Stability Testing Chambers in the Pharmaceutical Industry

Stability testing chambers are enclosures used to assess the effects of pre-specified environmental circumstances on biological materials and industrial/electronic components. The most common use of these stability chambers (sometimes referred to as environmental chambers) is that of stand-alone specimen testing for decomposition and reduced efficiency under various temperature and humidity ranges.

Small Scale Stability Testing

Stability chambers were originally large and immobile but the demands of modern testing applications have led to smaller, more portable units. This is often called "Small Scale Stability Testing" and is commonly used in Food and Pharmaceutical product testing.

Using wireless technology provides convenient wireless test kits complete with calibrated sensor caps, logger caps and related logging software compliant software.

How Stability Testing Works

1. Humidity capsules are used to control the humidity within the test chamber

2. The humidity capsule is pierced and placed in the test chamber

3. The test material is placed in one of the other compartments within the test chamber

4. Sensor caps incorporate a temperature and humidity sensor on the inside of the cap

5. The sensor cap is also used to seal the test chamber

6. A logger cap which contains a memory chip and short range transceiver is connected to the sensor cap and is used to collect and transmit data wirelessly to the Control Software

7. Before connection the logger cap must first receive the test settings by docking the logger cap on the basestation which is connected to a computer or laptop.

8. The logger cap is then connected to the sensor cap to initiate the test. The unit is then incubated at the required temperature for the require time.

9. The temperature and humidity test conditions are then transferred wirelessly to the Control Software for presentation and reporting.

Each test monitored in its own micro-humidity chamber and humidity settings can be varied according to the testing requirement. Some Stability Testing are sold complete with customisable control software and built in offsite backups which comes in handy if when testing a large number of samples or when many locations need to share testing data quickly.

If possible try to source your stability testing chambers from a provider that also offers repair and calibration services. The integrity of the data is based on properly calibrated and fully functional units.

Amebis Ltd specialises in small scale stability testing chambers for the pharmaceutical industry. Manufactured in Ireland and available to Europe and the US. http://www.amebisltd.com.

This post was made using the Auto Blogging Software from WebMagnates.org This line will not appear when posts are made after activating the software to full version.

Temperature-Humidity Sensors in Pharmaceutical Testing

Pharmaceutical Products fall under some of the most stringent regulations of any manufactured good out there. Product testing against varying environmental conditions need to be recorded using both accurate temperature-humidity sensors and reliable data logging software.

Such process control testing is referred to as stability testing because test materials are analysed for any degradation or significant physical changes throughout various temperature and relative humidity settings.

The stability of a pharmaceutical product is a measure of its ability to resist deterioration during the period within which its properties and characteristics can be expected to remain with certain limits. All articles intended for use in diagnosis, mitigation, treatment of prevention of disease undergo some form of testing, often multiple times in the product development cycle, from drug development to package selection. ?

Temperature-humidity sensors are just one portion of a stability testing system. Older more cumbersome systems make use of large environmental chambers to contain all the test samples. The disadvantages of environmental chambers are that you can only test the samples for one temperature and relative humidity setting in equipment that takes up a lot space and has high running costs. Modern bench-top stability testing units or "small scale stability testing units" allow for many different sensor readings to be logged at the same time in a relatively small amount of physical space. ?

Calibration requirements for temperature-humidity sensors ?

Generally speaking temperature sensors require less calibration as they tend to maintain better accuracy levels. The humidity sensor will require more frequent calibration as accuracy can shift at higher temperature ranges. This is not a substantial problem if the product in question needs to be tested for relatively low temperature ranges but is the control process requires cycling over a large temperature range then a robust temperature-humidity sensors with frequent calibrations is recommended.?

When purchasing new and used units it is also advisable to ensure that calibration certificates are provided with the purchase (Don't forget to ask if the certificates are traceable and for which regions they are valid). A calibration certificate should be a minimum requirement to conform for international standards. ?

Various international validation requirements also regulate the way electronic signatures are used, how electronic data is stored and other computerized system requirement affecting Stability Testing. So not only must your sensors be compliant but also any associated data storage units. Those interested in further reading would do well to reference the FDA 21 GMP's Eudralex volume 4 requirements.

Their unique temperature-humidity sensor and 21 CFR part II compliant Amebis Control Software provide one of the most flexible solutions available today. http://www.amebisltd.com/temperature-humidity-sensors-pharmaceutical/

This post was made using the Auto Blogging Software from WebMagnates.org This line will not appear when posts are made after activating the software to full version.