In the Spotlight November 2011

Editors' Picks of Pharmaceutical Science & Technology Innovations

FDA's recent guidance on process validation emphasizes scientific understanding and the effective control of manufacturing processes. The document reflects the shift towards monitoring and measuring process parameters to ensure product quality. This month's products can help drugmakers continue to verify that their production lines are operating as expected. A new mixer from Silverson provides users with information about the mixing process. Software from TrackWise helps companies track documents related to corrective actions. A process-control suite from Honeywell is designed to enable central control of all systems at a manufacturing plant.

Software centrally monitors process-control systems

Sparta Systems's TrackWise Preclinical GLP and Clinical GCP Auditing Solutions includes a wide range of document-control functions that enable the transfer of attachments, through a web service, to other enterprise applications. The software is designed to manage all information securely in a centralized, scalable, and reliable enterprise system. It also generates reports to monitor and review auditor resource allocation and scheduling, draft and formal audit reports, and reports to track and trend findings and corrective actions to enable continuous improvement.

TrackWise Auditing Solutions Sparta Systems www.spartasystems.com

The system allows an administrator to define user roles, as well as specific permissions and assignments directly from pre-existing enterprise applications. The creation of user accounts for supplier and customer access portals and web forms can be automated. TrackWise can also interact with other enterprise software systems through a web services interface, thus enabling constant communication with enterprise resource planning, customer relationship management, laboratory information management systems, and manufacturing execution systems software.

Mixer performs under full-scale conditions

Silverson's Verso In-Line laboratory mixer is equipped with a digital tachometer, integral programmable timer, and simultaneous amp reading, thus allowing the user to monitor power draw and mixer speed over time throughout the mixing process. It operates at variable speeds as high as 8000 rpm. The unit incorporates single or multistage interchangeable workheads and stator screens.

Verso In-Line Laboratory Mixer Silverson Machines www.silverson.com

The mixer has a 1-hp drive unit and a self-pumping flow rate of as much as 6.5 gal/min. Its instrumentation is augmented by the Silverson DataLogger program, which allows the user to plot information in a graph and archive readings or integrate them into databases. The Verso is a sanitary mixer designed for clean-in-place capabilities. The unit incorporates the design features of larger mixers in Silverson's UHS range.

Software manages information in a centralized enterprise system

Honeywell's vendor-neutral process-control suite allows plant operators to centrally monitor and control process-control systems. It is designed to avoid the information silos that can be created by Advanced Process Control (APC) systems.

Process-control suite Honeywell Process Solutions http://hpsweb.honeywell.com

The suite contains Honeywell's Loop Scout software, which gives control engineers the ability to identify and correct poorly performing control loops. In addition, the Control Performance Monitor detects, identifies, diagnoses, and remedies regulatory and APC asset issues throughout the plant.

The Honeywell Process Solutions suite can work with various APC technologies and processing facilities, thus contributing to consistent performance benchmarking across the enterprise and ensuring that proper corrective action is taken if necessary.