Annexures
Annexures
M/s. Rheomax Gums LLP
LIST OF ANNEXURES
Annexure : Description
ANNEXURE - 1 : Location of the Project Site
ANNEXURE - 2 : Plant Layout
ANNEXURE - 2.1 : Break-Up of Total Land Area
ANNEXURE - 3 : Details of Production Capacity and Raw Material
ANNEXURE - 4 : Details of Manufacturing Process
ANNEXURE - 5 : Details of Storage Facilities For Products, By-Products and Raw Materials
ANNEXURE - 6 : Details of Solid / Hazardous Waste and Mode of Disposal
ANNEXURE - 7 : Details of Water Consumption and Wastewater Generation
ANNEXURE - 7.1 : Details of Effluent (Wastewater) Management System
ANNEXURE - 8 : Details of Electricity and Fuel
ANNEXURE - 8.1 : Details of Stack / Vent, Flue Gas and Air Pollution Control Measures
M/s. Rheomax Gums LLP
Annexure-1 of Form-1
ANNEXURE – 1
Location of Project Site
(A). Gujarat Map Showing District- Ahmedabad
Ahmedabad District
M/s. Rheomax Gums LLP
Annexure-1 of Form-1
(B). Ahmedbad District Map Showing- Project Site at Village- Gangad
Gangad Village
M/s. Rheomax Gums LLP
Annexure-1 of Form-1
(C). Google Map Showing Project Site
M/s. Rheomax Gums LLP
Annexure-2 of Form-1
ANNEXURE – 2
Plant Layout
Please see the attached layout plan
(A)
GREEN SPACE
PARKING
FUTURE EXPANSION
(12)
PRODUCTION
BLOCK
(1)
OFFICE
PA
NT
RY
LA
DIE
S
TO
ILE
T
GE
NT
S
TO
ILE
T
PA
SS
AG
E
(2)
RAW MATERIAL
STORAGE
ROOM
(3)
PRODUCT
STORAGE
ROOM
(4)
SOLID
WASTE
STORAGE
ROOM
(5)
HAZARDOUS
CHEMICAL
STORAGE
ROOM
(6)
DRUMS
STORAGE
ROOM
(7)
ELECTRIC
ROOM
(8)
FIRE HYDRANT
ROOM
(9)
BOILER ROOM
(10)
UTILITIES
(11)
ETP AREA
(13) P
AS
SA
G
E
(13) P
AS
SA
G
E
RO
AD
OWNER :-
SCALE :- 1CM : 5MT.
RHEOMAX GUMS L.L.P.SUR NO. - 1905/PART, VILLAGE :- GANGADTALUKA :- BAVLA, DISTRICT :- AHMEDABAD
ENT.
104.9
0
175.12
155.17
51.74
50.58
1) OFFICE = 335.10
3) PRODUCTION STORAGE ROOM = 135.00 4) SOLID WASTE STORAGE ROOM = 135.00 5) HAZARDOUS CHEMICAL STORAGE ROOM = 135.00 6) DRUMS STORAGE ROOM = 135.00 7) ELECTRIC ROOM = 60.00 8) FIRE HYDRANT ROOM = 50.00 9) BOILER ROOM = 60.0010) UTILITIES = 129.4011) ETP + MEE ROOM = 213.0212) PRODUCTION BLOCK = 2405.1013) PASSAGE = 276.24
2) RAW MATERIAL STORAGE ROOM = 180.00
TOTAL FLOOR AREA = 4248.86(B)
88.05
49.79
TOTAL BUILT UP AREA - 4384.00 Sqmts.(A) GREEN SPACE AREA - 6074.26 Sqmts.(B) ROAD AREA - 3260.34 Sqmts.(C) FUTURE EXPANSION WITH PARKING - 3480.40 Sqmts. TOTAL AREA - 17199.00 Sqmts.
(C)
(C)
M/s. Rheomax Gums LLP
Annexure- 2.1 of Form-1 1
Annexure – 2.1
LAND AREA DETAILS
Break-up details of land area
Sr.No. Description Area Details (m²)
A Total built-up/ground coverage area (allocated for industrial uses) 4384.0
B Road area 3260.3
C Future expansion with parking 3480.4
D Green belt area (35% of total land area) 6074.3
TOTAL LAND AREA (A+B+C+D) 17199.0
Break-up details of floor area allocated for industrial uses
Sr.No. Description Area Details (m²)
1. Office 335.1
2. Production block 2405.1
3. Raw materials storage area 180.0
4. Products storage area 135.0
5. Fuel storage area 135.0
6. Hazardous chemical storage 135.0
7. Drums storage area 135.0
8. Electric area 60.0
9. Fire hydrant 50.0
10. Boiler room 60.0
11. Utilities area 129.4
12. ETP + MEE area 213.0
13. Passage 276.2
Total floor area 4248.8
M/s. Rheomax Gums LLP
Annexure- 3 of Form-1 1
Annexure - 3
Details of Production Capacity & Raw Material Consumption
(A) DETAILS OF PRODUCTS & PRODUCTION CAPACITY
Sr. No.
Name of Product Quantity
(MT/Month)
1. Chloro Compound (2-chloromethyl-3,4-dimethoxy pyridine hydrochloride)
10
2. Pantaprazole sodium 5
3. Phenylephrine HCl 2
4. Pregabalin 2
5. Telmisartan 2
6. Montekulast sodium 2
7. Ondansetron HCl 2
M/s. Rheomax Gums LLP
Annexure- 3 of Form-1 2
(B) DETAILS OF RAW MATERIALS & IT’S PRODUCT WISE CONSUMPTION
For Product Name of Raw Material Quantity
Kg/Batch MT/Month
1. Chloro Compound (2-chloromethyl-3,4-dimethoxy pyridine hydrochloride) (10 MT/Month)
Acetic acid 180.00 7.50
Acetic acid glacial 150.00 6.25
Acetic anhydride 1140.00 47.49
Ammonium carbonate 100.00 4.17
Chloroform 2293.50 95.55
Di methyl formamide (DMF) 30.00 1.25
Di methyl sulfate (DMS) 360.00 15.00
H2O2 330.00 13.75 Hexane 425.10 17.71
Ice 450.00 18.75
Iso propyl alcohol (IPA) 157.00 6.54
KOH 156.00 6.50
Methylene dichloride (MDC) 5569.2 232.01
Methanol 1665.30 69.38 Methyl maltol 300.00 12.50
NaOH (caustic lye) 1295.00 53.95
NH3 liquor 543.18 22.63 POCl3 560.00 23.33
SOCl2 195.00 8.12
Sodium methoxide 180.00 7.50
Sodium sulfate 50.00 2.08
Sodium tungstate 15.00 0.62
Toluene 1206.80 50.28
2. Pantaprazole Sodium (5 MT/Month)
10% NaOCl 279.00 1395.00 Acetone 623 3115
Diflouro methoxy-2-MB 73.50 367.50
IPA 1154 5770 NaOH 41.00 205.00
Pantoprazole chloro compound 77.00 385.00
Pantoprazole sulfide 115.00 575.00
3. Phenylephrine HCl (2 MT/Month)
Acidic isopropyl alcohol 275.00 1.83
Ranney nickel (10% charcoal) 12.00 0.08
An.aluminium chloride 17.50 0.12 Ethyl acetate 700.00 4.67
M/s. Rheomax Gums LLP
Annexure- 3 of Form-1 3
For Product Name of Raw Material Quantity
Kg/Batch MT/Month
HCl 88.00 0.59
Hydrogen gas 2.00 0.01
Hyflow powder 4.00 0.03
Isopropyl alcohol 4250.00 28.33
Liq. bromine 204.00 1.36 Methanol 2500.00 16.67
M-hydroxy aceto phenone 350.00 2.33
N-methyl benzyl amine 258.00 1.72 Ranney nickel (10% charcoa 25.00 0.17
Toluene 700.00 4.67
4. Pregabalin (2 MT/Month)
Activated charcoal 10.00 0.08
Chloroform 5100.00 40.80
Diethyl malonate 530.00 4.24
Di-n-propyl amine 25.40 0.20
Ethyl cyano acetate 390.00 3.12
Hydrochloric acid 150.00 1.20
Hyflow powder 3.00 0.02
Isoveraldehyde 300.00 2.40
Liq. bromine 245.00 1.96
Methanol 61.20 0.49
Sodium hydroxide 338.00 2.70 n-Hexane 450.00 3.60
R-(+)-(α)-phenyl ethyl amine 205.00 1.64
Urea 215.00 1.72
5. Telmisartan (2 MT/Month)
Acetone 295.10 2.66 Acetic acid 470.60 4.24
Activated carbon 13.10 0.12 Bibenzimidazole 186.70 1.68
Bromo methyl ester 187.30 1.69
Celite 8.80 0.08
Dimethyl formamide 969.60 8.73
Methanol 3304.60 29.74
Potassium hydroxide 76.10 0.68 Sodium hydroxide 33.10 0.30
Recoveries (-)
Acetone 280.30 2.52
M/s. Rheomax Gums LLP
Annexure- 3 of Form-1 4
For Product Name of Raw Material Quantity
Kg/Batch MT/Month
Dimethyl formamide 921.10 8.29
Methanol 3160.20 28.44
6. Montekulast Sodium (2 MT/Month)
Acetic acid 65.00 0.87 Acetone 1600.00 21.33
Carbon 15.00 0.20
Di isopropyl ethylamine 6.00 0.08
HCl for NaOH neutralization 55.50 0.74
MDC 1800.00 24.00
Methane sulfonyl chloride 15.00 0.20 Methanol 2219.80 29.60
N-vinyl pyrrolidone 108.10 1.44
Sodium chloride 120.00 1.60
Sodium hydroxide 86.80 1.16
Tertiary Butyl amine 29.40 0.39
Thiol Acetic acid 74.00 0.99
Thiophene-2-ethylamine 347.40 4.63
Toluene 7200.00 96.00
7. Ondansetron HCl (2 MT/Month)
1,2,3,9-Tetrahydo-4H-carbazole-4-one 325.00 1.86
2-Methyl imidazole 124.00 0.71
Activated charcoal 7.00 0.04
Dimethyl formamide (DMF) 127.00 0.73
Hydrochloric acid 120.00 0.69
Hyflow powder 2.00 0.01
Isopropyl alcohol 1700.00 9.71 Methylene dichloride 2200.00 12.57
Morpholine 30.00 0.17
P-formaldehyde 45.00 0.26
Sodium hydroxide 65.00 0.37
Tetra butyl ammonium bromide 2.00 0.01
Toluene 1600.00 9.14
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 1
ANNEXURE - 4
Details of Manufacturing Process Manufacturing process details of proposed products are as given under -
(1). Chloro Compound (2-Chloromethyl 3,4-Dimethoxy Pyridine Hydrochloride)
Manufacturing process, reaction chemistry, mass balance diagram and process flow chart of
Chloro Compound (2-Chloromethyl 3,4-Dimethoxy Pyridine Hydrochloride) are presented
here –
a) Manufacturing Process :
Brief Description: Maltol (2 methyl-3 hydroxy-4 pyrone) is reacted with Dimethyl Sulfate to
produce 2methyl 3-Methoxy 4 Pyrone. This methoxy Pyrone is condensed with NH3 liquor to
produce 2 methyl 3 methoxy4 pyridone. This pyridone is then reacted with POCl3 to form 2
methyl 3 methoxy 4 chloro pyridine. This chloro pyridine undergoes oxidation with H2O2 and
Tungstic Acid to give 2 methyl 3 methoxy 4 chloro pyridine anoxide which inturn reacts with
Sodium Methoxide to form dimethoxy in methanol medium. This dimethoxy pyridine
anoxide undergoes acetylation with Acetic Anhydride to give 2 Acetyl 3,4 dimethoxy
pyridine. This then undergoes hydrolysis with NaOH to give 2 hydroxy methyl 3,4 dimethoxy
pyridine. This is then reacted with ThionylChoride (SOCl2) to form 2 chloromethyl 3,4
dimethoxy pyridine Hydrochloride.
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 2
b) Chemical Reaction:
Stage- I : Methylation
Stage- II : Ammonialysis
Stage- III : Chlorination
Stage- IV : Oxidation
Methyl Maltol Di Methyl Sulphate (DMS) Potassium Hydroxide 2-methyl 3-methoxy 4-pyrone Potassium sulphate
ammonium carbonate
2-methyl 3-methoxy 4-pyrone
ammonia 2-methyl 3-methoxy 4-pyridone
ammonium hydroxide
carbon dioxide
2-methyl 3-methoxy 4-pyridone 2-methyl 3-methoxy 4- chloro pyridine sodium
chloride phosphoric
acid
2-methyl 3-methoxy 4- chloro pyridine
hydrogen peroxide 2-methyl 3-methoxy 4- chloro pyridine N-oxide
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 3
Stage- V : Methoxylation
Stage- VI : Acetylation
Stage- VII : Hydrolysis
Stage- VIII : Chlorination
2-methyl 3-methoxy 4- chloro pyridine N-oxide
sodium methoxide 2-methyl 3,4-dimethoxy pyridine N-oxide
sodium chloride
2-methyl 3,4-dimethoxy pyridine N-oxide
acetic anhydride 2-acetyl 3,4-dimethoxy pyridine
2-acetyl 3,4-dimethoxy pyridine sodium hydroxide 2-hydroxy methyl 3,4-dimethoxy pyridine
2-hydroxy methyl 3,4-dimethoxy pyridine thionyl chloride 2-chloromethyl 3,4- diimethoxy pyridine hydrochloride
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 4
a) Mass Balance Diagram :
Stage
INPUT OUTPUT
INPUT Kg/Batch MT/Month OUTPUT Kg/Batch MT/Month
Stage- I Methyl maltol 300.00 12.50 Methanol recovery 924.00 38.49
DMS 360.00 15.00 K2SO4 513.60 21.40
KOH 156.00 6.50 Stage-1 330.00 13.75
Methanol 951.60 39.64 0.00
Sub-total of stage-I 1767.60 73.64 Sub-total of stage-I 1767.60 73.64
Stage- II Stage-1 330.00 13.75 Ammonium hydroxide 228.80 9.53
NH3 liquor 543.18 22.63 Water 300.00 12.50
Ammonium carbonate 100.00 4.17 Toluene recovery 1180.00 49.16
Hexane 130.80 5.45 Hexane recovery 127.00 5.29
Toluene 1206.80 50.28 CO2 204.98 8.54
Stage-2 270.00 11.25
Sub-total of stage-II 2310.78 96.27 Sub-total of stage-II 2310.78 96.27
Stage- III Stage-2 270.00 11.25 Chloroform recovery 58.20 2.42
POCl3 560.00 23.33 Water 600.00 25.00
NaOH (caustic lye) 600.00 25.00 Wastewater (effluent) 531.80 22.15
Chloroform 60.00 2.50 Stage-3 300.00 12.50
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 5
Stage
INPUT OUTPUT
INPUT Kg/Batch MT/Month OUTPUT Kg/Batch MT/Month
Sub-total of stage-III 62.07 1490.00 Sub-total of stage-III 1490.00 62.07
Stage- IV Stage-3 300.00 12.50 Chloroform recovery 2166.50 90.26
Sodium tungstate 15.00 0.62 Wastewater (effluent) 1677.00 69.86
Acetic acid glacial 150.00 6.25 Stage-4 300.00 12.50
Chloroform 2233.50 93.05
H2O2 330.00 13.75
Water 630.00 26.25
Ice 450.00 18.75
NaOH (caustic lye) 35.00 1.46
Sub-total of stage-IV 4143.50 172.62 Sub-total of stage-IV 4143.50 172.62
Stage- V Stage-4 300.00 12.50 Methanol recovery 692.70 28.86
Sodium methoxide 180.00 7.50 Salt 51.00 2.12
Methanol 713.70 29.73 Stage- 5 450.00 18.75
Sub-total of stage-V 1193.70 49.73 Sub-total of stage-V 1193.70 49.73
Stage- VI Stage-5 450.00 18.75 Acetic anhydride distillate 780.00 32.49
Acetic acid 180.00 7.50 Stage- 6 990.00 41.24
Acetic anhydride 1140.00 47.49 0.00
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 6
Stage
INPUT OUTPUT
INPUT Kg/Batch MT/Month OUTPUT Kg/Batch MT/Month
Sub-total of stage-VI 1770.00 73.74 Sub-total of stage-VI 1770.00 73.74
Stage-VII Stage-6 990.00 41.24 0.00
Water 1500.00 62.49 Sodium Acetate 1407.90 58.65
NaOH (caustic lye) 660.00 27.50 MDC recovery 3938.90 164.09
Hexane 294.30 12.26 Hexane recovery 285.50 11.89
Methylene dichloride 3978.00 165.72 Water 1600.00 66.66
Sodium sulfate 50.00 2.08 Stage- 7 240.00 10.00
Sub-total of stage-VII 7472.30 311.30 Sub-total of stage-VII 7472.30 311.30
Stage- VIII Stage- 7 240.00 10.00 MDC recovery 1559.40 64.96
MDC 1591.20 66.29 IPA recovery 153.80 6.41
DMF 30.00 1.25 SO2 260.00 10.83
IPA 157.00 6.54 Chloro Compound- Product 240.00 10.00
SOCl2 195.00 8.12
Sub-total of stage-VIII 2213.20 92.20 Sub-total of stage-VIII 2213.20 92.20
TOTAL INPUT
(Sum of all stages’ sub-total) 22361.08 931.56 TOTAL OUTPUT (Sum of all stages’ sub-total) 22361.08 931.56
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 7
b) Process Flow Chart :
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 8
(2). Pantaprazole Sodium
Manufacturing process, reaction chemistry, mass balance diagram and process flow chart of Pantaprazole Sodium are presented here –
a) Manufacturing Process :
Brief Description: Pantoprazole chloro compound will react with 5-difluoromethoxy-2-
mercapto benzamidazole in presence of Base in organic solvent to get PT-S compound. PT-S
compound will react with sodium hypochlorite in presence of organic solvent to get PT-1
compound. PT-1 compound will reacts with sodium hydroxide in presence of organic solvent
to get Pantoprazole sodium sesquihydrate.
b) Chemical Reaction:
Stage- 1)
C8H10ClNO2.HCl + C8H6F2N2OS + 2NaOH Pantoprazole chloro compound
5-difluoromethoxy-2- mercapto benzamidazole
Sodium hydoxide
C16H15F2N3O3S + 2NaCl + 2H2O PT-S compound Sodium Chloride Water
Stage- 2)
C16H15F2N3O3S + NaOCl + H2O PT-S compound Sodium hypochlorite Water
C16H15F2N3O4S + NaOH + HCl PT-1 compound Sodium hydroxide Hydrogen chloride
Stage- 3)
C16H15F2N3O4S + NaOH + 1.5H2O PT-1 compound Sodium hydroxide Water
C16H14F2N3NaO4S 1.5H2O + H2O Pantoprazole sodium sesquihydrate Water
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 9
c) Mass Balance Diagram :
Stage INPUT OUTPUT
Input Kg / Batch MT/ Month Output Kg/Batch MT/Month
Stage- I Pantoprazole chloro compound 77.00 3.85 Aq. layer 168.50 8.43
Diflouro Methoxy-2-MB 73.50 3.68 IPA MLs 627.00 31.35
NaOH 30.00 1.50 Evaporation loss 15.10 0.76
R.O. water 138.50 6.93 Evaporation loss 8.40 0.42
IPA 385.00 19.25 PT-S compound 115.00 5.75
R.O. water 153.00 7.65
IPA for washing 77.00 3.85
Sub-total of stage-I 934.00 46.70 Sub-total of stage-I 934.00 46.70
Stage- II Pantoprazole sulfide 115.00 5.75 Aq. layer 472.00 23.60
10% NaOCl 279.00 13.95 Evaporation loss 8.00 0.40
IPA 577.00 28.85 IPA MLs 885.00 44.25
R.O. water 193.00 9.65 Evaporation loss 4.00 0.20
R.O. water 193.50 9.68 PT-1 103.50 5.18
IPA for washing 115.00 5.75
Sub-total of stage-II 1472.50 73.63 Sub-total of stage-II 1472.50 73.63
Stage- III Pantoprazole 103.50 5.18 Acetone MLs 638.50 31.93
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 10
Stage INPUT OUTPUT
Input Kg / Batch MT/ Month Output Kg/Batch MT/Month
NaOH 11.00 0.55 Evaporation loss 10.00 0.50
Acetone 519.00 25.95 Evaporation loss 7.00 0.35
R.O. water 18.00 0.90 Pantoprazole Sodium- API 100.00 5.00
Acetone washing 104.00 5.20
Sub-total of stage- III 755.50 37.78 Sub-total of stage-III 755.50 37.78
TOTAL INPUT (Sum of all stages’ sub-total) 3162.00 158.10
TOTAL INPUT (Sum of all stages’ sub-total) 3162.00 158.10
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 11
d) Process Flow Chart :
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 12
(3). Phenylephrine HCl
Manufacturing process, reaction chemistry, mass balance diagram and process flow chart of
Phenylephrine HCl are presented here –
a) Manufacturing Process :
Brief Description; M-hydroxy aceto phenone reacts with bromine in presence of aluminium
chloride to form M-hydroxyl bromo aceto phenone which will react with N-methyl benzyl
amine in presence of Ranney Nickel to obtain phenylephrine hydrochloride.
b) Chemical Reaction :
M-hydroxy aceto phenone N-methyl benzyl amine
Phenyl Ephrine crude Phenylephrine HCl
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 13
c) Mass Balance :
Stages
INPUT OUTPUT
Input Kg/Batch MT/Month Output Kg/Batch MT/Month
Stage- I m-hydroxy aceto phenone 350.00 2.33 Stage- I Mass 500.00 3.33
Ethyl acetate 700.00 4.67 HBr 210.00 1.40
An.Aluminium chloride 17.50 0.12 Solvent 0.00
Liq. Bromine 204.00 1.36 Toluene recovery 665.00 4.43
Toluene 700.00 4.67 Toluene loss 21.00 0.14
n-methyl benzyl amine 258.00 1.72 Ethyl acetate recovery 665.00 4.43
Water 250.00 1.67 Ethyl acetate loss 21.00 0.14
Acidic isopropyl alcohol 75.00 0.50 Liquid waste 0.00
Water 250.00 1.67
Aluminum chloride 17.50 0.12
Toluene 14.00 0.09
Ethyl acetate 14.00 0.09
Acidic Isopropyl alcohol 75.00 0.50
Solid waste 0.00 0.00
Gaseous waste 0.00 0.00
Organic residue 102.00 0.68
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 14
Sub-total of stage-I 2554.50 17.03 Sub-total of stage-I 2554.50 17.03
Stage- II Stage- I Mass 500.00 3.33 Stage- II mass 400.00 2.67
Methanol 2500.00 16.67 Solvent 0.00
Ranney nickel (10% charcoal) 25.00 0.17 Methyl recovery 2250.00 15.00
Hydrogen gas 2.00 0.01 Methyl loss 125.00 0.83
Hyflow powder 2.00 0.01 Liquid waste 0.00
Water 550.00 3.67 Water 550.00 3.67
Methanol 63.00 0.42
Organic 92.00 0.61
Solid waste 99.00 0.66
Gaseous waste 0.00 0.00
Organic residue 0.00 0.00
Sub-total of stage-II 3579.00 23.86 Sub-total of stage-II 3579.00 23.86
Stage- III Stage- II Mass 400.00 2.67 Stage- III Mass 375.00 2.50
Isopropyl alcohol 2000.00 13.33 Solvent 0.00
HCl 88.00 0.59 Isopropyl alcohol recovery 1800.00 12.00
water 400.00 2.67 Isopropyl alcohol loss 100.00 0.67
Acidic isopropyl alcohol 200.00 1.33 Liquid waste 0.00
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 15
Water 400.00 2.67
Isopropyl alcohol 100.00 0.67
Acidic isopropyl alcohol 200.00 1.33
Solid waste 113.00 0.75
Gaseous waste 0.00 0.00
Organic residue 0.00 0.00
Sub-total of stage-III 3088.00 20.59 Sub-total of stage-III 3088.00 20.59
Stage- IV Stage- III Mass 375.00 2.50 Phenylephrine HCL - Product 300.00 2.00
Isopropyl alcohol 2250.00 15.00 Solvent 0.00
Activated charcoal 12.00 0.08 Isopropyl alcohol recovery 1800.00 12.00
Hyflow powder 2.00 0.01 Isopropyl alcohol loss 112.50 0.75
Liquid waste 0.00 0.00
Solid waste 351.50 2.34
Gaseous waste 0.00 0.00
Organic residue 75.00 0.50
Sub-total of stage-IV 2639.00 17.59 Sub-total of stage-IV 2639.00 17.59
TOTAL INPUT (Sum of all stages’ sub-total) 11860.5 79.07 TOTAL OUTPUT
(Sum of all stages’ sub-total) 11860.5 79.07
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 16
d) Process Flow Chart :
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 17
(4). Pregabalin
Manufacturing process, reaction chemistry, mass balance diagram and process flow chart of
Pregabalin are presented here –
a) Manufacturing Process :
Ethyl cyano acetate was first condensed with isoveraldehyde to give the unsaturated ester
micheak addition of di ethyl malonate followed by acid–induced decarboxylation gave glutaric
acid which was then converted to the amide acid via the anhydride intermediate. Acid can be
resolved with (R) - methl benzyl amine to give the chiral acid in 98%. Hoffmann reaction
rearrangement of amide gave Pregabalin in good yield.
b) Chemical Reaction :
Isoveraldehyde Ethyl Cyano Acetate (Intermediate) Diethyl Malonate M/F: C5H10O M/F: C5H7O 2N M/F: C10H15O2N M/F: C7H12O4
M/W: 86.0 g/m M/W: 113.0 g/m M/W: 181.0 g/m M/W : 160.0 g/m
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 18
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 19
R-(+)-(α)-phenyl ethyl amine
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 20
c) Mass Balance :
Stages INPUT OUTPUT
Input Kg/Batch MT/Month Output Kg/Batch MT/Month
Stage- I A Isoveraldehyde 300.00 2.40 Stage- IA 506.00 4.05
Ethyl cyano acetate 390.00 3.12 Solvent
Di-n-propyl amine 25.40 0.20 Hexane recovery 427.50 3.42
n-Hexane 450.00 3.60 Hexane loss 13.50 0.11
Liquid waste
Water 60.00 0.48
Hexane 9.00 0.07
Di-n-propyl amine 25.40 0.20
Organic 124.00 0.99
Solid waste 0.00 0.00
Gaseous waste 0.00 0.00
Organic residue 0.00 0.00
Sub-total of stage-IA 1165.40 9.32 Sub-total of stage-IA 1165.40 9.32
Stage- I B Stage - IA 506.00 4.05 Stage- IB 510.00 4.08
Diethyl malonate 530.00 4.24 Liquid waste
Water 60.00 0.48
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 21
Ethanol 150.00 1.20
Diethyl malonate 38.00 0.30
Solid waste
Gaseous waste- CO2 144.00 1.15
Organic residue 134.00 1.07
Sub-total of stage-IB 1036.00 8.29 Sub-total of stage-IB 1036.00 8.29
Stage- IC Stage- IB 510.00 4.08 Stage- IC 510.00 4.08
Urea 215.00 1.72 Liquid waste
Sodium hydroxide 45.00 0.36 Water 750.00 6.00
Water 750.00 6.00 Sodium hydroxide 45.00 0.36
Activated charcoal 5.00 0.04 Organic 52.00 0.42
Solid waste 0.00 0.00
Gaseous waste
Gaseous waste- NH3 46.00 0.37
Gaseous waste- CO2 117.00 0.94
Organic residue 5.00 0.04
Sub-total of stage-IC 1525.00 12.20 Sub-total of stage-IC 1525.00 12.20
Stage- II Stage- IC 510.00 4.08 Stage- II 408.00 3.26
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 22
Chloroform 5100.00 40.80 Solvent
Methanol 61.00 0.49 Chloroform recovery 4080.00 32.64
R-(+)-(α)-phenyl ethyl amine 205.00 1.64 Chloroform loss 255.00 2.04
Liquid waste 0.00 0.00
Solid waste 307.00 2.46
Gaseous waste 0.00 0.00
Organic residue 826.00 6.61
Sub-total of stage-II 5876.00 47.01 Sub-total of stage-II 5876.00 47.01
Stage- III Stage- II 408.00 3.26 Stage- III 285.00 2.28
Hydrochloric acid 150.00 1.20 Liquid waste
Water 300.00 2.40 Water 376.00 3.01
Sodium hydroxide 170.00 1.36 Organic 123.00 0.98
NaCl 244.00 1.95
Solid waste 0.00 0.00
Gaseous waste 0.00 0.00
Organic residue 0.00 0.00
Sub-total of stage-III 1028.00 8.22 Sub-total of stage-III 1028.00 8.22
Stage- IV Stage- III 285.00 2.28 Pregabalin - Product 250.00 2.00
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 23
Liq. Bromine 245.00 1.96 Liquid waste
Sodium hydroxide 123.00 0.98 Water 326.00 2.61
Activated charcoal 5.00 0.04 Nabr 312.00 2.50
Hyflow powder 3.00 0.02 Solid waste 8.00 0.06
Water 300.00 2.40 Gaseous waste- CO2 65.00 0.52
Organic residue 0.00 0.00
Sub-total of stage-IV 961.00 7.69 Sub-total of stage-IV 961.00 7.69
TOTAL INPUT (Sum of all stages’ sub-total) 11591.40 92.73 TOTAL OUTPUT
(Sum of all stages’ sub-total) 11591.40 92.73
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 24
d) Process Flow Chart :
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 25
(5). Telmisartan
Manufacturing process, reaction chemistry, mass balance diagram and process flow chart of
Telmisartan are presented here –
a) Manufacturing Process :
Bibenzimidazole & bromomethyl ester is condensed in presence of sodium methoxide in
DMF to give Telmi-I (Methyl 4’–[[4-Methyl-6(1-methyl-1H benzimidazol-2-yl)-2-propyl-1H
benzimidazole-1yl] methyl] biphenyl-2-carboxylate).
Telmi-I is hydrolyzed using potassium hydroxide in methanol & water mixture to give
Telmisartan.
b) Chemical Reaction :
Stage I- Preparation of Telmi- I
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 26
Stage II- Preparation of Telmisartan
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 27
c) Mass Balance :
Stage INPUT OUTPUT
Input Kg/Batch MT/Month Output Kg/Batch MT/Month
Stage- I Bibenzimidazole 186.70 1.68 (Stage- i) - termi-i 261.40 2.35
Bromo methyl ester 187.30 1.69 Fugitive losses 0.00
Sodium hydroxide 33.10 0.30 Dimethyl formamide 38.80 0.35
Dimethyl formamide 969.60 8.73 Acetone 11.80 0.11
Acetone 295.10 2.66 Methanol 0.80 0.01
Water 2240.90 20.17 Wastewater
Water 2240.90 20.17
Recoveries (-) Sodium bromide 63.00 0.57
Dimethyl formamide 921.10 8.29 Organic waste
Acetone 280.30 2.52 Dimethyl formamide 9.70 0.09
Methanol 18.60 0.17 Acetone 3.00 0.03
Methanol 0.20 0.00
Organics 63.10 0.57
Sub-total of stage-I (Total - Recoveries) 2692.70 24.24 Sub-total of stage-I 2692.70 24.24
Stage- II (Stage- I) - Termi-I 261.40 2.35 Telmisartan 222.20 2.00
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 28
Potassium hydroxide 76.10 0.68 Fugitive losses
Acetic acid 470.60 4.24 Methanol 132.80 1.20
Methanol 3304.60 29.74 Wastewater
Activated carbon 13.10 0.12 Water 3660.10 32.94
Celite 8.80 0.08 Potassium acetate 133.00 1.20
Water 3817.00 34.36 Spent carbon
Spent carbon 21.90 0.20
Recoveries (-) Methanol 13.10 0.12
Methanol 3141.60 28.28 Organic waste 0.00 0.00
Methanol 33.20 0.30
Water 170.80 1.54
Organics 33.80 0.30
Acetic acid 389.10 3.50
Sub-total of stage-II (Total - Recoveries) 4810.00 43.29 Sub-total of stage-II 4810.00 43.29
TOTAL INPUT (Sum of all stages’ sub-total) 7502.70 67.53 TOTAL OUTPUT
(Sum of all stages’ sub-total) 7502.70 67.53
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 29
d) Process Flow Chart :
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 30
(6). Montekulast Sodium
Manufacturing process, reaction chemistry, mass balance diagram and process flow chart of
Montekulast Sodium are presented here –
a) Manufacturing Process :
Manufacturing process of Montelukast Sodium completed in following stages:
Stage-I : 1-(Hydoxy methyl) cyclo propane Acetonitrile (MEC-4) is reacted with
methane sulfonyl chloride in presence of Diisoprpylethyl amine, and the product is
further treated with Thiol acetic acid to give MAN.
Stage-II : Condensation of MAN and (2-(2-(3(S)-(3-(2-(7-Chloro-2-quinolinyl) ethenyl)
phenyl-3-(methane sulfonyloxy) propyl)-2-propanol) (QUID-8) in the presence with
n-butyl lithium in the presence of toluene and Dimethyl foramide which on further
hydrolysis with Caustic lye to give MOK-1 –Nitrile
Stage-III & IV : MOK-1 Nitrile underwent sodium hydroxide hydrolysis in the
presence of toluene to give MOK-1. MOK-1 treated with t-butyl amine protection with
acetone acid to give MOK-2 butyl amine.
Stage- V : MOK-2 t-butylamine on further treatment with caustic flakes to give
sodium Montelukast (MOK-3). On further carbon purification with methanol to give
Pure MK-3 salt (Montelukast Sodium).
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 31
b) Chemical Reaction :
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 32
c) Mass Balance :
Stage INPUT OUTPUT
Input Kg/Batch MT/Month Output Kg/Batch MT/Month
Stage- I N-vinyl pyrrolidone 108.10 1.44 Stage-I 96.50 1.29
Thiol acetic acid 74.00 0.99 Acetic acid 45.60 0.61
Diisopropyl ethylamine 6.00 0.08 Toluene recovered 1447.50 19.30
Toluene 1500.00 20.00 Toluene loss 7.50 0.10
Water 1500.00 20.00 Toluene residue 45.00 0.60
Methane sulfonyl Chloride 15.00 0.20 N-vinyl pyrrolidone 23.70 0.32
Thiol acetic acid 16.30 0.22
Diisopropyl ethylamine 6.00 0.08
Methane sulfonyl chloride 15.00 0.20
Water 1500.00 20.00
Sub-total of stage-I 3203.10 42.71 Sub-total of stage-I 3203.10 42.71
Stage- II Stage-I 96.50 1.29 Stage-II 350.60 4.67
Thiophene-2-ethylamine 347.40 4.63 Water generated during reaction 11.10 0.15
Toluene 2000.00 26.67 Toluene recovered 1940.00 25.87
Water 1200.00 16.00 Toluene loss 10.00 0.13
Acetic acid 10.00 0.13 Toluene residue 50.00 0.67
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 33
Stage INPUT OUTPUT
Input Kg/Batch MT/Month Output Kg/Batch MT/Month
Sodium chloride 50.00 0.67 Stage-I 17.90 0.24
Carbon 5.00 0.07 Thiophene-2-ethylamine 64.30 0.86
Acetic acid 10.00 0.13
Carbon 5.00 0.07
Sodium chloride 50.00 0.67
Water 1200.00 16.00
Sub-total of stage-II 3708.90 49.45 Sub-total of stage-II 3708.90 49.45
Stage- III Stage-II 350.60 4.67 Stage-III (Crude Nateglinide Form H) 235.60 3.14
Sodium hydroxide 24.70 0.33 Sodium methoxide 21.70 0.29
Methanol 1219.80 16.26 Ammonia 6.80 0.09
Toluene 1700.00 22.67 Methanol recovered 1152.00 15.36
Water 1500.00 20.00 Methanol loss 6.00 0.08
Acetic acid 30.00 0.40 Methanol wastewater 12.00 0.16
Sodium chloride 70.00 0.93 Methanol residue 30.00 0.40
HCl for NaOH neutralization 7.90 0.11 Toluene recovered 1632.00 21.76
Toluene loss 6.80 0.09
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 34
Stage INPUT OUTPUT
Input Kg/Batch MT/Month Output Kg/Batch MT/Month
Toluene residue 61.20 0.82
Stage-II 122.70 1.64
Methanol 6.90 0.09
Acetic acid 30.00 0.40
Sodium hydroxide 8.70 0.12
Sodium chloride 70.00 0.93
Water 1484.00 19.79
NaCl from NaOH neutralization 12.70 0.17
Water from NaOH neutralization 3.90 0.05
Sub-total of stage-III 4903.00 65.37 Sub-total of stage-III 4903.00 65.37
Stage-IV Stage-III 235.60 3.14 Stage-IV 198.70 2.65
Tertiary butyl amine 29.40 0.39 Acetone recovered 1536.00 20.48
Acetone 1600.00 21.33 Acetone loss 7.20 0.10
Toluene 2000.00 26.67 Acetone residue 56.80 0.76
Carbon 5.00 0.07 Toluene recovered 1920.00 25.60
Toluene loss 10.00 0.13
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 35
Stage INPUT OUTPUT
Input Kg/Batch MT/Month Output Kg/Batch MT/Month
Toluene residue 70.00 0.93
Stage-III 58.90 0.79
Tertiary butyl amine 7.40 0.10
Carbon 5.00 0.07
Sub-total of stage-IV 3870.00 51.60 Sub-total of stage-IV 3870.00 51.60
Stage- V Stage-IV 198.70 2.65 Montekulast Sodium 150.00 2.00
Sodium hydroxide 62.10 0.83 Tert-butylamine 18.00 0.24
Mdc 1800.00 24.00 Water generated during reaction 4.40 0.06
Acetic acid 25.00 0.33 MDC recovered 1737.00 23.16
Water 1800.00 24.00 MDC loss 9.00 0.12
Methanol 1000.00 13.33 MDC residue 54.00 0.72
Carbon 5.00 0.07 Methanol recovered 970.00 12.93
HCl for NaOH neutralization 47.60 0.63 Methanol loss 4.00 0.05
Methanol residue 26.00 0.35
Stage- IV 36.10 0.48
Acetic acid 25.00 0.33
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 36
Stage INPUT OUTPUT
Input Kg/Batch MT/Month Output Kg/Batch MT/Month
Carbon 5.00 0.07
Sodium hydroxide 52.20 0.70
Water 1747.90 23.30
NaCl from NaOH neutralization 76.30 1.02
Water from NaOH neutralization 23.50 0.31
Sub-total of stage-V 4938.40 65.84 Sub-total of stage-V 4938.40 65.84
TOTAL INPUT (Sum of all stages’ sub-total) 20623.40 274.97 TOTAL OUTPUT
(Sum of all stages’ sub-total) 20623.40 274.97
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 37
d) Process Flow Chart :
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 38
(7). Ondansetron HCL
Manufacturing process, reaction chemistry, mass balance diagram and process flow chart of
Ondansetron HCL are presented here –
a) Manufacturing Process :
1,2,3,9- tetrahydro-4H-carbazole is react with 2-methyl imidazole in presence of
hydrochloric acid and isopropyl alcohol to obtain Onadansetron hydrochloride.
b) Chemical Reaction :
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 39
c) Mass Balance :
Stage INPUT OUTPUT
Input Kg/Batch MT/Month Output Kg/Batch MT/Month
Stage-I 1,2,3,9-tetrahydo-4H-carbazole-4-one 325.00 1.86 Stage-I 300.00 1.71
Methylene dichloride 2200.00 12.57 Solvent
Sodium hydroxide 65.00 0.37 Methylene dichloride recovery 1540.00 8.80
Process water 165.00 0.94 Methylene dichloride loss 110.00 0.63
Dimethyl formamide 127.00 0.73 Liquid waste
Tetra butyl ammonium bromide 2.00 0.01 Water 165.00 0.94
Methylene dichloride 550.00 3.14
Dimethyl formaide 101.00 0.58
NaOH 65.00 0.37
Solid waste 28.00 0.16
Gaseous waste 0.00 0.00
Organic residue 25.00 0.14
Sub-total of stage-I 2884.00 16.48 Sub-total of stage-I 2884.00 16.48
Stage-II Stage-I 300.00 1.71 Stage-II 350.00 2.00
Morpholine 30.00 0.17 Solvent 0.00
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 40
p-formaldehyde 45.00 0.26 Toluene recovery 1280.00 7.31
Toluene 1600.00 9.14 Toluene loss 80.00 0.46
2-Methyl imidazole 124.00 0.71 Liquid waste
Process Water 300.00 1.71 Process water 328.00 1.87
Toluene 240.00 1.37
Morpholine 30.00 0.17
Solid waste 0.00 0.00
Gaseous waste 0.00 0.00
Organic waste 91.00 0.52
Sub-total of stage-II 2399.00 13.71 Sub-total of stage-II 2399.00 13.71
Stage-III Stage-II 350.00 2.00 Ondansetron HCL - Product 350.00 2.00
Isopropyl alcohol 1700.00 9.71 Solvent 0.00
Process water 1350.00 7.71 Isopropyl alcohol recovery 1026.00 5.86
Hydrochloric acid 120.00 0.69 Isopropyl alcohol loss 85.00 0.49
Activated charcoal 7.00 0.04 Liquid waste 0.00 0.00
Hyflow powder 2.00 0.01 Water 1350.00 7.71
Isopropyl alcohol 522.00 2.98
Organic 100.00 0.57
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 41
Solid waste 9.00 0.05
Gaseous waste 0.00 0.00
Organic residue 87.00 0.50
Sub-total of stage-III 3529.00 20.16 Sub-total of stage-III 3529.00 20.16
TOTAL INPUT (Sum of all stages’ sub-total) 8812.00 50.35 TOTAL INPUT
(Sum of all stages’ sub-total) 8812.00 50.35
M/s. Rheomax Gums LLP
Annexure- 4 of Form-1 42
d) Process Flow Chart :
M/s. Rheomax Gums LLP
Annexure- 5 of Form-1 1
ANNEXURE - 5
Details of Storage Facilities for Products and Raw Materials
(A) Storage Facilities for PRODUCTS
Sr. No.
Name of PRODUCT Production Maximum Storage
for 5 days (MT)
Status Storage MOC Capacity No. of containers/
bags
Temp.
(° C)
Pressure
MT/ Month
MT/ Day
1. Chloro compound 10 0.33 1.67 solid HDPE drum 25 kg 67 ambient ambient
2. Pantaprazole sodium 5 0.17 0.83 solid HDPE drum 25 kg 34 ambient ambient
3. Phenylephrine HCl 2 0.07 0.33 solid HDPE drum 25 kg 14 ambient ambient
4. Pregabalin 2 0.07 0.33 solid HDPE drum 25 kg 14 ambient ambient
5. Telmisartan 2 0.07 0.33 solid HDPE drum 25 kg 14 ambient ambient
6. Montekulast sodium 2 0.07 0.33 solid HDPE drum 25 kg 14 ambient ambient
7. OndansetronHCl 2 0.07 0.33 solid HDPE drum 25 kg 14 ambient ambient
(B) Storage Facilities for RAW MATERIALS
Sr. No.
Name of RAW MATERIAL Consumption Maximum Storage
for 5 days (MT)
Status Storage MOC Capacity (kg)
No of containers
/ bags
Temp.
(° C)
Pressure
MT/ Month
MT/ Day
1. 10% NaOCl 13.95 0.47 2.33 solid HDPE drum 50 kg 47 ambient ambient
2. 1,2,3,9-Tetrahydo-4H-carbazole-4-one
1.86 0.06 0.31 solid HDPE drum 25 kg 13 ambient ambient
3. 2-Methyl imidazole 0.71 0.02 0.12 solid HDPE drum 25 kg 5 ambient ambient
4. Acetic Acid 12.61 0.42 2.10 liquid HDPE drum 210 kg 10 ambient ambient
M/s. Rheomax Gums LLP
Annexure- 5 of Form-1 2
Sr. No.
Name of RAW MATERIAL Consumption Maximum Storage
for 5 days (MT)
Status Storage MOC Capacity (kg)
No of containers
/ bags
Temp.
(° C)
Pressure
MT/ Month
MT/ Day
5. Acetic acid glacial 6.25 0.21 1.04 liquid HDPE drum 210 kg 5 ambient ambient
6. Acetic anhydride 47.49 1.58 7.92 liquid HDPE drum 210 kg 38 ambient ambient
7. Acetone 55.14 1.84 9.19 liquid MS tank 15 KL 1 ambient ambient
8. Acidic isopropyl alcohol 1.83 0.06 0.31 liquid HDPE drum 210 kg 2 ambient ambient
9. Activated carbon 0.32 0.014 0.05 solid HDPE bags 25 kg 2 ambient ambient
10. Activated charcoal 0.20 0.01 0.03 solid HDPE bags 25 kg 2 ambient ambient
11. Ammonium carbonate 4.17 0.14 0.70 solid HDPE bags 50 kg 14 ambient ambient
12. An.aluminium chloride 0.12 0.004 0.02 solid MS drum 50 kg 1 ambient ambient
13. benzimidazole 1.68 0.06 0.28 solid HDPE bags 50 kg 6 ambient ambient
14. Bromo methyl ester 1.69 0.06 0.28 liquid HDPE drum 50 kg 6 ambient ambient
15. Celite 0.08 0.003 0.01 solid HDPE bags 25 kg 1 ambient ambient
16. Chloroform 136.55 4.55 22.76 liquid HDPE drum 180 litre 85 ambient ambient
17. Di isopropyl ethylamine 0.08 0.003 0.01 solid HDPE bags 25 kg 1 ambient ambient
18. Diethyl malonate 4.24 0.14 0.71 liquid HDPE drum 205 kg 4 ambient ambient
19. Diflouro methoxy-2-MB 3.68 0.12 0.61 solid HDPE drum 50 kg 13 ambient ambient
20. Dimethyl formamide (DMF) 19.00 0.63 3.17 liquid HDPE drum 210 litre 15 ambient ambient
21. Di-n-propyl amine 0.20 0.01 0.03 liquid HDPE drum 190 kg 1 ambient ambient
22. Dimethyl Sulfate 15.00 0.50 2.50 liquid HDPE drum 210 kg 12 ambient ambient
23. Ethyl acetate 4.67 0.16 0.78 liquid HDPE drum 210 litre 5 ambient ambient
24. Ethyl cyano acetate 3.12 0.10 0.52 liquid HDPE drum 210 kg 3 ambient ambient
25. Hydrogen peroxide (H2O2) 13.75 0.46 2.29 liquid HDPE drum 210 kg 11 ambient ambient
26. Hydrochloric acid 3.22 0.11 0.54 liquid HDPE drum 205 litre 3 ambient ambient
27. Hexane 21.31 0.71 3.55 liquid HDPE drum 210 litre 26 ambient ambient
28. Hydrogen gas 0.01 0.0003 0.002 gas MS cylinder 45 kg 1 ambient 200 kg/cm²
M/s. Rheomax Gums LLP
Annexure- 5 of Form-1 3
Sr. No.
Name of RAW MATERIAL Consumption Maximum Storage
for 5 days (MT)
Status Storage MOC Capacity (kg)
No of containers
/ bags
Temp.
(° C)
Pressure
MT/ Month
MT/ Day
29. Isopropyl alcohol (IPA) 102.28 3.14 17.05 liquid HDPE drum 210 litre 81 ambient ambient
30. Potassium hydroxide (KOH) 7.18 0.24 1.20 solid HDPE bags 50 kg 24 ambient ambient
31. Isoveraldehyde 2.40 0.08 0.40 liquid MS drum 160 kg 3 ambient ambient
32. Liq. bromine 3.32 0.11 0.55 liquid Glass bottles 18 kg 31 ambient ambient
33. Methane sulfonyl chloride 0.20 0.01 0.03 liquid HDPE drum 25 kg 2 ambient ambient
34. Methanol* 174.32 5.81 29.05 liquid HDPE drum 210 litre 174 ambient ambient
35. Methyl maltol 12.50 0.42 2.08 solid HDPE drum 50 kg 42 ambient ambient
36. Methylene dichloride (MDC) 244.58 8.15 40.76 liquid HDPE drum 205 litre 150 ambient ambient
37. M-hydroxyacetophenone 2.33 0.08 0.39 solid HDPE drum 30 kg 13 ambient ambient
38. Morpholine 0.17 0.01 0.03 liquid HDPE drum 50 litre 1 ambient ambient
39. Sodium hydroxide (NaOH) 263.48 8.78 43.91 solid HDPE bags 50 kg 879 ambient ambient
40. NH3 liquor 22.63 0.75 3.77 liquid HDPE drum 200 litre 23 ambient ambient
41. N-methyl benzyl amine 1.72 0.06 0.29 liquid MS drum 30 kg 10 ambient ambient
42. N-vinyl pyrrolidone 1.44 0.05 0.24 liquid MS drum 210 kg 2 ambient ambient
43. Pantoprazole chloro compound 3.85 0.13 0.64 solid HDPE drum 25 kg 26 ambient ambient
44. P-formaldehyde 0.26 0.01 0.04 solid HDPE bag 25 kg 2 ambient ambient
45. POCl3 23.33 0.78 3.89 liquid HDPE drum 210 kg 19 ambient ambient
46. R-(+)-(α)-phenyl ethyl amine 1.64 0.05 0.27 liquid MS drum 210 kg 2 ambient ambient
47. Ranney nickel (10% charcoal) 0.17 0.01 0.03 solid HDPE drum 25 kg 2 ambient ambient
48. SOCl2 8.12 0.27 1.35 liquid HDPE drum 210 kg 7 ambient ambient
49. Sodium methoxide 7.50 0.25 1.25 solid HDPE drum 50 kg 25 ambient ambient
50. Sodium sulfate 2.08 0.07 0.35 solid HDPE bags 50 kg 7 ambient ambient
51. Sodium tungstate 0.62 0.02 0.10 solid HDPE bags 25 kg 4 ambient ambient
M/s. Rheomax Gums LLP
Annexure- 5 of Form-1 4
Sr. No.
Name of RAW MATERIAL Consumption Maximum Storage
for 5 days (MT)
Status Storage MOC Capacity (kg)
No of containers
/ bags
Temp.
(° C)
Pressure
MT/ Month
MT/ Day
52. Sodium chloride 1.60 0.05 0.27 solid HDPE bags 50 kg 6 ambient ambient
53. Tertiary butyl amine 0.39 0.01 0.07 liquid HDPE drum 30 kg 3 ambient ambient
54. Thio acetic acid 0.99 0.03 0.17 liquid HDPE drum 30 kg 6 ambient ambient
55. Thiophene-2-ethylamine 4.63 0.15 0.77 liquid HDPE drum 210 kg 4 ambient ambient
56. Tetra butyl ammonium bromide 0.01 0.0003 0.002 solid HDPE bag 25 kg 1 ambient ambient
57. Toluene* 160.09 5.34 26.68 liquid MS drum 205 litre 151 ambient ambient
58. Urea 1.72 0.06 0.29 solid HDPE bag 50 kg 6 ambient ambient
NOTE : * Fall under the list of Hazardous Chemicals as per Manufacturing, Storage and Import of Hazardous Chemicals (MSIHC) Rules, 2000.
M/s. Rheomax Gums LLP
Annexure- 6 of Form-1 1
ANNEXURE - 6
Details of Solid/Hazardous Waste and Mode of Disposal
Sr. no.
Type of waste Hazardous waste
category*
Quantity per
month
Mode of storage & disposal
1. ETP sludge 34.3 0.5 MT Will be collected, stored and disposed to an authorized TSDF site.
2. MEE residue --- 30 kg Will be collected, stored and sent to a Common Hazardous Incineration Facility (CHWIF).
3. Sludge from wet scrubber
36.1 20 kg Will be collected, stored and disposed to an authorized TSDF site.
4. Process waste/ residue
36.4 0.5 MT Will be collected, stored and sent to a Common Hazardous Incineration Facility (CHWIF).
5. Spent carbon/ spent catalyst
28.2 10 kg Will be sent back for regeneration/ reactivation.
6. Used oil 5.1 0.5 kl Will be collected, stored reused as low grade lubrication and left over quantity (if any) sold to an authorized dealer or re-processor.
7. Discarded drum/ containers/carboys Plastic bags/ liners
33.3 600 Nos. Will be collected, stored and sold to an authorized/ registered recyclers.
8. Fly ash # # 10 MT Will be collected stored and given to nearest brick/cement manufacturing unit.
NOTE: * Hazardous waste category as per the Hazardous Waste (Management, Handling &
Transboundary Movement) Rules, 2008.
# Fly ash EXCLUDED from the category of Hazardous Waste (Management, Handling & Transboundary Movement) Rules, 2008.
M/s. Rheomax Gums LLP
Annexure- 7 of Form-1 1
ANNEXURE - 7
Details of Water Consumption and Wastewater Generation
Source of Water : Water will be met through tankers (local supplier) / bore-well.
WATER CONSUMPTION:
Sr.No. Description Water Consumption (kl/day)
Bore-well / tankers water
ETP treated/ recycled water TOTAL
1. Domestic 3 - 3
2. Industrial
DM / RO feed water # 30 - 30 Process # 11 kl/day
Boiler - makeup # 5 kl/day Cooling – makeup # 10 kl/day
Washing/other use - 7 7 3. Gardening - 18 18
TOTAL (1+2+3) 33 25 58
# Borewell/tanker water (30 kl/day) will be feed in DM/RO plant. DM/ RO treated water (26 kl/day) will be used for industrial purposes and DM/ RO reject will be sent to MEE/ETP.
WASTEWATER GENERATION:
Sr.No. Description Wastewater Generation (kl/day)
1. Domestic 2 * 2. Industrial
DM/RO reject 4
Process 13 Boiler- blow down 1
Cooling- purge 2
Washing/other use 7
Sub-total (2) 25 ** 3. Gardening -
TOTAL (1+2+3) 27
Note: * Domestic wastewater (sewage) will be disposed off through septic tank/soak pit system.
** High TDS effluent will be evaporated in MEE and condensate will be treated in ETP alongwith other trade effluent. A part of treated effluent will be re-used for washing/other purposes & remnant will be used on land for gardening purposes with in premises.
M/s. Rheomax Gums LLP
Annexure- 7 of Form-1 2
2 20
TOTAL WATER BALANCE DIAGRAM
NOTE:
All figures are given in kl/day. (MEE : Multiple Effect Evaporator, ETP: Effluent Treatment Plant)
Domestic wastewater (sewage) will be disposed off through septic tank/soak pit system.
High TDS effluent will be evaporated in MEE and condensate will be treated in ETP alongwith other trade effluent. A part of treated effluent will be re-used for washing/other purposes & remnant will be used on land for gardening purposes with in premises.
Industrial 30
Total Water Consumption
33
Process 11
Washing/ others
7
ETP 25
From Bore-well /Tanker
Cooling make-up
10
Boiler make-up
5
Gardening *
Domestic 3
15 (condensate)
13 7 2 (purge)
1 (blow-down)
DM/RO plant 30
4 (Reject)
26
MEE 17
Septic tank / soak pit system
2
Residue 1
Loss 1
10
10 5 11
7
20
7
18
2
M/s. Rheomax Gums LLP
Annexure- 7 of Form-1 3
DETAILS OF WASTE WATER TREATMENT & DISPOSAL
Domestic Wastewater (Sewage)
Domestic wastewater will be treated disposed off through septic tank/soak pit system.
Industrial Wastewater (Trade Effluent) High TDS effluent will be evaporated in MEE and condensate will be treated in ETP
alongwith other trade effluent. (Please refer Annexure- 7.1 for effluent treatment details) A part of treated effluent (7 kl/day) will be re-used for washing/other purposes and remnant (18 kl/day) will used on land for gardening purposes with in premises.
Break up details for our total land area is as given below.
Sr.No. Description Area Details (m²)
1. Total built-up/ground coverage area (allocated for industrial uses) 4384.0
2. Road area 3260.3
3. Future expansion with parking 3480.4
4. Green belt area ( 35% of total land area ) 6074.3
TOTAL LAND AREA * 17199.0
* for more detail please refer Annexure- 2.1 Details of land area available for gardening/plantation are 6074.3 m².
Total treated effluent quantity 18,000 liters per day will be used for gardening/
plantation.
Thus, hydraulic load on our land area would be 2.96 liters/ m²/ day (18,000 liters per day/ 6074.3 m²).
M/s. Rheomax Gums LLP.
Annexure- 7.1 of Form-1 1
ANNEXURE – 7.1
Details of Effluent (Wastewater) Management System
Details of Effluent Treatment Plant (ETP)
(Schematic flow Diagram of Effluent Treatment Plant is attached under).
GL
1
EFFL
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PH : 079 - 27484871
FAX
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M/s. Rheomax Gums LLP
Annexure- 8 of Form-1 1
ANNEXURE – 8
Details of Electricity and Fuel
Details of Electricity/Power
Description Estimated Power Requirement Source
Electricity 125 kVA Gujarat Electricity Board
Details of Fuel
Description Type of Fuel Fuel Consumption Rate
Source
Boiler (2 ton/hour ) Coal 160 kg/hr
Indigenous / Imported
D.G. Set * (100 KVA) HSD 5 Lit/hr Local supplier
Note : * D.G. set will be used only in case of emergency/power failure.
M/s. Rheomax Gums LLP.
Annexure- 8.1 of Form-1 1
ANNEXURE – 8.1
Details of Stack/Vent, Flue Gas and Air Pollution Control Measures
Sr. no.
Stack/vent attached to
Type & quantity of fuel
Height of the stack/vent
(m)
Diameter of the stack/vent
(m)
Expected emission
Air pollution control
measures
1. Boiler (2 Ton/hour)
Coal (160 kg/hr)
20 0.45 PM < 150mg/m3
SO2 < 100 ppm
NOx < 50 ppm
Multicyclone / Bag filter
2. Distillation Unit
-- 15 0.15 VOC Water Scrubber
3. D.G. Set * (100 KVA)
HSD * (5 Lit/hr)
15 0.15 PM < 150 mg/m3
SO2 < 100 ppm
NOx < 50 ppm
Not Applicable *
Note : * HSD (High Speed Diesel) for D.G. set will be used as fuel. It would not be out of place to mention that these are comparatively clean fuel and D.G. set will be used only in case of emergency / power failure.