3/20/2019 OPERATIONAL QUALIFICATION OF AIR COMPRESSOR - Pharmaceutical Guidance

OPERATIONAL QUALIFICATION OF AIR COMPRESSOR

PROTOCOL APPROVAL

Crank up your biologic - characterization & development OPEN

THE OQ PROTOCOL FOR AIR COMPRESSOR, HAS BEEN REVIEWED AND APPROVED FOR IMPLEMENTATION BY AUTHORISED

PERSONNEL FROM THE FOLLOWING DEPARTMENTS

Prepared by:

NAME SIGNATURE DATE

Approved by:

FUNCTION NAME SIGNATURE DATE

VALIDATION

PRODUCTION

SERVICES

QUALITY ASSURANCE

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

http://pharmaguidances.com/operational-qualification-of-air-compressor/ 1/5
3/20/2019 AND PURPOSE – To establish documented
OBJECTIVE OPERATIONAL
evidenceQUALIFICATION OF AIR can
that AIR COMPRESSOR  COMPRESSOR - Pharmaceutical
operate within tolerances and Guidance
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 speci cations.

PREPARATION / APPLICATION OF SOPs 

Name SOP number

Set-up & Operation SOP

Cleaning SOP

CONTROL PANEL TESTING 

Name of the component: Main switch

Description Speci ed Actual Checked By

‘ON’ switch Should start the System

‘OFF’ switch Should stop the System

Start up sequence Not speci ed

Operational Description Speci ed Actual Checked By

Pressure switch –for  oil pressure Shall maintain set  point

Shall maintain set for loading and

Safety valves Shall control at set point.

INSTRUMENT CALIBRATION

Calibration
Sr. Instrument status Calibration certi cate reference

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 speci ed  quantity of air.
http://pharmaguidances.com/operational-qualification-of-air-compressor/ 2/5
 3/20/2019
INSTRUMENT USED    :  Pressure gauge  OPERATIONAL QUALIFICATION OF AIR COMPRESSOR - Pharmaceutical Guidance

ACCEPTANCE CRITERIA  : The pressure should not be less  than 7 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  (Kg/ sq cm) REMARKS

AIR LEAKAGE TEST 

OBJECTIVE : To demonstrate the integrity of compressor system 

EQUIPMENT : Pressure gauge, Stop watch

ACCEPTANCE CRITERIA : No leakage shall be present

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: 

Unload Load time

% 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  maximum permissible  pressure recommended is 150psi.

METHOD                                   :

1. Put the system under pressure up to 70psig 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.

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

OBSERVATIONS :

http://pharmaguidances.com/operational-qualification-of-air-compressor/ 3/5
3/20/2019 OPERATIONAL QUALIFICATION OF AIR COMPRESSOR - Pharmaceutical Guidance
Time in min. Pressure Drop
2 2
Sr, No   Standard Pressure (kg/cm ) (kg/cm ) Checked by

 Description Of Non- Conformance

S. No. Speci cations       Actual Probable reasons Checked by

1.

Correction of Non Conformance

S. No. Correction  Done Done by Checked  by

1.

Compliance Report

S. No. Description of conformance Checked by        Remarks

OPERATIONAL QUALIFICATION 

Operational Quali cation  – Discussions

Recommendations

Validation Team:

Department Name Signature Date

Validation

Production

Services

Quality Assurance

CONCLUSION: The AIR COMPRESSOR (Equipment Code:                       ) has been tested and veri ed for Operational

Quali cation as per the Services, Air COMPRESSOR Validation Protocol. 

The Equipment is said to be Quali ed / Disquali ed as per the observations made therein.

 APPROVED BY:

FUNCTION NAME SIGNATURE DATE

VALIDATION      

PRODUCTION      

SERVICES      

http://pharmaguidances.com/operational-qualification-of-air-compressor/ 4/5
3/20/2019 OPERATIONAL QUALIFICATION OF AIR COMPRESSOR - Pharmaceutical Guidance
QUALITY ASSURANCE      

Thank you for helping us measure the

Thank you for helping us measure the

Giảm 30% khi đặt túi Hãng Nano Chip tài trợ giảm 30% khi "đặt túi Nano
Bệnh viện thẩm mỹ Việt Mỹ Chip"

http://pharmaguidances.com/operational-qualification-of-air-compressor/ 5/5