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Thermal Validation for Compliance and Quality Assurance

Thermal validation is the process of validating and qualifying equipment and storage facilities to prove that they will create and maintain the temperatures they are designed for.
A broad spectrum of instruments and processes require thermal validation. It can be a simple temperature map of laboratory Incubator, Freezer, Furnace or a full fledged autoclave unit.
A typical thermal validation setup would include a thermocouple/RTD or a set of sensors with Traceable accuracy and a Datalogger. Sensors would require pre and post calibration records which is done typically with Dry Block Calibrators.
Wireless dataloggers with Integral sensors for Temperature can make the Thermal Validation much easier. With Multiple dataloggers, Pharma Industries can execute multiple thermal mapping exercises at once.
Validation software should be compliant to 21 CFR Part 11 and be validated. Some software goes further allowing complex calculations to be performed with a clear pass and fail criteria.
As reliable equipment validation is so critical in the pharmaceutical industry, IQ OQ PQ represents a way to help ensure reliable performance for equipment for pharmaceutical industry purposes. 
Installation Qualification (IQ)
Installation qualification, or IQ, is a documented verification process that the instrument or piece of equipment has been properly delivered, installed and configured according to standards set by the manufacturer or by an approved installation checklist.
Installation qualification requirements for equipment include checking for proper location, proper energy supply and acceptable environmental conditions. There is also checking of contents against the packing list, verifying software installation, documenting computer-controlled instrumentation, verifying connections with peripherals, and recording calibration and validation dates, among others.
Operational Qualification (OQ)
Operational qualification is the next step in quality assurance and involves testing the equipment and making sure it performs as specified, within operating ranges as listed by the manufacturer. All aspects of the equipment receive individual testing and the tester documents the proper operation of each.
Operational Qualification for equipment is necessary after installation, significant maintenance or modifications to the equipment, or as a feature of scheduled quality assurance testing. Operational qualification aspects that will be tested may include leveling and fluctuation, repeatability, keyboard controls, deviation reports, calibration and certificates, as well as performance reports.
Performance Qualification (PQ)
Before your equipment can be truly rated as qualified, you will need to put it through performance qualification. Your process performance qualification protocol will feature verification and documentation that all equipment is working within the accepted range as specified, does it perform as expected under real conditions. All instruments are tested together according to a detailed test plan and must generate reproducible results.

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