Temperature Control Units EQ&C

Mesa’s Compliance and Validation Services Temperature Control Unit Qualification protocols include:

• Documentation of the Temperature Control Unit information (Make, Model, Serial Number, etc.). (IQ)
• Identification and Verification of the Critical Instruments utilized by the Temperature Control Unit. (IQ)
• Verification that the System Controls and Alarms operate per the manufacturer’s and customers’ requirements. (OQ)
• Verification that Standard Operating Procedures are available for the operation, maintenance and/or cleaning of the Temperature Control Unit.  (Link to SOP page) (OQ)
• Verification that the storage conditions within the Temperature Control Units are maintained within the required range with an empty chamber. (OQ)
• Verification that the storage conditions can recover to the required operating conditions when operation is disrupted while the chamber is empty. (OQ)

• Verification that the storage conditions are maintained within the required range with a loaded chamber. (PQ)
• Verification that the storage conditions can recover to the required operating conditions when normal operation is disrupted while the chamber is loaded. (PQ)

By using Mesa’s Compliance and Validation Services to complete your Temperature Control Unit qualifications, the completed IQ, OQ, or PQ protocols will provide a level of assurance that the Temperature Control Unit has been installed properly, is operating correctly and is able to continuously maintain the correct storage conditions to meet your needs.

Types of units:

• Incubators
• Freezers
• Refrigerators
• Stability Chambers
• Product Storage Rooms