Stability Test Chambers in the pharmaceutical sector

Stability test chambers are enclosures used to evaluate the effects of prescribed environmental conditions on biological materials and industrial services / electronic components. The most common use of this stability rooms (sometimes also referred to as tubes) is that the stand-alone test sample decomposition and reduced efficiency in different conditions of temperature and humidity.

Small-scale nuclear tests of stability

Humidity Control Chamber

Rooms were initially high and Stabilityproperty, but the demands of modern test applications, have led to smaller, portable devices. This is often called the "Small scale tests of stability" and is often used in food and pharmaceutical testing.

The use of wireless technology provides convenient wireless kit, complete with calibrated sensor data logger plugs and related software compatible with the recording software.

How stability test works

1 Capsule humidity are used to control the humidity in the testRoom
2 The capsule pierced and humidity in the test chamber
3 The test material is placed in one of the other subjects in the test chamber
4 Caps contain a temperature sensor and humidity sensor on the inside of the cap
5 The sensor cap is also used to seal the test chamber
A cap 6 logger, which contains a memory chip and short-range transceiver, is connected to the sensor cap and serves to collect and transmit data by radio to the controlSoftware
7 Before connecting the cap logger must first check the settings got the docking of the cap logger at the base station that is connected to a computer or laptop.
8 The logger is then connected to the cap of the sensor cap to start the test. The device is then maintained at the required temperature for the incubation time needed.
9 The temperature and humidity in the test are then transmitted wirelessly to the control software for the presentation and documentation.

Each test monitormay, in its micro-humidity chamber and humidity settings for the test requirements are manifold. Some stability tests to be sold complete with control software customizable and integrated offsite backup, which is useful when testing a large number of samples or if many places will need to share test data quickly.

If possible, try to get your stability test chambers from a provider that also offers repair and calibration. The integrity of the data basedon properly calibrated and fully functional units.

Stability Test Chambers in the pharmaceutical sector

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