transportation Specific Concerns
Concern Road
Spill on Water Over or near a body of water
Unconfined Pools In an undisturbed flat area
BELVE-Induced catastrophic Possible if sufficient quantity in car with small leak to feed fire
vessel failure or if double tank trailer or burning fuel leak
Toxic products of combustion Dependent on material and whether ignition occurs
or reaction
6.8 DISASTER MANAGEMENT PLAN (Terms of Reference No: 7(xiii))
6.8.1 INTRODUCTION
A disaster is a catastrophic situation in which suddenly, people are plunged into
helplessness and suffering and, as a result, need protection, clothing, shelter, medical and
social care and other necessities of life.
Disasters can be divided into two main groups. In the first, are disasters resulting from
natural phenomena like earthquakes, volcanic eruptions, storm surges, cyclones, tropical
storms, floods, avalanches, landslides, and forest fires. The second group includes
disastrous events occasioned by man, or by man's impact upon the environment.
Examples are armed conflict, industrial accidents, radiation accidents, factory fires,
explosions and escape of toxic gases or chemical substances, river pollution, mining or
other structural collapses, air, sea, rail and road transport accidents and can reach
catastrophic dimensions in terms of human loss.

There can be no set criteria for assessing the gravity of a disaster in the abstract since this
depends to a large extent on the physical, economic and social environment in which it
occurs. However, all disasters bring in their wake similar consequences that call for
immediate action, whether at the local, national or international level, for the rescue and
relief of the victims. This includes the search for the dead and injured, medical and social
care, removal of the debris, the provision of temporary shelter for the homeless, food,
clothing and medical supplies, and the rapid re- establishment of essential services.
An emergency may be said to begin when operator at the plant or in charge of storage of
hazardous chemicals cannot cope up with a potentially hazardous incident, which may
turn into an emergency. The emergencies could be a major fire or explosion or release of
toxic gas or a combination of them.
The proposed plant will store fuels, which are flammable in nature, and the storage will
be as per the Controller of Explosives and OISD norms. The hierarchy of the employees
is yet to be determined and the project is still in the initial stages of designing. Hence a
tentative disaster management plan is prepared to be suitably modified before
commissioning of the plant.
6.8.2 OBJECTIVES OF EMERGENCY MANAGEMENT PLAN (ON-SITE)

A quick and effective response during emergency can have tremendous significance on
whether the situation is controlled with little loss or it turns into a major emergency
Therefore, the objectives of this Onsite Emergency Plan (ONSEP);
During Emergency: Is to provide basic guidance to the personnel for effectively

combating such situations to minimize loss of life, damage to property and loss of
property.
• To localize the emergency and if possible eliminate it;

• To minimize the consequences of an emergency;
• To prevent spreading of the damage in other areas;
• To give necessary warning to plant personnel and neighborhood;

To maximize resource utilization and combined efforts towards the emergency

operations;
• To mobilize internal resources and utilize them in the most effective way;
• To arrange rescue of persons, transport and treatment of causalities;
• To seek necessary help from industries in neighborhood or local authorities;
• To provide information to government agencies and to provide information to
public.
During Normal Time:
• To keep the required emergency equipment in stock at right places and ensure
their working condition;
• To keep the concerned personnel fully trained in the use of emergency equipment;
• Preserving records, evidence of situation for subsequent emergency etc.
6.8.3 SCOPE OF ONSEP (Terms of Reference No: 7(xiii))

This ONSEP is prepared for industrial emergencies like fires, explosions, toxic releases,
asphyxia and does not cover natural calamities and societal disturbances related
emergencies (like strikes, bomb threats, civil Commissions etc). Also, the scope of this
ONSEP is limited to onsite emergencies and does not include measures for offsite
Emergency Management. Necessary information with regards to Off Site Emergency
Management will be furnished to district authorities.
6.8.4 METHODOLOGY OF DEVELOPING ONSEP

The consideration in preparing this Emergency Plan includes the following steps:
• Identification and assessment of hazards and risks;
• Identifying, appointment of personnel & Assignment of Responsibilities;
• Identification and equipping Emergency Control Center;
• Identification of Assembly, Rescue points, Medical Facilities;
• Formulation of plan and of emergency sources;

• Training, Rehearsal & Evaluation;

• Action on Site.
Earlier, a detailed Hazard Analysis and Risk Assessment were carried out for the plant
facilities and the hazards are quantified. The likely locations of hazards and consequences
are evaluated, duly following the standard procedure.
6.8.5 ELEMENTS OF ONSITE EMERGENCY PLAN

Important elements considered in this plan are:
• Identification of emergencies
• Emergency organization
• Emergency facilities
• Emergency procedures
• Communications during emergency
• Rescue, Transport and Rehabilitation
• Roles and responsibilities of key personnel and essential employees
• Mutual aid.
6.8.5.1 Emergencies Identified

Spillage, pool fire, are the possible emergencies in the pipelines, fire near storage, DG set,
and Transformers are the other possible emergencies.
The other emergencies are asphyxiation of persons, apart from risks due to cyclonic
conditions, earth quake, lightning, floods (natural calamities), sabotage, bombing (social
and other reasons) etc. which are not under the management control.
Priority of protection in the event of an emergency is; Life and safety of personnel,
preservation of property, restoration of normalcy.
6.8.5.2 Emergency Organization

The project employs works in 3 shifts. The general shift will be for the administrative
employees, while the three shifts of 8 hours each are for technical employees. Key

personnel and essential employees are identified and are assigned emergency
responsibilities. The organogram of the essential organization are presented below:
Security personnel, all operators, fitters, electricians etc. in the shifts are designated
essential employees. During emergencies, their services are drafted for essential
operations.
6.8.5.3 Emergency Facilities

a) Emergency Control Center (ECC)
It is a location where all key personnel like Chief Coordinator, Emergency controller,
maintenance coordinator can assemble and monitor aspects related to emergency and
take decisions related to emergency. The office room is designated as ECC. In case if this
area is affected, zone security room is designated as alternative ECC.
The following information and facilities would be maintained at the ECC in Plant Control
room:
Latest copy of Onsite Emergency Plan and Offsite Emergency Plan (as provided by
District Emergency Authority)
• Intercom Telephone;
• P& T Telephone;
• Telephone directories (internal and P&T);
• Factory Layout, site plan;
• P&I diagrams, electrical connections plans indicating locations of hazardous
inventories, sources of safety equipment, hydrant layout, location of pump house,
road plan, assembly points, vulnerable zones, escape routes;
• Hazard chart;
• Emergency shutdown procedures for generators and fuel supply system;
• Nominal roll of employees;
• List and addresses of key personnel;
• List and addresses of emergency coordinators;

• List and addresses of first aid providers;

• List and addresses of employees trained in firefighting;
• List and addresses of qualified trained persons;
• Material safety data sheets of raw materials;
• Duties of key personnel;
• Important addresses and telephone numbers including those of fuel supplying
company, government agencies, neighboring industries and other sources of help,
outs side experts;
The following emergency equipment is made available at alternate ECC (Security point):
• Fire proximity suit/Gloves/Helmets;
• Hand tools suitable for pipe lines (non sparking type);
• Gaskets;
• Teflon tape;
• Gas Explosive meter;
• Flame proof torches/batteries;
• Crow bar;
• Spade;
• Manila rope;
• Spark arrestor;
• Spare fan belt for truck;
• First aid box;
• Special firefighting information related to Hydrocarbon fuels;
• Public address megaphone, hand bell, Emergency torch.
b) Assembly points
Office room is identified as Assembly point and is in a low intensity fire affected zone.
Additionally the following places in plan are designated as safe assembly points: Time

office, and green belt area near the main road. The locations of assembly points would be
reviewed later.
c) Fire fighting Facilities

The fire fighting facilities which shall be provided are presented in Table 6.18.
Table 6.18 List of Fire Extinguishers
S.No Description of Item Quantity S.No Description of Item Quantity
1 DCP 150 kg 02 Nos. 10 M/Foam 135 ltrs 02 Nos.
2 DCP 10 kg 128 Nos. 11 Foam 50 ltrs 03 Nos.
3 DCP 5 kg 19 Nos. 12 CO2 9 kg 03 Nos.
4 DCP 2 kg 04 Nos. 13 CO2 6.8 kg 25 Nos.
5 ABC 150 kg 07 Nos. 14 CO2 6.5 kg 24 Nos.
6 ABC 2 kg 04 Nos. 15 CO2 4.5 kg 99 Nos.
7 M/Foam 150 ltrs 02 Nos. 16 CO2 2 kg 03 Nos.
8 M/Foam 09 ltrs 38 Nos. 17 CO2 3 kg 01 Nos.
9 M/Foam 50 ltrs 12 Nos. 18 Fire Buckets with stand 240Nos.
d) Location of First aid Boxes

The first aid boxes will be located at the following places: preparation areas,
administrative office, time office, and will be under the charge of security coordinator.
e) Emergency siren
Emergency siren will be provided with 0.5 km range of audibility and the location will be
time office. The siren will operate on regular supply and also on emergency electrical
supply. Shift electrical engineer of plant on receipt of information from shift in charge, is
authorized to operate the siren.
f) Emergency escapes
Emergency escapes in the plant area and floor wise emergency escapes will be
conspicuously marked.
g) Wind sock
Wind socks to observe the wind directions will be installed on the top of Admin building.

6.8.5.4 Emergency Procedures

a) Procedure for Raising Emergency alarm
Whenever and whoever notices an emergency or a situation with a potential emergency
should forthwith raise alarm by calling on the available communication network or
shouting or approaching the shift in charge, furnishing details. Anybody noticing fire
should inform the plant control room immediately. The shift electrical engineer at control
room informs the site controller.
b) Control Room staff

If an emergency is reported then plant control room staff must, request for the location,
nature and severity of emergency and obtain the caller's name, telephone number, and
inform the shift in charge or site controller who ever are available in the shift.
c) Emergency communication
The following communications will be used during emergencies; P&T Telephones,
intercom, walkie-talkies, hand bell and siren. If any of the equipment is not working,
runners would be engaged to send the communication.
d) Warning/Alarm Communication of emergency

Emergency siren would be operated to alert all other employees on the orders of manager
(electrical). The emergency is communicated by the Emergency siren mode of wailing for
3 minutes. When the emergency has been brought under control, the Emergency
controller will direct plant control staff giving an 'all clear signal', by way of normal siren
(continuously for 3 minutes).
6.8.5.5 Rescue and Rehabilitation
Emergency vehicle will be made available round the clock under the charge of manager
(electrical) who is emergency coordinator. Security personnel are trained in rescue
operations. Persons rescued would be taken to First aid centre for further medical
attention or Safe Assembly Points as per the condition of the rescued person.

a) Transport Vehicles and Material Trucks

The transport vehicles and vehicles with materials would immediately withdraw to
outside the factory. Security guard of the shift is responsible for this. Transport vehicles
would wait at the security at the main entrance to provide emergency transport. This is
ensured by security coordinator.
b) Mock drill
Occasional mock drill is essential to evaluate that the ONSEP is meeting the objectives.
Adequate training is given to all staff members before conducting the mock drill. Mock
drills will be initiated with table top exercise, followed by pre-informed mock drills, and
few uninformed mock drills in the first phase. Functional exercises (communication,
Emergency shut down, firefighting at different locations, rescue etc.) are carried out in
the second phase.
Mock drills will familiarize the employees with the concept and procedures and help in
evaluating their performance. These scheduled and unscheduled mock drills are
conducted during shift change, public holidays, in night shift once in 6 months.
Response time, strict adherence to discharge of responsibilities, difficulties and
inconsistencies experienced are recorded and evaluated. Fire officer will assists
Emergency coordinator in designing and extending such mock drills and in evaluating
the response.
c) Review
The Emergency plan is reviewed periodically to evaluate the effectiveness, and during
change in organizational structure, isolation of equipment for longer duration, and
during increase in inventory of fuel and other chemicals. Manger Electrical and
Emergency coordinator initiates and authorizes such review as and when required, and
the changes if any will be duly informed to all the employees concerned.

6.8.5.6 Emergency Responsibilities

Responsibilities assigned to key personnel in case of emergency. ERT Members shall be
trained regularly as per schedule in a year.
1. Incident Controller
• Block – in-charge of the affected Block is the incident controller and in-charge of
duty team also.
• As soon as he is informed of the emergency, he shall rush to the emergency site,
assess the magnitude of the emergency, take overall control and report to the
emergency controller.
1. He shall take immediate actions to minimize the damage to staff,
equipment, plant and environment.
2. Take control of the emergency teams and allocate the respective duties.
3. Ensure Power cut-off, if required to the Block and shutdown the plant, if not
already done.
4. Decide the safe escape route and announce the same through public
announcement system or mega phone.
5. Direct all operating personnel except ERT members in the affected plant to
go out of the plant and assemble at the nearest Assembly point.
6. Direct ERT members
o To use appropriate fire extinguishers to cover the area affected by fire.
o To attend fire pumps and maintain adequate water pressure in the
hydrant system.
o To maintain supply of fire extinguishing media and equipment as
necessary
o To guide outside firefighting agencies
o To start rescue operations
o To transport casualties to first aid-post or safe places.
o To guide employees to reach Assembly point.
o To search for missing personnel.

7. Do not permit the use of water or fire extinguishers in areas where, Sodium
Hydride and Sodium Borohydride are likely to be present.
8. Arrange for specific analysis of toxic gases at any suspected place to
facilitate rescue operations.
9. Direct the mechanical technicians to attend to the repair jobs of the
emergency with precautions and as per the requirement of shift in charge.
10. Wait for further instructions from Emergency controller.
2. Safety Team
The leader of the safety team has to arrange for simultaneous actions by Security officer &
Company’s medical doctor as to the jobs allocated to them.
The security officer has to arrange
a. Inform HOD-Production. HOD-Engg., Block in-charge, Manager (Safety) on
phone.
b. Keep visitors out.
c. Control traffic around emergency area.
d. Direct personnel to Assembly point. Communicating through Public Address
System
e. If Fire brigade comes in, direct them to incident controller. Before they commence
any operation.
f. Keep Telephone free for incoming calls.
g. On receiving the information from emergency controller, he blows the emergency
siren for declaration of emergency.
h. Communicate location of the incident, Safe Escape routes, wind direction &
assembly point’s location by public addressing system/mega phone with the help
of incident controller.
i. Depute one security guard to close the main gate to bar entry of unauthorized
persons.

j. Depute one guard with red flag to indicate the location of incident to the ERT
members.
k. Ensure transport of injured persons and other transport requirements in absence of
P & A personnel.
l. Ensure all the security guards (near main gate, Canteen hall) are reporting to site
controller.
m. Permit minimum delay in the entry of unauthorized personnel and outside
agencies, vehicles, etc., who have come to help
n. Co-ordinate with the Matrix unit 1 security for help if required and instruct the
guard to allow the ambulances, etc., to go through the gates without normal
checks.
o. If needed on the advice of incident controller, he rushes to emergency control
center and reports to emergency controller, with the attendance record of
employees, list of contract workmen and visitors for head count purpose.
p. To direct all drivers of vehicles/ tankers which are waiting outside the main gate
for entry into the plant to remove the vehicles and take away from the factory.
q. On arrival of police team, co-ordinate with them for permitting entry/exit of
vehicles related to emergency. Collect work permits issued on the day from safety
dept. to identify possible locations of deployment of contract laborers for the
purposes of reconciling any missing employees (head count).
r. After the mitigation of emergency situation on the advice of emergency
controller/incident controller all clear siren will be blown on which the normalcy
will be restored.
1. Inform Company Medical Officer on phone.
2. First aiders to assemble at Emergency control center and organize first aid.
3. To arrange for all transport requirements.
4. The company doctor has to arrange:
a)For rendering first aid.
b) To administer O2 in case of toxic gas inhalation

c) To arrange stretches to the FF & rescue team.

d) To arrange for sending the causalities to hospital. On the advice of these
hospitals, arrange for, if necessary transportation of patients to any of the
specialty hospital as needed.
e) To send antidotes where necessary, when patients are sent to the outside
hospitals.
f) To shift affected personnel to hospitals.
g) Arrange for taking Role call
3. Supporting Team
(1) On hearing the emergency, Shift in-charges of the plants not affected by
emergency shall shutdown their plants if required.
(2) Evacuate all personnel from the plants and standby to assist the duty
Team.
(3) Assist in supplying dry sand and appropriate fire extinguishers for fire
fighting
(4) Help for the start of Fire water pump motor driven/diesel driven as per
availability to fight fire and to spray water for cooling the nearby
equipment if required.
(5) Direct affected employees to assembly point.
(6) Assist security in controlling visitors and traffic.
4. Auxiliary Team
(1) Personnel not connected with the plant operation but on site, shall be
directed to the assembly point.
(2) Standby for instructions from the Emergency Leader.
5. Communication Team
1) Contacting other industries for help.
2) Notifying the emergency to civil/local authorities as per the advice of the
emergency controller.

3) Giving necessary details to statutory bodies regarding the emergency and

keeping them abreast of the development
4) Informing kith and kin of causalities
5) Arranging alternative transportation in case of breakdown of transport
vehicles, ambulance, etc.
6) Arranging transportation of causalities to hospitals.
7) Contacting medical centers/hospitals identified for mutual aid.
8) Arranging transportation (I) for persons connected with emergency
functions including relieving staff if emergency prolongs (II) transportation
of materials / equivalent needed from outside.
6. Role of Advisory Teams
(1) Report to emergency controller.
(2) Advise the controller on developments or change of strategy.
(3) Assist the controller in assessing the damage and check out operations, after
getting the all clear signal.
7. Emergency Controller/Dy. Emergency Controller
Unit Head & Head - Production. are Emergency Controller & Dy.
Emergency controller respectively. In their absence at site the Executive of the
shift or Block in-charge (incident controller) will conduct all emergency operations
until either or both of them arrive at the scene.
(1). He shall be in touch with the incident controller and other emergency team
leaders and assess the situation continuously.
(2) He shall ensure that power supply is totally cut off to the affected Block.
(3) He shall ensure that sufficient dry sand and appropriate fire extinguishers
are made available to the affected area for firefighting.
(4) He shall ensure that all personnel except Incident Controller his team
members and ERT members of the affected plant in the block are evacuated
to the assembly point and that role call is taken.

(5) He shall ensure immediate medical assistance or shift the affected personnel
to hospitals.
(6) He shall inform regarding the emergency to
(1) Police station.
(2) Factory inspector.
(3) Pollution Control Board.
(4) Fire Brigade.
(5) Senior Corporate management
(7) Fire Brigade should be advised not to use conventional firefighting
apparatus or water for firefighting where sodium hydride or sodium
borohydride is likely to be present.
(8) Neighboring Population shall be cautioned and evacuated, if necessary.
(9) Arrange photographing or logging of events.
(10) Preserve evidence.
(11) Deal with Media & Statutory authorities.
(12) Organize investigation teams.
(13) Give all clear signal
(14) Enter the plant after all clear signal and carry out careful check.
(15) Shall arrange clearing of debris and spillages.
(16) Commence mechanical testing of plant only after ensuring that all is safe.
(17) Do not restart the plant until mechanical testing is done.
(18) Restart the plant only after taking action to prevent recurrence of the
Emergency.
An Emergency in a Unit is one which has the potential to cause serious injury, damage to
property and serious description both inside and outside the industry. Effective action in
such cases if possible, due to existing of a planned system for handling such emergencies
with the existing resources of the Unit concerned and outside services.
Scope:

Emergency situation likely to occurs:

1. Fire
2. Fire and Explosion
3. Release of Toxic gas / Chemical spill.
4. Natural calamities like Floods/ Lightening Thunders and Earthquakes.
5. Collapse of Building/Structure
6. Food Poisoning
7. Neighborhood factories onsite emergency may extend to our Factory premises.
8. Social Emergency (Riots)
We have prepared a detailed disaster Management Plan from HR side for considering
various emergencies. This plan offers clear guidelines for actions that need to be initiated
during emergencies.
This Plan is linked up to the SOP Document which provides procedures that is essential
to protect the employees and take in response to any emergency and to enhance
emergency preparedness and response capabilities in Mylan Laboratories Limited.
Objective:
• To protect lives and to prevent the degree of injuries.
• Rescue and arrange treatment to casualties.
• Shifting of persons injured to the right hospital in right time.
• To inform and collaborate with statutory authorities / News Media / Police etc.
basing on the degree of the situation.
• Identifying of persons effected notification of connected blood relations to extend
necessary assistance.

ACTION PLAN:
On hearing of an emergency, In-charge (HR/ Concerned Security personnel) will rush to
the spot of the occurrence and assess the scale of emergency and decide of major
emergency exists or is likely and inform to their site HR In-charge and vice versa as per
the onsite emergency plan.
H.R./ Security Concern will assess the scale of the incident and ensure that casualties
receive adequate attention, to arrange additional help if required basing on scale of
incident. If it is minor, he handle himself the situation and moves the injured to nearby
notified hospital after primary First Aid Treatment..
If the scale of injury is high, he immediately informs to the one the Medical Emergency
Service Team Members and with their directions he shifts the casualties to the hospital as
per the team directions.
As soon as the Team is informed of the situation, talking to each other team shall assess
the magnitude of the situation and decide their roles as per the situation.
Role Distribution:

• Who shall move to Hospital

• Move to the Place of incident
• handle transport department
• Hospitality Management
• Administration activities
a) Vehicle arrangements
b) Care taking of employees & employee families
c) Cash arrangement and other admin. Formalities.
• Communication (Information to Statutory Authorities Media, Police)
The Medical Emergency Service Team will move to the hospital / place of incident and
take the situation into their hands and inform the level of situation to H.R. Head.
Medical Emergency Service Team will retain overall responsibility of the situation.
The Team shall maintain a continuous review of possible development and assess in
consultation with the G.M. – H.R. and G.M.-H.R. can review the situation to key
personnel / Top Management. G.M. – H.R. also helps in getting in cash assistance for
controlling the situation.
The Senior Management team shall act accordingly as per the recommendations given by
Medical Emergency Service Team.
ROLE OF IN-CHARGES AT PLANT LEVEL:
HR/ Security Personnel:
• As soon as he identifies the incident, immediately he becomes aware of the
emergency, he will proceed to the scene. On arrival he will assess the scale of the
incident and direct / advise / alert the Security Guards at the gate to call necessary
Senior Officers of the Plant.
• Secure the Safety of the persons.
• Arrange to pass on the information urgently to the Emergency Controller as per
On Site Emergency Plan.
• Arrange to pass on the information to Medical Emergency Service Team..

• Move out casualties to the nearby notified hospital as per EST directions.
ROLE OF MEDICAL EMERGENCY SERVICE TEAM:
• Exercise direct Operational control over service areas
• Ensure that casualties and their families receive adequate attention and to arrange
help if required and inform relatives of the effected
• When emergency is prolonged, arrange for the relief of personnel and organize
boarding / lodging facilities to the effected families
• Maintain a continuous review of possible development and assess in consultation
with key personnel as to whether evacuation of person’s from the place of incident
is required
• Communicate the incident to statutory bodies / Media only with prior Approval
of Top Management.
• Direct all operations within the affected areas with the proper priorities for safety
of personnel, minimize damage to the plant, property, environment with co-
ordination of Plant Heads / EHS Head
• Liaison with senior Officials of Police, Fire brigade, Medical and Factories
Inspectorate. Provide advice on possible effect on areas outside the factory
premises
• Provide advice and information to Security Department as and when required
• Report on all significant developments at the hospital / place of incident to the
G.M. – H.R. from time to time.
• Assist EHS Department in preparation and exhibition of display boards of all
safety, operation and maintenance points that are needed for the safety of Plant &
Personnel
• Provide assistance, guidance and council to EHS Department to initiate, plan and
execute required HRD programs and preparation of Safety Plans and Training
Programs.
• Recruit suitable inside staff to act as helpers when and where required during the
process

• Senior Members of Medical Emergency Service Team will visit all the Units for
every three months and discuss with Plant heads / Site controllers and take their
suggestions from time to time and act as helpers when and where required.
ROLE OF SECURITY PERSONNEL DURING EMERGENCIES:
• Information to Emergency Site Controller
• Information to Fire brigade basing on the scale of incident.
• Assess the situation and decide if staff needs to be evacuated from the assembly
points.
• In the event of failure of electric supply and there by internal telephone setup
communication point and establish contact with emergency center.
• Provide assistance to Site emergency team and First Aid Team.
• Advise and alert other Security personnel at gate to pass on information to
necessary Senior Officials.
• Provide advice and help to the Fire brigade as and when they arrive.
• Vehicle Management
• Preserving evidence for enquiry
• Should maintain records of Head count, Telephone numbers of all important key
personnel and statutory bodies like Fire, Police etc.
EMERGENCY INFORMATION FLOW CHART:

ROLE OF HEAD – CORPORATE MEDICAL SERVICES:

• From information received HEAD – Corporate Services shall move to the hospital
wherever the injured are either sent or planned to be sent.
• Co-ordinate with the Doctors of the hospital and can take further decision whether
the casualties can be treated in the same notified hospital or to be moved to the
hospital where doctors of expertise are available.
• Advise doctors during the course of treatment and giving the information (MSDS)
about the antidote and line of treatment for some selective chemicals.
• When treatment is prolonged, review the developments from time to time and
report to the Senior Management personnel.
• Conducting training programs on First Aid at all the sites at regular intervals.
• In co-ordination with other EST Team members, he will visit all the locations and
monitor OHC operations
• Provide advice and information to doctors working at OHC’s on First Aid
Treatment procedures.
• Assist EHS Department / other EST Team Members in preparation of
Communication which has to be passed to the statutory bodies.
ROLE OF G.M. – H.R:
• Exercise direct operational control over service areas and provide advice and
suggestions to EST on possible effect on areas.
• Collecting information about all significant developments at place of incident and
hospital and maintain a continuous review of incident and access in consultation
with Sr. Vice President and other key personnel as to whether any decisions has to
be made like informing the incident to Statutory bodies, Insurance authorities,
Media, Business partners and to the business customers.
• Ensure that casualties and their families receive adequate attention during the
course of emergencies.
• Co-ordinate with finance team for cash assistance when and where required.

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MYLAN LABORATORIES LIMITED, UNIT ‐ 3

6.0 RISK ASSESSMENT AND DAMAGE CONTROL

6.1. OBJECTIVES AND SCOPE

6-1 Team Labs and Consultants

• visualizing various probable undesirable events which lead to major accidents

6.2 PROJECT DETAILS:

6-2 Team Labs and Consultants

in northeast direction, Gaudavalli RF is at a distance of 6.8 km in northeast direction,

6-3 Team Labs and Consultants

Table 6.2 List of By-Products – After Expansion

6-4 Team Labs and Consultants

6-5 Team Labs and Consultants

6-6 Team Labs and Consultants

63 Lactic acid 0.63 Solid Corrosive Bags By Road

6-7 Team Labs and Consultants

100 Tri Ethyl Amine 29.7 Liquid Flammable Drums By Road

6.3 PROCESS DESCRIPTION

6.4 PLANT FACILITIES

6-8 Team Labs and Consultants

6.4.1 Production Blocks:

6-9 Team Labs and Consultants

6.4.3 Quality Control, R&D Lab:

Also a process development laboratory provided for in-house process development,

6.4.4 ETP and Solid waste storage:

6.4.5 Ware Houses:

6.4.6 Tank Farm Area:

6.4.7 Cylinders storage Area:

6-10 Team Labs and Consultants

6.4.8 Administrative Office:

6.4.9 Water Sump:

6.4.10 House Keeping:

6.4.11 Facility layout and design:

6-11 Team Labs and Consultants

Fig 6.1 Plant Layout of Mylan Laboratories Limited, Unit -3

6-12 Team Labs and Consultants

6.5 Hazard Analysis and Risk Assessment

6.5.2 Hazard Identification (Terms of Reference No. 3(ix))

6-13 Team Labs and Consultants

Hazard identification and risk assessment involves a critical sequence of information

After identifying hazards through a qualitative process, quantification of potential

6-14 Team Labs and Consultants

The interpretation of “The Manufacture Storage and Import of Hazardous chemicals”

6-15 Team Labs and Consultants

Table 6.6 Physical Properties of Raw Materials and Solvents

6-16 Team Labs and Consultants

6.5.3 Fire & Explosion Index (F & EI):

6-17 Team Labs and Consultants

Table 6.7 Degree of Hazard for F&EI

6-18 Team Labs and Consultants

13 Chloroform 59.35 15.43 Moderate

6.5.4 Hazard and Operability Study (HAZOP)

6-19 Team Labs and Consultants

Potential problems as represented by the consequences of the deviation should be

6.5.5 Hazard Factors

6-20 Team Labs and Consultants

A study by AIChE (1972) indicates that majority of equipment of component failures

S. No Equipment Frequency (%)

6-21 Team Labs and Consultants

Failure rate Failures 10-6/h

6-22 Team Labs and Consultants

Failure rate Failures 10-6/h

6.5.6 Common Causes of Accidents

Failures of Human Systems

• Stress induced by poor equipment design, unfavorable environmental conditions,