Formula Management and Download
For many manufacturing processes, the rapid and consistent set-up of equipment is the key to flexibility and consistent quality. Formula management has its focus on the management of formulas and equipment, for consistent parameter value transfer to control systems. Formulas are defined as independent of shop floor equipment. This enables users to centrally manage product definitions for use in multiple production locations, irrespective of each location’s automation system.
Formula download is simple, making use of the web-based user interface. Operators assign formulas by browsing and then making a selection from a list of available and approved formula instances for specific equipment. Operators are then able to review the assigned target values, adjust them within the supplied limits, then download the formula to the connected automation system.
Recipe Management and Execution
Recipe management and execution enable users to create procedures which define the order of equipment execution. A recipe contains the defined procedure, as well as a mapped formula defining the making of a product, through the association of a formula and capability parameters.
Manual capabilities are at hand for manual data entry and acknowledgement. In order to execute a recipe, an operator simply assigns a recipe to the appropriate equipment. Then the operator starts, monitors and controls its execution. Operators can adjust parameter values within the defined limits. This can be done before the recipe start, or even just before the capability is executed.
Electronic Change and Execution History Record
Comprehensive reporting and history records enable users to view historical information relating to formulas and recipes that have been created, changed or executed. Equipment, formulas, as well as recipes, are all “versioned” items. This means that any configuration change increments the version number. Electronic records are automatically created for formula downloads documenting the parameter values, as well as for recipe execution.
Electronic records can be configured for electronic signatures as well. Electronic signatures (done by/check by), which include optional comment enforcement for actions, are available for the facilitation of implementations that comply with life science industry regulations. These include FDA 21 CFR Part 11, or cGMP guidelines (EudraLex Vol. 4 Annex 11).
Integrate with All Automation Systems
It is possible to integrate the software with System Platform, or it can be used stand-alone with any control system, via the OPC UA Data Access specification. Using a state interface that can be configured to provide full alignment with ISA-88 standards, the recipe procedure is coordinated with the control system. The Recipe Management user interface can be accessed via a web browser on mobile devices, via a desktop or via HMI. Operators can access the execution web page in a browser, or by using a browser control within InTouch for System Platform, or by making use of other HMI software.