FORMEL LABS PRIVATE LIMITED

DEPARTMENT- PRODUCTION

OPERATIONAL QUALIFICATION PROTOCOL

Equipment. CENTRIFUGE Effective Date

Protocol No. FL1/OQ/P/CF-005/001-00

OPERATIONAL QUALIFICATION PROTOCOL

FOR THE

CENTRIFUGE

A/PD/CF-005

Table of content

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 FORMEL LABS PRIVATE LIMITED

DEPARTMENT- PRODUCTION

OPERATIONAL QUALIFICATION PROTOCOL

Equipment. CENTRIFUGE Effective Date

Protocol No. FL1/OQ/P/CF-005/001-00

SR. NO. DESCRIPTION Page No.

-- Cover page 1

-- Table of contents 2

-- Protocol approval page 3

1.0 Purpose 4

2.0 Scope 4

3.0 Responsibility 4

4.0 Equipment Name 5

5.0 Equipment Code 5

6.0 Equipment / System Description 5

7.0 Operating conditions 6

8.0 Attachments 6

9.0 Test for operational qualification 7-12

10.0 Deviation Report 13

11.0 Summary and Conclusion 14

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 FORMEL LABS PRIVATE LIMITED

DEPARTMENT- PRODUCTION

OPERATIONAL QUALIFICATION PROTOCOL

Equipment. CENTRIFUGE Effective Date

Protocol No. FL1/OQ/P/CF-005/001-00

PROTOCOL SIGNATUCF PAGE:

This protocol Operational Qualification (OQ) has been developed and the individuals listed below have
reviewed the document and agree with its content and with their signature grant approval for
qualification activity to be performed.

OPERATIONAL QUALIFICATION PROTOCOL APPROVAL

Signature
Activity Name Department Designation
& Date

Prepared by
(PR)

Checked by
(PR)

Checked by
(EN)

Approved by
(QA)

1.0 PURPOSE:

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 FORMEL LABS PRIVATE LIMITED

DEPARTMENT- PRODUCTION

OPERATIONAL QUALIFICATION PROTOCOL

Equipment. CENTRIFUGE Effective Date

Protocol No. FL1/OQ/P/CF-005/001-00

The objective of this protocol is to provide guideline and evidence for operational
qualification of Centrifuge (ID No.- A/PD/CF-005) located at Production Block – A.
2.0 SCOPE:

This protocol is applicable for operational qualification of Centrifuge available in.

3.0 RESPONSIBILITY
3.1 Production Department
a) To prepare Operational qualification protocol.
b)To execute the operational qualification activity as per approved protocol.
3.2 Engineering Department
a) To provide necessary support during execution of qualification activity.
3.3 Quality Assurance Department
a) To review and approve Operational qualification protocol.

4.0 EQUIPMENT NAME

CENTRIFUGE
5.0 EQUIPMENT CODE

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 FORMEL LABS PRIVATE LIMITED

DEPARTMENT- PRODUCTION

OPERATIONAL QUALIFICATION PROTOCOL

Equipment. CENTRIFUGE Effective Date

Protocol No. FL1/OQ/P/CF-005/001-00

A/PD/CF-005
6.0 EQUIPMENTS / SYSTEM DESCRIPTION

Item / Facility Observed Checked

Sr. No. Specifications Observations
description By By
Material of
1. SS316L
Construction
Capacity of
2. 36” HALAR
Equipment
Manufacture Joflo Industries Pvt.
3.
Name Ltd
Location of Production Block -A
4.
Equipment First Floor

7.0 OPERATING CONDITIONS

Sr. No. Test of Condition

1. Note the installation qualification report number: ……………………………………….

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 FORMEL LABS PRIVATE LIMITED

DEPARTMENT- PRODUCTION

OPERATIONAL QUALIFICATION PROTOCOL

Equipment. CENTRIFUGE Effective Date

Protocol No. FL1/OQ/P/CF-005/001-00

2. Ensure that SOP is available for Operation of Centrifuge……………………………….

3. Ensure that SOP is available for cleaning of Centrifuge. ………………………………..
4. Ensure that Equipment uses log book is available for Centrifuge. ………………………
Ensure that SOP is available for maintenance of centrifuge.
5.
………………………………….

8.0 ATTACHMENTS

1. Calibration Certificate of Clamp meter.

2. Calibration Certificate of Tachometer.

9.0 TEST FOR OPERATIONAL QUALIFICATION

 CF-Operational checklist

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 FORMEL LABS PRIVATE LIMITED

DEPARTMENT- PRODUCTION

OPERATIONAL QUALIFICATION PROTOCOL

Equipment. CENTRIFUGE Effective Date

Protocol No. FL1/OQ/P/CF-005/001-00

Sr. No. Checkpoint Yes / No

1. Verify installation qualification is completed

2. Verify earthing and bonding is proper.

3. Sufficient lighting is provided in surrounding area.

4. Ensure ON and OFF switches are working properly.

5. Ensure calibrated instruments provided on centrifuge

6. Check the motor and pulley is working properly.

7. Ensure all inter lock are properly working.

8. Ensure all the moving parts are guarded.

9. Check control panel is installed and electrical connection is provided.

 Instrument calibration list

Observation
Sr. Observed Checked
Name instrument Instrument ID No. Calibration Calibration
No By By
date due date

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 FORMEL LABS PRIVATE LIMITED

DEPARTMENT- PRODUCTION

OPERATIONAL QUALIFICATION PROTOCOL

Equipment. CENTRIFUGE Effective Date

Protocol No. FL1/OQ/P/CF-005/001-00

1. Clamp meter DCM-001

2. Tachometer TM-001

Pressure gauge
3. A/CF-005/PG-001
Pressure gauge for
nitrogen line
A/PD/CF-005/RPM-
4. RPM 001

 RPM, Direction of Rotation and Motor current.

Specification: RPM: 1100, Rotation: Clock wise, Current: 4.95 Amps.
Acceptance criteria: RPM: 1100+5, Rotation: Should be clock wise.
Current: Should not be more than 10.5 Amps.

Sr. No Activity Observation Observed Checked

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 FORMEL LABS PRIVATE LIMITED

DEPARTMENT- PRODUCTION

OPERATIONAL QUALIFICATION PROTOCOL

Equipment. CENTRIFUGE Effective Date

Protocol No. FL1/OQ/P/CF-005/001-00

By By

Machine should be start by pressing RPM ________________

1. the ON switch on control panel.
Check RPM and rotation of motor. Rotation: _____________

Motor Current
2. Check the motor current. __________amps.

3. Machine should stop by pressing

the OFF switch on the control panel

 Equipment functioning verification without load

Sr. Acceptance Criteria Observed Checke
Description Observation
No. / Specification By d By
1 Open and Close the It should open and
lid of centrifuge close smoothly.
manually

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 FORMEL LABS PRIVATE LIMITED

DEPARTMENT- PRODUCTION

OPERATIONAL QUALIFICATION PROTOCOL

Equipment. CENTRIFUGE Effective Date

Protocol No. FL1/OQ/P/CF-005/001-00

open the lid and Start

centrifuge (For Centrifuge should
3
checking function of not start.
limit switch)
Close the lid and
start centrifuge (For Centrifuge should
4
checking function of start.
limit switch)

Start the centrifuge

Its RPM should be
and set speed of
approximately
centrifuge at set
5 400 RPM ± 5
point 1,2,3 by knob
600 RPM ± 5
and measure RPM
1100 RPM ±5
approx.

Measure current of It should not be more R: _______

6 the motor in three than 10.5 Ampere in Y: _______
phase for high speed high speed. B: _______
There should not be
7 Vibration and Noise any vibration and
abnormal sound.

 Leak Test of centrifuge

Acceptance
Observed Checked
Sr. No. Description Criteria / Observation
By By
Specification

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 FORMEL LABS PRIVATE LIMITED

DEPARTMENT- PRODUCTION

OPERATIONAL QUALIFICATION PROTOCOL

Equipment. CENTRIFUGE Effective Date

Protocol No. FL1/OQ/P/CF-005/001-00

Close all the

opening of the
Centrifuge and
1 No any leakages
fill up the water
up to lead
opening.
Drain the water in
2 -
Catch pot

 Leak Test of Catchpot tank and Pump

Acceptance
Observed Checked
Sr. No. Description Criteria / Observation
By By
Specification

There should be no
Centrifuge water leakage. Water
1 to be drain in should transfer
Catchpot completely to
Catchpot

Start Catchpot
transfer pump and Water should
2 pump water to transfer from the
another tank or Catchpot
drain.

 Operation of centrifuge with load

Acceptance
Sr. Observed Checked
Description Criteria / Observation
No. By By
Specification
1 Ensure that centrifuge Centrifuge bag should

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 FORMEL LABS PRIVATE LIMITED

DEPARTMENT- PRODUCTION

OPERATIONAL QUALIFICATION PROTOCOL

Equipment. CENTRIFUGE Effective Date

Protocol No. FL1/OQ/P/CF-005/001-00

is off. Check
centrifuge bag is as per
be as per design of
requirement i.e. as per
centrifuge.
design of centrifuge.
Centrifuge bag fitting
Fit the bag to
should not be loose.
centrifuge and confirm
the fitting.

Start centrifuge at
approx. 400 RPM and Water should be filter
2
feed water and spin for from bag.
15 minutes.

Increase the speed of

centrifuge to approx. R: _______
1100 RPM and run
It should not be more
3 centrifuge and Y: _______
than 10.5 Ampere.
Measure current of the
motor in three phases B: _______
for high speed.
Centrifuge should be
4 Clean the centrifuge.
properly cleaned.

10.0 DEVIATION CFPORT

 Deviation if any:

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 FORMEL LABS PRIVATE LIMITED

DEPARTMENT- PRODUCTION

OPERATIONAL QUALIFICATION PROTOCOL

Equipment. CENTRIFUGE Effective Date

Protocol No. FL1/OQ/P/CF-005/001-00

 Justification of Deviation:

 Conclusion:

11.0 SUMMARY AND CONCLUSION

___________________________________________________________________________

___________________________________________________________________________

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 FORMEL LABS PRIVATE LIMITED

DEPARTMENT- PRODUCTION

OPERATIONAL QUALIFICATION PROTOCOL

Equipment. CENTRIFUGE Effective Date

Protocol No. FL1/OQ/P/CF-005/001-00

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Prepared By Checked By
Sign & Date Sign & Date

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