Dana Pharmaceuticals STANDARD OPERATING SOP NO.

: ENG 024/00
Ltd PROCEDURE
Minna

Issue Date : 13.01.2014 PREVENTIVE Supersedes: NEW

Effective Date: 15.01.2014 MAINTENANCE OF
Review Date : March 2014 MULTIMILL
Page No. : 1 of 14
Copy : 1of 2

PURPOSE : This SOP gives the method of Preventive maintenance of Multimill for the
smooth operation of the equipment to achieve the desired process result of the batch.

SCOPE : This SOP covers the preventive Maintenance of Multimill ( Equipment No:
T-005/T-013) available in encore paithan.

RESPONSIBILITY : Senior Manager Engineering , Senior Executive Engineering ,Officer

Engineering.

ACCEPTANCE CRITERIA :

 Achievement of desired operating condition .

 Impact assessment study should be done during every yearly preventive maintenance
program to see that the equipment is working as per it’s operating conditions & is
performing as per the desired performance parameters & product quality is not
affected.

GENERAL CONDITIONS :

 The preventive maintenance job should be carried out by a trained person under the
supervision of qualified competent person.
 The operator/ technician who performs the job will enter his name/sign in "Done By"
column and responsible engineer/ supervisor will put sign in "Checked by " column of
recording format. The record will be reviewed by dept. Head monthly.

FREQUENCY :

 As per the time interval given in the procedure.

PREPARED BY CHECKED BY APPROVED BY

SR.EXECUTIVE ENGG. SR.MANAGER ENGG. SR. MANAGER QUALITY

 Dana Pharmaceuticals STANDARD OPERATING SOP NO. : ENG 024/00
Ltd PROCEDURE
Minna

Issue Date : 13.01.2014 PREVENTIVE Supersedes: NEW

Effective Date: 15.01.2014 MAINTENANCE OF
Review Date : March 2014 MULTIMILL
Page No. : 2 of 14
Copy : 1of 2

PRECAUTIONS : The machine should always be switched off before starting the
maintenance.
 Parts should be handled carefully.
 Always use correct size of tools.
 Precision parts should be handled very carefully and if needed hammered with Teflon
hammers with gentle strokes.
 Product quality should not be jeopardized while attending the machine.

1.0 PROCEDURE :
1.1 Preventive maintenance of this equipment will be done every month in order to run
the equipment smoothly & efficiently.
1.2 The preventive maintenance will be done mostly on weekly holidays or any other
convenient day as long as Production work does not suffer.
1.3 Following things should be done for the preventive maintenance of this equipment:

S.No. Check points/Operations Expectations /

Specifications
1. MONTHLY:
1.1 Check & tighten all nuts & bolts as follows: All the nut bolts should be
a) Motor mounting bolts tightened firmly & should not
b) Column to base fixing bolts be loose.
c) Column to drive box fixing bolts
d) Bearing housing fixing bolts
e) Drive pulley retaining bolts
f) Driven pulley retaining bolts
g) Dome nut castor wheel fixing bolt
Stuffing box
2 QUARTERLY: ( This is in addition to the
monthly checks)
2.1 Check V belt condition. It should not be broken/cut or
PREPARED BY CHECKED BY APPROVED BY

SR.EXECUTIVE ENGG. SR.MANAGER ENGG. SR. MANAGER QUALITY

 Dana Pharmaceuticals STANDARD OPERATING SOP NO. : ENG 024/00
Ltd PROCEDURE
Minna

Issue Date : 13.01.2014 PREVENTIVE Supersedes: NEW

Effective Date: 15.01.2014 MAINTENANCE OF
Review Date : March 2014 MULTIMILL
Page No. : 3 of 14
Copy : 1of 2

damaged. If found loose,

2.2 Check the gland packings.
2.3 Lubricate rack & pinion
2.4 Lubricate the motor mounting plate slide
shafts.
2.5 Check the main motor
3 HALF YEARLY ( This is in addition to
monthly & Quarterly checks)
3.1 Lubricate the main bearing.
3.2 Check the electrical accessories
a) Check the ON/OFF operation of main
switch.
b) Clean motor starter contractors,
contact points with CRC( cleaning
spray)
c) Clean the main switch with CRC
d) Check the earthing points for continuity
with Multimeter.
4 YEARLY( This is in addition to monthly,
Quarterly & Half Yearly checks)
PREPARED BY CHECKED BY
tighten the same. If required,
replace.
They should not be cut or
damaged. Tighten the check
nut. If required, replace the
gland packings.
Apply grease on rack & pinion.
Apply oil on motor mounting
plates & slide shafts.
It should be free from any
abnormal noise.
Lubricate the main bearing
with grease gun through
grease cup.
It should get switched on &
switched off.
Should be visually clean.
Should be seen visually clean.
If there is continuity, then it
gives a buzzer sound. If not
,no sound is heard. In case,
continuity is not found, rectify
the problem & note down the
details.
APPROVED BY

SR.EXECUTIVE ENGG. SR.MANAGER ENGG. SR. MANAGER QUALITY

 Dana Pharmaceuticals STANDARD OPERATING SOP NO. : ENG 024/00
Ltd PROCEDURE
Minna

Issue Date : 13.01.2014 PREVENTIVE Supersedes: NEW

Effective Date: 15.01.2014 MAINTENANCE OF
Review Date : March 2014 MULTIMILL
Page No. : 4 of 14
Copy : 1of 2

4.1 Dismantle the rotor shaft

a) Clean the rotor shaft
b) Check the bearings
It should be seen visually
clean & there should not be
any wear mark on the shaft.
It should freely rotate & there
should not be any play. If
required, replace.

2.0 ABBREVIATION : N. A.

3.0 ANNEXURE : Annexure I: - Monthly preventive maintenance record.

Annexure II: - Quarterly preventive maintenance record.
Annexure III: - Half yearly preventive maintenance record.
Annexure IV: - Yearly preventive maintenance record.
Annexure V: - preventive maintenance record summary.

4.0 REFERENCE :. NIL.

HISTORY OF CHANGE
Version No. Effective Date Reason for Change
00 21.07.2003 Original Issue

End of the document.

Annexure I

PREPARED BY CHECKED BY APPROVED BY

SR.EXECUTIVE ENGG. SR.MANAGER ENGG. SR. MANAGER QUALITY

 Dana Pharmaceuticals STANDARD OPERATING SOP NO. : ENG 024/00
Ltd PROCEDURE
Minna

Issue Date : 13.01.2014 PREVENTIVE Supersedes: NEW

Effective Date: 15.01.2014 MAINTENANCE OF
Review Date : March 2014 MULTIMILL
Page No. : 5 of 14
Copy : 1of 2

MONTHLY PREVENTIVE MAINTENANCE RECORD

Date: Ref. SOP No: ENG 024/00

Equipment Name : MULTIMILL Equipment NO:

S.No. Check Expectations / Observations/ Done Checked Remarks

points/Operations Specifications Findings by by if any
1. MONTHLY:
1.1 Check & tighten all All the nut bolts
nuts & bolts as should be
follows: tightened firmly
a) Motor mounting & should not be
bolts loose.
b) Column to base
fixing bolts
c) Column to drive
box fixing bolts
d) Bearing housing
fixing bolts
e) Drive pulley
retaining bolts
f) Driven pulley
retaining bolts
g) Dome nut castor
wheel fixing bolt
Stuffing box

The Preventive maintenance of the said equipment has been done/ Not Done & the
equipment is working /Not working Properly.

Annexure II

PREPARED BY CHECKED BY APPROVED BY

SR.EXECUTIVE ENGG. SR.MANAGER ENGG. SR. MANAGER QUALITY

 Dana Pharmaceuticals STANDARD OPERATING SOP NO. : ENG 024/00
Ltd PROCEDURE
Minna

Issue Date : 13.01.2014 PREVENTIVE Supersedes: NEW

Effective Date: 15.01.2014 MAINTENANCE OF
Review Date : March 2014 MULTIMILL
Page No. : 6 of 14
Copy : 1of 2

QUARTERLY PREVENTIVE MAINTENANCE RECORD

Date: Ref. SOP No: ENG 024/00

Equipment Name : MULTIMILL Equipment NO:

S.No. Check Expectations / Observation Done Checked Remarks

points/Operations Specifications s/Findings by by if any
1. QUARTERLY:
1.1 Check & tighten all All the nut bolts
nuts & bolts as should be tightened
follows: firmly & should not be
a) Motor mounting loose.
bolts
b) Column to base
fixing bolts
c) Column to drive
box fixing bolts
d) Bearing housing
fixing bolts
e) Drive pulley
retaining bolts
f) Driven pulley
retaining bolts
g) Dome nut castor
wheel fixing bolt
Stuffing box
2.1 Check V belt It should not be
condition. broken/cut or
damaged. If found
loose, tighten the
same. If required,
replace.
PREPARED BY CHECKED BY APPROVED BY

SR.EXECUTIVE ENGG. SR.MANAGER ENGG. SR. MANAGER QUALITY

 Dana Pharmaceuticals STANDARD OPERATING SOP NO. : ENG 024/00
Ltd PROCEDURE
Minna

Issue Date : 13.01.2014 PREVENTIVE Supersedes: NEW

Effective Date: 15.01.2014 MAINTENANCE OF
Review Date : March 2014 MULTIMILL
Page No. : 7 of 14
Copy : 1of 2

2.2 Check the gland They should not be

packings. cut or damaged.
Tighten the check
nut. If required,
replace the gland
packings.
2.3 Lubricate rack & Apply grease on rack
pinion & pinion.
2.4 Lubricate the motor Apply oil on motor
mounting plate slide mounting plates &
shafts. slide shafts.
2.5 Check the main It should be free
motor from any abnormal
noise.
2.3 Check the motor Motor should move
lead screw for to & to & fro easily.
fro motion Lubricate the lead
screw with grease.
2.4 Check the trolley Trolley should move
wheels for free free. If not, check
movement. the problem and
rectify as per the
situation.

The Preventive maintenance of the said equipment has been done/ Not Done & the
equipment is working /Not working Properly.

Annexure III

PREPARED BY CHECKED BY APPROVED BY

SR.EXECUTIVE ENGG. SR.MANAGER ENGG. SR. MANAGER QUALITY

 Dana Pharmaceuticals STANDARD OPERATING SOP NO. : ENG 024/00
Ltd PROCEDURE
Minna

Issue Date : 13.01.2014 PREVENTIVE Supersedes: NEW

Effective Date: 15.01.2014 MAINTENANCE OF
Review Date : March 2014 MULTIMILL
Page No. : 8 of 14
Copy : 1of 2

HALF YEARLY PREVENTIVE MAINTENANCE RECORD

Date: Ref. SOP No: ENG 024/00

Equipment Name : MULTIMILL Equipment NO:

S.No. Check Expectations / Observatio Done Checked Remarks

points/Operations Specifications ns/Findings by by if any
1. MONTHLY:
1.1 Check & tighten all All the nut bolts should
nuts & bolts as be tightened firmly &
follows: should not be loose.
a) Motor mounting
bolts
b) Column to base
fixing bolts
c) Column to drive
box fixing bolts
d) Bearing housing
fixing bolts
e) Drive pulley
retaining bolts
f) Driven pulley
retaining bolts
g) Dome nut castor
wheel fixing bolt
Stuffing box
2.1 Check V belt It should not be
condition. broken/cut or
damaged. If found
loose, tighten the
same. If required,
replace.
PREPARED BY CHECKED BY APPROVED BY

SR.EXECUTIVE ENGG. SR.MANAGER ENGG. SR. MANAGER QUALITY

 Dana Pharmaceuticals STANDARD OPERATING SOP NO. : ENG 024/00
Ltd PROCEDURE
Minna

Issue Date : 13.01.2014 PREVENTIVE Supersedes: NEW

Effective Date: 15.01.2014 MAINTENANCE OF
Review Date : March 2014 MULTIMILL
Page No. : 9 of 14
Copy : 1of 2

2.2 Check the gland They should not be cut

packings. or damaged. Tighten
the check nut. If
required, replace the
gland packings.
2.3 Lubricate rack & Apply grease on rack &
pinion pinion.
2.4 Lubricate the motor Apply oil on motor
mounting plate slide mounting plates & slide
shafts. shafts.
2.5 Check the main It should be free from
motor any abnormal noise.
3.1 Lubricate the main Lubricate the main
bearing. bearing with grease
gun through grease
cup.
3.2 Check the electrical
accessories It should get switched
a) Check the on & switched off.
ON/OFF Should be visually
operation of clean.
main switch.
b) Clean motor
starter Should be seen
contractors, visually clean.
contact points
with
CRC( cleaning
spray) Should be seen
c) Clean the main visually clean.
switch with CRC If there is continuity,
d) Check the then it gives a buzzer
PREPARED BY CHECKED BY APPROVED BY

SR.EXECUTIVE ENGG. SR.MANAGER ENGG. SR. MANAGER QUALITY

Dana Pharmaceuticals STANDARD OPERATING SOP NO. : ENG 024/00
Ltd PROCEDURE
Minna

Issue Date : 13.01.2014 PREVENTIVE Supersedes: NEW

Effective Date: 15.01.2014 MAINTENANCE OF
Review Date : March 2014 MULTIMILL
Page No. : 10 of 14
Copy : 1of 2

earthing points sound. If not ,no sound

for continuity is heard. In case,
with Multimeter. continuity is not found,
rectify the problem &
note down the details.

The Preventive maintenance of the said equipment has been done/ Not Done & the
equipment is working /Not working Properly.

Annexure IV

PREPARED BY CHECKED BY APPROVED BY

SR.EXECUTIVE ENGG. SR.MANAGER ENGG. SR. MANAGER QUALITY

 Dana Pharmaceuticals STANDARD OPERATING SOP NO. : ENG 024/00
Ltd PROCEDURE
Minna

Issue Date : 13.01.2014 PREVENTIVE Supersedes: NEW

Effective Date: 15.01.2014 MAINTENANCE OF
Review Date : March 2014 MULTIMILL
Page No. : 11 of 14
Copy : 1of 2

YEARLY PREVENTIVE MAINTENANCE RECORD

Date: Ref. SOP No: ENG 024/00

Equipment Name : MULTIMILL Equipment NO:

S.No. Check Expectations / Observatio Done Checked Remarks

points/Operations Specifications ns/Findings by by if any
1. MONTHLY:
1.1 Check & tighten all All the nut bolts should
nuts & bolts as be tightened firmly &
follows: should not be loose.
a) Motor mounting
bolts
b) Column to base
fixing bolts
c) Column to drive
box fixing bolts
d) Bearing housing
fixing bolts
e) Drive pulley
retaining bolts
f) Driven pulley
retaining bolts
g) Dome nut castor
wheel fixing bolt
Stuffing box
2.1 Check V belt It should not be
condition. broken/cut or
damaged. If found
loose, tighten the
same. If required,
replace.
PREPARED BY CHECKED BY APPROVED BY

SR.EXECUTIVE ENGG. SR.MANAGER ENGG. SR. MANAGER QUALITY

 Dana Pharmaceuticals STANDARD OPERATING SOP NO. : ENG 024/00
Ltd PROCEDURE
Minna

Issue Date : 13.01.2014 PREVENTIVE Supersedes: NEW

Effective Date: 15.01.2014 MAINTENANCE OF
Review Date : March 2014 MULTIMILL
Page No. : 12 of 14
Copy : 1of 2

2.2 Check the gland They should not be cut

packings. or damaged. Tighten
the check nut. If
required, replace the
gland packings.
2.3 Lubricate rack & Apply grease on rack &
pinion pinion.
2.4 Lubricate the motor Apply oil on motor
mounting plate slide mounting plates & slide
shafts. shafts.
2.5 Check the main It should be free from
motor any abnormal noise.
3.1 Lubricate the main Lubricate the main
bearing. bearing with grease
gun through grease
cup.
3.2 Check the electrical
accessories
a) Check the It should get switched
ON/OFF on & switched off.
operation of Should be visually
main switch. clean.
b) Clean motor Should be seen
starter visually clean.
contractors,
contact points
with
CRC( cleaning
spray) Should be seen
c) Clean the main visually clean.
switch with CRC If there is continuity,
d) Check the then it gives a buzzer
PREPARED BY CHECKED BY APPROVED BY

SR.EXECUTIVE ENGG. SR.MANAGER ENGG. SR. MANAGER QUALITY

 Dana Pharmaceuticals STANDARD OPERATING SOP NO. : ENG 024/00
Ltd PROCEDURE
Minna

Issue Date : 13.01.2014 PREVENTIVE Supersedes: NEW

Effective Date: 15.01.2014 MAINTENANCE OF
Review Date : March 2014 MULTIMILL
Page No. : 13 of 14
Copy : 1of 2

earthing points sound. If not ,no sound

for continuity is heard. In case,
with Multimeter. continuity is not found,
rectify the problem &
note down the details.
4.1 Dismantle the rotor
shaft It should be seen
b) Clean the rotor visually clean & there
shaft should not be any wear
mark on the shaft.
It should freely rotate &
b) Check the there should not be
bearings any play. If required,
replace.

The Preventive maintenance of the said equipment has been done/ Not Done & the
equipment is working /Not working Properly.

Impact Assessment : Required / Not Required

If Required : Done / Not Done ( Reasons for Not Done)

Results of Impact Assessment:

Annexure V
PREVENTIVE MAINTENANCE RECORD SUMMARY

PREPARED BY CHECKED BY APPROVED BY

SR.EXECUTIVE ENGG. SR.MANAGER ENGG. SR. MANAGER QUALITY

 Dana Pharmaceuticals STANDARD OPERATING SOP NO. : ENG 024/00
Ltd PROCEDURE
Minna

Issue Date : 13.01.2014 PREVENTIVE Supersedes: NEW

Effective Date: 15.01.2014 MAINTENANCE OF
Review Date : March 2014 MULTIMILL
Page No. : 14 of 14
Copy : 1of 2

Ref.SOP No: ENG 024/00 Equipment Name: MULTIMILL Equipment No:

Preventive Jan Feb March Apr
Maintenance
Date Done Ckd Date Done Ckd Date Done Ckd Date Done Ckd
By by By by By by By by
Monthly
Quarterly
Half Yearly
Yearly

Reviewed By

Preventive May June July August

Maintenance
Date Done Ckd Date Done Ckd Date Done Ckd Date Done Ckd
By by By by By by By by
Monthly
Quarterly
Half Yearly
Yearly

Reviewed By

Preventive September October November December

Maintenance
Date Done Ckd Date Done Ckd Date Done Ckd Date Done Ckd
By by By by By by By by
Monthly
Quarterly
Half Yearly
Yearly

Reviewed By

PREPARED BY CHECKED BY APPROVED BY

SR.EXECUTIVE ENGG. SR.MANAGER ENGG. SR. MANAGER QUALITY