TUSTIN, Calif. – Symbion Systems, Inc., a leader in providing process analytical software for analytical instrument control, analysis, and connectivity, today announced the introduction of the Symbion Appliance, a hardware device which provides the first fully locked down approach to the deployment of analytical instruments in a process 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 the process environment. 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 ruggedized yet standard off-the-shelf single-board industrial device. It contains a solid-state hard-drive and is ready for immediate deployment in a process environment. 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 which is designed for a specific PAT-related application such as drying, blending, or reaction monitoring.

The Symbion Appliance employs the concept of Concentric Levels of Confinement. 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.

About Symbion Systems, Inc.

Symbion Systems, Inc. was founded in 2002 to develop and market standardized instrument control and data management software for the analytical instrument and process analytical industries. The company’s products are employed both by instruments manufacturers for instrument control and data handling and by end-users for integrating diverse functions in laboratory and process installations. In addition, Symbion works closely with its sister company, Axiom Analytical, Inc. to develop and implement hardware and software systems for on-line process analysis.

More information about Symbion Systems, Inc. can be found at http://www.gosymbion.com/.