HAC Report of Megafine Pharma (P) LTD, Nashik
HAC Report of Megafine Pharma (P) LTD, Nashik
Nashik, Maharashtra
January 2020
Conducted by:
Cholamandalam MS Risk Services Limited
Chennai, India
(An ISO 9001:2008 Certified Organisation)
DOCUMENT HISTORY
Revision
S.No. Document Identification Comments / Nature of Changes
No Date
Revision comments
1 HAC/SR/MPPL/19-20/166 01 03.03.2020 incorporated
EXECUTIVE SUMMARY
The management of Megafine Pharma (P) Ltd, Nashik had approached Cholamandalam MS Risk Services
Ltd. (hereinafter referred as Chola MS Risk) to conduct Hazardous area classification study for their
facilities located at Nashik, Maharashtra. Accordingly, Consultants from Chola MS Risk visited the plant
and carried out site study from 28th to 30th January, 2020.
The hazardous zone classifications of various production blocks are summarized below
Predominant area classification for the particular location is listed in the below table. Recommended to
verify the detailed report to find out other hazardous zones for the particular mentioned location
REQUIRED
ZONE GAS TEMPERATURE
S.NO BLOCK Location EQUIPMENT
CLASSIFICATION GROUP CLASSIFICATION
SPECIFICATION
1 PB - A 1st Floor Zone 1 IIA/IIB T3 Ex d IIA/IIB T3
Ex d IIA/IIB T3
(or)
Ex “e” IIA/IIB T3
In Zone 2 areas.
16 QC Chemical Zone 2 IIA/IIB T3 Ex d IIA/IIB T3
Storage (or)
Room Ex “e” IIA/IIB T3
17 Pilot Plant Indoor Zone 1 IIA/IIB T3 Ex d IIA/IIB T3
Salient findings:-
PB – A
PB – A – 1st Floor:
• Earthing connection was found to be missing for the methanol tank. Static earthing connection shall be
provided for the methanol tank to dissipate the static charges.
• It is suggested to maintain minimum ventilation rate of about 12 air changes in the reactor 1st floor
area.
• Cable gland was observed to be loose and not fully engaged to the Temperature detector in SSR-08.
Cable gland size shall be matching the cable diameter and cable gland shall be engaged with five full
threads or 8 mm with the Ex d enclosure. Only certified cable cables shall be used.
• It shall be ensured that nitrogen blanketing be provided while performing cleaning operation of the
reactor.
PB – A – 2nd Floor:
• Allen bolt was observed to be in loose condition for the sparkler filter A/SF 005. Openings or
inadequate fastener tightening in the flameproof enclosure will result in loss of integrity and efficiency
to perform as flame proof.
• Oxygen level sensor shall be provided in the enclosed centrifuge room. It shall also be ensured that LEL
dedectors be provided in the enclosed centrifuge room.
• It is suggested to let the vent to open atmosphere, instead of letting so in corridor. Else, all the
electrical equipment installed in the corridor shall be of Flame proof type with the specification Ex d
IIA/IIB T3.
PB – B
PB – B – 4th Floor:
• Vent of the methanol storage tank shall be let out to the open free area.
• It is recommended to bond the connections across the flanges in the methanol pipe lines, in order to
avoid accumulation of static charges during transfer process. The electrical continuity across is essential
to dissipate static charges safely.
• Non Ex light fitting was observed above the hydrogen cylinder. It shall be replaced with flameproof
light fitting with the specification Ex “ d” IIC T1.
• External earthing connection was found to be missing for the flame proof light fitting. External earthing
connection shall be provided for the light fitting.
• Flange bonding was found to be missing in the glass vapour line of GLR -002. It is recommended to
bond the connections across the flanges in the vapour lines, in order to avoid accumulation of static
charges during transfer process. The electrical continuity across is essential to dissipate static charges
safely.
• Cable gland was found to be missing for temperature transducer GLR – 002. Cable gland size shall be
provided in matching the cable diameter and cable gland shall be engaged with five full threads or 8
mm with the Ex d enclosure. Only certified cable cables shall be used.
• Non Ex light fittings have been provided in the washing area. It shall be replaced with flameproof light
fitting with the specification Ex “d” IIA/IIB T3.
• Supply and exhaust ducts are located at the top. Exhaust louver shall be provided at floor level as
flammable materials handle are denser than air.
• Space in the wall was observed through which the AHU duct was found communicating with nearby
office area. Space around the AHU duct shall be sealed to prevent the escape of vapours to non-
hazardous areas.
• Doors which segregate reactor area and office area are not air tight. Doors segregating reactor area
and office area shall be air tight with auto closure provision. Dorr gaskets in the door shall be intact. It
is also recommended to maintain office area at positive pressurization of 2.5 mm of water column.
PB – F – Ground Floor:
• Nitrogen blanketing has been provided for the centrifuges but interlock is not provided. Interlock with
N2 shall be provided.
• Oxygen level sensor shall be provided in the centrifuge room.
• 1 no. of fastener was found to be missing in the flame proof weighing display unit. Openings or
inadequate fastener tightening in the flameproof enclosure will result in loss of integrity and efficiency
to perform as flame proof.
• Non Ex telephone has been provided in the ground floor centrifuge room. Ex telephone with the
specification Ex d IIA/IIB T3 shall be provided.
PB – D – 2nd Floor:
• Flange bonding was found to be missing for the vapour column line of the reactor. Bonding across the
flanges shall be provided. This shall be followed across all the production blocks.
SRP
• High flame path gap was observed on the for T2 Temperature J2. All allen bolts shall be provided and
tightened fully to meet the required flame path gap in the Ex enclosure.
• Temperature indicator (conde no: SRP1 TCH -001/T1) was found to be cracked and bolts are found to
be missing. All allen bolts shall be provided and tightened fully to meet the required flame path gap in
the Ex enclosure.
• Unused gland hole was observed to the light fitting near new GLR. It shall be sealed using flame proof
blanking element.
• Non Ex automatic level controller shall be replaced using flame proof and intrinsically safe level
controller.
• Non Ex gland has been used to terminate the cable for EX “d” IIC Telephone. It shall be replaced with
flame proof type double compression gland.
Hydrogenation
• It shall be ensured that explosion proof clock near the hydrogen cylinder shall be suitable for the
hydrogen gas area and it shall be of specification Ex “d” IIC T3.
• Unused gland hole was observed for the push button station of sparkler filter. It shall be replaced with
flame proof type blanking element.
• Effluent treatment pump was of flameproof type with specification Ex “d” IIA/ IIB. It shall be replaced
with EX “d” IIC T3.
CONTENTS
I EXECUTIVE SUMMARY 3
II INTRODUCTION 13
The management of Megafine Pharma (P) Ltd had approached Cholamandalam MS Risk Services Ltd.
(hereinafter referred as Chola MS Risk) to conduct Hazardous area classification study for their facilities at
Nashik. Accordingly, Consultants from Chola MS Risk visited the plant and carried out site study from 28th
to 30th January, 2020.
Mega Fine Pharma Private Limited is a Private incorporated on 22 August 1995. It is classified as Non-
govt company and is registered at Registrar of Companies, Mumbai. Its authorized share capital is Rs.
20,000,000 and its paid up capital is Rs. 15,534,450. It is inolved in Manufacture of other chemical
products
Cholamandalam MS Risk Services Limited (Chola MS Risk) is a joint venture between the Murugappa Group
and Mitsui Sumitomo Insurance Group of Japan. Chola MS Risk offers specialized and innovative risk
management solutions to clients in Asia and Africa. Chola MS Risk has carried out consultancy, investigation
and training services to more than 2500 units / locations of various organizations belonging to various
industrial sectors including some of the major oil & gas, petrochemical and Pharma industries. In addition,
industrial sector and service sector located in Asia and Africa have been engaging the services of Chola MS
Risk to carry out a number of specialized safety studies. The team members have wide experience in risk
management studies and have carried out studies for a number of commercial and industrial sectors. For
further details, the reader may visit the website www.cholarisk.com
Area classification is a method of analyzing and classifying the environment where explosive gas
atmospheres may occur so as to facilitate the proper selection and installation of equipment to be
used safely in that environment. The classification also takes into account the ignition characteristics
of the gas or vapour such as ignition energy (gas group) and ignition temperature (temperature
class).
Objective is to analyze and classify the environment where explosive gas atmospheres may occur to allow
the proper selection of electrical apparatus to be installed in that Hazardous environment.
In most practical situations where flammable materials are used, it is difficult to ensure that an explosive
gas atmosphere will never occur. It may also be difficult to ensure that equipment will never give
rise to a source of ignition. Therefore, in situations where an explosive gas atmosphere has a high
likelihood of occurring, reliance is placed on using equipment which has a low likelihood of creating
a source of ignition. Conversely, where the likelihood of an explosive gas atmosphere occurring is
reduced, equipment constructed with less rigorous requirements may be used.
SCOPE OF WORK
• To identify and classify the hazardous atmosphere present in the plant in to different zones and to
specify the equipment specification suitable for the particular zone based on the HAC Standards
mentioned in the reference.
• To review the electrical equipment installed in the plant on a sampling basis, based on IS 5572 (type of
protection, Temperature classifications, and Gas groups)
TEAM
STUDY COVERAGE
Installations
Day 1:
• Production Block – PB - A
• Production Block – PB – B
• PB -F
• PB – I
• PB - D
Day 2:
• PB - C
• PB – D
• PB – I
• PB – K
• PB – J
• Warehouse WH -3
• WH -5
• WH -1
• AG Storage Tank
Day 3:
• PB – G
• PB – E
• SRP
• Hydrogenation
• ETP
• MEE
• XRD Lab
• Potentiometer Lab
• Pilot Plant
• PB – H
HAC METHODOLOGY
Data collection and
review
Interaction with
employees
Site Visit
Identification of source of
release
Examination of
Determination of grade how flammable
of release materials are
handled
Classification of areas in
to different Zones and Ventilation factors
determining Zone assessment
extent
Submission of
Report
✓ HAC is to be carried out for plants where the chemical Flash Point (FP) is less than 65° C as per
IS 5572. Hence all plants / areas where any chemical stored/handled has a FP less than 65° C will be
✓ Depending on the lowest Auto Ignition Point (AIT) of the chemicals used in process plants, the
✓ Wherever there is a doubt in classifying hazardous areas- from the safety point of view- higher zone
✓ Chemical properties of chemicals used in the report are from the details provided by M/s Megafine
Pharma (p) Ltd
Sources of release:
A point or location from which a gas, vapour, mist or liquid may be released into the atmosphere
so that an explosive gas atmosphere could be formed
There are three basic grades of release, as listed below in order of decreasing frequency and Likelihood of
the explosive gas atmosphere being present:
A release which can be expected to occur periodically or occasionally during normal operation
A release which is not expected to occur in normal operation and, if it does occur, is likely to do
so only infrequently and for short periods
• Zone 0
An area in which an explosive gas atmosphere is present continuously or for long periods
or frequently
• Zone 1
• Zone 2
An area in which an explosive gas atmosphere is not likely to occur in normal operation but, if it
does occur, will persist for a short period only
Topography
The terms referred by Indian Standard “normal” and “abnormal” require some interpretation.
Normal conditions should be taken to be not ideal but real conditions as they actually exists, taking in to
account the precautions that are taken on a well run plant.
Abnormal conditions should be read to refer NOT to catastrophic accidents such as a major equipment
rupture but to the events that are generally non - catastrophic such as a pump gland or pipe gasket failure.
The ICI (Imperial chemical industries) Electrical Installations in Flammable Atmospheres Code describes the
two basic methods of HAC: (1) The generalized method and (2) the source of hazard method.
While this blanket application of a Zone 1 classification is in itself conservative, it is also expensive,
Vapor-when it is released. i.e. denser gas would settle down and the lighter gas would move upwards. In
case of HAC, if the relative density of the gas is less than 0.75 times of relative density of air, then the gas is
considered to be lighter gas and any gas having relative density above 0.75 times of air is considered to be
a heavy gas. Chemicals with vapor density less than 0.75 are classified as lighter than air
• Quantity of flammable chemical released- Proximity towards the highest risk area.
• Climatic conditions
Gas Group:
Flammable materials are sub-divided into groups based on minimum ignition energy required for igniting
them
Ventilation: -
With increased ventilation, the extent of hazardous zone would be reduced.
In case if 12 air changes or more is maintained then it is considered to be safe ventilation.
If the gas – air mixture in the area is below 25 % of the LEL concentration then the area is
Considered to be adequately ventilated.
Table below provides the guidelines for classification of zone with respect to effect of Ventilation.
Temperature Classification: -
The surface temperature of the electrical equipment is selected based on the Auto Ignition Temperature of
the chemicals being handled. The details are given in Table 2.
• Zone 1 – 3 m vertically above the tank level and extended 3 m horizontally from the sides of
the tank.
• Zone 1 area – to be extended up to the dyke wall or up to a distance of 3m at ground level
whichever is greater. The height of Zone 1 area will be equal to the height of the dyke wall.
This study is based on the present operating conditions, solvent handled and the inputs provided by the
operators and data collected from the site. Any change in process operating conditons, method of handling
solvents will result in different results and warrants equipments with different protection levels. Hazardous
area classification study shall be reviewed accordingly and HAC drawings shall be updated to take account
of
Hazardous area classification should be incorporated into a company’s Health, Safety and
Environmental Management System.
The person responsible for the co-ordination of the hazardous area classification should be identified and
be competent in this field. The work, which requires an interdisciplinary approach, should be carried out by
persons who have full knowledge of the process systems and equipment, in consultation with safety, loss
prevention and electrical engineering personnel, as appropriate. Agreements reached on the hazardous
area classification should be formally recorded, continually reviewed and kept updated. Records, such
as drawings and/or tabulated data sheets, should include details as to the type of protection selected to
meet the zone requirements and the apparatus sub-group and temperature class
In classifying a new facility or a modification, the hazardous area classification should be carried out before
the design and layout of equipment are finalised. At this stage, it may be possible to make considerable
improvements at little cost. The hazardous area classification should always be reviewed and
drawings modified, if necessary, on completion of design and before any change is made to existing
plants handling flammable fluids. The company operating a facility has the prime responsibility to
ensure that hazardous area classification has been carried out on installations handling
flammable fluids
Chola MS Risk Services gratefully acknowledges the co-operation received from the management of
M/s Megafine Pharma (P) Ltd during the site visit. Chola MS Risk in particular would like to thank Mr. Rahul
Shitole and their team for their full support and coordination throughout the study and courtesy extended
to the Chola MS team members during the site visit.
DISCLAIMER
This report is for the sole use by the Client for the purpose for which they have claimed it is required to us.
We are not responsible to any other person/party for any decision of such person/party based on this
report. It is hereby notified that reproduction, copying or otherwise quoting of our report or any part
thereof other than the aforementioned purpose, can be done only with our prior permission.
The report cannot be used or relied by the Client for any other purpose or any other third party for any
purpose whatsoever and we will not be liable which the client may incur on this account including in tort
(including but not limited to negligence) arising out of or in connection with this Report. This Report is not
intended to identify all hazards which may exist nor is it intended to be an exhaustive review of all possible
eventualities. The recommendations for risk improvement contained in the report are purely advisory and
the decision and responsibility for implementation rests with the Client.
SUMMARY
Observations
S.NO Flammable Flash Vapour Boiling LEL UEL Auto Ignition T Gas Group
Materials point Density Point (%) (%) Temperature Class
(°C) (o C) (o C)
1. N - Butanol 35 2.55 118 1.4 12.0 343 T2 IIA
2. Toluene 4 3.20 111 1.1 7.1 480 T1 IIA
3. Methanol 9 1.11 65 6.0 36 440 T1 IIA
4. n-Heptane -7 3.46 105 0.85 6.7 204 T3 IIA
5. Methanol 9 1.11 65 6 36 440 T2 IIA
6. IPA 12 2.1 83 2 12.7 399 T2 IIA
7. Tetra Hydro -14 2.49 64 1.5 12.4 230 T3 IIB
Furan (THF)
8. MDC Non – Flammable Material
9. Aqueous Non – flammable Material
Ammonia
10. DMF 58 2.51 153 1.8 16 440 T2 IIA
(Dimethyl
Formamide)
11. Tri Ethyl -8 3.5 89 1.2 8 215 T3 IIA
Amine
12. Ethyl Acetate -4 3.04 77 2 12.8 470 T1 IIA
13. Methyl Tert. -27 3.03 55 1.5 8.4 385 T2 IIA
Butyl Ether
14. 1-3 Dimethyl 58 201.5
admantane
15. Methyl -20 2.07 32 5.0 23.0 525 T1 II A
Formate
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Megafine Pharma (P) Ltd, Nashik
16. Di-isopropyl -28 3.52 69 1.0 21.0 405 T2 IIA
ether(DIPE)
17. Acetone -20 2.0 56 2.5 14.3 399 T2 IIA
18. Isopropyl 2 3.52 89 1.8 7.8 460 T1 IIA
Acetate
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Megafine Pharma (P) Ltd, Nashik
receiver vessel
• When zones created by adjacent sources of release overlap and are of different zonal classification,
the higher classification criteria will apply in the area of overlap. Where overlapping zones are of the
same classification, the common classification will normally apply.
• Entire first floor building area is classified as Zone 1 hazardous location and a distance of 3m
surrounding the building is classified as Zone 2 hazardous location
• A distance of 3m surrounding the building at first floor level is classified as zone 2 hazardous location,
if the solvent pipe lines are running around.
• Electrical equipments shall be with the specification Ex d IIA/IIB T3 and instruments mounted on the
process equipments shall be Ex ia IIA/IIB T3.
• Solvent storage barrel was stored in the service area. A distance of 3m in all the directions from the
barrel storage area is classified as zone 2. Therefore, electrical equipment installation in that region
shall be flameproof with the specification Ex d IIA/IIB T3. If lift communicates, then it should also be of
the flameproof type.
• Earthing connection was found to be missing for the methanol tank. Static earthing connection shall
be provided for the methanol tank to dissipate the static charges.
• It is suggested to maintain minimum ventilation rate of about 12 air changes in the reactor 1 st floor
area.
• Cable gland was observed to be loose and not fully engaged to the Temperature detector in SSR-08.
Cable gland size shall be matching the cable diameter and cable gland shall be engaged with five full
threads or 8 mm with the Ex d enclosure. Only certified cable cables shall be used.
• It shall be ensured that nitrogen blanketing be provided while performing cleaning operation of the
reactor.
• It shall be ensured that minimum of 6 air changes shall be maintained in the reactor first floor area in
the PB – A.
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Megafine Pharma (P) Ltd, Nashik
PB – A Ground Floor
Observations
• SSR & GLRs bottom reactor transfer line, centrifuge area, sparkler filter, Tray dryer area
• Nitrogen blanketing has been provided with interlock provision to oxygen sensor for the centrifuge.
• Sifter is located in the room. 3 in ground floor area.
• Washing and cleaning of the equipments using mater and methanol is carried out with LEV at vicinity
Hazardous area classification – PB- A- Ground Floor Area - Source data sheet
4 Vapours while Primary Artifici Obstructe Fair Medium Zone 1 2 m from the
unloading al d/ centrifuge in all the
material from Enclosed directions is
centrifuge Area classified as Zone 1
and further 2m in
all directions is
zone 2 hazardous
area.
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Megafine Pharma (P) Ltd, Nashik
Ventilation Extent of Zone in (m)
Grade of
S.NO Source of release Type Area Availa Degree Zone H V
release
bility
In enclosed
centrifuge room,
entire room is
classified as zone 1
5 Centrifuge Secondary Natural Obstructe Fair Medium Zone 2 A distance of 3 m
solvent line and d& around valve,
ML (mother Enclosed fitting and flanges
liquor) line
6 Centrifuge Primary Natural Obstructe Fair Medium Zone 1 Zone 1 Entire area
Cleaning d&
Enclosed
7 Leak from Secondary Natural Obstructe Fair Medium Zone 2 A distance of 3 m
Centrifuge d around valve,
solvent line, ML fitting and flanges
Tank
8 Sparkler Filter Secondary Natural Obstructe Fair Medium Zone 2 A distance of 3 m
Transfer pump d around the transfer
& ML Transfer pump
pump
9 Tray dryer Primary Artifici Enclosed Fair Medium Zone 1 Zone 1
cleaning al Entire area is zone
1
10 Tray dryer Primary Artifici Enclosed Fair Medium Zone 2 Zone 2 / Zone 22
material al / Zone (During unloading
unloading 22 of powder after
drying, vapour
content may be
small
11 Washing room Primary Artifici Enclosed Fair Medium Zone 2 Zone 1
(washing carried al Entire area is zone
under the 1
process of LEV,
but the vent Zone 1 in room 5
pipe was found washing area, since
to be LEV is not used
disconnected) there.
12 Sifter Secondary Artifici Enclosed Fair Medium Zone 1m from the
al Area 22 equipment is Zone
22 hazardous
location
(Considering the
operation of dust
collector)
13 Blending, Sifting Secondary Artifici Enclosed Fair Medium Zone 1m from the
and packing in al Area 22 equipment is Zone
room-6 22 hazardous
location
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Megafine Pharma (P) Ltd, Nashik
Ventilation Extent of Zone in (m)
Grade of
S.NO Source of release Type Area Availa Degree Zone H V
release
bility
(Considering the
operation of dust
collector)
14 Drain pit Primary Natural Obstructe Fair Poor Zone 1 Entire pit zone 1
d
Note: Dust classification group and Temperature classification shall be decided after laboratory test
results
• Allen bolt was observed to be in loose condition for the sparkler filter A/SF 005. Openings or
inadequate fastener tightening in the flameproof enclosure will result in loss of integrity and efficiency
to perform as flame proof.
• Oxygen level sensor shall be provided in the enclosed centrifuge room. It shall also be ensured that
LEL dedectors be provided in the enclosed centrifuge room.
• It is suggested to let the vent to open atmosphere, instead of letting so in corridor. Else, all the
electrical equipment installed in the corridor shall be of Flame proof type with the specification Ex d
IIA/IIB T3.
• Spiral hose metallic part of LEV is not bonded properly and it was observed in other areas too. Metallic
part of the hose shall be in tact in order to provide continuity for the static charges generated.
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Megafine Pharma (P) Ltd, Nashik
• LEV vent line was found to be detached in the water washing area. It shall be connected to prevent
the escape of vapours from the vent line.
• Name plate of the reactor agitator flame proof motor have been completely painted. It is absolute
necessary to install and maintain the Ex equipments to ensure the integrity so as to avoid it becoming
an ignition source. In many locations the flame path of Ex installations are obstructed/painted (even
enclosed inside the wall). This will prevent escape of hot gas from the installations resulting in
explosion due to pressure pilling. Ex survey of all installations shall be carried out in all the blocks to
ascertain their integrity and Ex register shall be maintained for the Ex equipments.
• LEV was not covering the charging area of the sifter. LEV shall be place at the vicinity of the sifter for
efficiency.
• ATD – 001 back side, 15 A domestic socket was in place. It shall be replaced with flameproof type
socket of specification Ex d IIA/IIB T3.
• Stand alone split AC was being used in packing room and FG store room. Domestic split Ac are not
rated to run for 24/7. Therefore, 2 nos. of split AC shall be installed with timer for the operation
interchange.
• It shall be ensured that minimum of 6 air changes shall be maintained in the ground floor area in the
PB – A.
PB – A Terrace:
Observations:
• All the steam ejector circulation tanks and vacuum trap tanks are located in the terrace.
• 4 nos. of scrubber column are also located in the terrace
• Ventilation is natural.
Hazardous area classification –Distillate receiver / Ejector tank Source data sheet
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Megafine Pharma (P) Ltd, Nashik
Summary:
AHU unit for the block C, D, H are provided in the utility section. It was informed that Flame proof blower
and exhaust motors are provided. It is suggested to ensure flame proof motors provided are with the
specification Ex d IIA/IIB T3. Megafine shall consider providing fire detectors in the duct.
Observation:
• Methanol storage tank of 1.3 kL has been located in the 4th floor inside a room.
• Process cooling towers 07, 08 are located in the terrace. FD cooling fans have non FLP motors.
• Area is well ventilated.
• Hydrogen cylinder storage was also observed.
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Megafine Pharma (P) Ltd, Nashik
cylinder pipeline is considered as
flanges and zone 2 in all the
valves in open directions.
areas
Recommendations:
• Vent of the methanol storage tank shall be let out to the open free area.
• It is recommended to bond the connections across the flanges in the methanol pipe lines, in order to
avoid accumulation of static charges during transfer process. The electrical continuity across is
essential to dissipate static charges safely.
• Non Ex light fitting was observed above the hydrogen cylinder. It shall be replaced with flameproof
light fitting with the specification Ex “ d” IIC T1.
• External earthing connection was found to be missing for the flame proof light fitting. External
earthing connection shall be provided for the light fitting.
PB – B 3rd Floor:
Observations:
• Reactors SSR – 001, 001, 003, 004, 005 & GLR 001, 002, 003 are located in the 3rd floor
• Hydrogen is used in the reactor SSR – 003 & SSR - 005.
• Hydrogen from the pressurized cylinder is reduced to atmospheric pressure using pressure reducing
valve.
• Solvent is charged through the reactor vessel through vacuum process from the barrel.
• Nitrogen purging has been carried out before solvent dispensing process.
• Cleaning of the reactor is through methanol solvent. It was informed that methanol is flushed through
manhole for Type B cleaning.
• Local exhaust ventilation is available for the reactors and it is connected to the scrubber.
These are the list of solvents used utilized in the various Reactors / process vessel
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Megafine Pharma (P) Ltd, Nashik
S.NO Flammable Flash Vapour Boiling LEL UEL Auto Ignition T Gas Group
Materials point Density Point (%) (%) Temperature Class
(°C) (o C) (o C)
1. Toluene 4 3.20 111 1.1 7.1 480 T1 IIA
2. Acetone - 20 2.0 56 2.5 14.3 539 T1 IIA
3. Methanol 9 1.11 65 6 36 440 T2 IIA
4. MDC Non – Flammable Material
5. Ethyl Acetate -4 3.04 77 2 12.8 470 T1 IIA
6. IPA 12 2.1 83 2 12.7 399 T2 IIA
7. Tetra Hydro -14 2.49 64 1.5 12.4 230 T3 IIB
Furan (THF)
8. Acetonitrile 2 1.42 82 3.0 16.0 523 T1 IIA
9. Tri Ethyl -8 3.5 89 1.2 8 215 T3 IIA
Amine
10. Dimethyl 89 2.71 189 2.6 28.5 215 T3 IIA
Sulfoxide
11. DMF 58 2.51 153 1.8 16 440 T2 IIA
(Dimethyl
Formamide)
12. n-Heptane -7 3.46 105 0.85 6.7 204 T3 IIA
13. Aqueous Non – flammable Material
Ammonia
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Megafine Pharma (P) Ltd, Nashik
Open charging Since, series of
of methanol reactors are
solvent drum located nearby,
entire area is
classified as Zone 1
4 Sampling from Primary Artificial Obstruc Fair Medium Zone 1 A distance of 1m
the reactors ted Area from the reactor
through or from the sample
manhole port in all
directions is Zone
1.
5 Condenser & Secondary Artificial Obstruc Fair Medium Zone 2 A distance of 3 m
reflux / vapour ted Area around valve,
column line fitting and flanges
flange leaks ( for
reactors which
has condenser)
6 Flanges, valves Secondary Artificial Obstruc Fair Medium Zone 2 A distance of 4.5 m
and fittings of ted Area around valve,
hydrogen fitting and flanges,
pipeline of manhole is zone 2
reactor SSR -003 and vertically 8m
& SSR - 005 distance is zone 2.
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Megafine Pharma (P) Ltd, Nashik
Recommendations:
• Flange bonding was found to be missing in the glass vapour line of GLR -002. It is recommended to
bond the connections across the flanges in the vapour lines, in order to avoid accumulation of static
charges during transfer process. The electrical continuity across is essential to dissipate static charges
safely.
• Cable gland was found to be missing for temperature transducer GLR – 002. Cable gland size shall be
provided in matching the cable diameter and cable gland shall be engaged with five full threads or 8
mm with the Ex d enclosure. Only certified cable cables shall be used.
• Non Ex light fittings have been provided in the washing area. It shall be replaced with flameproof light
fitting with the specification Ex “d” IIA/IIB T3.
• Supply and exhaust ducts are located at the top. Exhaust louver shall be provided at floor level as
flammable materials handle are denser than air.
• Space in the wall was observed through which the AHU duct was found communicating with nearby
office area. Space around the AHU duct shall be sealed to prevent the escape of vapours to non-
hazardous areas.
• Doors which segregate reactor area and office area are not air tight. Doors segregating reactor area
and office area shall be air tight with auto closure provision. Dorr gaskets in the door shall be intact. It
is also recommended to maintain office area at positive pressurization of 2.5 mm of water column.
• It shall be ensured that minimum of 6 air changes shall be maintained in the 3 rd floor area in the PB –
B.
PB – B 2nd Floor:
Observations:
• 2 nos. of reactors GLR -005 and SSR – 001 are located in the 2nd floor.
• Sparkler filter has been provided and the reaction mass is transferred through sparkler filter to the
next reactor.
• Cleaning of the reactor is through methanol solvent. It was informed that methanol is flushed through
manhole for Type B cleaning.
• Process was under shutdown during the time of audit.
Since, series of
reactors are
located nearby,
entire area is
classified as Zone 1
5. Sampling from Primary Natural Obstruc Fair Medium Zone 1 A distance of 1m
the reactors ted Area from the reactor
through or from the sample
manhole port in all
directions is Zone
1.
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Megafine Pharma (P) Ltd, Nashik
6 Condenser & Secondary Natural Obstruc Fair Medium Zone 2 A distance of 3 m
reflux / vapour ted Area around valve,
column line fitting and flanges
flange leaks ( for
reactors which
has condenser)
7 Sparkler filter Primary Natural Obstruc Fair Medium Zone 1 A distance of 3 m
transfer pump ted around the pump
• Entire first floor building area is classified as Zone 1 hazardous location and a distance of 3m
surrounding the building is classified as Zone 1 hazardous location.
• Electrical equipments shall be with the specification Ex d IIA/IIB T3 and instruments mounted on the
process equipments shall be Ex ia IIA/IIB T3.
• It shall be ensured that minimum of 6 air changes shall be maintained in the 2 nd floor area in the PB –
B.
Hazardous area classification PB- F (1st Floor) – Flammable material list and characteristics
These are the list of solvents used utilized in the various Reactors / process vessel
S.NO Flammable Flash Vapour Boiling LEL UEL Auto Ignition T Gas Group
Materials point Density Point (%) (%) Temperature Class
(°C) (o C) (o C)
1. Toluene 4 3.20 111 1.1 7.1 480 T1 IIA
2. Acetone - 20 2.0 56 2.5 14.3 539 T1 IIA
3. Methanol 9 1.11 65 6 36 440 T2 IIA
4. MDC Non – Flammable Material
5. Ethyl Acetate -4 3.04 77 2 12.8 470 T1 IIA
6. Aqueous Non – flammable Material
Ammonia
7. Di-isopropyl -28 3.52 69 1.0 21.0 405 T2 IIA
ether (DIPE)
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Megafine Pharma (P) Ltd, Nashik
Hazardous area classification – “F” Block 1st floor – (PB -B – 1st floor)
(Bottom of the
reactors
located in the
3rd floor
extended to 2nd
floor)
Since, series of
reactors are
located nearby,
entire area is
classified as Zone 1
4 Sampling from Primary Natural Obstruct Fair Medium Zone 1 A distance of 1m
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Megafine Pharma (P) Ltd, Nashik
the reactors ed Area from the reactor
through or from the sample
manhole port in all
directions is Zone
1.
5 Condenser & Secondary Natural Obstruct Fair Medium Zone 2 A distance of 3 m
reflux / vapour ed Area around valve,
column line fitting and flanges
flange leaks (
for reactors
which has
condenser)
6 Transfer of Secondary Natural Obstruct Fair Medium Zone 2 3 m in all directions
slurry mass ed from filling point.
from reactors (For multiple tanks
to the sparkler Zone 2 Area gets
filter and to extended)
the centrifuge
through
bottom
transfer line
7 Collection of Primary Natural Obstruct Fair Medium Zone 1 A distance of 2m
solvents or ed from the reactor in
solvent all directions is
content slurry Zone 1 and further
mass remains 2m in all directions
in the open is zone 2 hazardous
container while area.
manual
cleaning of Since, series of
reactors from reactors are
bottom reactor located nearby,
valve or entire area is
adapter classified as Zone 1
(Bottom of the
reactors
located in the
2nd floor
extended to 1st
floor)
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Megafine Pharma (P) Ltd, Nashik
the reactors ed Area from the reactor
or from the sample
port in all
directions is Zone
1.
10 Condenser & Secondary Natural Obstruct Fair Medium Zone 2 A distance of 3 m
reflux / vapour ed Area around valve,
column line fitting and flanges
flange leaks (
for reactors
which has
condenser)
11. Sparkler filter Primary Natural Obstruct Fair Medium Zone 1 A distance of 3 m
transfer pump ed around the pump
• Entire floor area is classified as Zone 1 hazardous location and a distance of 3m surrounding the
building is classified as Zone 2 hazardous location.
• Electrical equipments shall be with the specification Ex d IIA/IIB T2 and instruments mounted on the
process equipments shall be Ex ia IIA/IIB T2.
Observation:
• Nitrogen blanketing has been provided for the centrifuges but interlock is not provided.
• Oxygen level sensor shall be provided.
Hazardous area classification – PB -F Block (PB-B Ground Floor) - Source data sheet
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Megafine Pharma (P) Ltd, Nashik
Ventilation Extent of Zone in
(m)
Grade of
S.NO Source of release Type Area Avail Degree Zone H V
release
abilit
y
Solvent line, fitting and flanges
vent of the
centrifuge
connected to
scrubber line
3 Leakage from Secondary Artificial Enclosed Fair Medium Zone 1 A distance of 3 m
centrifuge around valve,
charging lines fitting and flanges
(Bottom of the
reactors located
in the 1st floor
extended to
Ground floor)
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Megafine Pharma (P) Ltd, Nashik
• Entire PB – B classified as Zone 1 hazardous location and a distance of 1.5m surrounding the building is
classified as Zone 1 hazardous location.
• Electrical equipments shall be with the specification Ex d IIA/IIB T2 and instruments mounted on the
process equipments shall be Ex ia IIA/IIB T2.
• Solvent to the first floor reactor has been discharged from ground floor service area. Therefore,
service area in the ground floor is classifies as zone 1.
• Nitrogen blanketing has been provided for the centrifuges but interlock is not provided. Interlock with
N2 shall be provided.
• Oxygen level sensor shall be provided in the centrifuge room.
• 1 no. of fastener was found to be missing in the flame proof weighing display unit. Openings or
inadequate fastener tightening in the flameproof enclosure will result in loss of integrity and efficiency
to perform as flame proof.
• Non Ex telephone has been provided in the ground floor centrifuge room. Ex telephone with the
specification Ex d IIA/IIB T3 shall be provided.
IV. PB -D – Block:
“D” Block – 1st Floor Area:
• Reactors DGLR – 001 and DSSR – 001 are located in the first floor.
• Ventilation is artificial.
These are the list of solvents used utilized in the various Reactors / process vessel
S.NO Flammable Flash Vapour Boiling LEL UEL Auto Ignition T Gas Group
Materials point Density Point (%) (%) Temperature Class
(°C) (o C) (o C)
1. Toluene 4 3.20 111 1.1 7.1 480 T1 IIA
2. Acetone - 20 2.0 56 2.5 14.3 539 T1 IIA
3. Methanol 9 1.11 65 6 36 440 T2 IIA
4. MDC Non – Flammable Material
5. Ethyl Acetate -4 3.04 77 2 12.8 470 T1 IIA
6. Aqueous Non – flammable Material
Ammonia
7. Di-isopropyl -28 3.52 69 1.0 21.0 405 T2 IIA
ether (DIPE)
8. DMF 58 2.51 153 1.8 16 440 T2 IIA
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Megafine Pharma (P) Ltd, Nashik
(Dimethyl
Formamide)
9. Di-ethylene 138 3.66 245.8 2.0 12.3 143 T3 IIA
Glycol
Since, series of
reactors are
located nearby,
entire area is
classified as Zone 1
4 Sampling from Primary Natural Obstruct Fair Medium Zone 1 A distance of 1m
the reactors ed Area from the reactor
or from the sample
port in all
directions is Zone
1.
5 Condenser & Secondary Natural Obstruct Fair Medium Zone 2 A distance of 3 m
reflux / vapour ed Area around valve,
column line fitting and flanges
flange leaks (
for reactors
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Megafine Pharma (P) Ltd, Nashik
which has
condenser)
• Entire floor area is classified as Zone 1 hazardous location and a distance of 3m surrounding the
building is classified as Zone 1 hazardous location.
• Electrical equipments shall be with the specification Ex d IIA/IIB T3 and instruments mounted on the
process equipments shall be Ex ia IIA/IIB T3.
• Bottom transfer port of the Reactors DGLR – 001 and DSSR – 001 are located in the first floor.
• Centrifuge D – SSCF is located at the ground floor.
• Multimill DMM 001, sifter DSFT 001 are located.
• D-GLR – 001 (crystallizer) reactor and D-RCVD 001 are also located in the PB – D block
• Ventilation is artificial and in once through mode.
Hazardous area classification – PB-D- Ground Floor Area - Source data sheet
4 Vapours while Primary Artifici Obstructe Fair Medium Zone 1 2 m from the
unloading al d/ centrifuge in all the
material from Enclosed directions is
centrifuge Area classified as Zone
1.
In enclosed
centrifuge room,
entire room is
classified as zone 1
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Megafine Pharma (P) Ltd, Nashik
Ventilation Extent of Zone in (m)
Grade of
S.NO Source of release Type Area Availa Degree Zone H V
release
bility
(Considering the
operation of dust
collector)
• Entire floor area is classified as Zone 1 hazardous location and a distance of 3m surrounding the
building is classified as Zone 2 hazardous location.
• Electrical equipments shall be with the specification Ex d IIA/IIB T3 and instruments mounted on the
process equipments shall be Ex ia IIA/IIB T3.
• Sifter – C/SFT -001 and multimiller room is classified as zone 22
• Electrical equipments shall be with the specification Ex d IIA/IIB T3 and instruments mounted on the
process equipments shall be Ex ia IIA/IIB T3.
• In an enclosed sifter & multimiller room, flameproof equipment shall be with the specification Ex d
IIA/IIB T* or Ex “td” *
Interlock between dehumidifier and AHU unit was not provided. Interlock shall be provided in the AHU
unit so that dehumidifier shall not be in ON condition when the blower is in off condition.
V. PB – C:
PB -C – Ground Floor:
Observation:
Summary:
Recommendations:
• Spot extractor LEV shall be provided in the washing room and to be in vicinity during equipment
cleaning process.
• Ventilation failure alarm shall be provided in RCVD, VTD, sifter and multimiller room. Ventilation unit
failure alarm needs to be provided in the centrifuge area. Alarm shall be triggered if ventilation unit
stops. All flammable material handling operations like cleaning process need to stopped. Solvent
container need to be closed. Manual open solvent handling operations need to be done only with the
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Megafine Pharma (P) Ltd, Nashik
presence of adequate ventilation. This shall be commonly followed across all the enclosed areas of the
plant.
• Magnehelic differential pressure gauge was showing zero. It is recommended to rectify or replace the
faulty gauge. It shall be ensured that minimum of 2.5 mm of water column differential pressure shall
be maintained.
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Megafine Pharma (P) Ltd, Nashik
VI. PB – I:
PB - I – 2nd Floor:
Observation:
• Reactors I/GLR – 008, I/GLR -002, I/SSR -001, I/SSR -002, are located.
• Ventilation is natural
These are the list of solvents used utilized in the various Reactors / process vessel
S.NO Flammable Flash Vapour Boiling LEL UEL Auto Ignition T Gas Group
Materials point Density Point (%) (%) Temperature Class
(°C) (o C) (o C)
1. Methyl Tert. -27 3.03 55 1.5 8.4 385 T2 IIA
Butyl Ether
2. Toluene 4 3.20 111 1.1 7.1 480 T1 IIA
3. Methanol 9 1.11 65 6.0 36 440 T1 IIA
4. Ethyl Acetate -4 3.04 77 2 12.8 470 T1 IIA
8. MDC Non – Flammable Material
9. Aqueous Non – flammable Material
Ammonia
10. Di-isopropyl -28 3.52 69 1.0 21.0 405 T2 IIA
ether(DIPE)
11. DMF 58 2.51 153 1.8 16 440 T2 IIA
(Dimethyl
Formamide)
12. Acetone -20 2.0 56 2.5 14.3 399 T2 IIA
13. n-Heptane -7 3.46 105 0.85 6.7 204 T3 IIA
14. Tri Ethyl -8 3.5 89 1.2 8 215 T3 IIA
Amine
15. IPA 12 2.1 83 2 12.7 399 T2 IIA
16. Ethanol 12 1.59 78 3.1 19.0 400 T2 IIB
• Entire 2nd floor building area is classified as Zone 1 hazardous location and a distance of 3m
surrounding the building is classified as Zone 2 hazardous location
• A distance of 3m surrounding the building is classified as zone 2 hazardous location, if the solvent pipe
lines containing source of release are running around.
• Electrical equipments shall be with the specification Ex d IIA/IIB T3 and instruments mounted on the
process equipments shall be Ex ia IIA/IIB T3. Light fittings shall also be ensured to be flameproof type
with specification Ex d IIA/IIB T3
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Megafine Pharma (P) Ltd, Nashik
PB - I – 1st Floor:
Observation:
• I/GLR -007, I/SSR-004 , I/ SSR -004, I/GLR -004are located in the first floor.
• Bottom of the reactor GLR 008, GLR 002, SSR 001 and SSR -002 are located.
• I/SF-003 sparkler filter has been provided.
• Ventilation is natural.
(Bottom of the
reactors
located in the
3rd floor
extended to 2nd
floor)
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Megafine Pharma (P) Ltd, Nashik
4 Sampling from Primary Natural Obstruct Fair Medium Zone 1 A distance of 1m
the reactors ed Area from the reactor
or from the sample
port in all
directions is Zone
1.
5 Condenser & Secondary Natural Obstruct Fair Medium Zone 2 A distance of 3 m
reflux / vapour ed Area around valve,
column line fitting and flanges
flange leaks (
for reactors
which has
condenser)
6 Transfer of Secondary Natural Obstruct Fair Medium Zone 2 3 m in all directions
slurry mass ed from filling point.
from reactors (For multiple tanks
to the sparkler Zone 2 Area gets
filter and to extended)
the centrifuge
through
bottom
transfer line
7 Collection of Primary Natural Obstruct Fair Medium Zone 1 A distance of 2m
solvents or ed from the reactor in
solvent all directions is
content slurry Zone 1 and further
mass remains 2m in all directions
in the open is zone 2 hazardous
container while area.
manual
cleaning of Since, series of
reactors from reactors are
bottom reactor located nearby,
valve or entire area is
adapter classified as Zone 1
(Bottom of the
reactors
located in the
2nd floor
extended to 1st
floor)
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Megafine Pharma (P) Ltd, Nashik
is zone 2 hazardous
area.
9 Sampling from Primary Natural Obstruct Fair Medium Zone 1 A distance of 2m
the reactors ed Area from the reactor
through or from the sample
manhole port in all
directions is Zone
1.
10 Condenser & Secondary Natural Obstruct Fair Medium Zone 2 A distance of 3 m
reflux / vapour ed Area around valve,
column line fitting and flanges
flange leaks (
for reactors
which has
condenser)
11. Sparkler filter Primary Natural Obstruct Fair Medium Zone 1 A distance of 3 m
transfer pump ed around the pump
• Entire 1st floor building area is classified as Zone 1 hazardous location and a distance of 3m
surrounding the building is classified as Zone 1 hazardous location
• A distance of 3m surrounding the building is classified as zone 2 hazardous location, if the solvent pipe
lines containing source of release are running around.
• Electrical equipments shall be with the specification Ex d IIA/IIB T3 and instruments mounted on the
process equipments shall be Ex ia IIA/IIB T3. Light fittings shall also be ensured to be flameproof type
with specification Ex d IIA/IIB T3
PB - I – Ground Floor:
Observation:
• Centrifuge SSCF – 003, SSCF -002 are located in the ground floor.
• All 1st floor reactor bottom and receiver vessel
• Milling and sifting room is also located and equipments multimiller A/MM-002 and sifter I/SFT 001
have been deployed. Vacuum Tray drier I/VTD-001, I/VTD -002 and I/VTD -003 are located.
• It was informed that VTD tray cleaning is carried out in the same location.
• Solvent storage in barrels have been observed in the intermediate area near the entrance of “ I” & “J”
block.
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Megafine Pharma (P) Ltd, Nashik
Hazardous area classification – PB- I- Ground Floor Area - Source data sheet
4 Vapours while Primary Artifici Obstructe Fair Medium Zone 1 2 m from the
unloading al d/ centrifuge in all the
material from Enclosed directions is
centrifuge Area classified as Zone
1.
In enclosed
centrifuge room,
entire room is
classified as zone 1
5 Centrifuge Secondary Natural Obstructe Fair Medium Zone 2 A distance of 3 m
solvent line and d& around valve,
ML (mother Enclosed fitting and flanges
liquor) line
6 Centrifuge Primary Natural Obstructe Fair Medium Zone 1 Zone 1 Entire area
Cleaning d&
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Megafine Pharma (P) Ltd, Nashik
Ventilation Extent of Zone in (m)
Grade of
S.NO Source of release Type Area Availa Degree Zone H V
release
bility
Enclosed
7 Leak from Secondary Natural Obstructe Fair Medium Zone 2 A distance of 3 m
Centrifuge d around valve,
solvent line, ML fitting and flanges
Tank
8 ML Transfer Secondary Natural Obstructe Fair Medium Zone 2 A distance of 3 m
pump d around the transfer
pump
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Megafine Pharma (P) Ltd, Nashik
Summary - PB -I - Ground Floor :
• Entire Ground floor building area is classified as Zone 1 hazardous location and a distance of 3m
surrounding the building is classified as Zone 1 hazardous location.
• Sifter and multimiller location is classified as Zone 22
• A distance of 3m surrounding the building at ground floor level is classified as zone 2 hazardous
location, if solvent pipelines are running by.
• Vent of the safety relief valve and the condenser valve have been let out in the corridor.
• Electrical equipments shall be with the specification Ex d IIA/IIB T3 and instruments mounted on the
process equipments shall be Ex ia IIA/IIB T3.
• In an enclosed sifter room, flameproof equipment shall be with the with the specification Ex d IIA/IIB
T* or Ex “td” *
Note: Dust classification group and Temperature classification shall be decided after laboratory test
results
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Megafine Pharma (P) Ltd, Nashik
VII. PB – K:
PB – K – 1st & Ground Floor:
Observation:
• Process reactors such as KGLR 001, 002 and KHLC F001are located.
• It was informed that acids such as chlorosulphonic acid and bases such as thynyl chloride are used.
They are non flammable.
• Ventilation is natural with all the sides open.
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Megafine Pharma (P) Ltd, Nashik
VIII. PB – J:
PB – “ J “ 2nd Floor:
Observation:
• Reactors J/GLR 001, J/SSR -002, J/SSR-001, J/GLR -008, J/SSR-009 and J/GLR -006 are located in the 2nd
floor.
• Solvent to the process reactor is transferred through AOD pump.
• Ventilation is natural and obstructed.
These are the list of solvents used utilized in the second floor
S.NO Flammable Flash Vapour Boiling LEL UEL Auto Ignition T Gas Group
Materials point Density Point (%) (%) Temperature Class
(°C) (o C) (o C)
1. N - Butanol 35 2.55 118 1.4 12.0 343 T2 IIA
2. Toluene 4 3.20 111 1.1 7.1 480 T1 IIA
3. Acetone -20 2.0 56 2.5 14.3 399 T2 IIA
4. MDC Non – Flammable Material
5. Aqueous Non – flammable Material
Ammonia
6. Tri Ethyl -8 3.5 89 1.2 8 215 T3 IIA
Amine
7. IPA 12 2.1 83 2 12.7 399 T2 IIA
8. Methanol 9 1.11 65 6 36 440 T2 IIA
9. Ethanol 12 1.59 78 3.1 19.0 400 T2 IIB
10. Ethyl Acetate -4 3.04 77 2 12.8 470 T1 IIA
11. Di-isopropyl -28 3.52 69 1.0 21.0 405 T2 IIA
ether(DIPE)
12. Dimethyl 89 2.71 189 2.6 28.5 215 T3 IIA
Sulfoxide
13. Methyl -20 2.07 32 5.0 23.0 525 T1 II A
Formate
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Megafine Pharma (P) Ltd, Nashik
Hazardous area classification – PB “J”- 2nd Floor - Source data sheet
Since, series of
reactors are
located nearby,
entire area is
classified as Zone 1
5. Addition of Primary Natural Obstruc Fair Medium Zone 1 1m from the
solvent to the ted solvent charging
reactor through area
AOD pump
6 Condenser & Secondary Natural Obstruc Fair Medium Zone 2 A distance of 3 m
reflux / vapour ted Area around valve,
column line fitting and flanges
flange leaks ( for
reactors which
has condenser)
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Megafine Pharma (P) Ltd, Nashik
Summary:
• Entire PB “J” second floor building reactor area is classified as Zone 1 hazardous location and a
distance of 3m surrounding the building is classified as Zone 2 hazardous location.
• A distance of 3m surrounding the building at second floor level is classified as zone 2 hazardous
location
• Electrical equipments shall be with the specification Ex d IIA/IIB T3 and instruments mounted on the
process equipments shall be Ex ia IIA/IIB T3.
PB – “ J “ 1st Floor:
Observation:
• Reactors J/SSR -006, J/SSR -005, J/SSR -004, J/GLR -002, J/SSR 008, J/GLR-007, J/GLR-003 are located in
the 1st floor.
• Ventilation is natural
Hazardous area classification – PB “J” – 1st Floor Area - Source data sheet
Since, series of
reactors are
located nearby,
entire area is
classified as Zone 1
6 Addition of Primary Natural Obstruc Fair Medium Zone 1 1m from the
solvent to the ted solvent charging
reactor through area
AOD pump
7 Condenser & Secondary Natural Obstruc Fair Medium Zone 2 A distance of 3 m
reflux / vapour ted Area around valve,
column line fitting and flanges
flange leaks ( for
reactors which
has condenser)
• Entire first floor building reactor area is classified as Zone 1 hazardous location and a distance of 3m
surrounding the building is classified as Zone 1 hazardous location.
• A distance of 3m surrounding the building at first floor level is classified as zone 2 hazardous location
• Electrical equipments shall be with the specification Ex d IIA/IIB T3 and instruments mounted on the
process equipments shall be Ex ia IIA/IIB T3.
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Megafine Pharma (P) Ltd, Nashik
PB “J” – Ground Area :
Observation:
• Crystallizer - J / GLR 004 has been installed in the clean rooms.
• Reactor bottom of the 1st floor are also located.
• Centrifuges J/SSCF 005, J/SSCF 001, J/SSCF 004.
• Ventilation is artificial in crystallizer clean room
In enclosed
centrifuge room,
entire room is
classified as zone 1
5 Centrifuge Secondary Natural Obstructe Fair Medium Zone 2 A distance of 3 m
solvent line and d& around valve,
ML (mother Enclosed fitting and flanges
liquor) line
6 Centrifuge Primary Natural Obstructe Fair Medium Zone 1 Zone 1 Entire area
Cleaning d&
Enclosed
7 Leak from Secondary Natural Obstructe Fair Medium Zone 2 A distance of 3 m
Centrifuge d& around valve,
solvent line, ML Enclosed fitting and flanges
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Megafine Pharma (P) Ltd, Nashik
Ventilation Extent of Zone in (m)
Grade of
S.NO Source of release Type Area Availa Degree Zone H V
release
bility
Tank
8 ML Transfer Secondary Natural Obstructe Fair Medium Zone 2 A distance of 3 m
pump d& around the transfer
Enclosed pump
(Bottom of the
reactors located
in the 1st floor
extended to
Ground floor
floor)
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Megafine Pharma (P) Ltd, Nashik
Ventilation Extent of Zone in (m)
Grade of
S.NO Source of release Type Area Availa Degree Zone H V
release
bility
13. Valves, Fittings Secondary Artifici Enclosed Fair Medium Zone 2 A distance of 3 m
of ANFD al Area around valve,
fitting and flanges
14 ANFD cleaning Primary Artifici Enclosed Fair Medium Zone 1 Entire ANFD room
activity al Area
15 ML and receiver Secondary Artifici Enclosed Fair Medium Zone 2 A distance of 3 m
tank in ANFD al Area around valve,
room fitting and flanges
• Ground floor centrifuge area and crystallizer room are classified as Zone 1.
• ANFD area is considered Zone 1
• Electrical equipments shall be with the specification Ex d IIA/IIB T3 and instruments mounted on the
process equipments shall be Ex ia IIA/IIB T3.
• PRV vent of the crystallizer is vent out in the same location. PRV shall be extended and connected to
scrubber line or to be let out
• Vacuum Trap pumps have been installed in the PB – “J” service area.
• It is an open are with restricted ventilation.
• Distance of 3 m around Vacuum Trap pump is classified as zone 2.
• Non Ex starter switch and temperature display have been installed. All the equipments shall be of
type Ex “ d” IIA / IIB T3.
PB – J – Service Area:
Observation:
3 Inside the dust Primary Natural Enclosed Fair Medium Zone Zone 22
collector 22
chamber –
Clean side of the
filter
• A distance of 1m from the dust collector manhole is considered as zone 22. This is applicable across all
dust collectors in the plant.
• All electrical fittings shall be suitable to dust type and with specification Ex d IIA/IIB T* or Ex “td” *
Note: Dust classification group and Temperature classification shall be decided after laboratory test
results
• A distance of 3m around the scrubber is Zone 2. This is applicable across all the scrubber units in the
plant.
• Solvent line consisting of flanges was observed to be passing close to the AC outdoor unit. A distance
of 3m from the solvent line is classified as zone 2. Therefore, if the AC outdoor unit falls within the
range, it shall be relocated.
• Solvent pipelines with flanges was found to be running above AHU unit in utility. If the flanges in the
solvent line passing by are sealed, then the area will be unclassified or distance of 3m from flange
joints will be classified as zone 2.
• Steam ejector tanks are located above the brine tank area (Outside first floor area of Block J). A
distance of 3m around the ejector tank and pipeline shall also be classified as zone 2.
Chiller Plant:
MEG has been used as brine solution at present for the process chiller and it is non -flammable.
But it was informed that MEG will be replaced by Methanol (35 %) + water in future. From the laboratory
report shared from the Megafine, it was observed that the flash point for 35 % of methanol brine solution
is 35 °C.
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Megafine Pharma (P) Ltd, Nashik
If that is the case, then a distance of 3m around the tank and pipelines containing source of release shall
be considered as Zone 2. Therefore, transfer pump motors, all other electrical installation shall be of
flameproof type with the specification Ex “d” IIA/IIB T2 or Ex “e” IIA/IIB T2.
IX. PB – G:
Observation:
Summary – PB – “G”:
• In an enclosed sifter room, flameproof equipment shall be with the with the specification Ex d IIA/IIB
T* or Ex “td” *
Note: Dust classification group and Temperature classification shall be decided after laboratory test
results
• In wash area, all the electrical equipments shall be of type Ex “d” IIA/IIB T3.
• Megafine can consider replacing compressed air with N2 for the micronizing process.
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Megafine Pharma (P) Ltd, Nashik
X. PB – E:
Observation:
• E/FBD equipment and Multimiller CMM -001 are located in the E – block
• Ventilation is artificial through AHU.
Summary – PB – “E”:
• Entire FBD room is classifies as zone 1. All the electrical equipments shall be of type Ex “d” IIA/IIB T3.
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Megafine Pharma (P) Ltd, Nashik
XI. Recovered Solvent Storage Tanks:
Observation:
• 12 nos. of recovered solvent storage tanks are deployed.
• Tank no. 10, 11, and 12 are of 3 kL capacity and are dedicated for Toluene storage.
• Spent solvent is stored in the 6 tanks.
• Tanks are located in the open area with free ventilation
• It was informed that all storage tanks will be blanketed with nitrogen
4 Solvent Transfer Secondary Natural Open Fair Medium Zone 2 3m horizontally &
pump 1 m above ground
• Electrical equipments shall be with the specification Ex d IIA/IIB T3 and instruments mounted on the
process equipments shall be Ex ia IIA/IIB T3.
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Megafine Pharma (P) Ltd, Nashik
XII. SRP:
Observation:
S.NO Flammable Flash Vapour Boiling LEL UEL Auto Ignition T Gas Group
Materials point Density Point (%) (%) Temperature Class
o
(°C) ( C) (o C)
1. Ethanol 12 1.59 78 3.1 19.0 400 T2 IIB
2. Ethyl Acetate -4 3.04 77 2 12.8 470 T1 IIA
3. Acetone -20 2.0 56 2.5 14.3 399 T2 IIA
6. Toluene 4 3.20 111 1.1 7.1 480 T1 IIA
7. Hydrogen 0.1 4 75 500 T1 IIC
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Megafine Pharma (P) Ltd, Nashik
4 Opening of Primary Natural Open Fair Medium Zone 1 A distance of 2m
reactor manhole + from the reactor in
while cleaning Zone 2 all directions is
process Zone 1 and further
2m in all directions
is zone 2 hazardous
area.
Summary - SRP:
Recommendations - SRP:
• High flame path gap was observed on the for T2 Temperature J2. All allen bolts shall be provided and
tightened fully to meet the required flame path gap in the Ex enclosure.
• Temperature indicator (conde no: SRP1 TCH -001/T1) was found to be cracked and bolts are found to
be missing. All allen bolts shall be provided and tightened fully to meet the required flame path gap in
the Ex enclosure.
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Megafine Pharma (P) Ltd, Nashik
• Unused gland hole was observed to the light fitting near new GLR. It shall be sealed using flame proof
blanking element.
• Non Ex automatic level controller shall be replaced using flame proof and intrinsically safe level
controller.
• Non Ex gland has been used to terminate the cable for EX “d” IIC Telephone. It shall be replaced with
flame proof type double compression gland.
• Hydrogen reactor GLR -001 is located in the open area. It is close to the SRP area.
• 4 cylinders of pressurized at 150 kg/cm2 are provided for charging the reaction
• When the hydrogen is charged to the process reactor, pressure is reduced to 8 kG/cm2.
• From reactor vessel, reaction mass is transferred through sparkler filter.
• Reaction mass is added through scoop to the charging port.
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Megafine Pharma (P) Ltd, Nashik
4 Powder Primary Natural Open Fair Medium Zone 1 Zone 1
charging
through port
Summary - Hydrogenation:
Recommendation - Hydrogenation:
• It shall be ensured that explosion proof clock near the hydrogen cylinder shall be suitable for the
hydrogen gas area and it shall be of specification Ex “d” IIC T3.
• Unused gland hole was observed for the push button station of sparkler filter. It shall be replaced with
flame proof type blanking element.
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Megafine Pharma (P) Ltd, Nashik
• Effluent treatment pump was of flameproof type with specification Ex “d” IIA/ IIB. It shall be replaced
with EX “d” IIC T3.
XIV. ETP:
Observation:
• It was informed that only low TDS liquid are sent to ETP and neutralizer tank. Therefore, concentration
of the flammable solvent may be less and the ETP shall be considered as hazardously non classified.
XIV. MEE:
Observation:
• High TDS solvent are heated in the MEE to evaporate the waste and solvent is collected.
• Ventilation is open air.
• High TDS solvent is stored in the tank.
Summary - MEE:
• Electrical equipments shall be with the specification Ex d IIA/IIB T3 in Zone 1 and it shall of Ex d or Ex
“e” IIA/IIB T3 in Zone 2 region.
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Megafine Pharma (P) Ltd, Nashik
DG Diesel Day Tank , Diesel Fire pump day tank and Canteen LG:
Summary:
• A distance of 3m from the diesel day tank, fire pump day tank, LPG cylinder and pipelines shall be
classified as zone 2.
• It shall be ensured that vent of diesel day tank shall be let out to free open space.
• Any electrical installation within the 3m from the diesel tank or pipeline shall be of flame proof with
the specification Ex “d” IIA/IIB T3 or Ex “e” IIA/IIB T3 .
• Any electrical installation within the 3m from the LPG cylinder or pipeline shall be flameproof with
specification Ex “d” IIA/IIB T2. Power supply socket was observed adjacent to the LPG cylinder. It
shall be discarded or replaced with flameproof socket of type Ex “d” IIA/IIB T2 or Ex “e” IIA/IIB T2.
TFH Oil:
• From MSDS information, Flash point of heater oil was found to be 220 °C. Therefore, if oil is heated
above its flash point then the TFH area will be classified as zone 2 and flame proof equipment shall
be installed with the specification Ex “ d” IIA/IIB T2 or Ex “ e” IIA/IIB T2.
According to International and Indian standards, Laboratories are not considered for Hazardous
classification, provided good and standard storage practice and engineering controls are followed.
• Solvent container of 30 Liters capacity has been provided at the wash area of QC lab. Quantity of
single barrel shall be restricted below 20 Litres.
• VC Wash area is not provided with the spot extractors and spot extractor was found to be in off
condition in QC lab. Spot extractors shall be provided in all the washing areas in vicinity and ensured
that it will be in the working condition. Megafine can even consider installing spot extractors at HPLC
areas
• Spot extractor LEV was also not provided in the potentiometer lab washroom area.
• 10 litres of solvent HDPE (4 nos) container are stored in the area below fume hood. Area below fime
hood shall not be used to store solvent containers.
• 35 L waste solvent storage barrel was observed in the R & D unit. Quantity of single barrel shall be
restricted below 20 Litres.
• GCs are installed and the hydrogen cylinder for the same has been installed in the corridor, which was
found to be closed to the Ac compressor unit. A distance of 4.5 m clearance shall be maintained.
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Megafine Pharma (P) Ltd, Nashik
• Chemical storage room will be classified as zone 2 and all electrical equipment shall be of flame proof
type with the specification Ex “d” IIA/IIB T3 or Ex “e” IIA/IIB T3.
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Megafine Pharma (P) Ltd, Nashik
XVII. PB – H:
PB – H – 1st Floor:
Observation:
• Reactors such as H/SSR -003, H/SSR -002, H/GLR -002, H/SSR -001 and F/GLR – 001 are located in the
first floor.
• Ventilation is artificial with AHU.
Hazardous area classification – PB “H” – 1st Floor Area - Source data sheet
In enclosed
centrifuge room,
entire room is
classified as zone 1
8 Centrifuge Secondary Natural Obstruc Fair Medium Zone 2 A distance of 3 m
solvent line and ted & around valve,
ML (mother Enclose fitting and flanges
liquor) line d
9 Centrifuge Primary Natural Obstruc Fair Medium Zone 1 Zone 1 Entire area
Cleaning and ted &
equipment Enclose
cleaning in same d
place
10 Valves, Fittings Secondary Artificial Enclose Fair Medium Zone 2 A distance of 3 m
of Nutsche filter d Area around valve,
fitting and flanges
11 Nutsche filter Primary Artificial Enclose Fair Medium Zone 1 Entire ANFD room
cleaning activity d Area
12 ML and receiver Secondary Artificial Enclose Fair Medium Zone 2 A distance of 3 m
tank of Nutsche d Area around valve,
filter fitting and flanges
• Electrical equipments shall be with the specification Ex d IIA/IIB T3 and instruments mounted on the
process equipments shall be Ex ia IIA/IIB T3.
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Megafine Pharma (P) Ltd, Nashik
PB – H – 2nd Floor:
PB – H (API):
Observation – PB – H (API):
Hazardous area classification – PB “H” – API Floor Area - Source data sheet
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Megafine Pharma (P) Ltd, Nashik
Summary – PB -H – API:
• Electrical equipments shall be with the specification Ex d IIA/IIB T3 and instruments mounted on the
process equipments shall be Ex ia IIA/IIB T3.
3 Inside the dust Primary Natural Enclosed Fair Medium Zone Zone 22
collector 22
chamber –
Clean side of the
filter
• A distance of 1m from the dust collector manhole is considered as zone 22. This is applicable across all
dust collectors in the plant.
• All electrical fittings shall be suitable to dust type and with specification Ex d IIA/IIB T* or Ex “td” *
Note: Dust classification group and Temperature classification shall be decided after laboratory test
results
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Megafine Pharma (P) Ltd, Nashik
XVIII. Warehouse:
Observation and Summary – Warehouse:
• Warehouse I, II, III, IV, V are used for the storage of raw material powder in the paper fiber drum.
• Sample dispensing of powder is carried out under RALF.
• Therefore, warehouse area is considered to be hazardously unclassified area.
• Storage tanks such as SSST /14 (15 kL – Ethyl acetate), MSST /05 (13 kL - Aqueous Ammonia),
SSST/01(13 kL – Ethyl acetate), SSST/02 (13 kL – MDC), MSST/08 (6 kL – MDC), MSST/07 (6 kL – MDC)
• IPA Tanks SSST 03 (7 kL), SSST – 04 (7 kL) and MSST 06 (12 kL) are also located.
• All the tanks are located in the open area.
• SSST/14 tank provided with safety vent and SSST/01 tank provided with open vent.
• Nitrogen blanketing is carried out only during storage tank filling.
• Vent of the storage tank is open to the transformer
S.NO Flammable Flash Vapour Boiling LEL UEL Auto Ignition T Gas Group
Materials point Density Point (%) (%) Temperature Class
(°C) (o C) (o C)
1. Ethyl Acetate -4 3.04 77 2 12.8 470 T1 IIA
2. IPA 12 2.1 83 2 12.7 399 T2 IIA
3. MDC Non – Flammable Material
4. Aqueous Non – flammable Material
Ammonia
2. Storage Tank Secondary Natural Open Fair Medium Zone 2 3m around the
Pipeline, valves, valve, fittings and
fittings and flanges or up to
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Megafine Pharma (P) Ltd, Nashik
flanges bund wall
whichever is
greater
3. Pits or Primary Natural Open Fair Medium Zone 2 Any pits or
depression in depressions Zone
tank farm area 1, because of
greater tendency
of heavier than air
Vapour to persist
4. Solvent Transfer Secondary Natural Open Fair Medium Zone 2 3 m from the pump
pumps
4. Tanker vent Primary & Natural Open Fair Medium Zone 1 1.5m around the
Secondary vent in all
directions
5. Opening of tank Primary Natural Open Fair Medium Zone 1 A distance of 1.5m
hatches at the in all the direction
top of tanker
6. Manual Primary Natural Open Fair Medium Zone 1 A distance of 1.5m
sampling at the in all the direction
top of tank and extends 2m
hatch vertically
7. Tanker Secondary Natural Open Fair Medium Zone 2 Zone 2. 3m radius
Unloading from the tanker
connections unloading
connections.
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Megafine Pharma (P) Ltd, Nashik
Summary:
• A distance of 3m from the storage tanks containing flammable liquid SSST/14, SSST/01, SSST 03, SSST
04, MSST 06 in all directions is classified as Zone 1 hazardous location Pit/depressions in the tank farm
area is Zone 1 hazardous location and a distance of 1.5m from the storage tank vent is Zone 1
hazardous location.
• A distance of 1.5 m in all directions up to the ground level from the tanker bottom loading adaptors is
classified as Zone 1 hazardous location and further a distance of 3m from the unloading pipe
connections is classified a Zone 2 hazardous location and its extends 0.63 m vertically above the
ground level.
• Electrical equipments shall be with the specification Ex d IIA/IIB T2 and instruments mounted directly
on the storage tanks shall be Ex ia IIA/IIB T2
• UG storage tanks SSST 05 (Methanol), SSST 06 (Acetone), SSST 07 (Toluene), SSST 08 (Ethanol), SSST
09(Methanol) of each capacity 30 kL are located.
• UG storage tanks are blanketed with Nitrogen.
S.NO Flammable Flash Vapour Boiling LEL UEL Auto Ignition T Gas Group
Materials point Density Point (%) (%) Temperature Class
o
(°C) ( C) (o C)
1. Methanol 9 1.11 65 6 36 440 T2 IIA
2. Acetone - 20 2.0 56 2.5 14.3 539 T1 IIA
3. Toluene 4 3.20 111 1.1 7.1 480 T1 IIA
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Megafine Pharma (P) Ltd, Nashik
4. Ethanol 12 1.59 78 3.1 19.0 400 T2 IIB
2. Storage Tank Secondary Natural Open Fair Medium Zone 2 3m around the
Pipeline, valves, valve, fittings and
fittings and flanges or up to
flanges bund wall
whichever is
greater Zone 2.
3. Pits or Primary Natural Open Fair Medium Zone 2 Any pits or
depression in depressions Zone
tank farm area 1, because of
greater tendency
of heavier than air
Vapour to persist
4. Solvent Transfer Secondary Natural Open Fair Medium Zone 2 3 m from the pump
pumps
Summary:
• A distance of 3m from the storage tank in all directions is classified as Zone 2 hazardous location
Pit/depressions in the tank farm area is Zone 1 hazardous location and a distance of 1.5m from the
storage tank vent is Zone 2 hazardous location.
• A distance of 1.5 m in all directions up to the ground level from the tanker bottom loading adaptors is
classified as Zone 1 hazardous location and further a distance of 3m from the unloading pipe
connections is classified a Zone 2 hazardous location and its extends 0.63 m vertically above the
ground level.
• Electrical equipments shall be with the specification Ex d IIA/IIB T2 and instruments mounted directly
on the storage tanks shall be Ex ia IIA/IIB T2
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Megafine Pharma (P) Ltd, Nashik
XXI. Dispensing Room & Barrel Storage Room:
Dispensing Room – Observations & Recommendations:
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Megafine Pharma (P) Ltd, Nashik
Annexure – A - Ventilation ACPH details Shared by Megafine:
2
Primary packing material storage area 55.67
3 Sampling & testing area WH/AHU-001 3863 CFM 29.62
4 Quarantine room 47.85
5 Buffer Room 51.87
6 Receiving & dispensing area 69.42
Production Block-D
1 Change room 41.39
2 Centrifuge Room VU-301 9498 CFM 31.73
3 Material air lock 60.71
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Megafine Pharma (P) Ltd, Nashik
4 wash & ancillary room 72.15
5 Reactor area 56.15
6 staircase 25.27
Production Block-C & D
1 Change room 43.44
2 Repacking area 12317 30.23
VU-302
3 wash & ancillary room-C CFM 22.42
4 wash & ancillary room-D 22.8
Production block-E
1 Air lock-I 37.93
2 Change room 27.4
3 FBD Area 38.13
4 Air lock-II 56.14
5 Wash room E/AHU-001 5850 CFM 30.23
6 Ancillary area 28.3
7 Sifter, milling & packing room 33.84
8 Intermediate F.G area 41.39
9 Material In/Out 38.78
Production block-J (API)
1 Air lock 84.4
2 Change room 28.63
3 Reactor area 11456 37.69
J/AHU-001
4 Filteration & drying area CFM 32.68
5 Wash room 52.02
6 Buffer Room 93.13
DMB-C
1 Air lock-I 81.31
2 Change room 62.65
3 clean corridor 40.16
4 Air Lock-II 10633 57.88
AHU-301
5 Packing room CFM 83.02
6 RCVD Room 54.2
7 Milling & sifting room 76.41
8 wet material storage area 43.05
DMB-F
1 WIP Room 40.73
2 Quarantine room 29.46
3 Finish goods storage room AHU-502 5243 CFM 41.51
4 Packing material in 32.86
5 packing area 37.13
Production Block-F
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Megafine Pharma (P) Ltd, Nashik
1 Air Lock 59.15
2 Centrifuge area 30.56
3 Material In/Out F/AHU-001 9746 CFM 41.32
4 Wash room 24.2
5 Reactor area 51.43
Production Block-G
1 Air Lock-I 44.06
2 Air Lock -II 40.85
AHU-503 2820 CFM
3 Microniser room 29.1
4 Wash room 59
Production Block-H(API)
1 Air lock 52.77
2 Change room 50.08
3 Centrifuge area H/AHU-001 4762 CFM 34.37
4 Dryer, Sifter & Milling Room 36.26
5 Reactor area 36.51
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Megafine Pharma (P) Ltd, Nashik
S
E W
N
Zone 1 Ex d IIA/IIB T3
A/GLR - 002 A/SSR - 010 A/SSR - 004 A/SSR - 003 A/SSR - 002 A/SSR - 001
Capacity 630 Ltr. Capacity 600 Ltr. Capacity 600 Ltr. Capacity 600 Ltr. Capacity 600 Ltr. Capacity 600 Ltr.
MOC MSGL MOC SS 316 MOC SS 316 MOC SS 316 MOC SS 316 MOC SS 316
A/GLR - 002 A/SSR - 010 A/SSR - 004 A/SSR - 003 A/SSR - 002 A/SSR - 001
DN
A/SSR - 007 A/GLR - 001 A/SSR - 006 A/SSR - 008 A/GLR - 003
Capacity 1200 Ltr. Capacity 1000 Ltr. Capacity 2000 Ltr. Capacity 2000 Ltr. Capacity 1000 Ltr.
MOC SS 316 MOC MSGL MOC SS 316 MOC SS 316 MOC MSGL
A/SSR - 007
A/SSR - 006 A/SSR - 008 OPEN UP TO
A/GLR - 001 A/WT - 001 A/GLR - 003 GROUND FLOOR
Capacity 400 Ltr.
MOC SS 316
A/WT-001
MEZZANINE FLOOR
Zone 1 Ex d IIA/IIB T3
EE
PRODUCTION AREA
UP
GROUND FLOOR
S
Title :- EQUIPMENT LAYOUT - DMB AREA (PB-A)
E W
Zone 1 Ex d IIA/IIB T3
A/TD - 002 A/TD - 004
SCRUBBER
Capacity 48 Trays Capacity 48 Trays
SOLVENT
MOC SS 316 MOC SS 316
PASSAGE
AREA
CENTRIFUGE ROOM TRAY DRYER TRAY DRYER
ROOM ROOM
Zone 22 Zone 22
PASSAGE
INTERMEDIATE /
UP
F.G. STORE - 1
HOIST
Zone 1 Ex d IIA/IIB T3
PASSAGE
AIR
LOCK
WASH & UNDER QUARANTINE &
ANCILLARY APPROVED MATERIAL Zone
WASH
1 Ex d IIA/IIB T3
ROOM STORAGE ROOM
ROOM
ROOM
MULTIMILL
AREA
A/MM - 001 A/BL - 002
Capacity 1500 Ltr.
A/MM - 001 A/BL - 002
MOC SS 316
Capacity 100 Kg/Hr. SIFTER ROOM
MOC SS 316
BLENDER, SIFTER
A/SFT - 001
& PACKING ROOM
A/SFT - 001
Capacity 30" Dia.
MOC SS 316
A/SFT - 002 INTERMEDIATE /
A/SFT - 002
F.G. STORE - 2
Capacity 30" Dia.
Zone 22
A/TD - 003 A/TD - 001
COB TI
TI
CHANGE
ROOM F.G. OUT
AIR LOCK
COB
Zone 22
PERSONNEL GROUND FLOOR
ENTRY
S
E W
B/SSCF-001 B/VTD-001
EE
Zone 22
Capacity 36" Dia. Capacity 48 Trays
MOC SS 316 MOC SS 316
B/SSCF-001
B/VTD - 001
CENTRIFUGE ENTRY
ANCILLARY EE
SERVICE
VTD WASH ROOM
ROOM
SERVICE ROOM ROOM DRYER
ROOM ROOM
ROOM
B/SSCF-002
PRODUCTION AREA Capacity 24" Dia.
B/SSR-001 B/GLR-005 B/SSCF-003 B/GLR-003 B/WT-001 B/SSR-006 MOC SS 316
UP
HOIST Capacity 2000 Ltr. Capacity 2000 Ltr. Capacity 48" Dia. Capacity 250 Ltr. Capacity 2400 Ltr. Capacity 190 Ltr.
B/SSCF-002
MOC SS 316 MOC MSGL MOC SS 316 MOC MSGL MOC SS 316 MOC SS 316
B/SSCF-003
UP
UP DN
2.00 M SERVICE AREA
EE
Zone 1 Ex d IIA/IIB T3
SECOND FLOOR
S
E W
UP
ANCILLARY
CHEMIST OFFICE STORE ROOM WASH ROOM SERVICE ROOM
EE ROOM
EE
B/SSR-002 B/SSR-003 B/SSR-007 B/GLR-002 B/GLR-006 B/SSR-004 B/SSR-005 B/GLR-007
Capacity 3000 Ltr. Capacity 3000 Ltr. Capacity 3000 Ltr. Capacity 2000 Ltr. Capacity 1600 Ltr. Capacity 1000 Ltr. Capacity 1000 Ltr. Capacity 2000 Ltr.
HOIST
MOC SS 316 MOC SS 316 MOC SS 316 MOC MSGL MOC MSGL MOC SS 316 MOC SS 316 MOC MSGL
PRODUCTION
AREA
1.20 M CORRIDOR
DN
UP DN
2.00 M SERVICE AREA
EE
THIRD FLOOR
S
EQUIPMENT LAYOUT - CLEAN ROOM AREA (PB-C) E W
N
EE
Zone 2 Ex d IIA/IIB T3
ML TANK ROOM
EE
C/HLCF - 001
Capacity 36" Dia.
C/HLCF - 001
MOC SS 316 C/GLR - 001
Capacity 1000 Ltr.
MOC MSGL
Zone 1 Ex d IIA/IIB T3 CENTRIFUGE ROOM REACTOR AREA
UP UP DN
C/GLR - 001
PB
C
O CHANGE
B ROOM
PB
AIR
LOCK-III WASH ROOM ANCILLARY
WET MATERIAL
STORAGE ROOM
PB FIRST FLOOR
C/VTD - 001 C/VTD - 001
Zone 1 Ex d IIA/IIB T3
SERVICE
Capacity 12 Trays
AREA
MOC SS 316
C/RCVD - 001
VTD Capacity 300 Lit.
ROOM MOC SS 316
C/MM - 001 C/MM - 001
Zone 22 C/RCVD - 001
Capacity 100 Kg/Hr.
SIFTER &
MOC SS 316
MULTIMILL RCVD ROOM
ROOM
2.50 M CORRIDOR
C/SFT - 001
Capacity 30" Dia.
MOC SS 316 C/SFT - 001
C/BL - 001
CORRIDOR
C/BL - 001 Capacity 250 Lit.
MOC SS 316
PB
BLENDING ROOM
ANCILLARY
ROOM
Zone 22
WASH ROOM
PACKING ROOM
Zone 1 Ex d IIA/IIB T3
AIR LOCK - II PB
C
CHANGE
AIR LOCK - I ROOM
O
MATERIAL
B
IN / OUT
ENTRY ROOM
RAMP
GROUND FLOOR
S
EE
DN
D/SSCF - 001
Capacity 48" Dia.
MOC SS 316 UP
Zone 1 Ex d IIA/IIB T3 D/SSCF - 001
D/SSR - 001
Capacity 3000 Ltr.
EE D/GLR - 001
Capacity 3000 Ltr.
MOC SS 316
D/GLR - 001
REACTOR AREA
CENTRIFUGE ROOM Zone 1 Ex d IIA/IIB T3
CHANGE
WASH ROOM
ANCILLARY MAL
ROOM COB
ROOM
Zone 1 Ex d IIA/IIB T3
PB
AIR LOCK
1.78 M CORRIDOR PB
FIRST FLOOR
PB D/RCVD - 001
D/RCVD - 001
WET MATERIAL Capacity 2000 Lit.
STORAGE MOC SS 316
RCVD ROOM
Zone 1 Ex d IIA/IIB T3
2.75 M CORRIDOR
WASH ROOM
ANCILLARY
2.50 M CORRIDOR
ROOM
AIR LOCK
PASSAGE
PACKING ROOM
Zone 22
D/SFT - 001
MULTIMILL & SIFTER Capacity 30" Dia.
ROOM MOC SS 316
D/MM - 001
D/SFT - 001
D/MM - 001
Capacity 100 Kg/Hr.
PB MOC SS 316
QUARANTINE
C CHANGE
O ROOM AIR LOCK
F.G. STORE B
ENTRY ROOM
RAMP
GROUND FLOOR
S
E W
PB E/MM - 001
MULTIMILL, SIFTER
& PACKING ROOM
E/SFT - 001
WASH ROOM Capacity
MOC
30" Dia.
SS 316 E/SFT - 001
Zone 22
Zone 1 Ex d IIA/IIB T3
EE
FBD ROOM
M
O
T
O
R
INTERMEDIATE / F.G.
E/FBD - 001 STORAGE ROOM
S.P.
Capacity 120 Kg.
MOC SS 316
H
E
P
A
E/FBD - 001 F
I
L
T
E
R
H
E
A
T
I
N
G
C
O
I
L
Material In / Out
PASSAGE
PB
CHANGE
ROOM
COB
RAMP
AIR
LOCK
GROUND FLOOR
S
E W
N
F/SSR - 001
DN
Capacity 2500 Ltr.
MOC SS 316 F/GLR - 002
EE
HOIST Capacity 3000 Ltr.
MOC MSGL
REACTOR AREA
Zone 1 Ex d IIA/IIB T3
F/SSR - 001
F/GLR - 002
DPB
UP DN
2.00 M SERVICE AREA
EE
F/TD - 001
PB TI
F/MM - 001
F/MM - 001
F/TD - 001
Capacity 100 Kg / Hr.
Capacity 96 Trays
SERVICE AREA
MOC SS 316
MOC SS 316
F/RCVD - 001
PACKING
ANCILLARY
RCVD ROOM
Zone 22
F/SFT - 001
F/SFT - 001 Capacity 30" Dia.
MOC SS 316
EE
1.20M CORRIDOR
Zone 1 Ex d IIA/IIB T3
AIR PB
LOCK-2
COB
WORK IN PB
QUARANTINE ROOM FINISHED
PROCESS
ROOM GOODS PM IN
AIR STORAGE
LOCK- 1
EE
MOC
F/SSCF - 001
Capacity 48" Dia.
SS 316
FIRST FLOOR
F/SSCF - 001
UP
Zone 1 Ex d IIA/IIB T3
CENTRIFUGE ROOM
GROUND FLOOR
S
E W
Zone 1 Ex d IIA/IIB T3
PM IN
Zone 22
FIRST FLOOR
S
E W
DRYER ROOM - 1
UP
C
O CHANGE
B ROOM
A/MM - 002
PASSAGE
A/MM - 002
Capacity 100 Kg / Hr.
PB
MOC SS 316
MILLING &
SIFTING ROOM
I/SFT - 001
Capacity 30" Dia. I/SFT - 001 PRODUCTION AREA
MOC SS 316
I/TD - 001
TI
I/TD - 001
Capacity 96 Trays
MOC SS 316
DRYER ROOM - 2
UP
H.W. V.G. V.T.
I/VTD - 001
Capacity 48 Trays
MOC SS 316
I/VTD - 001
CHANGE ROOM
INPROCESS MATERIAL
STAGING AREA
UP
PORCH
GROUND FLOOR
S
OPEN UP TO
ANC. AREA
1st FLOOR
Zone 1 Ex d IIA/IIB T3
DN
SECOND FLOOR
I/SSR - 003
Capacity
MOC
1000 Lit.
SS 316
Zone 1 Ex d IIA/IIB T3
PRODUCTION AREA
(MEZZANINE FLOOR)
I/SSR - 004 I/GLR - 004 I/GLR - 007
Capacity 1000 Lit. Capacity 500 Lit. Capacity 3000 Lit.
UP
MOC SS 316 MOC SS 316 MOC MSGL
I/SSR - 003
DN
DN UP
FIRST FLOOR
UP
PRODUCTION AREA
UP
CHANGE
ROOM
COB
PB
GROUND FLOOR
S
E W
J/ANFD- 001
HOIST J/SSCF - 005
UTILITY AREA
FILTRATION &
slovent line passing DRYING AREA
above AHU ( Ref Pg:71) UP
UP
CENTRIFUGE AREA
J/SSCF - 002 J/SSCF - 003
Capacity 48" Dia. Capacity 48" Dia. CENTRIFUGE AREA
MOC SS 316 MOC SS 316
UTILITY AREA J/SSCF - 002 J/SSCF - 003
J/SSCF - 004
Capacity 48" Dia.
MOC SS 316
J/SSCF - 004
Zone 1 Ex d IIA/IIB T3
J/SSR - 010
UP Capacity 500 Lit.
MOC SS 316
J/SSR - 010
GROUND FLOOR
S
E W
Zone 1 Ex d IIA/IIB T3
J/SSR - 004
Capacity 10000 Lit.
J/GLR - 004
MOC SS 316
Capacity 6300 Lit.
HOIST
MOC MSGL
UTILITY AREA
J/GLR - 004
J/SSR - 004
REACTOR AREA
C AIR
EE CHANGE O
ROOM B LOCK J/SSR - 005
PRODUCTION AREA
UP DN J/GLR - 007 J/SSR - 008 J/GLR - 003
J/SSR - 006
Capacity 5000 Lit.
Capacity 8000 Lit. Capacity 5000 Lit. Capacity 6300 Lit.
MOC SS 316
MOC MSGL MOC SS 316 MOC MSGL
PRODUCTION
COMMUNICATION
MOC MSGL
Zone 1 Ex d IIA/IIB T3 DN
J/SSR - 007
J/GLR - 002
J/SSR - 007
FIRST FLOOR
S
E W
EQUIPMENT LAYOUT - PRODUCTION AREA (PB-J)
J/SSR - 001
WASH Capacity
MOC
5000 Lit.
SS 316
ROOM
UTILITY AREA HOIST
J/SSR - 001
UTILITY AREA
J/SSR - 002
Capacity 5000 Lit.
MOC SS 316
Zone 1 Ex d IIA/IIB T3
DN
J/SSR - 002 PRODUCTION
J/GLR - 006
Capacity 6300 Lit.
J/SSR - 009
Capacity 5000 Lit.
J/GLR - 005
Capacity 6300 Lit. AREA
COMMUNICATION
MOC MSGL MOC SS 316 MOC MSGL
J/GLR - 001
Capacity 2500 Lit.
PRODUCTION
BAY
J/GLR - 006 J/GLR - 005 MOC MSGL
J/SSR - 009
AREA
UP
J/GLR - 001
DN
Zone 1 Ex d IIA/IIB T3
SECOND FLOOR
S
E W
UTILITY AREA
CUTOUT
11.75 X 3.50
CUTOUT
K/GLR - 002
Capacity 6300 Lit.
MOC MSGL
K/GLR - 002
REACTOR AREA
11.75 X 11.00
Zone 1 Ex d IIA/IIB T3
LIFT AREA
2.10 X 2.40
FIRST FLOOR
S
E W
CUTOUT
UTILITY AREA
11.75 X 3.50
CUTOUT
REACTOR AREA
11.75 X 11.00
Zone 1 Ex d IIA/IIB T3
DN
LIFT AREA
2.10 X 2.40
SECOND FLOOR