Symbion Systems has announced the availability of a data sheet (PS:SA 2000) covering the Symbion Appliance.
This is a hardware device that provides the first fully locked-down approach to the deployment of analytical instruments in a process-analytical-technology (PAT) environment.
The deployment of analytical systems under the governance of FDA regulations is an ongoing concern for scientists and engineers wishing to transfer their research and development efforts to chemical process analysis.
The Symbion Appliance addresses this concern by providing a limited set of locked-down and rigorously tested algorithms, thus inherently providing for the compliance under 21 CFR Part 11.
Each algorithm is dedicated to a specific method and application, controlling a specified analytical instrument and sampling system, accepting structured inputs from the instrument and providing outputs in the form of process-variable predictions.
The hardware is a ruggedised yet standard off-the-shelf single-board industrial device.
It contains a solid-state hard drive and is ready for immediate deployment.
The interaction with the appliance is via a choice of a thin client or a client/server - allowing the user, with appropriate permissions, to select from the dedicated set of algorithms.
Each of these is designed for a specific application, such as drying, blending or reaction monitoring.
The Symbion Appliance employs the Concentric Levels of Confinement concept.
The individual method to be deployed operates under a secure application layer, which employs an embedded version of the Symbion RX Process Analytical Software package.
This in turn operates under the secure Windows Embedded operating system.
Finally, the software is resident in a secure, highly reliable, industrial hardware package employing no moving parts.
The application layer, operating system and hardware are prevalidated as a unit.
Individual methods can only be uploaded from a Symbion database - which provides the audit trail required by 21 CFR Part 11.
Communication between the appliance and individual analytical instruments is via a set of instrument-specific drivers, which do not require instrument vendor software to be resident on the appliance.
