Rotronic Stability Testing System Data sheet

Flexibility with Compliance

The Amebis Stability Testing System

The Amebis Stability and
Testing System offers
Pharmaceutical and Biotech
companies the ability to quickly
and easily test product quality
for humidity and temperature
stability. Smaller product
samples and speedy results
allow for inexpensive testing
saving time and money.



Flexible and compliant Small Scale Stability Testing System



21 CFR Part 11 and GAMP compliant



Wireless technology used for data transmission

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No humidity chambers required



Each test monitored in its own micro-humidity chamber



Full range of humidity conditions available (0-95%RH)

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Continuous data collection throughout with automatic data backup

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Improved sample integrity and less risk of cross contamination

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Incorporates latest sensor technology (ROTRONIC HygroMer®
humidity sensor with Airchip 3000 )



Sensors can be easily calibrated

ROTRONIC Instrument Corp, 135 Engineers Rd, Suite 150, Hauppauge, NY 11788

Email: [e-mail]. Web: www.rotronic-usa.com Phone: [phone]

The Amebis Stability Testing System is a flexible and compliant means of performing small scale stability testing.
The system can be set up in minutes with a full range of environmental conditions available. The humidity capsule
which generates the required humidity and the test material are placed in separate compartments within the test
chamber and the chamber is then sealed with a sensor cap. The humidity capsule controls the humidity within the
test chamber and the sensor on the inside of the sensor cap measures the temperature and humidity within the
chamber. 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.

The sensor cap contains the latest in sensor technology, the ROTRONIC HygroMer® humidity sensor with Airchip

3000. Each sensor cap contains a unique serial number and is supplied with a calibration certificate. A logger cap
is docked to the base station which is connected to the laptop via a USB cable. Test settings are sent to the logger
cap which is then attached to the sensor cap. The logger cap is powered by a 9V battery and contains a memory
chip and a short range transceiver. The logger cap collects and stores the temperature and humidity readings and
transmits the data wirelessly to the control software. If the initiated tests are outside wireless range for
communication with the base station then cabling and aerials can be provided to ensure wireless communication.

1. Pierce humidity capsule
seal and place in test
chamber

5. Connection of the logger cap to the sensor cap initiates the
test. Temperature and relative humidity readings are collected
and stored on the logger cap. The data is transferred wirelessly
to the control software as required by the user.

2. Place test material in either or both

3. Seal the chamber with a sensor cap

of the two smaller compartments

4. Dock logger cap on base station for programming