STANDARD OPERATING PROCEDURE

Operating Procedure of Centrifuge

Topic SOP No. IMF062
( Non Lifting Type and Lifting Type)
Revision
Department Manufacturing 02
Number
Area All Manufacturing Blocks Review Date

Effective Date

Name Title Date

Prepared By

Reviewed By

Approved By

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 STANDARD OPERATING PROCEDURE
Operating Procedure of Centrifuge
Topic SOP No. IMF062
( Non Lifting Type and Lifting Type)
Revision
Department Manufacturing 02
Number
Area All Manufacturing Blocks Review Date

REVISION SUMMARY

Revision
Effective Date Reason for Revision
Number
First issue.
(SOP No: PR023 is changed as SOP number IMF062 to make the
00 10/03/2016
Harmonized as per CQA SOP No: ZQA001).

1. Format Number modified as per revised CQA SOP No.:

ZQA001 & ZQA002.

2. Editorial correction is made in procedure.

3. Operating procedure elaborated for Centrifuge (Non Lifting

Type and Lifting Type). and Topic of the SOP changed inline
01 20/06/2018 with procedure from Operating Procedure of Centrifuge to
Operating Procedure of Centrifuge ( Non Lifting Type and
Lifting Type)

4. Procedure elaborated for Level-1, Level-2, Level-3 and

Level-4 based on CAPA (Ref: CAPA-U09-001748)
recommendation.

Operating procedure elaborated for Thick/ Gummy material

02
centrifugation.

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 STANDARD OPERATING PROCEDURE
Operating Procedure of Centrifuge
Topic SOP No. IMF062
( Non Lifting Type and Lifting Type)
Revision
Department Manufacturing 02
Number
Area All Manufacturing Blocks Review Date

1.0 PURPOSE

To lay down the procedure for operation of Centrifuge (Non Lifting Type and Lifting Type).

2.0 SCOPE

This procedure is applicable for operation of Centrifuge (Non Lifting and Lifting Type) using
in all Manufacturing Blocks at Aurobindo Pharma Limited Unit - IX.

3.0 RESPONSIBILITY

Assistant / Executive - Manufacturing

4.0 ACCOUNTABILITY

HOD / Deputy - Manufacturing

5.0 PROCEDURE

5.1 OPERATION OF CENTRIFUGE (Non Lifting Type):

5.1.1 Procedure for Centrifuges with VFD:

5.1.1.1 Check visually and ensure that the Equipment is cleaned and ready for
operational use.

5.1.1.2 Update the Equipment status board as “UNDER OPERATION” in the

current version format “Equipment Status”.

5.1.1.3 Enter the equipment operation starting time in the equipment usage log
book in the current version format “Equipment Usage Log”.

5.1.1.4 Wear personnel protective equipments as required.

5.1.1.5 Open the top lid of the Centrifuge.

5.1.1.6 Ensure the required Centrifuge bag is fix in the Centrifuge basket
firmly.

5.1.1.7 Close the top lid of the Centrifuge with clamps.

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 STANDARD OPERATING PROCEDURE
Operating Procedure of Centrifuge
Topic SOP No. IMF062
( Non Lifting Type and Lifting Type)
Revision
Department Manufacturing 02
Number
Area All Manufacturing Blocks Review Date
5.1.1.8 Open the Nitrogen valve and switch ‘ON’ to start the centrifuge and run
for ~ 5 minutes under nitrogen atmosphere by keeping centrifuge
spinning at Level-1.

5.1.1.9 Check the abnormalities, if any observed rectify with the help of
Engineering department.

5.1.1.10 Close the nitrogen valve and Switch ‘OFF’ to stop the Centrifuge and
ensure it is stopped.

5.1.1.11 Open the lid of the Centrifuge and ensure that the Centrifuge bag is
firmly fixed.

5.1.1.12 Ensure the catch pot / MLs tank should be empty.

5.1.1.13 Close the top lid of the Centrifuge with clamps.

5.1.1.14 Open the Nitrogen valve and switch ‘ON’ to start the centrifuge.

5.1.1.15 Feed the material into the Centrifuge from reactor by controlling the
feeding valve by keeping centrifuge spinning at Level-1.

5.1.1.16 Check visually, clarity of mother liquor. It should be clear.

5.1.1.17 Mother liquor is not clear, stop the feeding of centrifuge.

5.1.1.18 Switch ‘OFF’ to stop the centrifuge. Check the Centrifuge bag for
proper fitting or any damage. If it is damaged replace with the new bag
and enter in the equipment usage log book.

5.1.1.19 Feed the mass till the cake of required thickness forms under nitrogen
atmosphere.

5.1.1.20 Close the bottom valve of the reactor.

5.1.1.21 Spin dry the material till the mother liquor is expelled out completely
by keeping centrifuge spinning at Level-2.

5.1.1.22 Give the washings to the material as per BPCR from reactor as required
by keeping centrifuge spinning at Level-1.

5.1.1.23 Spin dry the material till the mother liquor is expelled out completely as
per BPCR by keeping centrifuge spinning at Level-3 for three speed
centrifuges and Level-4 for four speed centrifuges.
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 STANDARD OPERATING PROCEDURE
Operating Procedure of Centrifuge
Topic SOP No. IMF062
( Non Lifting Type and Lifting Type)
Revision
Department Manufacturing 02
Number
Area All Manufacturing Blocks Review Date
5.1.1.24 Switch ‘OFF’ to stop the Centrifuge and ensure centrifuge is stopped as
required.

5.1.1.25 Collect the mother liquor completely from catch pot / MLs tank to
container/ Reactor/ Receiver etc.

5.1.1.26 Open the clamps and top lid of the centrifuge.

5.1.1.27 Unload the material into clean pre-weighed HDPE container having
two LDPE bags by using of cleaned and dry SS scoop under nitrogen
atmosphere as required.

5.1.1.28 After performing batch to batch cleaning, close the lid of the
Centrifuge.

5.1.1.29 Send the SS Scoop to washing area, then clean and dry the SS Scoop
and keep them at designated place with identification label as cleaned
as per respective SOP No.IMF046-F01.

5.1.1.30 Update the equipment status board as “TO BE CLEANED” in the

current version format “Equipment Status”.

5.1.1.31 Enter the equipment operation completion time in the equipment usage
logbook in the current version format “Equipment Usage Log”.

5.1.2 Procedure for Centrifuges without VFD:

5.1.2.1 Check visually and ensure that the Equipment is cleaned and ready for
operational use.

5.1.2.2 Update the Equipment status board as “UNDER OPERATION” in the

current version format “Equipment Status”.

5.1.2.3 Enter the equipment operation starting time in the equipment usage log
book in the current version format “Equipment Usage Log”.

5.1.2.4 Wear personnel protective equipments as required.

5.1.2.5 Open the top lid of the Centrifuge.

5.1.2.6 Ensure the required Centrifuge bag is fix in the Centrifuge basket
firmly.

5.1.2.7 Close the top lid of the Centrifuge with clamps.

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 STANDARD OPERATING PROCEDURE
Operating Procedure of Centrifuge
Topic SOP No. IMF062
( Non Lifting Type and Lifting Type)
Revision
Department Manufacturing 02
Number
Area All Manufacturing Blocks Review Date
5.1.2.8 Open the Nitrogen valve and switch ‘ON’ to start the centrifuge and run
for ~ 5 minutes under nitrogen atmosphere.

5.1.2.9 Check the abnormalities, if any observed rectify with the help of
Engineering department.

5.1.2.10 Close the nitrogen valve and Switch ‘OFF’ to stop the Centrifuge and
ensure it is stopped.

5.1.2.11 Open the lid of the Centrifuge and ensure that the Centrifuge bag is
firmly fixed.

5.1.2.12 Ensure the catch pot / MLs tank should be empty.

5.1.2.13 Close the top lid of the Centrifuge with clamps.

5.1.2.14 Open the Nitrogen valve and switch ‘ON’ to start the centrifuge.

5.1.2.15 Feed the material into the Centrifuge from reactor by controlling the
feeding valve.

Note: Feed the material into centrifuge by controlling speed by switch

‘OFF’, then switch ‘ON’ the centrifuge to prevent vibration/over flow
of mass till completion of the feeding operation.

5.1.2.16 Check visually, clarity of mother liquor. It should be clear.

5.1.2.17 Mother liquor is not clear, stop the feeding of centrifuge.

5.1.2.18 Switch ‘OFF’ to stop the centrifuge. Check the Centrifuge bag for
proper fitting or any damage. If it is damaged replace with the new bag
and enter in the equipment usage log book.

5.1.2.19 Feed the mass till the cake of required thickness forms under nitrogen
atmosphere.

5.1.2.20 Close the bottom valve of the reactor.

5.1.2.21 Spin dry the material till the mother liquor is expelled out completely.

5.1.2.22 Give the washings to the material as per BPCR from reactor as
required.

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 STANDARD OPERATING PROCEDURE
Operating Procedure of Centrifuge
Topic SOP No. IMF062
( Non Lifting Type and Lifting Type)
Revision
Department Manufacturing 02
Number
Area All Manufacturing Blocks Review Date
Note: Wash the wet material into centrifuge by controlling speed by
switch ‘OFF’, then switch ‘ON’ the centrifuge to prevent
vibration/over flow of mass till completion of the washing operation.

5.1.2.23 Spin dry the material till the mother liquor is expelled out completely as
per BPCR.

5.1.2.24 Switch ‘OFF’ to stop the Centrifuge and ensure centrifuge is stopped as
required.

5.1.2.25 Collect the mother liquor completely from catch pot / MLs tank to
container/ Reactor/ Receiver etc.

5.1.2.26 Open the clamps and top lid of the centrifuge.

5.1.2.27 Unload the material into clean pre-weighed HDPE container having
two LDPE bags by using of cleaned and dry SS scoop under nitrogen
atmosphere as required.

5.1.2.28 After performing batch to batch cleaning, close the lid of the
Centrifuge.

5.1.2.29 Send the SS Scoop to washing area, then clean and dry the SS Scoop
and keep them at designated place with identification label as cleaned
as per respective SOP No.IMF046-F01.

5.1.2.30 Update the equipment status board as “TO BE CLEANED” in the

current version format “Equipment Status”.

5.1.2.31 Enter the equipment operation completion time in the equipment usage
logbook in the current version format “Equipment Usage Log”.

5.1.3 Procedure for Thick/ Gummy material Centrifugation:

5.1.3.1 Check visually and ensure that the Equipment is cleaned and ready for
operational use.

5.1.3.2 Update the Equipment status board as “UNDER OPERATION” in the

current version format “Equipment Status”.

5.1.3.3 Enter the equipment operation starting time in the equipment usage log
book in the current version format “Equipment Usage Log”.

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 STANDARD OPERATING PROCEDURE
Operating Procedure of Centrifuge
Topic SOP No. IMF062
( Non Lifting Type and Lifting Type)
Revision
Department Manufacturing 02
Number
Area All Manufacturing Blocks Review Date
5.1.3.4 Wear personnel protective equipment’s as required.

5.1.3.5 Open the top lid of the Centrifuge.

5.1.3.6 Ensure the required Centrifuge bag is fix in the Centrifuge basket
firmly.

5.1.3.7 Close the top lid of the Centrifuge with clamps.

5.1.3.8 Open the Nitrogen valve and switch ‘ON’ to start the centrifuge and run
for ~ 5 minutes under nitrogen atmosphere.

5.1.3.9 Check the abnormalities, if any observed rectify with the help of
Engineering department.

5.1.3.10 Close the nitrogen valve and Switch ‘OFF’ to stop the Centrifuge and
ensure it is stopped.

5.1.3.11 Open the lid of the Centrifuge and ensure that the Centrifuge bag is
firmly fixed.

5.1.3.12 Ensure the catch pot / MLs tank should be empty.

5.1.3.13 Feed the material into the Centrifuge from reactor by SS Bin/
Container.

5.1.3.14 Close the lid of the Centrifuge.

5.1.3.15 Open the Nitrogen valve and switch ‘ON’ to start the centrifuge.

5.1.3.16 Check visually, clarity of mother liquor. It should be clear.

5.1.3.17 If Mother liquor is not clear, stop the centrifuge.

5.1.3.18 Check the Centrifuge bag for proper fitting or any damage. If it is
damaged replace with the new bag and enter in the equipment usage log
book.

5.1.3.19 Ensure that there is no further MLs expelled out.

5.1.3.20 Stop the centrifuge.

5.1.3.21 Repeat the step no 5.1.3.13 to 5.1.3.20 till complete of the material.

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 STANDARD OPERATING PROCEDURE
Operating Procedure of Centrifuge
Topic SOP No. IMF062
( Non Lifting Type and Lifting Type)
Revision
Department Manufacturing 02
Number
Area All Manufacturing Blocks Review Date
5.1.3.22 Spin dry the material as per mention in the BPCR.

5.1.3.23 Give the washings to the material as per BPCR.

5.1.3.24 Spin dry the material as per mention in the BPCR.

5.1.3.25 Switch ‘OFF’ to stop the Centrifuge and ensure centrifuge is stopped as
required.

5.1.3.26 Collect the mother liquor completely from catch pot / MLs tank to
container/ Reactor/ Receiver etc.

5.1.3.27 Open the clamps and top lid of the centrifuge.

5.1.3.28 Unload the material into clean pre-weighed HDPE container having
double LDPE bags by using of cleaned and dry SS scoop under
nitrogen atmosphere as required.

5.1.3.29 After performing batch to batch cleaning, close the lid of the
Centrifuge.

5.1.3.30 Send the SS Scoop to washing area, then clean and dry the SS Scoop
and keep them at designated place with identification label as cleaned
as per respective SOP No.IMF046-F01.

5.1.3.31 Update the equipment status board as “TO BE CLEANED” in the

current version format “Equipment Status”.

5.1.3.32 Enter the equipment operation completion time in the equipment usage
logbook in the current version format “Equipment Usage Log”.

5.2 OPERATION OF CENTRIFUGE (Lifting Type):

5.2.1 Check visually and ensure that the Equipment is cleaned and ready for operational
use.

5.2.2 Update the Equipment status board as “UNDER OPERATION” in the current
version format “Equipment Status”.

5.2.3 Enter the equipment operation starting time in the equipment usage log book in
the current version format “Equipment Usage Log”.

5.2.4 Wear personnel protective equipments as required.

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 STANDARD OPERATING PROCEDURE
Operating Procedure of Centrifuge
Topic SOP No. IMF062
( Non Lifting Type and Lifting Type)
Revision
Department Manufacturing 02
Number
Area All Manufacturing Blocks Review Date
5.2.5 Ensure the centrifuge top lid close with clamps.

5.2.6 Ensure the required Centrifuge bag is fix in the Centrifuge basket firmly.

5.2.7 Close the top lid by hydraulic system and tighten the nuts/clamps firmly.

5.2.8 Switch ‘ON’ to start the centrifuge by nitrogen system and run for ~ 5 minutes by
keeping centrifuge spinning at Level-1.

5.2.9 Check the abnormalities, if any observed rectify with the help of Engineering
department.

5.2.10 Switch ‘OFF’ to stop the Centrifuge and ensure it is stopped.

5.2.11 Loosen the nuts/clamps and open the top lid of the Centrifuge and ensure that the
Centrifuge bag is firmly fixed.

5.2.12 Ensure the catch pot / MLs tank should be empty.

5.2.13 Close the centrifuge top lid by hydraulic system and tighten the nuts/clamps
firmly.

5.2.14 Switch ‘ON’ to start the centrifuge by nitrogen system.

5.2.15 Feed the material into the Centrifuge from reactor by controlling the feeding
valve by keeping centrifuge spinning at Level-1.

5.2.16 Check visually, clarity of mother liquor. It should be clear.

5.2.17 Mother liquor is not clear, stop the feeding of centrifuge.

5.2.18 Switch ‘OFF’ to stop the centrifuge. Check the Centrifuge bag for proper fitting or
any damage. If it is damaged replace with the new bag and enter in the equipment
usage log book.

5.2.19 Feed the mass till the cake of required thickness forms by nitrogen pressure by
keeping centrifuge spinning at Level-1.

5.2.20 Close the bottom valve of the reactor.

5.2.21 Spin dry the material till the mother liquor is expelled out completely by keeping
centrifuge spinning at Level-2.

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 STANDARD OPERATING PROCEDURE
Operating Procedure of Centrifuge
Topic SOP No. IMF062
( Non Lifting Type and Lifting Type)
Revision
Department Manufacturing 02
Number
Area All Manufacturing Blocks Review Date
5.2.22 Give the washings to the material as per BPCR from reactor as required by
keeping centrifuge spinning at Level-1.

5.2.23 Spin dry the material till the mother liquor is expelled out completely as per
BPCR by keeping centrifuge spinning at Level-3 for three speed centrifuges and
Level-4 for four speed centrifuges.

5.2.24 Switch ‘OFF’ to stop the Centrifuge and ensure centrifuge is stopped.

5.2.25 Collect the mother liquor completely from catch pot / MLs tank to container/
Reactor/ Receiver etc.

5.2.26 Loosen the nuts/clamps and open the top lid of the Centrifuge by hydraulic
system.

5.2.27 Loosen the nuts/clamps and remove the Lifting centrifuge bag from the basket
and move it to beside the Centrifuge area by hydraulic system

5.2.28 Unload the material into clean pre-weighed HDPE container having two LDPE
bags by using of cleaned and dry SS scoop.

5.2.29 After performing of the batch to batch cleaning, fix the Lifting centrifuge bag by
hydraulic system and tighten the nuts/clamps firmly.

5.2.30 Close the Centrifuge top lid by hydraulic system and tighten the nuts/clamps
firmly

5.2.31 If using the SS Scoop, send it to washing area, then clean and dry the SS Scoop
and keep them at designated place with identification label as cleaned as per
respective SOP No.IMF046-F01.

5.2.32 Update the equipment status board as “TO BE CLEANED” in the current version
format “Equipment Status”.

5.2.33 Enter the equipment operation completion time in the equipment usage logbook in
the current version format “Equipment Usage Log”.

5.3 Procedure for Thick/ Gummy material Centrifugation (Lifting Type):

5.3.1 Check visually and ensure that the Equipment is cleaned and ready for operational
use.

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 STANDARD OPERATING PROCEDURE
Operating Procedure of Centrifuge
Topic SOP No. IMF062
( Non Lifting Type and Lifting Type)
Revision
Department Manufacturing 02
Number
Area All Manufacturing Blocks Review Date
5.3.2 Update the Equipment status board as “UNDER OPERATION” in the current
version format “Equipment Status”.

5.3.3 Enter the equipment operation starting time in the equipment usage log book in
the current version format “Equipment Usage Log”.

5.3.4 Wear personnel protective equipments as required.

5.3.5 Ensure the centrifuge top lid close with clamps.

5.3.6 Ensure the required Centrifuge bag is fix in the Centrifuge basket firmly.

5.3.7 Close the top lid by hydraulic system and tighten the nuts/clamps firmly.

5.3.8 Switch ‘ON’ to start the centrifuge by nitrogen system and run for ~ 5 minutes by
keeping centrifuge spinning at Level-1.

5.3.9 Check the abnormalities, if any observed rectify with the help of Engineering
department.

5.3.10 Switch ‘OFF’ to stop the Centrifuge and ensure it is stopped.

5.3.11 Loosen the nuts/clamps and open the top lid of the Centrifuge and ensure that the
Centrifuge bag is firmly fixed.

5.3.12 Ensure the catch pot / MLs tank should be empty.

5.3.13 Open the centrifuge top lid by hydraulic system.

5.3.14 Feed the material into the Centrifuge from reactor by SS Bin/ Container.

5.3.15 Check visually, clarity of mother liquor. It should be clear.

5.3.16 Mother liquor is not clear, stop the feeding of centrifuge.

5.3.17 Switch ‘OFF’ to stop the centrifuge. Check the Centrifuge bag for proper fitting or
any damage. If it is damaged replace with the new bag and enter in the equipment
usage log book.

5.3.18 Ensure that there is no further MLs expelled out.

5.3.19 Stop the centrifuge.

5.3.20 Repeat the step no 5.3.13 to 5.3.19 till complete of the material.
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 STANDARD OPERATING PROCEDURE
Operating Procedure of Centrifuge
Topic SOP No. IMF062
( Non Lifting Type and Lifting Type)
Revision
Department Manufacturing 02
Number
Area All Manufacturing Blocks Review Date
5.3.21 Spin dry the material as per mention in the BPCR by keeping centrifuge spinning
at Level-2.

5.3.22 Give the washings to the material as per BPCR from reactor as required by
keeping centrifuge spinning at Level-1.

5.3.23 Spin dry the material as per mention in the BPCR as per BPCR by keeping
centrifuge spinning at Level-3 for three speed centrifuges and Level-4 for four
speed centrifuges.

5.3.24 Switch ‘OFF’ to stop the Centrifuge and ensure centrifuge is stopped.

5.3.25 Collect the mother liquor completely from catch pot / MLs tank to container/
Reactor/ Receiver etc.

5.3.26 Loosen the nuts/clamps and open the top lid of the Centrifuge by hydraulic
system.

5.3.27 Loosen the nuts/clamps and remove the Lifting centrifuge bag from the basket
and move it to beside the Centrifuge area by hydraulic system

5.3.28 Unload the material into clean pre-weighed HDPE container having two LDPE
bags by using of cleaned and dry SS scoop.

5.3.29 After performing of the batch to batch cleaning, fix the Lifting centrifuge bag by
hydraulic system and tighten the nuts/clamps firmly.

5.3.30 Close the Centrifuge top lid by hydraulic system and tighten the nuts/clamps
firmly

5.3.31 If using the SS Scoop, send it to washing area, then clean and dry the SS Scoop
and keep them at designated place with identification label as cleaned as per
respective SOP No.IMF046-F01.

5.3.32 Update the equipment status board as “TO BE CLEANED” in the current version
format “Equipment Status”.

5.3.33 Enter the equipment operation completion time in the equipment usage logbook in
the current version format “Equipment Usage Log”.

6.0 `LIST OF DOCUMENTS/ RECORDS

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 STANDARD OPERATING PROCEDURE
Operating Procedure of Centrifuge
Topic SOP No. IMF062
( Non Lifting Type and Lifting Type)
Revision
Department Manufacturing 02
Number
Area All Manufacturing Blocks Review Date
Not Applicable

7.0 REFERENCES

ICH Q7

8.0 CROSS REFERENCES

ZQA001 - SOP on SOP/Guideline.

ZQA002 - Format Preparation and Numbering System.

IMF044 - Cleaning and Maintenance of Production Equipment’s.

IQA006 - Equipment design and usage policy.

IMF046 - Usage and cleaning of Utensils.

IMF003 - Cleaning Procedure of Centrifuge.

9.0 ABBREVIATIONS
Abbreviation: Full Form:
SOP Standard Operating Procedure
CQA Corporate Quality Assurance
MF Manufacturing
ICH International Council for Harmonization
QA Quality Assurance
BPCR Batch Production and Control Record
LDPE Low Density Poly Ethylene
HDPE High Density Poly Ethylene

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 STANDARD OPERATING PROCEDURE
Operating Procedure of Centrifuge
Topic SOP No. IMF062
( Non Lifting Type and Lifting Type)
Revision
Department Manufacturing 02
Number
Area All Manufacturing Blocks Review Date

Abbreviation: Full Form:

SS Stainless Steel
ML Mother Liquor
ICH Q7 Good Manufacturing Practice
HOD Head of the Department
No. Number

END OF DOCUMENT

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