Temperature Mapping Validation
Most phases of processing of product within the pharmaceutical and food industry specify controls parameters for temperature, pressure, and humidity. Thus thermal mapping is essential to control these processes.
Data is collected and analyzed for cold spots or hot spots. Mapping tests must be made on empty chambers and fully loaded chambers. Most types of chambers require this treatment from incubators and storage areas and warehouses to autoclaves, EtO chambers, stability chambers, tunnels, dry heat sterilizers. Mapping must be performed on a quality schedule and in special circumstances.
Thermocouples can be used in some cases but often it is easier to use battery powered remote loggers. In both cases TQSoft™ thermal validation software can be used to calibrate before a mapping test, and calibration check during or at the end of the mapping process using the Calibration and Calibration Check feature.
Three mapping tests are required, and if there is a discrepancy between tests another mapping must be performed.
Large areas require many more mapped points than small areas or chambers to a minimum of 12. TQSoft™ can handle 128 separate loggers in a single mapping. MadgeTech Loggers are used for this procedure and have a batch handling interface in TQSoft™ to greatly improve setup and download times.
Storage areas and very large chambers are sometimes sub-divided into smaller areas. TQSoft™ Mapping Features allow users to create smaller map files and then merge data to create the whole picture up to 128 channels.
The accuracy of the sensors and data acquisition hardware used to perform thermal validation is critical. Calibration and calibration checking 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. TQSoft™ 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 TQSoft™ 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™ Interval Calculations feature can be used to track critical parameters and immediately highlight any test data that is not within specification.
Excel is often used to handle large mapping projects but 21CFR Part 11 must be complied with and the excel macros and procedures employed must be continuously adjusted and re-validated and audited. TQSoft™ offers built in thermal mapping and auditing. Moreover TQSoft™ handles calibration information and final reports as an integral part of a mapping project.
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.