Dr.Reddys Laboratories Ltd.

T & P department Product : Fexofenadine HCl Stage : FFA2&3

vent
vent
Nitrogen Nitrogen

vent
Nitrogen

Vent Scrubber Vacuum Nitrogen

Process water FFA1
Sodium bicarbonate Potassium iodide Azacyclonol
CWR HWR

HCl
SS/150NB

Toluene

Nitrogen

Toluene

MeOH

Process water

Vent Scrubber Vacuum Nitrogen

NaOH Soln

Acetic acid

Vent Scrubber Vacuum Nitrogen

Nitrogen

Nitrogen

Sodium flakes Sodiumboro hydride Activated carbon

CWR

CWR
HWR

HWR

CHBR LPS

CHBR LPS

CHBR LPS

CWS
HWS

CWS HWS

CWS
HWS

CHBS

CHBS

CHBS

Vent
PG

PG

Nitrogen

Vacuum

Aq.layer to spent
Vent
Nitrogen Vacuum
PG

Toluene & water decant layer

FEXOFENADINE HYDROCHLORIDE (FORM-X) EQUIPMENT MAPPING DETAILS OF CTO-6 Batch input Batch output
Sno 1 2 3 4 5 6 7 8 9 10 11 13 14 15 Opearation
Coupling reaction Filtration

= =
Reactor SSR-1 PNF GLR-1

600.00 580

Kg Kg
Min Vol ratio 3 4030.8 6.718 6.698 1.948 1.948 9.331 9.366 10.366 4.4 4.4 5.9 6.467 6.467 6.4 4350

Water washing pH Adjustment Decantation Hydrolysis Reduction Charcol treatment

Filtration

SSR-1

Distillation Water addition pH Adjustment Isolation Filtration Leaching Filtration

SSR-2 ANFD/CNF SSR -2 ANFD/CNF

EQUIPMENT DETAILS FOR FFA2&3 Capacity Min Vol Max Vol (KL) 2830.80 6 1800.00 6.72 4030.80 5230.80 10 4018.80 5968.80 1168.80 3568.80 1168.80 5598.60 10 5598.60 5619.60 5619.60 5634.60 6219.60 2640.00 6219.60 2640.00 3540.00 6 3540.00 3880.20 3880.20 3880.20 3880.20 6 3840.00 4350.00 7.25

Batch input Batch output

= =

580.00 191.4

Kg Kg

Sno 1 2 3 4 5 6 7 8 9 10

Opearation 1stWater&methanol leaching Filtration 2ndToluene& Methanol Leaching Filtration 3rdToluene& Methanol Leaching Filtration 4thToluene& Methanol Leaching Filtration Azetropic separation Filtration&Drying

Reactor SSR CNF SSR ANFD SSR ANFD SSR ANFD SSR ANFD

EQUIPMENT DETAILS FOR FFA4&5 Capacity Min Vol Min Vol Max Vol (KL) ratio 6 2813.00 3816.40 4.85 6.58 3816.4 6 667.00 3509.00 1.15 6.05 3509 3 643.80 1914.00 1.11 0.55 319 3 291.74 1747.54 0.503 0.502172414 291.26 10 6090.00 8120.00 10.5 14 8120

OF CTO-6

Max Vol ratio 4.718 8.718 9.948 5.948 9.331 9.366 9.391 10.366 5.9 6.467 6.467 7.25

Min Occ% 30% 40% 40% 12% 12% 56% 56% 44% 44% 59% 65% 64%

Max Occ% 47% 52% 60% 36% 56% 56% 56% 104% 59% 65% 65% 73%

Time (hrs) 34 3 13.25

28.5 1 17 4 3 5

&5 Max Vol ratio 6.58 6.05 3.3 3.013 14 Min Occ% 47% 11% 11% 5% 61% Max Occ% 64% 58% 64% 58% 81% Time (hrs) Remarks 11 4.5 9.75 4 9.75 6 9.75 4 8.25 13.5

Planning to use ANF with condenser for all leaching operations

Product: Fexofenadine-HCl
Batch size S.No Stage Step
Coupling Reaction Salt Filtration Water Washing pH adjustment Toluene+ water washing Hydrolysis Reduction Charcol Filtration Distillation ph adjustment&Isolation Filtration Leaching Filtration 1stWater&methanol leaching Filtration 2ndToluene& Methanol Leaching Filtration 3rdToluene& Methanol Leaching Filtration 4thToluene& Methanol Leaching Filtration Azetropic separation Filtration&Drying

Min.Vol Yield Ratio

3.00 6.72 6.72 6.70 1.95 1.95 9.33 9.37 10.37 4.40 5.90 6.47 6.40 7.25 4.85 7 1 6.05

Min Vol(L)
1800 4031 4019 1169 1169 5599 5620 2640 3540 3840.00

Max.Vol Ratio
4.72 4031 8.72 9.95 5.95 9.33 9.4 9.4 6219.6 10.4 6.5 3880.2 7.3 4350.0

Max Vol(L)
2831 5231 5969 3569 5599 5620 5620 6220 3880 4350.0

No.of Batch

Total input

Total output

Equiv. Prod. Equipt

Reactor-1 PNF Reactor-2

Equipment planning No Of Equipments

2 1 1

Effec. Capacity(L)
6000

Critical RM

IP(Kg)

OP (Kg)

Tag no

MOC
SS SS GL

Agt.type
PBT

Utilities

Occupancy
47% 140-180 kg 52% 60% 36% 56% 56% 56% 104% 65% 73%

Cyc. time (Hrs)

34 3 13

Cy.T
17 3 13

10000

Prop.

FFA-2&3

FFA1

600

580.00

0.97

36.71

22024

21289

7026

Reactor-3 Sparkler Reactor-4 CNF/ANF Reactor-4 CNF/ANF Reactor-1 ANF Reactor-1 ANF Reactor-2 ANF Reactor-2 ANF Reactor-3 ANFD

2 1 2 1 2 1 2 1 1 1 2 1 1 1 1 1

One New

SS SS SS

10000

PBT

29 1

14 1 9 4 2 5 108 17 0 0 0 17 0 0 0 8.25 13.2 89.45

6000

PBT PBT

17 4 3 5 34

SS SS 6000 SS Total Cycle Time One New SS 6000 SS SS 6000 SS SS 3000 SS SS 3000 SS SS 10000 SS Total Cycle Time

2813.00 667 643.80 0.55 291.74 0.50 8120.00 14.00

6.6 3816 6 3509 3.30 319.0 3.0 291.3 10.5 8120.0

3816 3509 1914.00 1748 6090 36.71 21289 7026 7026

PBT PBT PBT PBT PBT

64% 58% 64% 58% 61%

FFA-4&5

FFA3

580.0

191.4

0.33

1.11 0.50 14.00

34

8.25 13.2

FFA2&3 FFA2 &3 quantity FFA4&5 Quantity FFA4&5 Quantity

21289 255 7026 84.3

Kg per month Tons/annum Kg per month Tons/annum

Batch charging frequency

No of Days

Time Occupancy
100.00% 17.65%

Remarks

75.00% 17 26

83.82%

50.00% 23.53% 8.82% 29.41%

17

26

S.No

Stage

Step
Salt Filtration Carbon filtration Crude filtration Slurry wash filtration 1st Crude filtration 2nd crude filtration 3rd crude filtration 4th crude filtration 5th crude filtration Drying

Batch size IP(Kg) OP (Kg)

Yield

FFA2&3

FFA4&5

Product: Fexofenadine-HCl
Density Max Vol(L) No.of Batch Total input Total output Equiv. Prod.

Equipme Equipt
PNF/ANF Sparkler ANF CNF

ofenadine-HCl
Equipment planning Tag no No Of Equipments Occupancy

MOC

Capacity(L)

Cyc. time (Hrs)

Effec. Cy.T

Batch charging frequency

No of Days

Time Occupancy

Remarks