Downtime Solutions Batch Management

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1 Downtime Solutions Batch Management INCREASE PRODUCTIVITY AND QUALITY WHILST ACHIEVING SIGNIFICANT COST SAVINGS With the market demanding faster deliveries, lower prices and higher quality, you need a flexible and reliable batch management system that is consistent with ISA S88 and delivers fast and incremental benefits. In addition, internationally recognized standards require that you comply with increasing regulations such as the US Food and Drug Administration (FDA) 21 CFR Part 11. CitectSCADA Batch is the most reliable batch management solution available to the food and beverage, pharmaceuticals and chemicals industries, enabling you to: Increase productivity Achieve consistent high quality Reduce life-cycle costs Minimize waste Gain regulatory compliance Photo Source: Symrise Germany

2 Improve production efficiencies, lower costs CitectSCADA Batch provides users with many advantages over custom batch solutions including being more open, reliable, scalable and can easily be integrated with other enterprise applications. In addition, it helps manufacturing facilities to become more flexible by allowing them to increase the number of products they produce whilst still maximizing asset utilization John Blanchard, Director of Research, Food, Beverage and Pharmaceutical Industries CitectSCADA Batch enables customers to lower their Total Cost of Ownership (TCO) by delivering a highly flexible, scalable batch management solution to increase productivity and achieve consistent high quality. Providing unrivalled reliability, this easy-to-use offering integrates tightly with existing systems and facilitates compliance with international regulations. With the market demanding you keep costs down and quality up, CitectSCADA Batch is the all-in-one solution of choice to optimize your production process efficiencies whilst increasing your competitive advantage. A fully integrated module, CitectSCADA Batch s design is centered on reliability with multi-level, hardware independent redundancy to ensure continuous production. With exceptional reporting, control and visualization capabilities specific to the needs of the food and beverage, pharmaceuticals and chemicals industries, CitectSCADA Batch controls and documents all automatic actions and manual operations prescribed by the Batch Recipe in accordance with international regulations. CUSTOM VERSUS CITECTSCADA BATCH Unlike custom Batch solutions, which are too often difficult and costly to maintain, this all-inone solution is quick to configure, easy-to-use and inexpensive to maintain. In addition, Citect is quick to respond to revised regulations, and delivers regular product upgrades to ensure you remain compliant. CitectSCADA Batch provides a comprehensive system with which you can model your plant floor, execute parallel processing of Batch Recipes, control up to 99 independent Batch units simultaneously, link to business systems for better tracking and tracing of materials, stock levels, plant utilization and supply chain management, as well as enabling the control of basic operations from any CitectSCADA client/ server. Also, being highly flexible and expandable, it offers an unlimited number of recipes, operations and phases. With local support and training available, CitectSCADA Batch is the way forward for strategic business managers to assure your company's competitive advantage. REGULATORY COMPLIANCE As international regulations governing the security, product specification and quality increase, it is essential that regulated automation manufacturers act quickly but with a strategic business vision for longterm growth. Following the introduction and ongoing revisions of key regulations such as FDA 21 CFR Part 11, manufacturers are using CitectSCADA Batch which facilitates compliance now, and at the same time, delivers continuous efficiency gains through increased productivity, consistent high quality and reduced maintenance and labor costs. Custom versus CitectSCADA Batch FEATURE CUSTOM SOLUTION CITECTSCADA BATCH Lifecycle costs Variable Minimized; controllable Regulatory compliance Difficult to maintain Product enhancements as regulations are revised Flexibility Proprietary standards reduce choices International standards promote choices Scalability Limited Easy to scale Upgradeability Not available Free for Gold Support membership Integration with other software Difficult Included in open solution Global support and training Difficult World-class and available locally

3 and gain compliance APPLIED KNOW-HOW First developed in 1995, CitectSCADA Batch is based on a flexible database structure and has progressed from being designed for MS Windows 3.11 with the ability to execute four simultaneous batches to one which can execute 99, in Windows 2000/XP. Since its inception, customers worldwide have reported increased production efficiency and Citect will continue to deliver exceptional value to customers by developing enhancements as new technology standards evolve. TOTAL INTEGRATED SOLUTION The value CitectSCADA Batch provides to customers increases significantly when delivered as part of a total integrated solution, combining CitectIIM solutions an outstanding suite of analytic modules focused on increasing ROI through the delivery of real-time information on KPIs enabling decision-makers to optimize plant and business processes. Of particular benefit to the regulated industries are CitectIIM Tracking and CitectIIM Quality modules which deliver continuous improvements to areas driving your business. INDUSTRY BENEFITS Companies in regulated automation industries worldwide will realize significant benefits IMPROVE PRODUCTION EFFICIENCIES CitectSCADA Batch offers built-in redundancy for continuous operations and is designed to manage both simple and complex batch control strategies to increase throughput, reduce waste and achieve consistent high quality. Parallel processing and reusable recipe components accelerate the time-to-market whilst superior supervisory control capabilities enable quick changeover time and optimized asset utilization. LOWER TOTAL COST OF OWNERSHIP A low-risk, low capital investment open system solution, CitectSCADA Batch is easy to configure and maintain and continues making you savings as it expands to meet your future requirements. Configuration and system maintenance costs are minimized through powerful functionality, as is the cost of being compliant, with Citect providing automatic upgrades aligned with regulatory revisions. GAIN REGULATORY COMPLIANCE CitectSCADA Batch enables companies to be compliant with Food and Drug Administration (FDA) 21 CFR Part 11 and is consistent with the Instrumentation, Systems and Automation (ISA) S88. INCREASE RETURN ON INVESTMENT (ROI) By integrating CitectSCADA Batch with business level systems such as ERP or CitectIIM Tracking, ROI is increased through the presentation of targeted information to key personnel. This allows for better, more informed decision-making for continuous process improvements. FLEXIBILITY CitectSCADA Batch allows users to develop recipes independently of the equipment on which they are produced, allowing flexibility of the scheduling and execution of the batches. CitectSCADA Batch is independent of the controller hardware and as a result, can communicate with over 100 PLCs, RTUs or DCSs. FEATURES AND BENEFITS AT A GLANCE Easy to configure Easy to use Automate, manage and execute recipes, production orders, reports, audit-trail of creating recipes, and audit-trail of all production activities. Integrated visualization of HMI/SCADA graphics and batch execution Plant Modelling Redundant Batch Server Enable regulatory compliance Seamless integration with other enterprise systems Maintain comprehensive batch history and reports Improve supply chain and order management ACHIEVE CONSISTENT HIGH QUALITY Comprehensive features inherent in CitectSCADA Batch ensure consistent high quality by only permitting authorized users to modify batch operations.

4 Delivering measurable benefits to you and With CitectSCADA Batch, we have been able to reduce our manual operations and are able to release our products earlier. Emil Klostermann, Plant Manager ACC Symrise, Holzminden, Germany Whilst at each level of operations, the process efficiencies to be gained from the application of CitectSCADA Batch can be drastically enhanced when put in the hands of experienced personnel, the system quickly instills confidence in all users by providing intuitive, easy-to-use tools such as automatic work instructions and production reports, thereby reducing the margin for error. YOUR CUSTOMERS Enjoy consistent, high quality, value-formoney products from supplier who always delivers on time. PRODUCTION MANAGERS Meet production schedule on time by organizing the sequence of batch orders and releasing them to be executed on the production units from any computer on the office LAN using CitectSCADA Batch s Recipe Editor. Using CitectSCADA Batch s flexibility, create an unlimited number of recipes, with each recipe including an unlimited numbers of operations, and each operation having an unlimited number of parallel phases. Gain better inventory control and reduce shelf-life by accurately managing ERP orders through CitectSCADA. QUALITY ASSURANCE/ VALIDATION MANAGERS Meet the regulatory requirements for your industry with a solution designed to enable FDA 21 CFR Part 11 compliance. Produce batch reports in accordance with the GMP regulations. Accurately trace used raw materials as well as all operator activities, events or errors during production. Increase your visibility on quality processes and make better informed decisions based on real-time information delivered through the powerful integration of CitectSCADA Batch and existing systems with CitectIIM Tracking and Quality modules. PLANT MANAGERS Consistently meet your production targets as CitectSCADA Batch provides 24/7 full redundancy during batch execution Maximize asset utilization and production throughput by running consecutive batches in-line. Create automatic production reports during running batches to ensure optimized efficiency and quality. OPERATORS Improve your knowledge and skills with easy- to-use, integrated graphical user interface for viewing the production process, batch operations and phases. Achieve consistent high quality and regulatory compliance using easy-to-use automatic work instructions. Reduce margin for error using FDA 21 CFR Part 11 Electronic Records and Electronic Signatures for all operator activities. SYSTEM INTEGRATORS Integrate quickly and easily, using automation hardware such as PLCs, that you are familiar with. No designing of databases or coding is required just install CitectSCADA Batch and configure your system. Both online and offline configuration is supported by CitectSCADA Batch meaning you can work from anywhere. Utilize existing automation infrastructure such as PLCs or DCSs.

5 your customers Providing improved Process automation and better Interface between ERP and production During the manufacture of flavoring and aromas in the productions halls of Symrise, a large number of production processes are run in parallel. Each production step must be documented and evaluated in detail. This is carried out by Symrise s production management system (PMS). It co-ordinates management of orders, the administration of production, materials and master data and provides the user with all important information regarding production status. The CitectSCADA Batch system at Symrise is linked to two additional function modules; the weighing system (WDS) and the production management system. Both modules are linked directly to the processing level. The PMS organizes and controls orders from the SAP system and provides for good manufacturing practice (GMP), processing linked to the subsystems that have been executed. Over 10,000 different recipes exist at Symrise alone in the flavoring production area. Today, Symrise s customers expect to be able to access information about the manufacturing status of the products they have ordered. This requirement for a transparent supply chain is completely met by the installed system. Symrise case study Instrumentation, Systems and Automation (ISA) S88 Part 1 of ISA S88 standard provides models and terminology applicable to batch control. Part 2 defines data models that describe batch control as applied in the process industries, data structures for facilitating communications within and between batch control implementations, and language guidelines for representing recipes. The S88 standard defines an ''industry best practice,'' and is not a mandatory standard. Good Manufacturing Practice GMP GMP aims to assist companies such as those in the food and beverage and healthcare industries, to improve process efficiencies leading to improved quality. As part of GAMP 4, it assists companies to achieve validated and compliant computer automated systems. It provides guidance to the suppliers of those automated systems on their development and maintenance by following good practice, and assists the suppliers in producing the necessary documentation required to support validation. Food and Drug Association (FDA) 21 CFR Part 11 The set of regulations known as FDA 21 CFR Part 11 was introduced in 1997 and defines the guidelines for recording and managing electronic data in research, development and production. It also describes the criteria under which an electronic signature can be regarded as reliable and the equivalent of a handwritten signature. The intent of the FDA regulations is to protect consumers from fluctuating quality, or manufacturing mishaps. This is achieved by ensuring no changes are introduced to a production process without appropriate authorization. Photo Source: Symrise Germany

6 Powerful Functionality for Optimized Operati CitectSCADA Batch increases the efficiency of our plants and ensures a continuously high quality of manufacturing. [It] offers the required flexibility in order to meet all demands concerning a user-friendly operation as well as GMP-compliant documentation Klaus Maiwald, Production Management, Beiersdorf AG CPG, Berlin BATCH STRUCTURE CitectSCADA Batch is a high performance, fully integrated batch management system that controls and documents all automatic actions and manual operations prescribed by the recipes, in accordance with international standards and regulations. It can be set up as a fully redundant Client/ Server system that can utilize any of the hundreds of different PLCs, RTUs, DCSs and other controllers that CitectSCADA connects to. All the basic operations for the batch are executed by these controllers while CitectSCADA Batch manages the execution of the operations. CitectSCADA Batch is a modular, hierarchical solution that is matched to the structure of your plant. It includes software components used during the configuration of the project through to batch execution: Recipe Editor Batch Engine Batch Viewer, Batch Scheduler Batch Reports and Audit Trails Data Store (MS SQL Server) Equipment Editor RANGE OF FUNCTIONS CitectSCADA Batch supports a full range of functions for compliance: configuration, documentation, batch execution and batch reporting: Define and manage plant equipment Define and organize Master Recipes Organize production orders Schedule and control batch recipe execution Processing of the batch order in accordance with manufacturing instructions Control of process parameters related to the plant Tracking of Lot Numbers and Quantities in accordance with GMP Automatic documentation of the manufacturing in accordance with the GMP Electronic Record, Electronic Signatures and audit trailing in accordance with FDA Management of up to 99 simultaneous batches Unlimited number of process phases per recipe Parallel processing of operations in similar process phases with no limitations Multi-language capability BATCH PROCESSING PRODUCTION ORDER > MASTER RECIPE > CONTROL RECIPE > OPERATIONS ERP / Host eg SAP-R3 Automatic division in single batches with similar action program The number of batch orders corresponds to the volume of the production order Generation of the charge number Batch Execution Audit trailing Electronic Records and Signatures Device groups eg Agitation, Tempering Verification Availability of materials Manufacturing regulations Plant equipment status Processing consistent with FDA and ISA S88

7 ons Execution PLANT MODELLING CitectSCADA Batch recipes are based on the batch plant information and control capabilities, which in turn, define the plant s equipment and processing capabilities as well as the plant s control and information requirements. Control recipes can then be quickly and simply designed, scheduled and executed in accordance with industry regulations. BATCH HISTORY CitectSCADA Batch automatically captures and stores information on the batch execution including operation and phase events, equipment status, operator actions and comments as well as a batch audit trail. A batch history is maintained that includes: order, process and production data (such as raw materials tracking); operator interventions; alarm messages, and electronic records and signatures. LEFT: CitectSCADA Batch Viewer BELOW: CitectSCADA Batch s Recipe Editor will help you meet production schedules on time by managing batch orders from any computer on the office LAN. BATCH REPORT CitectSCADA Batch Report documents all executed batches in accordance with the requirements of GMP and FDA. Visualization of the report is available from any CitectSCADA operator station. ADD-ONS OPTIONAL ADD-ON WEIGHING SYSTEM Many batch management systems require the availability of a large amount of raw materials data which is often complex, decentralized and paper-based. Seamless integration of an online weighing system, permits the automatic and accurate conversion of production orders into weighing orders for improved manufacturing processes and associated documentation. Processing is carried out in accordance with the Standard Operation Procedure, (SOP). The verification of expiry dates and the automatic documentation of the LOT number, is facilitated through the use of barcode-readers. The data on the weighed raw materials are then transferred to the production management system. A barcode label is printed off and remains with each item as a type of reference document. This weighing system is an integral part of the production and material-flow chain. It is the basis for all security and quality process data documentation.

8 Maximize Return on Investment HARDWARE REQUIREMENTS Minimum Pentium 500MHz CPU 256MB RAM Recommended Pentium 800MHz 1GB RAM SOFTWARE REQUIREMENTS Requirements CitectSCADA V5.5 Windows 2000 Service Pack 2 Windows XP Professional or Windows 2000 Server (English Editions) Windows 2000 Server Optional MS SQL Server 2000 TOTAL INTEGRATED SOLUTION To get the maximum return on your automation investment, you need enterprise-wide, real-time analytical information for all your business and production processes. Enhancing the value provided in CitectSCADA Batch, Citect offers a total integrated solution, combining Industrial Information Management (IIM) solutions and Citect services. CITECTIIM SOLUTIONS CitectIIM solutions are deployed in a modular fashion to return a fast, incremental and measurable ROI to your business in the areas of production, quality, tracking, downtime and metrics. Aggregating real-time information from existing systems, and presenting it to key personnel enables quick and effective decision-making for continuous process and quality improvements. CitectIIM Tracking and Quality modules bring considerable benefits to the regulated manufacturing industry and help you satisfy both regulatory and customer requirements. With CitectIIM Tracking, you can reliably trace the genealogy of product lots from raw material suppliers through to production and packaging, satisfying both regulatory and customer requirements. Using CitectIIM Quality, the automatic identification and modification of out-of-spec values during production facilitates fast operations activities to bring the product back into specification and minimize wastage. By integrating with Tracking, the genealogy of product quality as well as of product components is facilitated. CITECT SERVICES To help provide the best efficiencies out of your production and business processes, Citect offers worldwide local integration services delivered through our highly-skilled, experienced Professional Services and Integration Partners. Citect Support is available 24/7 with offices located around the world to ensure local support when you need it. Our Gold Membership support package delivers free product upgrades; essential when keeping up with regulatory requirements. To complete the solution and ensure the sustained optimization of your system, Citect delivers professional training in-house or in accredited centers. ABOUT CITECT Citect Pty Ltd is a worldwide leader in industrial automation and information management. Its CitectHMI/SCADA and Plant2Business software and IIM analysis modules are complemented by professional services, customer support and training. These solutions are enhanced by strong partner programs and are sold in numerous industries, including food and beverage, pharmaceuticals, chemicals, mining, pipelines, facilities monitoring, water and wastewater and power distribution. Citect is headquartered in Sydney Australia, has 17 offices in Australia, USA, Europe, China and Africa, and its products are distributed in more than 50 countries worldwide. To learn more about how you can optimize your batch automation, contact your nearest citect representative today! For further information visit or call your regional office AMERICAS Tel AUSTRALIA Tel EUROPE Tel CHINA Tel SOUTH AFRICA Tel Citect Corporation Ltd. All rights reserved. Citect and Citect Plant2Business are registered trademarks of Citect Corporation Ltd All other brands or names are property of their respective holders. PR10411