Glossary of Terms

Amebis System 

An Amebis product used to provide controlled environments for use in pharmaceutical stability studies. The product will provide a means by which the temperature and humidity in those environments can be controlled, monitored, collected, stored and transferred to a PC interface where the data can be retrieved and viewed. The product can also be used for the wireless monitoring and mapping of rooms and cabinets.

Test

An individual unit that is initiated on the Amebis Control Software. For stability studies a unit will have a sample of the product contained within a test chamber connected to the sensor cap with an activated attached logger cap. For Monitoring and Mapping there will be no attached test chamber. If the Amebis Control Software is used as a diary for Stability Studies only then there won’t be an activated logger cap attached to the test.

Run

A number of tests set up for incubation at the same environmental conditions and with the same limits on these environmental conditions.

Session

The time monitored by a run.

Run time

The time period for which an individual test’s run is controlled i.e. readings are collected and compared to limits if set.

Controlled Status

A test is said to have a controlled status during the period of its run time. During the run time the data collected by the test is compared to limits if set and can be automatically downloaded via a designated remote station.

Monitoring Status

A test is said to have a monitoring status when its run time has expired. The data collected by a test with a monitoring status is not compared to limits and can only be downloaded by manual remote or direct commands at the basestation.

Download

The retrieval of data collected by the logger cap to the system database.

Remote download

A download operation in which the retrieval of data is performed from an undocked logger cap through radio frequency commands.

Automatic download

A remote download that is performed by the Amebis system at intervals set by the user. Only tests which are currently controlled will be downloaded.

Controlled Download

A remote download that is performed by the Amebis system, similar to the automatic download, but initiated manually. Only tests which are currently controlled will be downloaded.

Manual download

A remote download that is performed by a direct command to the system by the user.

Direct download

A download operation that involves direct connection of the logger cap to the system’s basestation.

Profile

Target environmental conditions for a test during a run. Will also include limits on the environmental conditions and a text title for the Profile.

Sensor Cap

A cap, which incorporates a humidity and temperature sensor and the associated electronics that allows the environment to be monitored.

Logger cap

A device that connects to the sensor cap and collects and stores the temperature and humidity readings taken by the sensor in the sensor cap. This data is transmitted via radio frequency to the remote station or basestation components of the system from where it is transferred to the interface software. The logger cap also accepts the session settings and commands that are inputted at the interface software.

Remote station

A device that is placed in the temperature cabinets or other location where the test units are held. The remote station wirelessly communicates with the logger caps and transmits the data and information sent to it by the PC via the basestation.

Basestation

A device that is hardwire connected to the remote station and the PC on which the system’s interface software is held. The basestation communicates settings that are entered into the software by the user to the logger caps and accepts the data collected by the logger cap that is transferred from the remote stations. The basestation can also accept data from logger caps without the remote stations either remotely by radio frequency or directly by connecting the logger cap to a d-sub connection on its upper surface.

Run ID

Unique number provided by database to every run which is successfully initiated.


Test ID

Unique number provided by database to every test which is successfully initiated. The first part of the number is made up of the run ID followed by a dash and two digits representing the test within the run i.e. 054-03.

Station ID

Number on every remote station and basestation which is used to communicate with logger caps associated with run conditions linked to the remote station or basestation.