SHILPA MEDICARE LTD, UNIT-IV

STANDARD OPERATING PROCEDURE

Document No.: SOP/ENG/PMT/028-00 Effective date :
Review date :
Supersedes : Nil
Page 1 of 7
ENGINEERING
TITLE: Procedure for Preventive Maintenance of Vial filling and Stoppering
Machine

1.0 Purpose:

To lay down a Procedure for Preventive maintenance of Vial filling and Stoppering Machine.

2.0 Scope:

This procedure applies to Steriline Make Vial filling and Stoppering Machine Installed at
Shilpa Medicare Limited, Unit-IV, Jadcherla.

3.0 Definitions: NA

4.0 Responsibility:

4.1 Asst. Manager/ Sr. Executive Engineering Shall co-ordinate with user dept to
make the equipment available for preventive maintenance purpose.

4.2 Executive/ Officer Engineering Shall perform Preventive maintenance activity.

4.3 Concern department shall ensure the cleanliness of the place.

4.4 Head of Engineering/Designee shall ensure its compliance.

5.0 Procedure:

5.1 Precautions:

5.1.1 Use Electrical hand gloves where ever necessary.

5.1.2 Follow electrical safety before starting the job. In case of electric shock
follow resuscitation first aid chart

5.1.3 Label the equipment with tag UNDER PREVENTIVE MAINTENANCE as

in Annexure ENG/GEN/003/A03.

5.2 Drive Assembly:

5.2.1 Lubricate chain, gears, cams, cam followers, roller chains & cam rails by
silicon grease.
5.3 Check the oil level in Main motor drive gearbox. If not found up to the mark, top up
with oil

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 SHILPA MEDICARE LTD, UNIT-IV
STANDARD OPERATING PROCEDURE
Document No.: SOP/ENG/PMT/028-00 Effective date :
Review date :
Supersedes : Nil
Page 2 of 7
ENGINEERING
TITLE: Procedure for Preventive Maintenance of Vial filling and Stoppering
Machine

5.4 Tighten idlers of drive chain and ensure chain tension is set correctly, also ensure
chain sprocket lock screws tightened properly
5.5 Lubricate all ball bearings and replace if found, faulty / damaged / worn
5.6 Check operation of combo clutch centering, pump position sensors and door
interlock, if required adjust the position
5.7 Nitrogen Line:
5.7.1 Check nitrogen line and leakages, rectify it, if any
5.8 Cam:
5.8.1 Check cam for any damage, scratches, play & wear, rectify it; if any.
5.9 Check cam followers for bearing play, corrosion, damage, fixing device, noise, wear
and play, rectify it; if any
5.10 Control all detachable connections and connecting elements. Tighten released
screw connections
5.11 Check the gear for corrosion, cracks, damage, slippage, noise, temperature,
vibrations and wear, rectify it if any
5.12 Check the motor for any abnormal noise & vibration, rectify it, if any
5.13 Grease the Cam followers, Lubricant Roller bearings and cam Fills.
5.14 Control Panel:
5.14.1 Check loose connections, faulty insulations, PLC battery, fuse links,
indicating lamps for healthy operation
5.15 Verify that Instrument calibration status is within its validity limit.
6 Abbreviations:

6.1 SOP : Standard Operating Procedure.

6.2 PLC : Programmable Logic Controller
7 References:

7.1 SOP No. SOP/ENG/GEN/001: Electrical safety

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QAD/OPC/001/F01-00
 SHILPA MEDICARE LTD, UNIT-IV
STANDARD OPERATING PROCEDURE
Document No.: SOP/ENG/PMT/028-00 Effective date :
Review date :
Supersedes : Nil
Page 3 of 7
ENGINEERING
TITLE: Procedure for Preventive Maintenance of Vial filling and Stoppering
Machine

7.2 SOP No. SOP/ENG/GEN/003: Preventive Maintanance

8 Annexure:

8.1 Annexure ENG/PMT/028/A01: Preventive

Maintenance Check sheet for Vial filling and
Stoppering Machine

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QAD/OPC/001/F01-00
 SHILPA MEDICARE LTD, UNIT-IV
STANDARD OPERATING PROCEDURE
Document No.: SOP/ENG/PMT/028-00 Effective date :
Review date :
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Page 4 of 7
ENGINEERING
TITLE: Procedure for Preventive Maintenance of Vial filling and Stoppering
Machine

ANEXURE ENG/PMT/028/A01

Shilpa Medicare Limited, Unit-IV.

Jadcherla.

PREVENTIVE MAINTENANCE CHECKLIST FOR VIAL FILLING AND STOPPERING

MACHINE
(Ref. SOP No. - SOP/ENG/PMT/028)

Equipment Name :

Equipment No: Location:

Done Users Remark

Sr. Description FREQ By/ Sign
Date
Drive Assembly
Lubricate chain, gears,
cam, cam followers,
roller chains & cam rails
by silicon grease.
Top up oil in gearbox if
required.
Tighten idlers of drive
1 QLY
chain and ensure chain
tension is set correctly,
also ensure chain
sprocket lock screws
tightened properly.
Lubricate all ball
bearings and replace if
found, faulty /
damaged / worn.

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QAD/OPC/001/F01-00
 SHILPA MEDICARE LTD, UNIT-IV
STANDARD OPERATING PROCEDURE
Document No.: SOP/ENG/PMT/028-00 Effective date :
Review date :
Supersedes : Nil
Page 5 of 7
ENGINEERING
TITLE: Procedure for Preventive Maintenance of Vial filling and Stoppering
Machine

Interlocking:
2 Check operation of all
sensors, if required QLY
adjust the position.

Nitrogen Line:
3 QLY
Check Nitrogen line
leakages.

Cam:
Check cam for any
damage, scratches, play
& wear, rectify it; if any.
4 Check cam followers for QLY
bearing play, corrosion,
damage, fixing device,
noise, wear,
temperature and play,
rectify it; if any.

Control all detachable

connectio
ns and
connectin
g
5 elements HLY
. Tighten
released
screw
connectio
ns.

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QAD/OPC/001/F01-00
 SHILPA MEDICARE LTD, UNIT-IV
STANDARD OPERATING PROCEDURE
Document No.: SOP/ENG/PMT/028-00 Effective date :
Review date :
Supersedes : Nil
Page 6 of 7
ENGINEERING
TITLE: Procedure for Preventive Maintenance of Vial filling and Stoppering
Machine

Check the gear for

corrosion, cracks,
damage, slippage,
6 HLY
noise, temperature,
vibrations and wear,
rectify it; if any.
Check the motor for any
abnormal noise
7 HLY
& vibration, rectify it, if
any.

Control Panel:
Check loose
8 connections, faulty YLY
insulations, PLC battery,
fuse links and indicating
lamps.

Check the cam shaft for

contact
pattern,
corrosion
,
deformati
9 on, YLY
extension
, non
smooth
running &
wear,
rectify it;
if any.

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QAD/OPC/001/F01-00
 SHILPA MEDICARE LTD, UNIT-IV
STANDARD OPERATING PROCEDURE
Document No.: SOP/ENG/PMT/028-00 Effective date :
Review date :
Supersedes : Nil
Page 7 of 7
ENGINEERING
TITLE: Procedure for Preventive Maintenance of Vial filling and Stoppering
Machine

Verify that Instrument

calibratio
n status
10 is within QLY
its
validity
limit.

QLY: Quarterly HLY: Half Yearly

YLY: yearly

End of the Document

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