PAT (Process Analytical Technology)

Process Analytical Technologies (PAT) has become an increasingly important approach to improved process characterization in the development of pharmaceuticals including products created from fermentation and bioprocessing. The ILS Batch Expert software is designed for incorporation of various PAT sensors and on-line analyzers such as the YSI glucose analyzer (www.ysi.com), the VG Prima dB mass spectrometer from Thermo Electron (www.thermo.com), optical density probes from Optek (www.optek.com), and capacitance-based biomass probes from Aber Instruments (www.aberinstruments.com). Real-time data from these instruments are used within the control recipes of Batch Expert to improve the yield and operation of fermenters and bioreactors. Please contact ILS for more information on how you can incorporate PAT technology with real-time process control.

Data Management

System Integration

Batch Expert provides a platform to interface real-time, offline, and laboratory data.  This data becomes available for data warehousing and reporting, process control and monitoring, event detection, alarming, and auditing.  Interfaces are available to real-time instrument such controllers and distributed control systems.  Off-line measurements, such as glucose and off-gas analyzers can be brought into Batch Expert through a variety of interfaces.  In addition, laboratory assays directly enter through simple web browser or collected from laboratory information systems (LIMS).  In combination with batch header information that describes the initial culture provides a means to streamline and optimize the process development or manufacturing process.

Data Warehousing

In many laboratories it is difficult to quickly collect batch header, real-time, and laboratory information regarding a particular batch run.  Generating reports based upon this data is often an arduous and time-consuming process.   Based upon affordable off-the-shelf databases, it is possible to centralize this data so that it can be archived and quickly retrieved in the future.  This includes batch-header information, real-time, and laboratory measurements.  Batch Expert and its database are configured specially for batch processes.  This ensures data is efficiently stored and easily retrieved.  End users have a seamless and simple interface to configure batch runs to collect data and retrieve historical data and their desktop.  In a matter of moments, users can query past data based upon such criteria as batch-id, operator or project name, culture type, and more.  

Event Detection and Auditing

Event detection is a key component in improving a process through real-time process identification, monitoring, and control of critical process parameters conditions.  Events are categorized as detection, control, or manual intervention.  Physical events include such items as tracking initial culture or batch conditions, patterns in measured or inferred values (a peaks in DO, a time pH dropped, etc.).  Control events can include auditing changes in the batch phase (when induction occurs), tracking changes in set point, and changes in set point or supervisory control conditions.  Manual events include operator interaction with controllers and or feedback in the form of checklists.  Events can be the basis for process control and monitoring.  In addition they provide a means to audit and diagnosis the process.

Batch Control and Monitoring

Combining Recipe Execution and Process Monitoring

Recipe execution requires performing a set of actions on one or many processing units.  These action may range from automated tasks such as downloading set-points to controllers to manual tasks such as adding ingredients.  The recipes often differ based upon the product produced but may differ based upon available equipment.  In order, to provide the most value to operations the recipe should combine the execution of process actions with process monitoring.  Process monitoring generates events that execute process actions.  For example, the rate-of-change of temperature has exceeded 10 degF/minute for 2 minutes it is appropriate to lower the batch temperature set-point.  Batch Expert has a highly flexible recipe execution system based upon the ISA S88 guideline.  The system can incorporate process monitoring and model based control with process actions.  In addition, the system is designed to take into account for communication or equipment failures that may lead to operations aborting or stopping the recipe.  For further details please contact ILS.

Event/Rule Based Control

Batch Expert is uniquely designed to automate rules and reason over a set of events.  Rules and events can be based upon process measurements or combine to include operator decisions.  An example rule is the dissolved oxygen (DO) has not increased at least 10% after a pulse of glucose nutrient, reduce the glucose feed set-point by 10%.  Batch Expert includes several means of implementing rules from graphical programming to traditional procedural programming.  For further technical or application details please contact ILS.