Standard Operating Procedure

ISSUE DATE: TITLE: OPERATION OF RAPID SOP No:

15.08.2019 MIXER GRANULATOR AP/WI/QA/H-805.00
EFFECTIVE DATE: DEPARTMENT: RESEARCH AND SUPERCEDE SOP No:
15.08.2019 DEVELOPMENT NEW
REVIEW DATE: SECTION: RESEARCH AND Page No: Page 1 of 5
15.08.2021 DEVELOPMENT

1. PURPOSE: To lay down the procedure for the operation of Rapid Mixer
Granulator.
2. SCOPE: This SOP is applicable for operation of RMG in R&D facilities of
Arrow Pharmaceuticals Pvt. Ltd.
3. RESPONSIBILITY: Operator is responsible to follow and maintain this SOP in guidance
of R&D officer.
4. ACCOUNTABILITY: Research and Development Head/officer
5. SCHEDULE: As and when applicable
6. RELATED Not applicable
DOCUMENTS:

7. PROCEDURE (k|s[ofx?):
7.1 Ensure that the area is cleaned and free from the previous product.
Pl/of ;ˆmf / klxn]sf] product gePsf] kSsf ug'{xf]; .
7.2 Make sure that “Product Identification Card” of the product for which the machine is to be
operated is affixed on the door of Granulation room.
h'g Product machine df rnfpg]] xf] To;sf] nflu “Product Identification Card” Granulation room
sf] 9f]sfdf /fVg'Åf]; .
7.3 Ensure that QA/QC representative has signed “Line Clearance” label as line clearance for the
machine.
d]l;gsf] Line Clearance sf] nflu ;DalGwt QA/QC k|ltlglwn] Line Clearance df x:tfIf/ u/]sf] r]s
ug'{ xf]; .
7.4 Ensure that all the interchangeable parts of the machine (Chopper, Impellar, RMG bowl,
Gasket) that are used PREPARED
for operating BY
the machine areCHECKED
tightened well.
BY APPROVED BY
k|lsofdf k|of]u x'g] d]l;gsf] ljlgd]o efux? sl:Psf] kSsf x'g'xf]; .
SIGNATURE
7.5 Ensure all the moving parts are moving freely and are not rubbing against each other.
SIGNATORIES Aarati Karki
d]l;gsf] ;a} ;g]{ efux? :jtGq?kdf Rumi Koju
rNg] / Pscsf{ ;Fu g3if{]g] x'g k5{ . Nishant Kumar Gupta
7.6 Turn “ON” the main switch
DESIGNATION and control panel of theR&D
QA Officer machine and compressedQA
Officer air supply.
Manager
d]g
DATE switch, Control panel / sDk|]; xfjf “ON” ug'{xf]; .
7.7 Press HOME, then SECURITY and enter LOGIN button.
HOME, SECURITY, LOGIN k|]; u/L enter ug'{xf]; .
7.8 Enter operator name and password and after that again press HOME.
ckf]/]6/sf] gfd / kf;jf8{ OG6/ ug{'xf]; clg ˆml/ HOME k]|; ug'{xf]; .
 Standard Operating Procedure
ISSUE DATE: TITLE: OPERATION OF RAPID SOP No:
15.08.2019 MIXER GRANULATOR AP/WI/QA/H-805.00
EFFECTIVE DATE: DEPARTMENT: RESEARCH AND SUPERCEDE SOP No:
15.08.2019 DEVELOPMENT NEW
REVIEW DATE: SECTION: RESEARCH AND Page No: Page 2 of 5
15.08.2021 DEVELOPMENT
PROCEDURE (k|s[ofx?)…

7.9 MANAUL MODE

7.9.1 Press the manual mode on the home screen if the system is running in auto mode.
7.9.2 olb system manually rnfpg' 5 eg] xf]d screen df /x]sf] manual mode k|]; ug'{xf]; .
7.9.3 Check all the operative functions like Purging on/off, Impeller on/off, Chopper on/off,
Discharge open/close.
7.9.4 ;a} ckf]/]l6e functions h:t} Purging on/off, Impeller on/off, Chopper on/off, Discharge
open/close sf] hfFr ug'{xf]; .
7.9.5 Set the required parameters or SET value (SV) of Impeller and Chopper.
7.9.6 Impeller / Chopper sf cfjZos Kof/fld6/x? jf or SET value (SV) ;]6 ug'{xf]; .
7.9.7 Transfer the material to be mixed in RMG bowl and tighten the lid of RMG.
7.9.8 kbfy{nfO{ ld;fpgsf] nflu RMG bowl df /fVg'xf]; / RMG sf] ln8nfO{ s:g'xf]; .
7.9.9 Enter Purging “ON”, Impeller, and operate the RMG as per the preset values of the
parameters.
7.9.10 Purging “ON” OG6/ ug'{xf]; / Kof/fld6/x?sf lk|;]6 Eofn' cg';f/ RMG cfkf]/]6 ug'{xf]; .
7.9.11 Enter Chopper “ON” if required while adding binder to the powders.
7.9.12 Kfp8/df afOGb/ xfNbf cfjZostf cg';f/ rf]k/ “ON” ug'{xf]; .
7.9.13 Turn “OFF” all the parameters after completion of granulation.
7.9.14 Granulation ;lsP kl5 ;a} Kof/fld6/x?nfO{ “OFF” ug'{xf]; .
7.9.15 Enter the Discharge Open and Impeller for discharging the granulated material in polybag
or FBD Trolly and closed the discharge by pressing the Discharge Close.
7.9.16 Discharge Open OG6/ ug'{xf]; / granulated kbfy{nfO{ kf]lnAofu jf FBD Trolly df
/fVg'xf]; / To;kl5 Discharge Close k]|; ug'{xf]; .

PREPARED BY CHECKED BY APPROVED BY

SIGNATURE
SIGNATORIES Aarati Karki Rumi Koju Nishant Kumar Gupta
DESIGNATION QA Officer R&D Officer QA Manager
DATE
 Standard Operating Procedure
ISSUE DATE: TITLE: OPERATION OF RAPID SOP No:
15.08.2019 MIXER GRANULATOR AP/WI/QA/H-805.00
EFFECTIVE DATE: DEPARTMENT: RESEARCH AND SUPERCEDE SOP No:
15.08.2019 DEVELOPMENT NEW
REVIEW DATE: SECTION: RESEARCH AND Page No: Page 3 of 5
15.08.2021 DEVELOPMENT

PROCEDURE (k|s[ofx?)…

7.10 AUTO MODE

7.10.1 Press the auto mode on the home screen if the system is running manually.
olb system nfO{ Auto mode df rnfpg' 5 eg] xf]d screen df /x]sf] auto mode k|]; ug'{xf]; .
7.10.2 Enter the batch detail if necessary (PRODUCT NAME , LOT NO., BATCH CODE)
cfjZos k/]df batch sf] ljj/0f (PRODUCT sf] gfd , LOT NO., BATCH CODE) OG6/
ug'{xf]; .
7.10.3 Press next button and enter required time and rpm value for Impeller motor and Chopper
from step 1 to step 5.
g]S:6 a6g k|]; u/] kl5 ODk]N/ df]6/ / rf]k/ sf] cfjZos ;do / Eofn' ;]6 ug'{xf]; .
7.10.4 After setting the required parameter push the purging “ON” button.
cfjZos Kof/fld6/ ;]6 ePkl5 k|lh{ª “ON” ug'{xf]; .
7.10.5 Transfer the material to be granulated in RMG and tighten the lid of RMG properly.
kbfy{nfO{ RMG df /flvP kl5 ln8nfO{ s:g'xf]; .
7.10.6 Press the start button to operate the machine automatically.
d]l;g cfˆm} rNgsf] nflu start a6Dd k]|; ug'{xf]; .
7.10.7 After granulation, press the Discharge Open and Impeller to collect granulated material in
polybag or FBD Trolly.
Granulation ;lsPkl5 l8:rfh{ “OPEN” ug'{xf]; / Granulated kbfy{nfO{ kf]lnAofu jf FBD
Trolly df hDdf kg{'xf]; .
7.10.8 After completion of work, fill all required data Annex: AP/WI/QA/RD-805-Annex 1
sfd ;lsPkl5 cfjZos ;a} 8f6f Annex: AP/WI/QA/RD-805-Annex 1 eg{'xf]; .
7.10.9 Clean the Machine as per SOP No. AP/WI/QA/RD-806 and maintain the record in
Annex: AP/WI/QA/RD-805-Annex 1
SOP No. AP/WI/QA/RD-806 df pNn]lvt cg';f/ d]l;g ;fˆmf ug{'xf]; / Annex:
AP/WI/QA/RD-805-Annex 1 df /]s8{ ldnfpg'xf]; .

PREPARED BY CHECKED BY APPROVED BY

SIGNATURE
SIGNATORIES Aarati Karki Rumi Koju Nishant Kumar Gupta
DESIGNATION QA Officer R&D Officer QA Manager
DATE
 Standard Operating Procedure
ISSUE DATE: TITLE: OPERATION OF RAPID SOP No:
15.08.2019 MIXER GRANULATOR AP/WI/QA/H-805.00
EFFECTIVE DATE: DEPARTMENT: RESEARCH AND SUPERCEDE SOP No:
15.08.2019 DEVELOPMENT NEW
REVIEW DATE: SECTION: RESEARCH AND Page No: Page 4 of 5
15.08.2021 DEVELOPMENT

CAUTION
 Wear all the protective clothing and gloves while performing the work.
sfd ubf{ ;'/lt sk8f / kGhf nufpg'xf]; .
 The operator must not rub his face or hair while wearing such covering.
ckf]/]t/n] ;'/l>t sk8f / kGhf nufpg] s|ddf cfˆgf] cg'xf/ jf skfn rnfpg' x'b}g .
 Machine may start with a jerk, no physical contact should be kept while starting machine nor
loose parts placed on it.
d]l;g ;'? x'g] s|ddf wSsf kg{] x'gfn] d]l;g cyjf d]l;gsf] s'g]} klg efusf] ;Dks{df gcfpg'' xf]; .

Annex: AP/WI/QA/RD-805-Annex 1

S.no Date Start Time Off Time Operated By Cleaned By Remarks

REVISION HISTORY
Rev. No. Effective Date Details of revision
00 15.08.2019 New

PREPARED BY CHECKED BY APPROVED BY

SIGNATURE
SIGNATORIES Aarati Karki Rumi Koju Nishant Kumar Gupta
DESIGNATION QA Officer R&D Officer QA Manager
DATE
 Standard Operating Procedure
ISSUE DATE: TITLE: OPERATION OF RAPID SOP No:
15.08.2019 MIXER GRANULATOR AP/WI/QA/H-805.00
EFFECTIVE DATE: DEPARTMENT: RESEARCH AND SUPERCEDE SOP No:
15.08.2019 DEVELOPMENT NEW
REVIEW DATE: SECTION: RESEARCH AND Page No: Page 5 of 5
15.08.2021 DEVELOPMENT

PREPARED BY CHECKED BY APPROVED BY

SIGNATURE
SIGNATORIES Aarati Karki Rumi Koju Nishant Kumar Gupta
DESIGNATION QA Officer R&D Officer QA Manager
DATE