The purpose of stability testing is to provide evidence on how the quality of a pharmaceutical product or
cosmetic product varies with time under the influence of a variety of environmental factors such as temperature,
humidity, and light. The Rotronic Amebis stability testing system makes it possible to establish a re-test
period for the product and recommended storage conditions.
The Rotronic Amebis stability testing system uses small compartmentalized plastic test chambers for holding
the test material and a humidity capsule for controlling the humidity. Each test chamber is sealed with a
sensor cap with advanced humidity and temperature measurement technology. A logger cap is attached to the
sensor cap to store the temperature and humidity readings from the test chamber. The readings are then
transferred wirelessly to a base station and included laptop with the Amebis software for processing and presentation.
Humidity capsules providing relative humidity in the range 0-95% are available in 5% increments. The color
coded humidity capsules are labeled with a product code and batch number. Each sensor cap contains a unique
serial number and is supplied with a calibration certificate. The logger cap contains a memory chip and a
short range transceiver and connects to a laptop or PC via a USB cable
Standard Components
- Laptop with control software
- Base station
- USB cable for connection between base station and laptop
- 5 sensor caps with calibration certificates
- 5 logger caps
- 5 test chambers
- 5 batteries (9V)
Benefits of the Rotronic Amebis Stability Testing System
- High level of flexibility: each test is monitored in its own micro-humidity chamber
- Improved sample integrity with less risk of cross contamination
- Ideal for use with toxic materials
- Full range of humidity conditions available
- Can be used with a temperature incubator within the range of 0 to 60 °C
- Continuous data collection throughout the study for each test
- Data on environmental conditions can be collected up to analysis
- Automatic backup of data
- Complies with GAMP V and 21 CFR Part 11
- Easy to set-up
- Small space requirement
- Sensors can be easily calibrated
- System can also be used for monitoring and mapping applications
