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OPERATIONAL QUALIFICATION OF AIR COMPRESSOR

PROTOCOL APPROVAL

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

 

OBJECTIVE AND PURPOSE – To establish documented evidence that AIR COMPRESSOR  can 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
Cleaning SOP

 

  • CONTROL PANEL TESTING 
  • Name of the component: Main switch
Description Specified Actual Checked By
‘ON’ switch Should start the System
‘OFF’ switch Should stop the System
Start up sequence Not specified

 

Operational Description Specified Actual Checked By
Pressure switch –for  oil pressure Shall maintain set  point
Auxillary valve Shall maintain set for loading and unloading
Safety valves Shall control at set point.
  • INSTRUMENT CALIBRATION
Sr. Instrument Calibration

status

Calibration certificate 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 specified  quantity of air.

INSTRUMENT USED    :  Pressure gauge 

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: 

Sr. No Unload

Time(sec)

Load time

(sec)

Remarks

% 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.
  1. Prepare the soap solution and apply near the joints.
  2. Observe the pressure drop every 15 minutes and record in the observation table.

OBSERVATIONS :

Sr, No Time in min.

 

Standard Pressure (kg/cm2) Pressure Drop

(kg/cm2)

Checked by
         
  •  Description Of Non- Conformance
S. No. Specifications       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
1
  • OPERATIONAL QUALIFICATION 
  • Operational Qualification  – Discussions
  • Recommendations
  • Validation Team:
Department Name Signature Date
Validation
Production
Services
Quality Assurance
  • 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 / Disqualified as per the observations made therein.

 APPROVED BY:

FUNCTION NAME SIGNATURE DATE
VALIDATION      
PRODUCTION      
SERVICES      
QUALITY ASSURANCE      

 

 

 

 

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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