Stability Chamber Validation
Stability chambers are designed to control environmental parameters such as temperature, humidity and radiation levels.
Naturally it is essential to demonstrate that a chamber can in fact control these parameters within a specified accuracy, at all points in and around the chamber, over a time period specified.
Stability chamber can vary in size, and often they are used to store critical pharmaceutical product. After the initial validation exercise many companies proceed to monitor these chambers with alarms on the critical parameters. Strictly these chambers should operate with levels of assurance similar to those achieved in the validation of autoclaves. So a periodic re-validation exercise is necessary.
Stability chamber temperature ranges can vary from 40°C to -80°C. TQSoft™ can perform validation studies with industry standard recorders such as those from Yokogawa. Recorders are often the best choice because they can be setup easily with TQSoft™ to calibrate and map temperature, humidity and luminescence with one unit.
TQSoft™ with MadgeTech can be used to map temperature and TQSoft™ with TMI can be used for temperature and humidity.
TQSoft™ offers the validation engineer great flexibility because it can combine data from different measurement sources into a single 21CFR compliant audited chart and data report.
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 Check 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 setup Mean Kinetic Temperature calculations on any group of sensors over any interval of time.
TQSoft™ Interval Calculations feature can be used to track critical parameters and immediately highlight any test data that is not within specification.
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.