Rotronic Amebis Stability Testing System

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