Mfg. Unit Facility of G-Block: Water Content, PSD and

Reprocess (For
,PSD and in process water content failure in FFH6 stage)
Mfg. Location CTO Unit - I Batch Size & 100.00 Kg. of FFH6 Batch No
Facility & G-Block Process Order No
Document No. BPR-FFH6RP-002/03 and PF-FFH6RP-002/02 Effective Date 03.12.2020
OPERATION SHEET
Op. Equipment Time
Description Date Remarks
Performed by Checked by
No. Name & No. From To Sign & Date Sign & Date
Inertization: Close centrifuge vent and

admit nitrogen flow through rotameter
(NLT 5 NM3/h) for 15 mins and allow
N2 to flow through the vent of the ML
tub / receiver. At end of inertization,
Centrifuge
keep N2 flow of 3 NM3/h for
2800046t
blanketing, until next operation, to 2800048/
36
preserve inert atrnosphere. In case, 2800038/
blanketing is not kept on, re- 2800045/
inertization will be required, before 28000s0
taking-up centrifuge feeding. N2 flow
to be kept on, till end of relaxation
time. Inertizationto be done before
commencing each lot operation.
Reprocess ( For keto acid failure, RS by HPLC RS by GC BD, TD
,PSD and tn process water content fai ure tn FFH6 stage
)
Mfg. Location CTO Unit - I Batch Size & 100.00 Kg. of FFH6 Batch No.
Facility & G-Block Process Order No.
Document No BPR-FFH6RP-002/03 and PF-FFH6RP-002/02 Effective Date 03.12.2020
OPERATION SHEET
Op Equipment Time
No Name & No From To & Date Sign & Date
B) Check the cleanliness of the centrifuge Visual cleanliness: OK Atot OK
and accessories visually and also Check
the cleaning status validity in the Cleaning Validity: OK / Not OK
equipment log book.
Note: 1. If visualcleanliness OK and Bag Integrity: OK / Not OK
validify is within the stipulated time
proceed for further operations.
2. If visual cleanliness Not OK or if Cleaning Solvent: Potable water
Cleaning validity of the centrifuge is not Centrifuge
within the stipulated time clean the 2800046t
2800048/ Cleaning Qty.(L)
36 cenhifuge as per SOP and record the
cleaning details. 2800038/
3. Check the integrity of the centrifuge bag 280004st M.E.ID.No.:
visually, if integrity is OK, proceed for 28000s0
further operations.
4. Check the integrity of the centrifuge bag IH.B.No:
visually, if integrity is not Ok replace with
new bag after cleaning and check the OK / Not OIV
integrity visually. Cleanliness:
NA
5. Replace with new one if bag is not in
good condition. OK / Not
LF_
OPERATION SHEET
Op. Equipment Time
No. Name & No From To Sign & Date Sign& Date
i) Check the bag / bowlforforeign items
ie., scoop, mug, bolts / nuts, fibers from Unwanted
Yes / No
bag, etc Items present
ii) Check lid gasket condition lid gasket Good / damaged
iii) Hoses (Feed, N2, Solvent ) connections

Centrifuge Properly connected
and flange joints Yes / No
2800046t
iv) All C clamps / body bolts are available
36 and properlyfixed
2800048/ Lid Joint - Yes / No
2800038/ Proper?
v) Lock-nut on the cone isfixed properly
2800045t
28000s0 Lock Nutfixing Good/Not good
vi) Motor& belts guards are proper?

Guarding is prope.r Yes / No
vii) Interlocl{s Aid & zero speed ) check

Working Ok / Not ok
viii) Check CFfilter bag integrity; if not
found good, change filter bog Bag Integrity Good /ltlot good
Reprocess (For keto acid failure, RS by HPLC,RS by GC,BD,TD
Document No. BPR-FFH6RP-002/03 and PF-FFH 6RP -002t 02 Effective Date 03.12.2020
OPERATION SHEET
Op. Equipment Time
Description Date Performed by Checked by
No. Name & No. Remarks
From To Sign & Date Sign & Date

Centrifuge
keep N2 flow of 3 NM3/h for
2800046t
blanketing, until next operation, to 2800048t
36 Inertization: Yes/ No
preserve inert atmosphere. In case, 2800038/
blanketing is not kept on, re- 280004s/
time. Inertization to be done before
dvt
200017290
OPERATION SHBET
Op Equipment Time
No Name & No From To Sign & Date Sign & Date
C) Check the cleanliness of the centrifuge Visual cleanliness: OK Arlot OK
the cleaning status validity in the Cleaning Validity OK / Not OK
equipment log book.
Note: 1. If visualcleanliness OK and Bag Integrity OK / Not OK
validity is within the stipulated time
proceed for further operations. Cleaning Solvent: Potable water
2. If visual cleanliness Not OK or if
Cleaning Qty.(L):
36. centrifuge as per SOP and record the 2800048t
3. Check the integrity of the centrifuge bag 280004st M.E.ID.No.:
visually, if integrity is OK, proceed for 2800050
further operations. IH.B.No
4. Check the integrity of the centrifuge bag
new bag after cleaning and check the OK / Not OI?
Cleanliness
integrity visually. NA
good condition.
Bag Integrity:
OK/Not OIV
MP NA
'''''l
'J.: :t :i,i:iii.'lli' ' i"':,riir'.i..l:r :
ji.ir : :." 1...ll...

r'1 t rr"
. rr..: ,..
..1i,..
. i:ri
iir:...:.:r.:ti:: .'' ;,,'i'lti':'i
I r,.,-.,, ,ii,
:l.' :: :.:
"tr,.
&:FF.H6
Reprocess (For by HPLC,RS by GC,BD,TD
Document No BPR-FFH6RP-002/03 and PF-FFH6RP-002/02
Effective Date 03.12.2020
OPERATION SHEET
Op. Equipment
Description Time Performed by Che:ked by
No. Date Remarks
Name & No. From To Sign & Date Sign & Date
Cleaning solvent: Potable water
$\f4
*i Cleaning Qty.(L):
Nitrile gloves HDPE/GI
Containers M.E. ID No
A) Clean the HDPE/GI Containers with
20-30 L of Potable water. IH.B.No
HDPE/GI
37. Containers ID No
Cleaning Solvent: Methanol
Cleaning Qty.(L)
B) Clean the Earth rod and Earth rod Earth Rod &
holder with 5-10 L of Methanol Eanh Rod M.E.ID. No.:
Holder
IH.B. No. :
Earth rod ID No
htP
-P;EdNol'69'cif :-- '-'- "'
Reprocess (For keto acid failure, RS by HPLC,RS by GC,BD,TD AP Uode TD"---*"'--
,PSD and in process water content failure in FFH6 stage) 200017290
Mfg. Location Batch Size & 100.00 Kg. of FFH6 Batch No

CTO Unit - I
Op.
No. CENTRIFUGE OPERATIONS
Note:
A
qTJ
suit mask
sw ,.rr\ ".
Nomex Nitrile Gloves l{rist strap

I. Provide earth rod in the polyethylene bag & earth clip .
A' Feedine: Centrifuge the mass and spin the material in centrifuge till ML's expulsion stops. Note: Set the RPM of centrifuge at 300+50.
B. Cake Washins: Wash the material with 100 L of MethanolLot-2through receiver G/SSMT/17 at RpM 300+50.
38
C. Spin Dryine: Spin dry the material at RpM 600+50.
D. Relaxation: Switch off the centrifuge and keep the centrifuge for NLT 15 min. in relaxation.
E. Unloadins of wet cake: Unload the material into antistatic polythene bag lined HDpE containers.
Note: l.Write the product name, Batch number, Container No., Status and Sign & Date in the Label Tag. Keep NA for remaining columns.
2.Do not shake the poly bag while unloading.
t
Mfg. Location Batch Size & 100.00 Kg. of FFH6 Batch No.
CTO Unit - I
DocumentNo BPR-FFH6RP-002/03 and PF-FFH6RP-002/02 Effective Date 03.12.2020
CENTRIFUGE OPERATIONS (Lot-l )

Equipment A. Feeding B. Cake washing C. Spin drying
Date Duration Duration Duration by
Name & No Remarks
From To ign & Date
From To From To
Reactor Performed by
3000109 / Methanol Used Qty.
Sign & Date
300r992/ L.
3000136 D. Relaxation E. Unloading
G/SSMT/I7 Date Duration Duration M.E.ID No.:
To
(Centrifuge) From To From To
2800046t IH.B.No:
2804448/ No. of Containers
2800038/
280004st
2800050
Performed by
Sign & Date
Anti-static Polythene Bags: Used ety. KgA.{o's: IH.B.No:

MP..
&:FFH5
Reproce ss (For keto acid failure, RS by HPLC,RS by GC,BD,TD
Mfg. Location Batch Size & 100.00 Kg. of FFH6 Batch No

CTO Unit - I
CENTRIFUGB OPERATIONS (Lot-2)

Equipment A. Feeding B. Cake washing C. Spin drying
Date Duration Duration Duration by
Name & No Remarks
From To From
ign& Date
To From To
Reactor Performed by
3000109 / Sign & Date Methanol Used Qty.
300r992t
D. Relaxation E. Unloading
_L.
3000136
G/SSMT/I7 Date Duration Duration M.E.ID No.:
To From To From To
(Centrifuge)
2800046t IH.B.No:
2800048/ No. of Containers
2800038/
2804045t
2800050
Performed by
Sign & Date
Anti-static Polythene Bags: Used Qty. KgAllo's: IH.B.No

MP
3500
200017290
Batch Size & 100.00 Kg. of FFH6 Batch No.

Mfg. Location CTO Unit - I
CENTRIFUGE OPERATIONS (Lot3)

Equipment
A. Feeding B. Cake washing C. Spin drying Checked by
Date Duration Duration Duration Remarks Sign &
Name & No
From To From To From To Date
Reactor Performed by Methanol Used Qty.:

3000109 / Sign & Date
300r992t L.
G/SSMT/17 Duration Duration
M.E.ID No.:
Date
To
(Centrifuge) From To From To
2800046/
Total No. of Containers
IH.B.No:
2800048/
2800038/
2800045t
2800050
Performed by
Sign & Date
Anti-static Polythene Bags: Used Qty. KgA{o's IH.B.No

.fffte
Reproces s (For keto acid failure, RS by F{PLC,RS by GC,BD,TD
,PSD and in process water content failure in FFH6 qtage)
CTO Unit - I
OPERATION SHEET
Op Equipment Time
Description Date Performed by Che:ked by
No Name & No. Remarks
C Solvent Methanol
A) Clean the reactor with 30-50 L of Reactor
methanol and check cleanliness of the 3000109 /
300t992t M.E. ID No
reactor.
3000 i 36 IH.B.No.
39 Cleanliness: OK / Not OK
Solvent: Methanol
Earth Rod
B) Clean the Earth rod and Earth rod holder &
with 5-10 L of Methanol Earth Rod M.E.ID. No.:
Holder IH.B. No. :
Earth rod ID No
Solvent Methanol
Centrifuge Cleaning Qty.(L):
A) Cleanthe centrifuge with 30-50 L of 2800046t
2800048/ M.E. ID No.:
40 methanol and check cleanliness of the
2800038/
centrifuge. IH.B.No
280004st
28000s0
Cleanliness: OK / Not OK
MP
,PSD and in process water content failure in FFH6 stage) 2000t7290

OPERATION SIIEET
Op. Equipment Time
Cleaning Solvent Methanol
Centrifuge
2800046t Cleaning Qty.(L)
B) Clean the centrifuge with 30-100 L of
methanol and check cleanliness of the 2800048/
2800038/ M.E. ID No.:
centrifuge.
2800045t
IH.B.No.
28000s0
Centrifuge Cleaning Qty.(L):

C) Clean the centrifuge with 30-100 L of 2800046t
2800038/ M.E. ID No
centrifuge.
280004st
28000s0
IH.B.No
OK / Not OK
Product & Stage iAP ('nr
CTO Unit - I
OPERATION SHEET
Op. Equipment Time
Rp qc! s r
-?r p- - S. t q-r t up_ _Q !? e.s k s ;. Earthing bonding
i) Ensure earthing and bonding to the reactor OK/ Not OK
Check:
ii) Check Reactor is empty, foreign objects
no
Reactor Empty: Yes / No
iii) Valve positions are correct (Bottom valve
closed, Vent valve open, other valves Valve positions
- as
Yes / No
required. correct:
iv) Check availability of - Splash guards

(corrosive lines)/Belt guard for moving Reactor Guards available Yes / No
4i
machinery 3000109 /
v) PSV \afety Valve) / Rupture Discs - 300t992/ PSV/ Rupture Discs
available. 3000136 Yes / No
available :
N2 Rota meter /
vi) Ensure that N2 Rota meter / Pressure Pressure Gauge
Gauge available & calibrated. Yes / No
available &
calibrated:
vii) Ensure that scrubber system is in Scrubber system

working condition Yes / No
working:
w
:F'FH5.
2000t7290
Batch Size & 100.00 Kg. of FFH6 Batch No

Document No. BPR-FFH6RP-002/03 and PF-FFH6RP-002/02 Effective Date 03.12.2A20
OPERATION SHEET
Op Equipment Time Performed by Checked by
No Name & No. From To Sign & Date Sign & Date
i) r inertizatio n P r o ce dure :
R e acto
Apply vacuum to the reactor NLT 400

mmHg to 700 mm/Hg and Release the
vacuum with N2 then apply vacuum to
the reactor NLT 400 mmHg to 700
mm/Hg, release the vacuumwith N2.
Provide inertization to the reactor at
the time of solvent charging. Follow Reactor
inertizationfor before or after charging 3000109 /
41
solids also. 30019921
ii) If Reactor is not having vacuum 3000136
connection: Apply Nitrogen to the
reactor and build up to 0.8 to 1.0
Kg/Cm2 and open the reactor vent
valve till the pressure reaches to 0
kg/Cm2 and close the reactor vent
valve. Repeat the above operation 2 to
3 times respectively.
Reprocess (For keto acid fail ure, RS by HPLC,RS by GC,BD, TD
Document No BPR-FFH6RP-O02/03 and PF-FFH6RP-002/02 Effective Date 03.12.2020
OPERATION SHEET
Op. Equipment Time
No. Name & No From To Sign & Date Sign & Date
Visual cleanliness:
n w9
OK / Not OK
Cleaning Validity : OK / Not OK
Nomex Nitrile Flammable

Note: Ensure the continuity of bonding &
grounding.
Check the cleanliness of the Reactor and
accessories visually and also Check the
Cleaning Qry.(L)
Reactor
cleaning status validity in the equipment 3000109 /
log book.
300t992t
Note: 1. If visual cleanliness OK and M.E.ID. No
3000 1 36
IH.B. No:
Cleaning validity of the reactor is not
within the stipulated time clean the reactor
as per SOP and record the cleaning details.
OK/NotOK/
NA
MP
200017290
Mfg. Location CTO Unit - I Batch Size & i00.00 Kg. of FFH6 Batch No.
Document No. BPR-FFH6RP -0021 03 and PF-FFH6RP-002/02
OPERA TION SHEET
Op.
Description Equipment Time
No. Name & No Date Remarks Performed by Checked by
From To Sign & Date S & Date
Reactor
Charge 900 L ofMethanol Lot-3 into the Charged Qry.(L).
42 3000i09 /
reactor 300t992t M.E.ID. No.
3000 1 36 IH.B. No:
Charge crude material into the reactor
43 Note: Ensure the stirrer is in OFF
condition. No.of Containers:
Heat the mass to refl ux by applying hot
44.
water circulation. Attach electronic PR sheet
Maintain the mass under reflux for
45 45+15 6in.
Reactor Attach electronic PR sheet
3000109 /
3001992t
Cool the mass to 30r5"C by applying
46 3000136
RT water circulation. Attach electronic PR sheet
47
I
Reprocess ( For keto acid failure, RS by HPLC

,RS by GC ,BD, TD
,PSD and in process water content failure ln FF H 6 stage
)
Document No. BPR-FFH6RP-002/03 and pF-FFH6RP_002/02
Op.
o PERATION SHEET
Description Equipment Time
No. Name & No Date Remarks Performed by Chec<ed by
From To Sign & Date
i) Check the bag / bowtforforeign items ie., 'a Date
Unwanted
scoop, mug, bolts / nuts, fibersfrom bag, etc Yes / No
Items present
ii) Check lid gasket condition

lid gasket Good / damaged
andflange joints Properly connected Yes / No
Centrifuge
iv) AII C clamps / body bolts are available
and properlyfixed 28A0046t
Lid Joint - Proper? Yes / No
48 2800048/
2800038/
v) Lock-nut on the cone is fixed properly 280004s/ Lock Nutfixing Good/Not good
2800050
vi) Motor& belts guuds are proper?
Guarding is proper Yes / No
vii) Interlocks Aid A zero speed check

) Working Ok / Not ok
viii) Check CFfilter bag integrity;
f not
found good, changefilter bag Bag Integrity Good /Not good
35.0002864_&
200017290
Document No B PR-FFH6RP -002/ 03 and pF-FFH6RP-002/02
o PERATION SHEET
Op. Equipment
Description Time Performed by
No. Date Remarks Chec.ked by
Name & No From To Sign & Date Sign & Date

Centrifuge
keep N2 flow of 3 NM3lh for
2800046t
blanketing, until next operation, to
2800048t
blanketing is not kept on, re- 2800045t
inertization will be required, before 2800050
& F'FH5
Reprocess (F or keto acid failure, RS by HPLC, RS by GC,BD, TD
,P SD and tn process water content failure ln FFH6 stage 2000t7290
)
Document No BPR-FFH6RP-002/03 and PF-FFH 6Rp -002t 02 Effective Date 03.12.2020
OPERATION SHEET
Op Equipment Time
Performed by Chec.ked by
A) Check the cleanliness of the centrifuge
and accessories visually and also Check the
Visual cleanliness OK A{ot OK
cleaning status validity in the equipment
Cleaning Validity OK / Not OK
log book.
Note: 1. If visual cleanliness OK and
validity is within the stipulated time Bag Integrity OK / Not OK
Cleaning Solvent: Potable water
centrifuge as per SOP and record the Cleaning Qty.(L):
48 2800048t
cleaning details.
2800038i
2800045t M.E.lD.No.
visually, if integrity is OK, proceed for
further operations. 2800050
IH.B.No:
visually, if integrity is not Ok replace with OK / Not OFI/
Cleanliness
new bag after cleaning and check the NA
integrity visually.
good condition. Bag Integrity: OK / Not OK
,r'Fg0
Reprocess ( F or keto acid failure, RS by HPLC RS by GC B D TD
,PSD and ln proces S water content fai ure 1n FF H6 stage )
Document No. BPR-FFH6RP-002/03 and PF-FFH6RP-002/02 Effective Date 03.t2.2020
OPERATION SHEET
Op. Equipment Time
Performed bv Checked by
No. Name & No. From To S & Date Sign & Date
i) Check the bag / bowl for foreign items
ie., scoop, mug, bolts / nuts, fibersfrom Unwanted
Yes / No
ii) Check halar integrity (if halar lined)

Halar Lining Good / damaged
iii) Check lid gasket condition

Iid gasket Good / damaged
iv) Hoses (Feed, N2, Solvent Centrifuge

) connections
andflange joints 2800046t Properly connected Yes / No
48 2800048t
v)All C clamps / body bolts are available 2800038/
and properlyfixed 2800045t Lid Joint - Proper? Yes / No
28000s0
vi) Lock-nut on the cone isfixed properly
Lock Nutfixing Good/Not good
vii) Motor& belts guards are proper?
viii) Interlocl$ Qid & zero speed ) check Working Ok/ Not ok
ix) Check CFfilter bag integrity; if not
eee.d, .clst?s"grtUer bqe _ .. _ _
.3.1000286"4-&.-.". : .-..,. -Page --'J:"-:;: i-*
Reprocess (For keto acid failure, RS by HPLC,RS by GC,BD,TD N6l'8tc;f'l-ig
200017290

Document No BPR-FFH6RP-002/03 and PF-FFH6RP-002/02 Effective Date 03.r2.2020
OPERATION SHEET
Op. Equipment Time Performed by Checked by

Centrifuge
keep N2 flow of 3 NM3/h for 2800046t
blanketing is not kept on, re- 2800045t
I
i
i
;
& ppgo
Reprocess (For keto acid failure, RS by HPLC,RS by GC,BD, TD
,PSD and in process water content failure 1n FFH6 stage 200an290
Document No BPR-FFH6RP-002/03 and pF-FFH6RP-002/02
OPERATION SITEET
Op. Equipment
No. Date Remarks Checked by
B) Check the cleanliness of the centrifuge Visual cleanliness: OK Atrot OK
the cleaning status validity in the Cleaning Validity: OK / Not OK
equipment log book.
Note: 1.If visual cleanliness OK and Bag lntegrity: OK / Not OK
2. If visual cleanliness Not OK or if Cleaning Solvent: Potable water
centrifuge as per SOP and record the 2800048t Cleaning Qty.(L)
3. Check the integrity of the centrifuge bag 280004st M.E.ID.No.
visually, if integrity is OK, proceed for 2800050
further operations.
4. Check the integrity of the centrifuge bag IH,B.NO:
visually, if integrity is not Ok replacJ with
new bag after cleaning and check the
integrity visually. Cleanliness:
OK / Not OK/
NA
good condition.
MP OK / Not OIV
&
tage Reprocess (F or keto acid failure, RS by HPLC,RS by GC,BD,
TD
,P S D and n process water content fail ure 1n FFH6 stage 200017290
Document No BPR-FFH6RP-002/03 and pF-FFH6RP-002/02
OPERATION SHEET
Op. Equipment
No. Date Remarks Checked by
Name & No. From To Sign & Date Sign,& Date
i) Check the bag / bowlforforeign items
ie., scoop, mug, bolts / nuts, fibers from Unwanted
Yes / No
ii) Check lid gasket condition

lid gasket Good / damaged
andflange joints Properly connected Yes / No
Centrifuge
iv) All C clamps / body bolts are available 2800046t
and properlyfixed 2800048t
Lid Joint - Yes / No
48 Proper?
2800038/
v) Lock-nut on the cone isfixedproperly 280004s/ Lock Nutfixing Good/Not good
28000s0
vi) Motor& belts gumds are proper?
vii) Interlocks Aid & zero speed ) check

[4/orking Ok / Not ok
viii) Check CFfilter bag integrity; if not

found good, changefilter bag Bag lntegrity Good /Not good
INE FFI{6 350"002964-&,., :-,.
:.,.

200017290

OPERATION SITEET
Op Equipment Time Performed by Chec:ed by
No Name & No. From To Sign & Date Sign,l Date

Centrifuge
keep N2 flow of 3 NM3/h for 2800046t
48 Inertization: Yes/ No
preserve inert atmosphere. In case, 2800038i
blanketing is not kept on, re- 280004st
inertization will be required, before 2800050
w
,rpno
Reprocess (For keto acid fail ure, RS by HPLC,RS by GC,BD,TD
OPERATION SHEET
Op. Equipment Time
Performed by Chec.<ed by
No. Name & No From To Sign & Date Sign & Date
C) Check the cleanliness of the centrifuge Visual cleanliness OK A.{ot OK
the cleaning status validity in the Cleaning Validity OK / Not OK
equipment log book.
Note: 1. If visual cleanliness OK and Bag Integrity: OK / Not OK
Cleaning Solvent: Potable water
2800048t Cleaning QE.G):
centrifuge as per SOP and record the
3. Check the integrity of the centrifuge bag 280004st M.E.ID.No
visually, if integrity is OK, proceed for 28000s0
further operations.
IH.B.No
new bag after cleaning and check the
Cleanliness:
OK / Not OIV
integrity visually.
NA
good condition.
I
Product & Stage Reprocess (For keto acid failure, RS by HPLC,RS by GC,BD,TD SAP Code
,PSD and in process water content failure in FFH6 stage) 2000t7290
CTO Unit - I
OPERATION SHEET
Op. Equipment Time
Description Date Performed by Chec-ked by
From To Sign & Date S & Date
Ntu/'14
w Cleaning Qty.(L):
Nitrile FIDPE/GI M.E. ID No
Containers
A) Clean the HDPE/GI Containers with IH.B.No
20-40 L of Potable water.
HDPE/GI
49 Containers ID No.
fr wg
Nomex Nitrile Flammable
Earth rod and
Earth rod
Cleaning solvent:
Cleaning QIV.G)
M.E.ID. No.:
Methanol
B) Clean the Earth rod and Earth rod holder

IH.B. No.
holder with 5-10 L of Methanol
Earth rod ID No.
'r..ii-t. ''.'''''.l, , i,r".

n.t : +
i,, l,'.,:
,' ..*.'-i.t--.
i;,::':: ;' rt., , ', ti, i-riti1..i; :.:';lii::::
'
'::.':tL '::
",,;tn;t,'ttr'lrtr,ttt.,t,,,,'
''''.'''
..+. . i :jrrj
:FEXOFENADINE (FORM-X); &::FFH5

Product & Stage Reprocess (For keto acid failure, RS by HPLC,RS by GC,BD,TD age No 89of119

Op.
CENTRIFUGE OPERATIONS
No.
Note:fi g qli cv
Nomex suit mask gloves Wrist strap
l. Provide earth rod in the polyethylene bag & earth clip .
A. Feeding: Centrifuge the mass and spin the material in centrifuge till ML's expulsion stops. Note: Set the RPM of centrifuge at 300t50
B. Cake Washine: Wash the material with 100 L of Methanol Lot-4 through receiver G/SSMT/l7 at RPM 300t50.
50
C. Spin Dryine: Spin dry the material at 600*50 RPM.
D. Relaxation: Switch off the centrifuge and keep the centrifuge for NLT 15 min. in relaxation.
E. Unloadine: Unload the material into antistatic polythene bag lined HDPE containers.
Note: l.Write the product name, Batch number, Container No., Status and Sign & Date in the Label Tag. Keep NA for remaining columns
dft
(FORM-X)]&:FF
35"000236"4.&. :.:-..;-
Reprocess (For keto acid failure, RS by HPLC,RS by GC, BD,TD
Mfg. Location CTO Unit - I Batch Srze & 100.00 Kg. of FFH6 Batch No
CENTRIFUGE OPERATIONS (Lot-l )

Equipment A. Feeding B. Cake washing C. Spin drying Checked by
Date Duration Duration Duration
Name & No. Remarks Sign &
Reactor
3000109 i Performed by
Methanol Used Qty.:
300t992t Sign & Date
30001 36
D. Relaxation
_L.
E. Unloading
G/SSMT/17 M.E.ID No.:
Date Duration Duration
To
(Centrituge) From To From To
2800046t IH.B.No:
2800048t No. of Containers
2800038/
280004s/
28000s0 Performed by
Sign & Date
Anti-static Polythene Bags: Used Qty. KgAllo's: IH.B.No:

w
'i:,:....1.1:,:i!1
.. . rr,r::11..r..:i{
Product & Stage Reprocess (For keto acid failure, RS by HPLC,RS by GC,BD,TD
240017290

CENTRIFUGE OPERATIONS (Lot-2)
Equipment
Name & No.
Reactor
3000109 / Perfonned by Methanol Used Qty.:
300r9921 Sign & Date
3000 1 36
_L.
D. Relaxation E. Unloading
G/SSMT/17 Duration
M.E.ID No.:
Date Duration
To
2800046t IH.B.No:
28000481 No. of Containers
2800038/
280004st
2800050 Performed by
Sign & Date
Anti-static Polythene Bags: Used Qty. Kg/Trlo's IH.B.No:

&:FFH5
Reproces s (For keto acid failure, RS by HPLC,RS by GC,BD,TD iAP Cnde
2000t7290
Page No :92 of Il9

CENTRIFUGE OPERATIONS (Lot-3)
Equipment
Name & No.
Reactor
3000109 / Performed by Methanol Used Qty.:
30019921 Sign & Date
L.
G/SSMT/17 Duration M.E.ID No.
Date Duration
To
28000461 IH.B.No
TotalNo. of Containers
2800048/
2800038/
280004s1
2800050 Performed by
Sign & Date
Anti-static Polythene Bags: Used Qty. KgAtro's IH.B.No:

FEXO.F,ENAEINE.

OPERATION SHEET
Reactor
A) Clean the reactor with 30-50 L of Cleaning Qty.(L):
3000109 /
methanol and check cleanliness of the
reactor.
300t992t M.E. ID No.:
3000136
IH.B.No
5I
.s{nd'h
\ i) ./ solvent: Methanol
fi w
Earth rod
Nomex suit Nitrile gloves and Earth M.E.ID. No.:
B) Clean the Earth rod and Earth rod holder rod holder IH.B. No. :
with 5-i0 L of Methanol Earth rod ID No.
C Solvent Methanol
Centrifuge Cleaning QIV.G)
A) Clean the centrifuge with 30-100 L of 2800046t
M.E. ID No.:
2800048t
52 methanol and check cleanliness of the
2800038/
centrifuge. IH.B.No
2800045/
2800050
d$I
Reprocess (For keto acid failure, RS by HP LC,RS by GC,BD,TD
OPERATION SHEET
Op Equipment
Description Time Performed by Checked by
No Date Remarks
Centrifuge
B) Clean the centrifuge with 30-100 L of 2800046t Cleaning Qty.(L):
centrifuge 2800038/ M.E. ID No.
2800045/
2800050 IH.B.No
52 Cleaning Solvent Methanol
Centrifuge
Cleaning Qty.(L):
C) Clean the centrifuge with 30-100 L of 2800046/
2800038t M.E. ID No
centrifuge.
280004st
2800050
IH.B.No.
Reprocess (For keto acid failure, RS by HPLC,RS by GC,BD, TD
,P S D and 1n process water content failure ln FFH6 stage 2000r7290
Document No. BPR-FFH6RP-002/03 and pF-FFH6RP-002/02 Effective Date 03.12.2020
OPERATION SHEET
Op. Equipment
No. Date Remarks
Rp sp.t qr P.r
_ s_-_ S.t qr
tup Che c h ;. _
i) Ensure edrthing and bonding to the Earthing bonding

Check: OK/ Not OK
reactor.
ii) Check Reactor is empty, no foreign
objects. Reactor Empty. Yes / No
iii) Valve positions are correct (Bottom
valve closed, Vent valve open, other valves Valve positions
Yes / No
correct:
- as required.
Reactor
iv) Check availability of - Splash guards 3000109 /
(corrosive lines)/Belt guard for moving 3001992t
Guards available Yes / No
machinery 3000 1 36
v) PSV (safery Valve) / Rupture Discs - PSV/ Rupture Discs
available. Yes / No
available :
vi) Ensure that N2 Rota meter / pressttre

N2 Rota meter /
Pressure Gauge
Gauge available & calibrated. Yes / No
ovailable &
calibrated:
vii) Ensure that scrubber system is in
:FFH5
Product & Stage Reprocess (For keto acid failure, RS by HPLC,RS by GC,BD,TD P ('nr
35000286"4 &.::. ,
'
200017290

DocumentNo BPR-FFH6RP-002/03 and PF-FFH6RP-002/02 Effective Date 03.12.2020
OPERATION SHEET
i) Reactor inertizatio n Procedure :

Apply vacuum to the reactor NLT 400
mmHg to 700 mm/Hg and Release the
vacuumwith N2 then apply vacuum to
the reactor NLT 400 mmHg to 700
mm/Hg, release the vacuum with N2.
Provide inertization to the reactor at
the time of solvent charging. Follow Reactor
inertizationfor before or after 3000109 /
charging solids also. 300t992t
ii) If Reactor is not having vacuum 3000136
connection: Apply Nitrogen to the
reactor and build up to 0.8 to 1.0
Kg/Cm2 and open the reactor vent
valve till the pressure reaches to 0
kg/Cm2 and close the reactor vent
valve. Repeat the above operation 2 to
3 times respectively.
(FORM-a1:g: ?{ANN'RK4
Reprocess (For keto acid failure, RS by HPLC,RS by GC,BD,TD ageNo:9/otII9
2000t7290

OPERATION SHEET
Visual cleanliness OK / Not OK

+tqrri4l
\ t' /
Cleaning Validity
fi \1U : OK / Not OK
Nomex suit Nitrile. gloves

Cleaning
Note: Ensure the continuity of bonding & Methanol
Solvent:
grounding.
Check the cleanliness of the Reactor and
Reactor Cleaning Qty.(L)
log book. 3000109 /
Note: 1. If visual cleanliness OK and 30019921
validity is within the stipulated time 30001 36 M.E.ID. No
Cleaning validity of the reactor is not IH.B. No:
within the stipulated time clean the
reactor as per SOP and record the
cleaning details.
: j:t j. .iltrr r -.Lr-- rrrj
:'ii.'...... . : i1,:... :. ..:"'...,'
GORM-X) &:FFH6 :
?{AnotRK4
Product & Stage Reprocess (For keto acid failure, RS by HPLC,RS by GC,BD,TD Page No : 96 ot I 19
2000t7290

Document No. BPR-FFH6RP-002/03 and PF-FFH 6RP -0021 02 Effective Date 03.12.2020
OPERATION SHEET
Op. Equipment Time Performed by Checked bv
No. Name & No. From To Sign & Date S & Date
Reactor ).
Charge 1000 L of Toluene Lot-l into the 3000109 / M.E.ID. No.
54
reactor. 300t9921
IH.B. No
3000 I 36
Charge crude material into the reactor.
55 Note: Ensure the stirrer is in OFF No.of Containers:
condition.
Heat the reaction mass and distill off

Toluene under atmospheric pressure at
56 Attach electronic PR sheet
below 105"C and collect the distillate into
the receiver.
Reactor
3000109 /
Keep the reaction mass under reflux
3001992t
temperature and collect the water through
57 3000136 Attach electronic PR sheet
azeotrophically for 4 hrs 30 min * 30
min.
Cool the mass to 30+5oC by applying RT

water circulation.
fttP
350002864.*.:::.:.*
200017290

OPERATION SHEET
4I{ f DP re. -S.t-qrt up Ckp c.h ;

-
i) Discharge valve interlocks should be in Yes / No

working condition.
ii) CheckANF/ANFD "ON/OFF" panel

board earthing connection is available. Yes / No
iii) Ensure that ANF/ANFD have two ANFD

59 body earth connections. 1700873t Yes / No
1700929
iv) Ensure that earth connections are
Yes / No
fixed rigidly.
v) Ensure that ANF/ANFD baseframe

bolts are fixed properly and rigid. Yes / No
vi) Ensure that the Ml's tank earthing

is connected. Yes / No
rii
T1l
lo
&:FFH5
Product & Stage Reprocess (For keto acid failure, RS by HPLC,RS by GC,BD,TD {AP('nr

OPERATION SHEET
Op Equipment Time
vii) Ensure that ANF/ANFD provided
with fficient interlocking device,
which will ffictively prevent the Yes / No
access during motion. (Hydraulic
viii) Check hydraulic pump oil level &

connected SS pipe oil leakage. Yes / No
ix) Check the clogging gauge is in

ANFD Yes / No
working condition, if available.
1700873t
x) Ensure all nuts and bolts are fixed 1700929
firmly. (Check the tightness of all nut
and bolts) to the bottom dish wheels Yes / No
& connected pipe flanges.
xi) ANF/ANFD leak test to be done
with Nitrogen pressure I -2 Kg/cm2
and ensure pressure drop should not
be more than 20 mmHg in 30 + I5
..t .'..r... ..."..',:j', . rr ... ,. .'tt'{ ti:-.]j.i,. ,1.; . ,...
-X):&:FFH5 :.. 35.000286 4 -&....- j,:., ':. '.::'.::t:

Reprocess (For keto acid failure, RS by HPLC,RS by GC,BD,TD SAP Code
. -.. -.
- Page No : l0l ot 119
200017290
Mfg. Location
CTO Unit - I
OPERATION SHEET
Nomex
frwsuit Nitrile gloves
Visual cleanliness:
Cleaning Validity
OK / Not OK
OK / Not OK
Check the cleanliness of the ANFD and Integrity: OK / Not OK

log book. Cleaning Solvent: Potable water
Note: l. If visual cleanliness OK and
Cleaning QE.(L):
ANFD
2. If visual cleanliness Not OK or if 1700873t
Cleaning validity of the ANFD is not t700929 M.E.ID. No
within the stipulated time clean the ANFD
as per SOP and record the cleaning details. IH.B. No
Check the integrity of the bag by visually
If integrity is OK, proceed for fuither
OK AJot OK/
operations. Cleanliness
NA
Check the integrity of the bag by visually
If integrity is Not OK replace with new
Bug after cleaning and checking the
,:-7
&:FFH6
Reprocess (For keto acid failure, RS by HPLC,RS by GC,BD,TD SAP Code Page No : I02 of I 19
2000t7290

OPERATION SHEET
No Name & No. From To Sign & Date Sign & Date
{'itY Cleaning Qty.(L):
t# Ninile Gloves HDPE / GI M.E.ID. No.:
A. Clean the HDPE / GI Containers Containers IH.B. No. :
with 20-30 L of Potable water. HDPE / GI
Containers ID No
A Srf? Solvent: Methanol
tt/ t{rj
Nomex suit Nitrile gloves Scrappers M.E.ID. No.:

B. Cl"un the scrappers with 2-10 L of IH.B. No
Methanol. Scrappers ID No.
{19 Cleaning Solvent: Methanol

fi rdd
Earth Rod
Nomex suit Nitrile gloves &
C. Clean the Earth rod and Earth rod Earth Rod M.E.lD. No.:
holder with 5-10 L of Methanol before Holder IH.B. No. :
.. .i
t::
.&:FFH5
Product & Stage Reprocess (For keto acid failure, RS by HPLC,RS by GC,BD,TD iA P ('nr
Mfg. Location
CTO Unit - I
OPERATION SHEET
n
m\uU $qt9
Cleaning Qty.(L):
M.E.ID. No.
60 Nomex suit Nitrile gloves Spatula
IH.B. No. :
D. Clean the Spatula with 2-10 L of
Methanol before sampling. Spatula ID No.
FEXOFENADINE -X) &:FF]H6

61. Drying operations
fi s tdl *t'
Nomex suit mask Nitrile gloves Wrist strap. Note: Ensure the vacuum tnap emptiness before applying vacuum.
A. Transferrins: Filter the reaction mass through ANFD by applying Nitrogen pressure of 0.5 -2.0 Kglcm2 and collect the filtrate in the receiver.
Note: 1.If required apply vacuum (400*300 mmHg) to the receiver for better ML expulsion.
2. If required initially do filtration without pressure to allow cake formation.
B. Pressine & DrYins: Press dry the material by applying Nitrogen pressure of 0.5 -2.0 Kg/cm2 till no continuous flow of ML's is observed.
Note: If required apply vacuum (4001300 mmHg) to the receiver for better ML expulsion.
C. Charsins: Charge Toluene Lot-2 into the Reactor.
D. Rotation: Rotate the ANFD agitator in cutting mode.
E. Transferring: Transfer the Toluene Lot-2 from reactor into ANFD for cake washing.
F. Rotation: Rotate the ANFD agitator for 5 -i0 min.
G. Pressing & Drving: a) Press and dry the material by applying Nitrogen pressure of not more than 2.0Kg/cm} or not more than 1471 mmHg till no continuous flow
of ML's is observed and collect the filtrate in the receiver. Drain the vacuum pump trap after completion of operation, with proper earthing provision.
Note-1. If required apply vacuum (400+300 mmHg) to the receiver for better ML expulsion.
N than 0,5Kg/c.m?-or.
]NE
Reprocess (For keto acid failure, RS by HPLC,RS by GC,BD,TD N6l'iofot l19

H. Vacuum Dryins: Apply vacuum NLT 600 mmHg (S -141 mbar) to ANFD and rotate the agitator in cutting mode for 2 -3 hrs. Attach electronic PR sheet.
Note: Ensure that the rotation of ANFD agitator is in cutting mode before starting the operation.
I. Heatins: Apply heating with steam to ANFD and maintain the steam inlet temperature at 130t30oC under vacuum NLT 600 mmHg (8 -141
mbar).Attach electronic PR sheet. Note: 1. Maintain steam pressue above I Kg/cm2. Apply steam circulation to ANFD jacket. 2.lf any leakage /
maintenance work during the drying of the material, material has to be kept at below 90oC under nitrogen atmosphere or vacuum. 3. Preferable
temperature is i00oC - 120'C.
J. Drving: Dry the material for 13hrs+10 min. under vacuum NLT 600 mmHg (S -141 mbar) and steam inlet temperature at 130r30.C. Attach electronic
PR sheet.
Note: 1 . Maintain steam pressure above I Kglcmz - Apply steam circulation to ANFD jacket. 2. lf any leakage / maintenance work during the drying of the
material, material has to be kept at below 90oC under nitrogen atmosphere or vacuum. 3. Preferable temperature is 100.C - 120"C.
K. Coolins: Stop heating and apply cooling water circulation to ANFD jacket till cooling water outlet temperature is below 35oC under vacuum
NLT 600 mmHg. Attach electronic PR sheet. Note: During cooling operation ANFD vent valve should not be opened for releasing the pressure/vacuum.
It will lead to keto acid impurity formation.
" 1i'11
rr.:ili::r:r . '.:it:.:ii:j;i trrjl
*Pidffidi-A - 'EHX-QIFlJAP,N.e"--ttY"P&9"qro-o-NpF*€9BM:X)&-lItl-6-..,,,.,.- . 350002 S6.43' -,:.-;.--,.,.- :"
SfaC Reprocess (For keto acid failure, RS by HPLC,RS by GC,BD,TD
2000t7290

Document No BPR-FFH6RP-002/03 and PF-FFH6RP-002/02 Effective Date 03.t2.2020
L. Maintenance: Maintain cooling water outlet temperature at below 35 oC for 3-4 hours under vacuum NLT 600 mmHg, to get uniform cooling
temperature to material. Attach electronic PR sheet.
M. Vacuum release: Release vacuum with nitrogen. Attach temperature & vacuum data logger data to BPR.
Note: During cooling operation ANFD vent valve should not be opened for releasing the pressure/vacuum. It will lead to keto acid
impurity formation.
N. Sampling: Collect and Send the sample to QC for LOD & W.C as sample No. FFH5-04.(Record the rletails in section M)
O. Unloadins: Unload material from ANFD into antistatic polythene bag lined HDPE/GI Containers. Note: l.Write the product name, Batch number,
Container No., Status and Sign & Date in the Label Tag. Keep NA for remaining columns.
&
CTI
SAP Code
200017290

Document No BPR-FFH6RP-002/03 and PF-FFH 6RP -0021 02 Effective Date 03.12.2020
Equip. Name A.Transfening B. Pressing & C. Charging Duration Checked by

& No. Date Duration Drying Duration D. Rotation Duration Remarks
Sign & Date
From To From To From To From To
Performed by
Sign & Date Toluene Charged
E. Transferring Qty.(L)
F. Rotation Duration
G. a) Pressing & b) Pressing & Drying
Date Duration Drying Duration Duration
From To From To From To From To M.E.ID. No.:
Reactor Performed by IH.B. No. :

3000 1 36 Sign & Date
to H. Vacuum
ANFD I. Heating Duration J. Drying Duration K. Cooling Duration
Date Drying Duration
1700873t From To From To From To From To Antistatic Poly Bags
1700929
used in Kg /
Performed by No:
Sign & Date
L. Maintenance IH
M. Vacuum release
Date Duration N. Sampling Duration O. Unloading Duration B.No.
Duration
From To From To From To From To
,Pe{ormed by,, ,..

..j. .
lri
...r'ir!:r'rjr,'
,,i.i :t ::.--1,,
j:i. . lii t:'
'i,$ien & Date:t
dfl
-,-. iii , - ,t.::, ,-,:l
:itij. .:..:i+ ::: :.1...+: i
:i,i...n . . : : :i'ii.:.t'.{,'t'.
Product & Stage Reprocess (For keto RS bv by GC,BD, SAP Uode Page No : lOE of 119
200017290

LOD Results: Yowlw ( Limit: NMT 1.0 % dw)

w.C Results: % w/w ( Limit: NMT 0.5 % w/w)
o. :Current version of S-02-FFH5-04

(FORM-X)
Product & Stage Reprocess (For keto acid failure, RS by HPLC,RS by GC,BD,TD SAP Code

OPERATION SHEET
Op Equipment Time
.rl. fl9 Cleaning solvent: Methanol

\t \#
Cleaning Qty.(L)
Nomex suit Ninile gloves Spatula
M.E.ID. No
A.Clean the Spatula with 2-10 L of
Methanol after sampling. IH.B. No.
ID No.
Cleaning solvent: Methanol
fr '#
d{qrnb
Earth rod and Cleaning Qty.(L)

Nomex suit Ninile gloves Earth rod
holder M.E.ID. No
B. Clean the Earth rod and Earth rod holder
with 5-10 L of Methanol after unloading. IH.B. No.
Earth rod ID No
ft\?#
solvent Methanol
M.E.ID. No.:
Nomex suit Nitrile gloves
IH.B. No. :
C. Clean the Scrappers with 2-10 L of
methanol after ANFD unloading.
& FFH6
Reprocess ( F or keto acid failure, RS by HPLC,RS by GC, B D, TD
,P SD and ln process water content failure ln FF H6 stage )
Document No BPR-FFH6RP-002/03 and PF-FFH 6P(p -002/ 02 Effective Date 03.12.2020
OPERATION SHEET
Op. Equipment
No. Date Remarks
A w
Ss,1 iritltt
ut
Nomex suit Nitrile Cleaning Qty.(L):
gloves
Spatula
A) Clean the spatula with 2-i0 L of M.E.ID. No.:
Methanol. IH.B. No. :
63
g q'i :'nu
S ID No
Mask Ninile Gloves Wrist strap HDPE / GI

Container.
B) Collect the sample from the HDPE
/ GI Container.
Weigh the material container wise and HDPE/GI

64
record the details in the table below Containers
FFHS
Piodudf& Sftge - Reprocess (For keto acid failure, RS by HPLC,RS by GC,BD,TD

Document No BPR-FFH6RP-002/03 and PF-FFH6RP-002/02 Effective Date 03.r2.2020
Table-l: Weighing details Weighing balance ID.No

Cont. No. Gross Wt. (Kg) Tare Wt. (Kg) Net Wt.(Kg)
Sisn & Date Sign & Date
Total Qty. in Kg.

rir _iirr . ;::i.r::t: :l |,t .. . ..: ...i.,li.., ... .',.:i
"FtdAirct-&t - .35.0.00286"4-&.. :.- --.,- -;'!;: :':';-'---
Stu!ta.' Reprocess (For keto acid failure, RS by HPLC,RS by GC,BD,TD SAP Code lagaNA :'ITZ'dfnUr'rr"
2000t7290

Document No. BPR-FFH6RP-002/03 and PF-FFH 6RP -0021 02 Effective Date 03.12.2020
OPERATION SHEET
No Name & No. From To & Date Sign & Date
65 Label the containers with label tag
HDPE / GI
Send the uniform dry sample to QC for
Containers
66. Complete Analysis as Sample No.
FFH5-I-01.
.Slrr,?"
\0./ Cleaning Solvent Methanol
fr ',1U
Cleaning Qty.(L):
67
Nomex suit Nitrile Gloves
Spatula
Clean the spatula with 2-10 L of M.E.ID. No
Methanol. IH.B. No. :
Spatula ID No.
.srntlb
ft V/
Nomex suit Nitrile Gloves
ANFD M.E.ID. No.:
1700873t
Clean the ANFD with 30-50 L of IH.B. No.
1700929
Methanol and check cleanliness of
ANFD
:.ii
iri.
& :FFH5
Reprocess (For keto acid failure, RS by HPLC,RS by GC,BD,TD ,AP ('nr
200017290
Batch Size & i00.00 Kg. of FFH6 Batch No.

OPERATION SHEET
A s\,f? Cleaning Solvent: Methanol

\dr/
\d Reactor Cleaning Qty.(L):
69
Nomex suit Nitrile Gloves 3000109 /
M.E.ID. No.:
Clean the reactor with 30-50 L of 3001992t
methanol and check cleanliness of 3000136 IH.B. No.
Reactor.
Cleanliness OK / Not OK
70 Transfer the material to storage area.

HDPE/GI
Containers
.\.
,Png0
35"0"0
200017290

L. YIELD SUMMARY
Yield
Theoretical Expected Actual

Product Yield (Kg) Performed Checked
Analyical
(Stage) % %
by sign. & by sign.&
Output Mol. Wt. Report No.
date date
X Input (Qty.) Kg Kg Yield
Input Mol. Wt. 100
* yield
Fexofenadine
Hydrochloride
(Form-X) NA NA NA NA
(FFH6RP)
Record the Dried Material quantity as actual quantity of the yield.
tr''
t.
, t"t,o''i- i *rt;i+. tt t*"'
't' ,.t-. .,tt,,t'
i,:',,,.t, :.,,il t",.,,-r.tt,
.ri' , ,ttt,,..,.rttt. .,t.' ,, . ,,,, ,.,ti,a,u.,J
....:........:...:.:.:.:....:..............
t
&:FFH6 :


Document No BPR-FFH6RP-002/03 and PF-FFH6RP-002/02 Effective Date 03.t2.2020
M. IN PROCESS / VALIDATION SAMPLING DETAILS
Sample Sent by
Operation Test ( Sign & Date) Recorded by
S.No. Sample Name Sample No.(s) Test Results AR No.
No.(s) Requested ( Time- As ( Sign & Date)
applicable)
MP
r,::'..:iijj:.1...i, . . :jli:l.i,.ir.r: :tlirir'. .. :;i:l,.rr:j.rj,]::.
FEXOFENAE RM-X) &:FFH5 : :
75h0,{fiR64. Rl ;il]g-;'-:::'::"
Product & Stage Reprocess (For keto acid failure, RS by HPLC,RS by GC,BD,TD AP UodE PageNo:l16
200017290

Sample Sent by
S.No. Sample Name Sample No.(s) Test Results AR No. ( Sign & Date)
No.(s) Requested ( Time- As
applicable)
.r;ii'',iii ;.r ,:
,,.,:ilr-
:i.. j.:r:r
..ililr:.. :tr.
'::.r.....1.1i:iij:': . :::::i::ilr:1i' i:jr:. . .. ..: ir:l
&::FFH6 :
:..
-PasANol'l
Product & Stage Reprocess (For keto acid failure, RS by HPLC,RS by GC,BD,TD SAP Code f7-dil]9
200017290

Sample Sent by
S.No. Sample Name Sample No.(s) Test Results AR No.
No.(s) Requested ( Time- As ( Sign & Date)
applicable)
:. 'ritr. . .l+ri rr,rrr.i. i

j: r.j .Xt. ti
i.., iil. 1;rl . . lir".t.
rri..llr:l::lt:: lr".i;:ir::il
Product & Stage Reprocess (For keto acid failure, RS by HPLC,RS by GC,BD,TD
-SAPC6Ae"

N. List of attachments:
S. No. Name of document Number of copies (lncluding labels)
MP
&:
Reprocess (For keto acid failure, RS by HPLC,RS by GC,BD,TD Page No : 1i9 of 119
200017290

S. No. Name of document Number of copies (Including labels)

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Reprocess (For

,PSD and in process water content failure in FFH6 stage)

Inertization: Close centrifuge vent and

ii) Check lid gasket condition lid gasket Good / damaged

iii) Hoses (Feed, N2, Solvent ) connections

vi) Motor& belts guards are proper?

vii) Interlocl{s Aid & zero speed ) check

Inertization: Close centrifuge vent and

ji.ir : :." 1...ll...

Mfg. Location Batch Size & 100.00 Kg. of FFH6 Batch No

Nomex Nitrile Gloves l{rist strap

CENTRIFUGE OPERATIONS (Lot-l )

Anti-static Polythene Bags: Used ety. KgA.{o's: IH.B.No:

Mfg. Location Batch Size & 100.00 Kg. of FFH6 Batch No

CENTRIFUGB OPERATIONS (Lot-2)

Anti-static Polythene Bags: Used Qty. KgAllo's: IH.B.No

Batch Size & 100.00 Kg. of FFH6 Batch No.

CENTRIFUGE OPERATIONS (Lot3)

Reactor Performed by Methanol Used Qty.:

Anti-static Polythene Bags: Used Qty. KgA{o's IH.B.No

Mfg. Location CTO Unit - I

Cleaning Solvent Methanol

Centrifuge Cleaning Qty.(L):

iv) Check availability of - Splash guards

vii) Ensure that scrubber system is in Scrubber system

Batch Size & 100.00 Kg. of FFH6 Batch No

Document No. BPR-FFH6RP-002/03 and PF-FFH6RP-002/02 Effective Date 03.12.2A20

Apply vacuum to the reactor NLT 400

Cleaning Validity : OK / Not OK

Nomex Nitrile Flammable

Reprocess ( For keto acid failure, RS by HPLC

ii) Check lid gasket condition

vii) Interlocks Aid A zero speed check

Inertization: Close centrifuge vent and

ii) Check halar integrity (if halar lined)

iii) Check lid gasket condition

iv) Hoses (Feed, N2, Solvent Centrifuge

Batch Size & 100.00 Kg. of FFH6 Batch No

Document No BPR-FFH6RP-002/03 and PF-FFH6RP-002/02 Effective Date 03.r2.2020

Inertization: Close centrifuge vent and

ii) Check lid gasket condition

vii) Interlocks Aid & zero speed ) check

viii) Check CFfilter bag integrity; if not

Reprocess (For keto acid failure, RS by HPLC,RS by GC,BD,TD

Batch Size & 100.00 Kg. of FFH6 Batch No.

Inertization: Close centrifuge vent and

B) Clean the Earth rod and Earth rod holder

'r..ii-t. ''.'''''.l, , i,r".

:FEXOFENADINE (FORM-X); &::FFH5

Batch Size & 100.00 Kg. of FFH6 Batch No

Document No. BPR-FFH6RP-002/03 and PF-FFH6RP-002/02 Effective Date 03.12.2020

l. Provide earth rod in the polyethylene bag & earth clip .

CENTRIFUGE OPERATIONS (Lot-l )

Anti-static Polythene Bags: Used Qty. KgAllo's: IH.B.No:

Batch Size & 100.00 Kg. of FFH6 Batch No.

CENTRIFUGE OPERATIONS (Lot-2)

Anti-static Polythene Bags: Used Qty. Kg/Trlo's IH.B.No: