Tip:
Highlight text to annotate it
X
the Amebis Stability Testing and Monitoring System is a flexible and compliant
means the performing small-scale stability testing and the monitoring and
mapping of rooms and chambers.
The system can also be used to monitor the environmental storage conditions
during the shipment of samples.
For small scale stability testing a large range of environmental conditions from
zero to sixty degrees celsius
and zero to 100%RH can be generated, controlled
and controlled and accurately monitored with minimal space requirements and without the
need for desiccators or environmental chambers.
Stability testing is performed by the addition of the test material and
humidity capsule to a test chamber.
The test chambers the plastic piece divided into three compartments.
To the larger compartments is added the humidity capsule used to control the
humidity within the test environment.
The test material is placed in either two of the small compartments.
Sample vials can be used if only small amounts of test material are available.
The sample vial contains a porous membrane in the cap to
penetration.
Humidity capsules are available within the range 0 to 100%RH
at operating temperatures of zero to 60 degrees Celsius.
Each humidity capsule is labelled with the batch code, expiry date and
part code.
From the humidity capsule datasheet the user can ascertain the relative
humidity generated from each different type of humidity capsule
operation across a temperature range
The datasheet will allow the user to choose a humidity capsule to generate the
required humidity conditions
at the test temperature.
The sensor cap seals the test chamber and has an in-built Rotronic Hygromer
humidity sensor and Pt100
temperature sensor for the measurement of the environmental test
conditions.
Each sensor cap is uniquely numbered and comes with a Calibration
Certificate.
The small volume of the test environment ensures very accurate and
test specific data.
To capture and store the temperature and relative humidity measurements from
within the test chamber
requires the connection of a logger cap.
The logger cap includes a memory chip for the storage off eight thousand
five hundred temperature
and humidity readings
and a transceiver for the wireless transmission of data.
The logger cap is powered by a nine volt battery and this battery
also powers the sensor when the logger cap is connected to the
sensor cap.
The logger cap is first programmed by the Amebis Control Software
through the docking station on the basestation before connection to the sensor cap.
The initiated test can now be incubated at the required
temperature.
Test readings are taken and stored on the logger cap memory as programmed and
this ensures continuous data collection throughout the study for each test.
The Amebis Temperature Controlled Incubator
can be used to control the test temperature.
These compact incubators can be stacked three high
and have a working temperature range of five to sixty five degrees Celsius.
The temperature and relative humidity readings stored on a logger cap can be
downloaded wirelessly to the Amebis Control Software via the
basestation.
Both the basestation and the logger cap
contain a transceiver for wireless communication.
The user can request the data via the Amebis Control Software
or the software can be programmed to download the data at set times.
The data is maintained on the logger cap as a backup precaution until the
test is complete.
The logger cap can also continue to collect measurements once the test is
removed from the incubator resulting in the collection of data on the
environmental storage conditions for the test material right up to the time
of analysis.
Data can be downloaded from the logger cap wirelessly
or by connection of the logger cap to the basestation.
Once the data is downloaded to the Amebis Control Software it is processed
and presented in various reporting and graphical formats.
The Amebis Control Software is twenty one CFR Part eleven compliant and
includes a networked database.
The software has many features for alarming and presentation of data
The easy generation of a large range of environmental conditions and the
reviewed.
The easy generation of a large range of environmental conditions and the
accurate measurement of test specific data makes the Amebis system ideal
for performing stress testing, forced degradation, polymorph and
re-crystallization kinetic studies.
Pre-formulation and formulation development stability studies can also
be performed using the Amebis system.
The design of the test chamber ensures different test materials can be confined to
their own enclosed test environment
resulting in improved sample integrity and less risk of cross contamination
and is ideal for potent or toxic materials.
The Amebis system can be used for the wireless mapping and monitoring of
rooms or cabinets by simply replacing the test chamber with a
stand.
The Amebis Control Software can present the mapping and monitoring
data in a range of reporting formats.
In the context of ICH Q ten,
product can truly achieve a state of continual improvement
by quality access to significant real time data as facilitated by
Amebis technology. In addition, the concepts of process analytical technologies
and Quality by design, currently applied to pharmaceutical manufacturing,
could also be extended to include stability testing utilising
Amebis Technology.
Find our more at www.amebisltd.com