Regulations, Quality Boost Batch Software
The old family recipe: Sometimes it is carefully copied onto an index card and stashed away in a wooden box; sometimes it is scribbled in the margins of an old cookbook; and sometimes it is just part of someone's culinary experience committed to memory. Special recipes are part of family pride—history, lovingly preserved and passed on.
The old family recipe: Sometimes it is carefully copied onto an index card and stashed away in a wooden box; sometimes it is scribbled in the margins of an old cookbook; and sometimes it is just part of someone’s culinary experience committed to memory. Special recipes are part of family pride—history, lovingly preserved and passed on.
Similarly, industrial recipes are painstakingly preserved. Part of the intellectual property of a corporation, they need special attention and are often considered top secret. As often as not, however, these recipes are part of complex batch processing operations that turn out a wide variety of industrial products. Many are created in manufacturing systems that are process-oriented, customer-driven, and heavily regulated.
In its first-ever look at trends in the batch software user marketplace, Control Engineering and Reed Research Group—both divisions of Reed Business Information ( www.reedbusiness.com ) —recently asked subscribers in an email/Web survey about preferences in batch software and batch software implementation.
According to the survey—conducted in May 2004 and answered by subscribers who specify, purchase, or implement batch software—the commodity chemical industry is the largest user at 40%. (See graph, ‘Process Industry Applications of Batch Software,’ for a detailed breakdown of use patterns.)
According to Joachim (Jay) Ruhe, batch and MES business manager at ABB Inc., ABB serves many of these industries and sees potential for growth in each. ‘ABB groups prescription pharmaceutical, biotech, and personal and over-the-counter healthcare into ‘Life Sciences’ industries. Strong demand for advanced batch software in the Life Sciences industries is partially driven by regulatory compliance requirements, such as FDA 21 CFR Part 11. Additional demands for advanced software come from increasing interest in ‘quality by design’ concepts behind process analytical technology. Currently about 80% of ABB’s Life Sciences business uses batch software.’
ABB sees the demand for batch software in the specialty and commodity chemical industries as largely driven by the need for improved product consistency, reduced production cycle times, and improved quality. Food and beverage industries, on the other hand, make use of advanced batch software to secure the benefits of runtime flexibility, improved asset utilization, and automated electronic production history.
Industries traditionally considered “process” use the most batch software, with the commodity chemicals segment being the largest at 40%.
Mixing complexity, platform type
Batch operations can be divided into three main types—single product, single stream/ path; multiple products, single stream/path; and multiple products/multiple streams/paths. Type of batching system implemented is based on plant capacity, product mix, manufacturing system(s) flexibility, and other factors.
The type of manufacturing operation and facility in which the system is to be implemented influences the choice of hardware/software platforms. Timing of the system implementation also influences platform choice.
This survey looked at four hardware/ software platform combinations and how they relate to batch process complexity. The four combinations were were:
PLC with user-programmed batch solution and HMI. For purposes of this survey, software used in this type was not specifically designed for batch processes. The user created the necessary batch structure for control, operations, phases, recipes, etc. These systems often evolve over time and are often largely ‘home grown.’
PLC with a commercially available, batch server engine and HMI. Use of this type of system indicates that the control engineer or system integrator had existing software from which to choose when setting up the system.
Programmed batch solution and integrated operator interface. This essentially homegrown solution generally incorporates a commercial operator interface.
Available batch software engine and integrated operator interface. Such platform pairing is usually found in commercially available packages developed for specific batch process industries.
From scratch vs. packaged
Hardware/software platform preference tends to vary with operation complexity. Simpler systems are often “home-grown,” while off-the-shelf platforms are more frequently chosen for complex configurations.
As operations become more complex, hardware/software platforms change for good reasons, according to Daren Moffat, Foxboro’s batch solutions architect.
The first reason is system maintenance. With simple batch applications, an on-staff expert or two can maintain the system. But as the system grows, so does its complexity. It becomes more difficult to manage existing code and to add new code to the control system. If the persons with expertise leave the company, the manufacturer may be left with an undocumented control system that is very difficult to change. In addition, when engineering budgets tighten, fewer resources may be available to manage controller-based solutions. Existing resources may focus on business and process improvements, rather than on the control system.
A second reason is limited control system resources. As the number and complexity of products increases and recipe procedures are defined in the control system, along with the phase control logic, the amount of memory in a controller is consumed quickly. Additional controllers, their maintenance, and engineering the control application all add cost. In highly sophisticated solutions, recipe procedure logic, equipment allocation and arbitration, path management, security, and batch history are ‘out-of-the-box’ functionality managed in the batch server at the workstation level. The more active role of the batch management system frees the control system of this unnecessary logic, resulting in a more structured, easily supported code base, primarily of phase and exception logic.
A third reason for the shift to more advanced batch applications is the pressure to be more efficient and cost-effective. Batch manufacturers today need to be more responsive to customer needs and make products more economically. Manufacturers may add new recipes daily or weekly, resulting in more specialized batches that require a more sophisticated recipe and batch management system. Timely manufacturing demands the ability to add recipes easily through the HMI or batch software without directly altering control code.
Finally, the need to comply with government regulations promotes evolving to a more advanced hardware/software platform. ‘Advanced batch applications provide features that facilitate compliance with electronic records and electronic signature regulations, such as an electronic batch history, material traceability, change tracking, and user security management. This is more difficult to engineer on a PLC-based solution,’ Moffat adds.
‘Home grown’ batch systems continue to move towards more advanced applications. The ‘old family recipe’ may never change, but it also may never be the same again.
Batch software products
For more manufacturers, visit www.controleng.com/buyersguide ; for systems integrators, go to www.controleng.com/integrators . Also visit company Web sites of the products listed.
EXCLUSIVE: Object-oriented tools support S88 model
Telemecanique Unity Application Generator (UAG) object-oriented batch software tool automatically generates control system designs and simplifies PLC/HMI integration. Software can create, replicate, and validate control system designs consistent with the ISA S88 model. Top-down architecture emulates S88 standard and significantly reduces development time and costs. Software is applicable to the pharmaceutical industry and to improving continuous and hybrid process control for food and beverage, packaging, and other regulated industries.
Designed to create a universal structure that for design and integration of engineering processes inside a process control system, UAG batch software tool provides a level of integration between PLCs and a classical HMI/SCADA system that matches the single database technique of hybrid distributed control systems. Because it can be used by process and automation engineers, it eliminates intermediate steps of process interpretation. It incorporates the four control domains that must be properly managed to construct a functional and reliable automation system: configuration, control objects, interlocks, and sequence control. Object-oriented programming lets control system elements be pre-defined and pre-tested. www.us.telemecanique.com
Modules improve efficiency
RSBizWare family has added five new process software modules, including RSBizWareBatch. Open configurable solutions are designed to integrate plant-floor processes with top-floor business enterprise systems and are aimed at process industries, including pharmaceutical, biotech, consumer packaged goods, and specialty chemical. New modules can be deployed one at a time or all at once. Users can leverage S88 methodology and the principles of batch automation to reuse code, recipes, phases, and logic between processes with similar procedures. Batch logs can be used to create reports for batch production analysis. www.rockwellautomation.com
Security, regulatory compliance
InBatch Premier and FlexFormula batch management software products now support Microsoft Windows Server 2003 and Windows XP operating systems. Microsoft operating system security model in the new release offers a security-based authentication scheme that enforces various account policies and provides seamless integrated security throughout the system. InBatch Premier 8.1 is applicable when processing complexity requires flexible procedures and formulations. It features a batch engine for recipe execution, equipment management, and capturing complete batch history. Both products facilitate the design and implementation of systems, applications, and solutions compliant with FDA 21 CFR Part 11 regulations. www.wonderware.com
Electronic signature capabilities
Simatic Batch software, used with Simatic PCS 7 process control system, features new electronic signature capabilities to help users comply with FDA 21 CFR Part 11. It automatically records operator actions, electronic signatures, and events associated with a batch and lets users define multiple signatures for each operator action or batch event, as well as the specific signing order. Product provides security features, including password aging and unique user IDs, and has tools for creating master recipes, planning batches, and monitoring, controlling, and documenting batch execution. www.sea.siemens.com
Siemens Energy & Automation
Global system database
DeltaV Batch offers an integrated database that coordinates all configuration activities. System information is distributed globally in the run-time environment so each activity knows about the others. This architecture facilitates a single global system database without database mapping or dual data entry. Package features unit-relative equipment handling; access to all data by name without physical location references; fast and transparent request response and exception reporting communication between applications; and no configuration requirements for reporting, viewing, and analyzing batch history data. www.emersonprocess.com
Emerson Process Management
Improved quality, cycle time
IndustrialITSystem 800xA Batch Management provides recipe management, batch and procedural control, regulatory compliance, safety, and security. Tools allow modeling, executing, and tracking information associated with material and control flow across the plant. Product helps improve overall batch consistency, quality, and cycle times, reducing overall life cycle costs and production downtime. Production management capabilities are built to ISA S88, IEC 61512, IEC 61131-3, and ISA S95 standards. Package also provides tools to comply with FDA’s 21 CFR Part 11, cGMP requirements, and GAMP guidelines. www.us.abb.com
Batch solution without custom programming I/A Series batch software suits applications that require powerful, flexible batch management, including recipe management, redundant batch execution, and an electronic batch record, without custom programming. Combined with Foxboro’s I/A Series control system, this solution is consistent with ISA ANSI/ISA 88.01 standard and includes special equipment modules for connections and segments, material tracking and genealogy, pharma-ready security, and business system integration. Software is said to allow quick and easy creation of recipes and simulation against a process model and a scalable client/server environment with capabilities for materials tracking, short-term scheduling, batch history, and thin-client reporting. www.foxboro.com Invensys/Foxboro
Enhanced batch execution Proficy Batch Execution software features eSignature functionality for recipe and equipment editors, automatic versioning using XML, a comprehensive audit reporter, remote system configuration capabilities, a periodic “heartbeat” event for the Proficy Batch Execution server, and batch reporting and analysis capability. Electronic signatures enforce authentication prior to the execution of a command, and an application can be configured to require one or two signatures. Software also now implements automatic document versioning. Document can be either a new equipment configuration/area model or a new recipe. Proficy can also generate a report so an FDA auditor can examine document change history of documents according to 21 CFR 11. Proficy software solutions are said to help manufacturers better understand and control variations in batch-related production environments and provide powerful off-the-shelf reporting and analysis capabilities. GE Fanuc
Process, recipe management Centum CS Batch 3000 batch control package provides process management and recipe management functions, unit supervision and process control functions, and an XML enabled scheduling interface. Designed for multi-path, multi-product process, and variable-path processes, product is suitable for single product or single-train processes. It allows recipe downloading for any combination of equipment when multiple devices are required to manufacture a product. Recipe creation is independent of the control system software. System supports master and control recipes. Recipe builder runs on Microsoft Windows 2000 or Windows XP. Recipe author and control system operators may have different security profiles, allowing separation of recipe activities from control system activities. Easily edited master recipe contains all the product-specific information required to produce a batch, including procedure, formula, equipment requirements, and header information. Yokogawa Corp. of America
Flexible, robust batch management TotalPlant Batch is an advanced, flexible, and robust batch solution for designing, modeling, and automating batch-oriented production processes. It can handle a full range of requirements from single-unit to complex, network-structured, multi-product applications. Solution provides batch scheduling and dispatching, recipe and equipment management, batch management and execution, material management and tracking, batch history and reporting, and batch simulation. Product is built around ISA S88.01 standards and Honeywell’s Modular Batch Automation (MBA) methodology. MBA is said to offer a structured approach to batch automation design, implementation, and operation. Graphically configurable software modules are built and designed so that the user enters data once. Configuration of multiple databases and complex interface logic to communicate between batch logic and the controller-based phase logic is not required. Honeywell Hi-Spec Solutions