Temperature and moisture in pharmaceutical testing

Pharmaceutical products are covered by some of the strictest regulations of any product out there. Product testing to changing environmental conditions must be recorded with two temperature sensors and humidity accurate and reliable data-logging software.

These tests control process is called the stability test, since test materials are analyzed for any significant deterioration or physical changes during the different temperature and relative humiditySettings.

Humidity Control

The stability of a pharmaceutical product is a measure of deterioration during the period in which its properties are provided and features to be able to withstand certain limits. All items for the diagnosis, mitigation, treatment, prevention of disease undergo a form of tests, often several times in product development, development of drugs for the selection of packages.

Temperature and humidity are just aPart of a test system stability. On older systems use bulky tubes large, all samples included. The disadvantages of air chambers that can be tested samples of temperature and relative humidity setting in equipment that requires a lot of space and high management costs. Table unit stability test, or "smallest unit of stability test" allow for many different sensor data at the same time be registereda relatively small amount of physical space.

Calibration for temperature and humidity sensors

In general, the temperature sensors require less calibration, because they tend to maintain a higher degree of accuracy. The humidity sensor has an accuracy of calibration can move frequently at higher temperatures. This is not a significant problem if the product should be tested for relatively low temperature ranges, but the control requiresCycling on a wide range of temperatures, then a robust temperature-humidity sensors with frequent calibrations are recommended.

When purchasing new and used units, it is also appropriate to ensure that the calibration with the purchase (do not forget to ask if the certificates are traceable to the regions and which are valid) are provided. A calibration certificate is a minimum requirement to comply with international standards.

Several international validationRequirements also govern the manner of use of electronic signatures, electronic data stored, and other requirements of the computer system is to test the stability. Not only should the sensors must be compatible, but also stores all its data. Who could be interested in further reading to do well, the FDA GMP requirements Eudralex 21 Volume 4 of reference.

Temperature and moisture in pharmaceutical testing