Equipment Qualification and Calibration

Mesa’s Compliance and Validation Services can provide IQ, OQ, or PQ protocols to fit your validation needs.  Our experience in the validation field allows us to create highly-customizable documents that will meet all of your design, production, user, and regulatory requirements.  Mesa’s Compliance and Validation Services team can provide on-site validation services to help to ensure that your equipment, systems or processes are able to work properly, reliably, and as intended.

Calibration of the devices used to monitor your equipment or processes is necessary to ensure that any Qualification and Validation activities are valid. By having Mesa’s Compliance and Validation Services perform your calibration activities prior to performing a qualification will ensure that your equipment or processes are legitimate and accurate.

Temperature Control Units

When performing Installation, Operational, or Performance Qualifications on Temperature Control Units (any equipment that maintains a specific temperatures or humidity storage conditions) the protocols used need to verify that the Temperature Control Unit has been installed correctly (IQ), demonstrate that the Temperature Control Unit is working properly (OQ), and show that the Temperature Control Unit is able to continuously maintain the correct storage conditions (PQ).

Clean Rooms/Controlled Environments

When performing Installation, Operational, or Performance Qualifications on Clean Rooms the protocols used need to verify that the Clean Rooms have been built correctly (IQ), demonstrate that the Clean Rooms are able to maintain the necessary environmental conditions during normal operations (OQ), 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 (PQ).

Depyrogenation Ovens & Tunnels

When it comes to completing Depyrogenation Oven / Tunnel Installation, Operational, or Performance Qualifications, the protocols used need to verify that the Depyrogenation Oven / Tunnel has been installed correctly (IQ), demonstrate that the Depyrogenation Oven / Tunnel is operating properly (OQ), and show that the Depyrogenation Oven / Tunnel sterilization cycles are able to reproducibly meet your (the customer’s?) requirements (PQ).