Stability Testing: Mapping, Qualification, And Monitoring Temperature And Humidity

By Veriteq Instruments

Stability testing and monitoring is a critical step in drug research, development and manufacturing. It impacts how pharmaceuticals are produced, packaged, labeled and sold. However, creating the exact environmental conditions in a stability test is a complex process, but necessary to comply with standards defined by regulatory bodies like ICH and the FDA as well as to ensure the safety and efficacy of pharmaceutical products. If the data compiled during a stability study is inaccurate or incomplete, the credibility of the study is at risk and creates the potential for devastating liabilities and loss. Background knowledge of the basic attributes of sensors, their calibration details and the recording and reporting capabilities is helpful when deciding on a system for performing accurate, gap-free stability studies.

A sensor at a given point can record temperature and humidity, but there are other parameters that must be taken into account lest the data obtained comprise only evidence of conditions at that point. A truer picture is gained for the test environment by considering uniformity of conditions and calibration uncertainty of the measurement device.

To establish uniformity, mapping a stability chamber is necessary. To manage calibration uncertainty, Veriteq factors temperature non-uniformity into their calibration process. Before calibrating our humidity sensors, we perform a high-accuracy temperature calibration on every data recorder. Each recorder's measured temperature is then able to compensate for chamber nonuniformity during RH calibration — greatly reducing this source of error.