PHARMACEUTICALS LIMITED

Utility Operational Qualification Protocol

And
Report
For Air Compressor.

QUALIFICATION PROTOCOL NO: MA / 20 / 001.

PROTOCOL PREPARATION
PROTOCOL PREPARED BY:

PROTOCOL APPROVED BY:

REPORT APPROVAL
REPORT PREPARED BY:

REPORT REVIEWED BY:

APPROVED BY:
 PHARMACEUTICALS LIMITED

UTILITY OPERATIONL QUALIFICATION PROTOCOL

Protocol No: MA/20/001. Document No: MD/007 Page 1 of 6

Content

1. OBJECTIVE / PURPOSE

2. PREPARATION AND APPLCATION OF SOPs

3. CONTROL PANEL TESTING

4.INSTRUMENTS CALIBRATION

5.OPERATIONAL TESTING

6.DESCRIPTION OF NON CONFORMANCE

7.OPERATIONAL QUALIFICATION – DISCUSSIONS AND

RECOMMENDATIONS
8.CONCLUSION
 PHARMACEUTICALS LIMITED

UTILITY OPERATIONL QUALIFICATION PROTOCOL

Protocol No: MA/20/001. Document No: MD/007 Page 2 of 6

OBJECTIVE AND PURPOSE – To establish documented evidence that AIR

COMPRESSOR c a n operate within tolerances and limits.

Acceptance of Operation includes,

To demonstrate the operational capabilities of Air compressor

To ensure that air compressor is operating as intended and is under state of

Operational features to meet process requirements and equipment specifications.

PREPARATION / APPLICATION OF SOPs

Name
SOP number
Set-up & Operation SOP MD/007

Cleaning SOP

CONTROL PANEL TESTING

Name of the component: Main switch

Description Specified remark Checked By

‘ON’ switch Should start the Yes Bolu

System
‘OFF’ switch Should stop the Yes Bolu
System
Startup sequence Not specified Bolu

Operational Specified remark Checked By

Description
Pressure switch –for Shall maintain set Yes Johnathan
oil pressure point
Auxiliary valve Shall maintain set for Yes Johnathan
loading and
unloading
Safety valves Shall control at set Yes Johnathan
point.
 PHARMACEUTICALS LIMITED

UTILITY OPERATIONL QUALIFICATION PROTOCOL

Protocol No: MA/20/001. Document No: MD/007 Page 3 of 6

INSTRUMENT CALIBRATION
Sr. Instrument Calibration status Calibration
certificate
reference
1 Pressure gauge Calibrated to 9 bars In house
calibration
2 Auto water drain Calibrated to 30sec lock 2sec open

OPERATIONAL TESTING
AIR PRESSURE TEST

OBJECTIVE:

1. To verify the air pressure delivered from compressor

2. To demonstrate that the Air compressor is balanced and is capable of delivering

specified quantity of air.

INSTRUMENT USED: Pressure gauge

ACCEPTANCE CRITERIA: The pressure should not be less than 6 kg/ sq. cm at no load.

METHOD:

1. Measure and record the air pressure at the air receiver tank.

2. Monitor the reading after stabilization.

OBSERVATIONS:

SR. NO LOADING TIME PRESSURE OBSERVED REMARKS

(Kg/ sq cm)
1 4 min 10 OK
2 4min 10 OK
3 4min 10 OK
 PHARMACEUTICALS LIMITED

UTILITY OPERATIONL QUALIFICATION PROTOCOL

Protocol No: MA/20/001. Document No: MD/007 Page 4 of 6

AIR LEAKAGE TEST

OBJECTIVE:
To demonstrate the integrity of compressor system

EQUIPMENT:
Pressure gauge, stop watch

ACCEPTANCE CRITERIA:
no leakage

METHOD:
1. Air compressor unit is to be in continuous operations when the test is being
performed.

2. All the end valves must be closed

3. Record the loading time and unloading time continuously at air receiver tank for
certain period.

OBSERVATION:

Sr. No Unload Time(sec) Load time (sec) Remarks

1 3min 30sec 4min OK
2 3min 30sec 4min OK
3 3min 30sec 4min OK

% Leakage = (load time/load time +unload time) X100

AIR RECEIVER VESSEL PRESSURE TEST:

OBJECTIVE: To demonstrate the maximum permissible pressure of vessel.

EQUIPMENT: Hydraulic test.

ACCEPTANCE CRITERIA: The m a x i m u m permissible pressure recommended is 150psi.

METHOD:

1. Put the system under pressure up to 100psig for 2hrs.and check for any
pressure drop in order to identify the leakage from the chamber.
 2. Prepare the soap solution and apply near the joints.
PHARMACEUTICALS LIMITED

UTILITY OPERATIONL QUALIFICATION PROTOCOL

Protocol No: MA/20/001. Document No: MD/007 Page 5 of 6

3. Observe the pressure drop every 15 minutes and record in the observation table.

OBSERVATIONS:

Sr, No Time in min. 2 Standard Pressure Checked by

Pressure (kg/cm Drop 2
) (kg/cm )

1. 15 9 0 johnathan

Description of Non-Conformance

S. No. Specifications Actual Probable Checked by

reasons
1. Not in line with acceptance None None johnathan
criteria

Correction of Non-conformance

S. No. Correction Done Done by Checked by

1. NA NA NA

Compliance Report

S. No. Description of conformance Checked by Remarks

1 Complies with acceptance criteria Williams elvis OK

Validation Team:
Department Name Signature Date

MAINTENANCE

Production

Quality
Assurance
Management

PHARMACEUTICALS LIMITED
 UTILITY OPERATIONL QUALIFICATION PROTOCOL
Protocol No: MA/20/001. Document No: MD/007 Page 6 of 6

CONCLUSION: The AIR COMPRESSOR (Equipment Code: _____________) has been tested
and verified for Operational Qualification as per the Services, Air COMPRESSOR
Validation Protocol.
The Equipment is said to be Qualified as per the observations made therein.

APPROVED BY:

FUNCTION NAME SIGNATURE DATE

QUALITY
ASSURANCE
MANAGEMENT