MBG-1,2,3,4 All PFD
MBG-1,2,3,4 All PFD
MBG-1,2,3,4 All PFD
PHARMACEUTICALSERVICES
SERVICES
ISMS Class:Internal
ISMS Class: Restricted
PROCESS FLOW DIAGRAM CMBG-1
ISMS Version:1.0
CMPG-4 CMBG-1
Time
Min. Max.
Vol. Vol.
Cycle
Hr.
40.0 Acetonitrile Charge Acetonitrile into the reactor 160 200 0.3
at 27.5 ± 2.5°C.
Slowly add 4-
Methoxybenzaldehyde dimethyl
acetal into the reactor at 65 ± 5°C
over a period of 30 minutes with
32.0 4-Methoxybenzaldehyde simultaneous distillation of by 200 232 1.0
dimethylacetal product Methanol along with
acetonitrile U/vacuum of 400-450
mmHg.
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CUSTOM PHARMACEUTICAL
PHARMACEUTICALSERVICES
SERVICES
ISMS Class:Internal
ISMS Class: Restricted
PROCESS FLOW DIAGRAM CMBG-1
ISMS Version:1.0
Aq MLs
Wash the material with DM water
80.0 DM water Lot-2 80.0 1.0
Lot-2.
120.0 n-Hexane Lot-3 Slurry wash the material with n- 120 120 1.0
Hexane Lot-3.
Hex MLs
Filter the reaction mass through 120.0 1.0
Centrifuge.
Hex MLs
Spin dry the wet materila till no 80.00 1.0
ML comes out of the centrifuse
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CUSTOM PHARMACEUTICAL
PHARMACEUTICALSERVICES
SERVICES
ISMS Class:Internal
ISMS Class: Restricted
PROCESS FLOW DIAGRAM CMBG-1
ISMS Version:1.0
Agitator Time
Tag Capacity Max
Sr.No Equipment Detail MOC Type / Min vol Cycle Remarks
No. L/Size/Kg vol
RPM hr
Reaction, Work
1 GLR GLR 1000 SS 316 PBT 120 632 24.3
up and distillation
2 Centrifuse SS 100 L SS 316 … … … 12.0 Product Filtration
3 TD SS SS 317 … … … 32.0 Product drying
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CUSTOM PHARMACEUTICAL
PHARMACEUTICALSERVICES
SERVICES
ISMS Class:Internal
ISMS Class: Restricted
PROCESS FLOW DIAGRAM CMBG-2
ISMS Version:1.0
CMBG-1 CMBG-2
Time
Min. Max.
Vol. Vol. Cycle
Hr.
486.1 Toluene Lot-1 Charge Toluene Lot-1 into the reactor 486 493 1.0
followed by NaOH flakes at 27.5 ±
22.6 Sodium hydroxide flakes 2.5°C under N2 atmosphere
48.6 CMBG1 Charge CMBG1 into the reactor at 2.5 493 507 0.25
± 2.5°C for 15-20 minutes under N2
atmosphere.
*** Hyflow Hyflow Filtration of reaction mass through *** 636 636 3.0
*** Toluene Lot-2 bed nutch filter
F-PE-004/00-03.07.2009 Page 4 of 15
CUSTOM PHARMACEUTICAL
PHARMACEUTICALSERVICES
SERVICES
ISMS Class:Internal
ISMS Class: Restricted
PROCESS FLOW DIAGRAM CMBG-2
ISMS Version:1.0
MLs
Collect the MLs from nutch filter 583.3 0.5
243.06 Toluene Lot-3 Wash the bed with Toluene Lot-3 1.0
MLs
Suck dry the material till no more 243.06 1.0
filtrate observed.
826.4
Charge the total filtrate into the
826 826 0.5
reactor
388.90 DM water Lot-2 Wash the organic layer with DM 826 1215 0.5
water lot-2
388.90 DM water Lot-3 Wash the organic layer with sodium 826 1252 0.5
121.53 Sodium chloride chloride solution
972.24 Hexane Lot-1 Charge Hexane Lot-1 into the reactor 83 1055 2.0
under stirring.
F-PE-004/00-03.07.2009 Page 5 of 15
CUSTOM PHARMACEUTICAL
PHARMACEUTICALSERVICES
SERVICES
ISMS Class:Internal
ISMS Class: Restricted
PROCESS FLOW DIAGRAM CMBG-2
ISMS Version:1.0
Time
Tag Capacity Agitator Max
Sr.No Equipment Detail MOC Min vol Cycle Remarks
No. L/Size/Kg Type / RPM vol
hr
Reaction, Work
1 SSR … 2 Kl SS 316 PBT 83 1252 51.3
up and distillation
2 Nutch Filter … 200 Lt SS 317 … … … … Salt filtration
F-PE-004/00-03.07.2009 Page 6 of 15
CUSTOM PHARMACEUTICAL
PHARMACEUTICALSERVICES
SERVICES
ISMS Class:Internal
ISMS Class: Restricted
PROCESS FLOW DIAGRAM CMBG-3
ISMS Version:1.0
CMBG-2 CMBG-3
102.5 Trifluoro acetic acid Slowly add Trifluoro acetic acid drop 101 203 4.00
wise into the reactor at -5 ± 5°C under
Nitrogen atmosphere.
Note :Addition of Trifluoro acetic
acid is exothermic.
10.2 Trifluoro acetic anhydride Slowly add Trifluoro acetic anhydride 203 214 2.0
drop wise into the reactor at -5 ± 5°C
under Nitrogen atmosphere.
Note :Addition of Trifluoro acetic
anhydride is exothermic.
50.4 CMBG2 Charge CMBG2 into the reactor 403 419 0.5
under Nitrogen atmosphere at 30 ±
5°C.
If complies
If TLC does not comply, maintain the 632 632 2.0
reaction mass at 27.5 ± 2.5°C till
TLC complies.Note : 1.Send sample
to QC for TLC as CMBG3-01 for
every 2 hours maintenance.
F-PE-004/00-03.07.2009 Page 8 of 15
CUSTOM PHARMACEUTICAL
PHARMACEUTICALSERVICES
SERVICES
ISMS Class:Internal
ISMS Class: Restricted
PROCESS FLOW DIAGRAM CMBG-3
ISMS Version:1.0
504.2 Toluene Lot-2 Charge aqueous layer back into the 2706 3211 0.5
reactor.
504.23 DM water Lot-2 Wash the organic layer with sodium 1024 1555 0.5
90.76 Sodium bicarbonate Lot-2 bicarbonate solution
Distill off the solvent at below 50° C 921.23097 102 1024 10.0
under vacuum up to 2.0 volumes of
the input remains in reactor.
403.39 Heptane Lot-1 Slowly charge the Heptane Lot-1 into 102 506 2.0
the reactor at 45 ± 5°C.
Note:.During the addition solid
formation is observed.
F-PE-004/00-03.07.2009 Page 9 of 15
CUSTOM PHARMACEUTICAL
PHARMACEUTICALSERVICES
SERVICES
ISMS Class:Internal
ISMS Class: Restricted
PROCESS FLOW DIAGRAM CMBG-3
ISMS Version:1.0
F-PE-004/00-03.07.2009 Page 10 of 15
CUSTOM PHARMACEUTICAL
PHARMACEUTICALSERVICES
SERVICES
ISMS Class:Internal
ISMS Class: Restricted
PROCESS FLOW DIAGRAM CMBG-3
ISMS Version:1.0
Time
Tag Capacity Agitator Max
Sr.No Equipment Detail MOC Min vol Cycle Remarks
No. L/Size/Kg Type / RPM vol
hr
Reaction, Work
1 GLR … 3 KL SS 316 PBT 101 3226 64.5
up and distillation
Solution
2 GLR … 500 Lt SS 317 … … … …
Preparation
3 Centrifuse … 36" SS 316 … … … 6.0 Product Filtration
4 TD … 48 Trays SS 317 … … … 12.0 Product drying
F-PE-004/00-03.07.2009 Page 11 of 15
CUSTOM PHARMACEUTICAL
PHARMACEUTICALSERVICES
SERVICES
ISMS Class:Internal
ISMS Class: Restricted
PROCESS FLOW DIAGRAM CMBG-4
ISMS Version:1.0
CMBG-3 CMBG-4
Time
Min. Max.
Vol. Vol.
Cycle
Hr
Send sample to QC for water content of Raw
material (DMF-NMT:0.5%, CMBG3-NMT-0.5%,
Imidazole-NMT:0.5%) as sample No.CMBG4-
01A.
0.5
Cool the reaction mass to 22.5 ± 2.5°C.
If complies
ISMS Class:Internal
ISMS Class: Restricted
PROCESS FLOW DIAGRAM CMBG-4
ISMS Version:1.0
Cool the reaction mass to 30 ± 5°C.
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CUSTOM PHARMACEUTICAL
PHARMACEUTICALSERVICES
SERVICES
ISMS Class:Internal
ISMS Class: Restricted
PROCESS FLOW DIAGRAM CMBG-4
ISMS Version:1.0
409.9 Toluene Lot-1 Charge Toluene Lot-1 and DM water 82 902 1.0
409.9 DM water Lot-1 lot-1 into the reactor at 30 ± 5°C.
409.9 Toluene Lot-2 Charge aqueous layer back into the 492 902 0.5
reactor.
327.93 Heptane Lot-1 Distill off the solvent at below 50° C 82 410 2.0
under vacuum up to ~2.0 volumes of
the input remains in reactor.
F-PE-004/00-03.07.2009 Page 14 of 15
CUSTOM PHARMACEUTICAL
PHARMACEUTICALSERVICES
SERVICES
ISMS Class:Internal
ISMS Class: Restricted
PROCESS FLOW DIAGRAM CMBG-4
ISMS Version:1.0
Time
Tag Capacity Agitator Max
Sr.No Equipment Detail MOC Min vol Cycle Remarks
No. L/Size/Kg Type / RPM vol
hr
Reaction, Work
1 … SS 316 PBT 82 902 47.0
up and distillation
Glass lined reactor 1 KL
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