THE OQ PROTOCOL FOR AIR COMPRESSOR, HAS BEEN REVIEWED AND APPROVED FOR IMPLEMENTATION BY AUTHORISED PERSONNEL FROM THE FOLLOWING DEPARTMENTS
|1. OBJECTIVE / PURPOSE|
|2. PREPARATION AND APPLCATION OF SOPs|
|3. CONTROL PANEL TESTING|
|6.DESCRIPTION OF NON CONFORMANCE|
|7.OPERATIONAL QUALIFICATION – DISCUSSIONS AND RECOMMENDATIONS|
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
|Set-up & Operation SOP|
- CONTROL PANEL TESTING
- Name of the component: Main switch
|‘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
|Calibration certificate reference|
- OPERATIONAL TESTING
- AIR PRESSURE TEST
- To verify the air pressure delivered from compressor
- 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.
- Measure and record the air pressure at the air receiver tank .
- Monitor the reading after stabilization.
|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
- Air compressor unit is to be in continuous operations when the test is being performed.
- All the end valves must be closed
- Record the loading time and unloading time continuously at air receiver tank for certain period.
% 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.
- 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.
- Prepare the soap solution and apply near the joints.
- Observe the pressure drop every 15 minutes and record in the observation table.
|Sr, No||Time in min.
|Standard Pressure (kg/cm2)||Pressure Drop
- Description Of Non- Conformance
|S. No.||Specifications||Actual||Probable reasons||Checked by|
- Correction of Non Conformance
|S. No.||Correction Done||Done by||Checked by|
- Compliance Report
|S. No.||Description of conformance||Checked by||Remarks|
- OPERATIONAL QUALIFICATION
- Operational Qualification – Discussions
- Validation Team:
- 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.
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