Cleanroom Operation Qualification
Phase Three: Operation Qualification
The objective for this Operational Qualification (OQ) phase is to show through objective evidence that the cleanroom operates in conformance with design requirements and user defined requirements, and that it consistently operates within a defined range of conditions.
The OQ protocol should address the following:
• Testing HVAC (Heating-Ventilation-Air Conditioner) system operation against specified functional requirements
• Critical Alarms
• Interlock Alarms
• Critical operating parameters defined on the room data sheet
• Filter integrity tests
• Standard operation for the cleanroom
• Air speed and air flow
• Air flow patterns
• Pressure differential
The OQ phase should also address worst case scenarios. To design the worst case scenario for the operation of the cleanroom, critical operating parameters are identified from the cleanroom data sheet. Operation ranges, and extreme ranges, are set for each critical parameter and a worst case designed and documented. It should include the following:
• Maximum and minimum temperatures
• Maximum and minimum humidity
• Maintenance schedules
• Personnel contamination
The worst case scenario is usually carried out at the specified High and specified Low parameters.
The output of this phase is an OQ report addressing alarms and functional requirements of the cleanroom specified in the user requirement specifications.
Resources & Articles
CLIN ® "Resources" page is for individuals/companies seeking information on cleanrooms and controlled environments. Find Cleanroom News, Discussion Forums, Cleanroom Cleaning Recommendations, Cleanroom Terminology, Cleanroom Directory, and more.
Content Disclaimer
Information are contributed by/from different websites and all credit goes to its respective owners/writers/websites/companies and etc, and while we endeavour to keep the information up to date and correct, we make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability or availability with respect to the website or the information, products, services, or related graphics contained on the website for any purpose. Any reliance you place on such information is therefore strictly at your own risk.
In no event will we be liable for any loss or damage including without limitation, indirect or consequential loss or damage, or any loss or damage whatsoever arising from loss of data or profits arising out of, or in connection with, the use of this website.
Through this website you are able to link to other websites which are not under the control of respective owners/writers/websites/companies and etc. We have no control over the nature, content and availability of those sites. The inclusion of any links does not necessarily imply a recommendation or endorse the views expressed within them.
Every effort is made to keep the website up and running smoothly. However, CLIN ® takes no responsibility for, and will not be liable for, the website being temporarily unavailable due to technical issues beyond our control.
