SOLITAIRE PHARMACIA PVT. LTD.

RESTRICTED CIRCULATION
AUTHORISED PERSONS ONLY
STANDARD OPERATING PROCEDURE

Title: Operation & Cleaning procedure for Multi Mill SOP. No. : SPL/ SOP/PR/034
Page No. : 1 of 4
Supersedes : New
Revision No. : 00
Prepared By Checked By Reviewed By Approved By Effective Date Review Date
Concerned Dept Concerned Dept QA QA-Head

1. Objective
To define the procedure for operation and cleaning procedure for multi milll.

2. Scope
This procedure is applicable to all Production sections of Solitaire Pharmacia Pvt. Ltd., Baddi.

3. Responsibility
Production : Executive/Officer/Chemist

4. Accountability
Head- Production

5. Procedure

5.1. Instrument Detail:

Name MULTI MILLL
Make TECHX
Capacity

Instrument ID. Location

PG/MML/001 Granulation

5.2 Procedure For Integrity:

5.2.1 Check the cleanliness of the multi mill remove the “CLEANED EQUIPMENT” status label
and Affix “EQUIPMENT IN USE” label.
5.2.2 Take line clearance from the IPQA officer.
5.2.3 Switch “OFF” the main before setting and dismantling of the sifter cum multimill .
5.2.4 Open the locking clamps, lift upwards the mill chute by handle provided and fix the sifter screen,
multimill blades and multimill screen.
5.2.5. Match the slot of both the screen and ensure that the blades do not touch the perforated screen
by rotating the blades manually.
5.2.6. Fix the mill chute by rotating downwards and lock it by side clamps.
5.2.7. Bring the sifter cum multimill underneath tipper cone valve.
5.2.8. Bring down cone and position over the charging port of the sifter cum multimill.
5.2.9. Keep the conta bin at the discharge port of sifter cum multimill.
5.2.10. Switch “ON” the mains and release emergency push button.

Format No.SPL/QA/001
 SOLITAIRE PHARMACIA PVT. LTD.
RESTRICTED CIRCULATION
AUTHORISED PERSONS ONLY
STANDARD OPERATING PROCEDURE

Title: Operation & Cleaning procedure for Multi Mill SOP. No. : SPL/ SOP/PR/034
Page No. : 2 of 4
Supersedes : New
Revision No. : 00
Prepared By Checked By Reviewed By Approved By Effective Date Review Date
Concerned Dept Concerned Dept QA QA-Head
5.2.11. Seal the gaskets of the machine by pulling up pneumatic lever provided on the main stem.
5.2.12. Start the sifter by pressing green button on left side of operating panel and start right side of
operating panel.
5.2.13. Open the valve of tipper cone to charge the material,if required mill can be operated in high
speed by pressing black button on the control panel.
5.2.14. After process is over, stop the sifter followed by mill and deflate gasket by pneumatic lever.
5.2.15. Final mill material collected in to bin kept below the discharge and take it for further process.
5.2.16. Lift the bowl up take out the machine and keep it to its place.
5.2.17. Affix "TO BE CLEANED" status label to the sifter cum multimill after completing the operation.
5.2.18. Record the details of milling in the batch manufacturing record and respective equipment log as
per QAP :BD :014: F1.

5.3. Cleaning of Multi milll:

5.3.1. Type A Cleaning (Product to Product)
5.3.1.1. Ensure all the materials is discharged from the multi mill bowl before cleaning.
5.3.1.2. Ensure the multi mill bowl of milled granules is removed from the area
5.3.1.3. Ensure the discharge valve is opened.
5.3.1.4. Wash the multi mill with 250ltr potable water to remove the adhered material.
5.3.1.5. Close the discharge valve from the MMI screen.
5.3.1.6. Close the lid of the multi mill and fix the three clamps
5.3.1.7. Add approximately 250 liters potable water in the mixer through the charging chute and run the
mixer from 10 min on fast speed.
5.3.1.8. Put on the chopper at slow speed during running the mixer.
5.3.1.9. After 10 minutes open the discharge valve to drain the water from the multi mill.
5.3.1.10. Disconnect the cone mill from the multi mill.
5.3.1.11. Ensure the impeller blade at the rest position is not below the chopper blades.
5.3.1.12. Lift the main impeller from its position with the help of hydraulic pump provided at the Bottom
of the multi mill and tighten the knob to facilitate the cleaning of main impeller.
5.3.1.13. Open the lid of the multi mill.
5.3.1.14. Clean all the inner surfaces and impellers using 0.5 % Teepol solution and soft nylon scrubber.
5.3.1.15. Clean with sufficient potable water.
5.3.1.16. Close the discharge valve and lid of the multi mill.
5.3.1.17. Lower the main impeller shaft by releasing the knob provided on the hydraulic pump.
5.3.1.18. Add 250 liters of potable water in the mixer and run the mixer for 10 minutes at slow speed.
5.3.1.19. Clean the outer surface of the mixer, the lid, and cover of the mill with sufficient potable water.
5.3.1.20. Clean the outer surface, platform with0.5% Teepol solution and a soft nylon scrubber.
5.3.1.21. After 10 minutes drain the water from the mixer by opening the discharge valve.

Format No.SPL/QA/001
 SOLITAIRE PHARMACIA PVT. LTD.
RESTRICTED CIRCULATION
AUTHORISED PERSONS ONLY
STANDARD OPERATING PROCEDURE

Title: Operation & Cleaning procedure for Multi Mill SOP. No. : SPL/ SOP/PR/034
Page No. : 3 of 4
Supersedes : New
Revision No. : 00
Prepared By Checked By Reviewed By Approved By Effective Date Review Date
Concerned Dept Concerned Dept QA QA-Head
5.3.1.22. Close the discharge valve and lid of multi mill.
5.3.1.23. Add 50 liters of purified water in the mixer and run the mixer for 5 minutes at slow speed.
5.3.1.24. Remove the 5 µ vent filter provided on the top of the multi mill lid.
5.3.1.25. Clean the above parts with sufficient purified water.
5.3.1.26. Drain the water from the mixer by opening the discharge valve.
5.3.1.27. Open the top lid and discharge valve of the multi mill.
5.3.1.28. Rinse the inside and outside surface of the multi mill with sufficient 50 ltr. Purifiedwater.
5.3.1.29. Clean the cone mill using 0.5% teepol solution and a soft nylon scrubber.
5.3.1.30. Clean with sufficient portable water.
5.3.1.31. Rinse with sufficient purified water.
5.3.1.32. Connect the cone mill inlet to the discharge valve of the multi mill.
5.3.1.33. Intimate Q.A (Quality Assurance) department to collect the rinse samples.
5.3.1.34. Pour 250 liters of purified water in multi mill and run the mixer for 2min.
5.3.1.35. Collect the samples of rinse from the discharge chute of the cone mill.
5.3.1.36. After clearance from Q.A, wipe the mixer and cone mill using a clean dry lint free cloth.
5.3.1.37. Fix the vent filter and the respective gasket in the position.
5.3.1.38. Enter the cleaning activity in the respective equipment log.
5.3.1.39. Maintain record as per format No. SPL/PR/001.
5.3.2. Type B Cleaning: ( Batch to Batch)
5.3.2.1 Dismantle the main switch of the multi milll.
5.3.2.2 Without dismantling the machine parts the powder from the previous batch label and material
to be remove And clean with clean, dry lint free cloth.
5.3.2.3 Place a “TO BE CLEANED EQUIPMENT” status label on the blender.
5.3.2.4 Record the activity in the respective equipment log.
5.3.3 Type C Cleaning: (End of the shift)
5.3.3.1 Without dismantling the machine parts the powder from the machine to be remove And clean
with clean, dry lint free cloth at the end of the shift.
5.3.3.2 Record the activity in the respective equipment log.
6.0 Records/Formats:

SPL/PR/040 - Equipment Cleaning Checklist ( Type A)

SPL/PR/041 - Equipment Cleaning Checklist ( Type A)

SPL/PR/042 - Equipment Cleaning Checklist ( Type B)

SPL/PR/043 - Equipment Cleaning Checklist ( Type C)

Format No.SPL/QA/001
 SOLITAIRE PHARMACIA PVT. LTD.
RESTRICTED CIRCULATION
AUTHORISED PERSONS ONLY
STANDARD OPERATING PROCEDURE

Title: Operation & Cleaning procedure for Multi Mill SOP. No. : SPL/ SOP/PR/034
Page No. : 4 of 4
Supersedes : New
Revision No. : 00
Prepared By Checked By Reviewed By Approved By Effective Date Review Date
Concerned Dept Concerned Dept QA QA-Head
7. Annexure:
NA
8. Reference:
Nil
9. Abbreviations:

SPL - Solitaire Pharmacia Pvt. Ltd., Baddi.

SOP - Standard Operating Procedure

QA - Quality Assurance

PR - Production

10. Revision History:

Revision No Effective date Reason for Revision

00 New Document

Format No.SPL/QA/001
 SOLITAIRE PHARMACIA PVT. LTD.
RESTRICTED CIRCULATION
AUTHORISED PERSONS ONLY
STANDARD OPERATING PROCEDURE

Title: Operation & Cleaning procedure for Multi Mill SOP. No. : SPL/ SOP/PR/034
Page No. : 5 of 4
Supersedes : New
Revision No. : 00
Prepared By Checked By Reviewed By Approved By Effective Date Review Date
Concerned Dept Concerned Dept QA QA-Head

EQUIPMENT CLEANING CHECKLIST

Format No. SPL/PR/040 Date
Area: ……………………………………….. Area Code: ………………………………..
Month / Year: ………………………..
Equipment Name: Multi mill Equipment Code: ………………………………..
Date

Product:
Batch No.:
Sr.No. Description
Type –A
1 Inner surface of the multi mill
cleaned
2 Main Impeller cleaned
3 Chopper Impeller cleaned.
4 Charging port along with
gaskets cleaned.
5 All the gaskets cleaned
6 Lid cleaned
7 Outer surface, platform,
staircase cleaned
8 Discharge valve and
discharge port cleaned.
9 Vent filter along with vent filter
cover cleaned.
10 Chopper of cone mill cleaned
Put a  mark where applicable. Put NA where not applicable

Format No.SPL/QA/001
 SOLITAIRE PHARMACIA PVT. LTD.
RESTRICTED CIRCULATION
AUTHORISED PERSONS ONLY
STANDARD OPERATING PROCEDURE

Title: Operation & Cleaning procedure for Multi Mill SOP. No. : SPL/ SOP/PR/034
Page No. : 6 of 4
Supersedes : New
Revision No. : 00
Prepared By Checked By Reviewed By Approved By Effective Date Review Date
Concerned Dept Concerned Dept QA QA-Head

EQUIPMENT CLEANING CHECKLIST

Format No. SPL/PR/041 Date
Area: ……………………………………….. Area Code: ………………………………..
Month / Year: ………………………..
Equipment Name: Multi mill Equipment Code: ………………………………..

Date

Product:
Batch No.:
Sr.No Description
.
Type –A

1 All nut and bolts cleaned

2 Outer surface, Inner surface
of cone mill cleaned
3 electrical connection of multi
mill and cone mill cleaned
4 Motor covers of multi mill and
cone mill cleaned
5 Control panel of multi
millcleaned.
DONE By
From
To
CHECKED By
Put a  mark where applicable. Put NA where not applicable

Format No.SPL/QA/001
 SOLITAIRE PHARMACIA PVT. LTD.
RESTRICTED CIRCULATION
AUTHORISED PERSONS ONLY
STANDARD OPERATING PROCEDURE

Title: Operation & Cleaning procedure for Multi Mill SOP. No. : SPL/ SOP/PR/034
Page No. : 7 of 4
Supersedes : New
Revision No. : 00
Prepared By Checked By Reviewed By Approved By Effective Date Review Date
Concerned Dept Concerned Dept QA QA-Head

EQUIPMENT CLEANING CHECKLIST

Format No. SPL/PR/042 Date
Area: ……………………………………….. Area Code: ………………………………..
Month / Year: ………………………..

Equipment Name: Multi mill Equipment Code:

Date

Product:
Batch No.:
Sr.No Description
.
Type –B
1 Inner surface of the multi mill
cleaned
2 Lid cleaned
3 Outer surface, platform,
staircase cleaned
4 Discharge valve and
discharge port cleaned.
5 Outer surface, Inner surface
of cone mill cleaned
6 Electrical connection of multi
mill and cone mill cleaned
7 Motor covers of multi mill and
cone mill cleaned
8 Control panel of multi mill
cleaned.
DONE By
From
To
CHECKED By
Put a  mark where applicable. Put NA where not applicable

Format No.SPL/QA/001
 SOLITAIRE PHARMACIA PVT. LTD.
RESTRICTED CIRCULATION
AUTHORISED PERSONS ONLY
STANDARD OPERATING PROCEDURE

Title: Operation & Cleaning procedure for Multi Mill SOP. No. : SPL/ SOP/PR/034
Page No. : 8 of 4
Supersedes : New
Revision No. : 00
Prepared By Checked By Reviewed By Approved By Effective Date Review Date
Concerned Dept Concerned Dept QA QA-Head

EQUIPMENT CLEANING CHECKLIST

Format No. SPL/PR/043 Date
Area: ……………………………………….. Area Code: ………………………………..
Month / Year: ………………………..

Equipment Name: Multi mill Equipment Code:

Date

Product:
Batch No.:
Sr.No Description
.
Type – C

1 Outer surface of multi mill and

cone mill, platform, staircase
of multi mill cleaned
2 Electrical connection and
control panel cleaned.
DONE By
From
To
CHECKED By
Put a  mark where applicable. Put NA where not applicable

Format No.SPL/QA/001