Symbion Systems, Inc. has announced the release of Symbion-EX, Version 2.5 Chemical Process Analytical Deployment Software for continuous on-line monitoring.
The new software package provides a secure environment for the locked down deployment of analytical instruments for use in chemical process analysis.
The deployment of process analytical technology (PAT) 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.
Symbion-EX addresses this concern by providing a strictly controlled set of locked-down and rigorously tested algorithms - thus inherently providing for 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.
In addition, Symbion-EX can be configured to execute multiple algorithms simultaneously, allowing the control and coordination of multiple analytical systems within a given unit operation.
Analytical results are routinely reported to higher level (enterprise) data systems via a secure MODBUS or OPC link.
Methods to be deployed for statistical process control (SPC) using Symbion-EX are downloaded from the Symbion-RX Process Analytical Software Suite. These products provide a comprehensive capability for analytical process development.
The latest version, Version 2.5, preserves all of the advanced features of earlier versions while adding several new capabilities, including a significantly expanded database functionality, instrument control, spectroscopic data processing, and methods development capabilities.
The result is a true universal “Spectroscopic Data System” for use in LIMS, pharmaceutical PAT (Process Analytical Technology) development, and on-line chemical process monitoring - in essence, closing the loop in Quality by Design (QbD).
A significant development with the introduction of Version 2.5 was the inclusion of the Oracle™ products as the standard database platform underlying Symbion.
Symbion Systems has been certified for Gold Level membership in the Oracle Partner Network (OPN).
As a result, Symbion now offers a broad range of Oracle products, including the Oracle Standard Edition with full Oracle support.
In summary, the Symbion family of software products provides a standardized platform for controlling a wide range of spectrometers and other analytical instruments.
In addition, it provides comprehensive data manipulation and chemical development capabilities as well as the ability to communicate with numerous chemometric routines, other third party programs, and enterprise-wide data systems.
Symbion also provides comprehensive multi-instrument analytical capability within a single program, eliminating the need to train operators and analysts on a variety of different software platforms.
Symbion-EX allows all of these capabilities to be deployed continuously on-line in a secure, locked-down package, enabling the control of all analytical functions within a unit operation.