Topic: Batch Management
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White Papers: In Depth Research
Safety Logic in Modular Batch Automation
Author: Thomas E. Crowl, Principal Application Engineer, Siemens Moore Process Automation Inc; Cynthia L. Benedict, Lead Project Engineer, Siemens Moore Process Automation Inc.
In the early days of batch automation there was usually a central computer that controlled everything. This computer ran recipes, executed sequential logic, did data acquisition of process variables and also performed direct digital control (DDC) of analog and discrete devices. Since one computer did every thing from sequencing to DDC it was only natural to imbed the shutdown and safety logic into the batch sequential code that was running normal operations. And since one huge monolithic program ran the entire process, the safety logic was always running. In modern S88 (IEC61512) based modular batch automation systems the monolithic code has been replaced by smaller reusable phases controlled by a batch manager that runs recipes. Many who have grown up with DDC imbed safety logic inside the phases. This approach requires an active equipment phase at all times to keep safety logic available at all times. There is a problem with this approach. Phases are transient by nature. They have a beginning and an end. You cannot guarantee that there will always be an active equipment phase. Although there may be some holding logic associated only with a specific phase, often this logic is generic and should be moved up to the unit level. This paper looks at methods available to the user for safety and exception recovery logic in current modular batch systems. Included are case studies of five separate batch projects where recognizing exception conditions and executing safety shutdown logic was essential.
Integrating Batch Automation with New Product Development: Meeting the Challenge
Author: Steve Phelan, Senior Vice-President, Formation Systems Inc.
A major cosmetics manufacturer had just finished the first production run of a brand new skin cleanser, when the error was discovered – an ingredient in the cleanser was wrong. Upon investigating, it was discovered that a data entry person had accidentally keyed not the final approved formula, but a previous unapproved version into MES/ERP. The entire production run, including bottles and labels, was disposed of at a $250,000 loss. Traditionally, it has been difficult for product developers to share information not just with manufacturing, but even among themselves. Formulas, and other product development data has been scattered across the enterprise in various R&D labs, and isolated in spreadsheets, legacy systems, disorganized file cabinets or lab notebooks. Due to the lack of a centralized product development information system linked to MES/ERP, formulas have usually been manually keyed, inevitably creating batch errors. A new breed of product development software has emerged that centralizes all product development data, automates the product development process and creates a seamless link between R&D and MES/ERP, ensuring accurate and timely communication not only of new product formulas, but also of modifications to existing formulas. This presentation will highlight this software and detail how it can be used to improve integration of batch automation with new product development.
Integrated Batch Solution for Pharmaceutical Rubber Production: The IPS Approach
Author: Alastair Orchard, Application Technology Manager, ORSI Group
Talk integration to a vendor and a customer and you’re likely to get two very different points of view, despite the emergence of standards designed to reconcile these differences. By too carefully defining the limitations of software packages, we risk limiting the functionality of the very manufacturing operation we intended to improve. A responsive, integrated Batch Solution must be capable of positioning itself in the context of the Enterprise Production System, responsible not only for executing a planned sequence of operations, but also for the wider repercussions of its actions. This paper describes the implementation of an Integrated Plant System (IPS) for a major multi-national pharmaceutical company. Of particular interest from a Batch perspective, the asynchronous manual and automatic activities of over 100 recipes are tied to stock movements to ensure raw material is available at the right place and time. This illustrates the point that synchronization is integration, both at the Batch and Enterprise level. The production facility in Milan, Italy, was modeled using the IPS paradigm, and now coordinates all operational activities from equipment maintenance through inventory management to order scheduling and MRP.
Establishing Compliance of Batch SCADA Systems with FDA cGMP 21 CFR Part 11
Author: Stanley L. Whitman, Consulting Project Manager, Raytheon Consulting & Systems Integration Inc.
FDA enforcement of a 1997 cGMP regulation, 21 CFR Part 11, for electronic records and signatures, is imminent. Compliance policy Guidelines were issued May 1999 to clarify the agency’s expectations of pharmaceutical and medical device manufacturers. FDA scrutiny of system implementations is anticipated to be extensive. The popular use of “open” architectures and commercial-off-the-shelf software products for automated batch control and data management has introduced many challenges to compliance with this regulation. In addition, legacy systems are not exempt and verification of data integrity compliance is expected to be retroactive. Batch SCADA systems have the proven ability to reduce costs and improve product consistency and the industry is heavily dependent upon their continued application in the manufacturing environment. Regulatory requirements shall be reviewed, with real-world examples of assessment and compliance resolution for Batch SCADA Systems. System functionality requirements shall be stressed without direct reference to product or service brand names.
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