Incubator Validation
Incubator Validation
Laboratory Incubators require validation according to the normal pattern of installation qualification, or IQ, operational qualification, or OQ, and performance qualification, or PQ.
Incubators operate in the range 25°C to 75°C and so TQTech with MadgeTech loggers are ideal for the thermal mapping required for the qualification exercise.
The accuracy of the sensors and data acquisition hardware used to perform thermal validation is critical. Calibration and Calibration Check operating procedures are indispensible to normal acceptable validation practice, no matter what sensors are used (RTD’s, thermistors or thermocouples). The validation report must show that thermocouples, sensors, calibration and data acquisition equipment have been checked against a traceable standard at regular intervals. Thermocouples should be checked before and after a validation study. RTD’s and thermistors require less frequent checking, usually periodically every 6 months.
TQSoft thermal validation software can help achieve these accuracies by providing simple to operate automated calibration and calibration checking procedures and reports. TQS also stores all validation and calibration equipment details in a Test Equipment Database management system. Before a validation study the engineer can tick the items of equipment in use and TQS stores this information in each validation record. This allows users to create audit reports on individual items of the calibration or validation equipment.
Thermocouples have a limited life span and remote logger batteries can run low causing expensive problems during the validation process. TQSoft thermal validation software tracks thermocouple and logger usage and allows engineers to set limits.
TQSoft thermal validation software provides compliance with FDA regulation on electronic signatures in 21CFR Part 11 and has been developed and maintained according to GAMP.
