Clean Rooms/Controlled Environments EQ&C

Mesa’s Compliance and Validation Services Clean Room Qualification protocols include:

• Verification that the documentation for the construction of the Clean Rooms meets customer specifications and industry requirements. (IQ)
• Identification and Verification of all Critical Instruments used monitor and control the Clean Room environment. (IQ)
• Verification that Standard Operating Procedures are available for the operation, maintenance, and/or cleaning of the Clean Rooms.
• Verification that the Clean Rooms Operational Controls (temperature / relative humidity / differential pressure) and the associated Alarms operate correctly. (OQ)
• Verification that the environmental conditions (temperature, humidity, differential pressure, non-viable particulates and/or viable particulates) in the Clean Rooms are able to be maintained under normal operations. (OQ)
• Verification that the environmental conditions (temperature, humidity, differential pressure, non-viable particulates and/or viable particulates) in the Clean Rooms can recover to the operating conditions when normal operation is disrupted. (OQ)
• Verification that the environmental conditions (temperature, humidity, differential pressure, non-viable particulates and viable particulates) in the Clean Rooms are able to be maintained over an extended period of time and during the change of seasons (PQ)

By using Mesa’s Compliance and Validation Services to complete your Clean Room qualifications, the completed IQ, OQ, or PQ protocols will provide a level of assurance that the Clean Rooms have been built correctly, verify that the Clean Rooms are able to maintain the necessary environmental conditions during normal operations, and that the Clean Rooms are also able to maintain the required environmental conditions for an extended period of time and during the change of seasons.