White Papers

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  • Designing Batch Systems for e-Manufacturing

    In today’s global environment, a true competitive advantage can be attained for companies by designing their batch systems to integrate with technologies for “e-Manufacturing”. Through proper planning, design, and implementation, organizations not only have a means to efficiently automate batch operations, they now have an opportunity to optimize their operations. A properly integrated control domain / enterprise management system provides real time information needed for making timely management decisions. Interoperability of these systems for e-Manufacturing requires electronic data flows dependent upon such issues as production requirements, timing considerations, quality assurance results, resource allocation, and report generation. In addition, conformance with emerging U.S. Federal legislation such as the E-Sign Act (effective October 1, 2000), and FDA’s 21 CFR Part 11 (E-Records; E-Signatures, effective March 20, 1997) can be addressed as an integral part of project design. The importance of understanding the “electronic” requirements of e-Manufacturing provides a basis for designing new systems and upgrading legacy systems to meet each organization’s own enterprise demands. This paper provides insight into the design and requirements of batch process systems for integration with manufacturing and business systems for today’s e-Manufacturing environment.

    Kenneth S. Kovacs, V. P.- Pharmaceutical and Healthcare, Real Enterprise Solutions
    08/26/2008
  • Design Methods to Defer Costs on Batch Projects

    This paper analyzes two methods of deferring costs associated with the installation of batch automation systems. The first defers cost by postponing the configuration of recipes and batch management until after start-up. With this method operations personnel manually coordinate the execution of phases and maintain a paper batch record. Often this leads to a design that uses larger and more specialized phases since the execution of the recipe is not automated. A batch management package and recipes can be added at some later time to create a fully automated process. The alternative design implements the batch management package up-front, postponing the configuration of automatic phases until later. Operations personnel would then use the batch management package to guide them through the process as they manipulate the control modules at the direction of the batch management package. Automated phases are implemented in stages deferring costs over time. This implementation can be carried out in a prioritized order, based on operator input, specifying which process operations are the most time consuming and difficult. The two methodologies are examined for potential pitfalls and benefits of each. Compromises that must be made, as well as the functional advantages and deficiencies of each approach will be discussed.

    Thomas E. Crowl, Principal Application Engineer, Siemens Moore; James V. Heckmanski, Sr. Project Engineer – Batch Solutions, Siemens Moore
    08/26/2008
  • Do We Really Understand What We are Doing? Does anyone else?

    This paper focuses on the difficulty of adequately understanding and clearly describing the functionality a manufacturing process is to have before hard implementation decisions are cast in stone. Traditional functional specifications are necessary, but are often not complete until the design process is well along and are typically extensive, detailed documents that take a long time to write, are not completed until many design decisions have already been made, and require so much time to read and understand that timely feedback is difficult to get. This paper presents the argument that a clear, simple functional description, essentially a functional specification lite, is required very early in any design process. Based on the S88 model, the functional description is useful for any type of process, is the basis for early agreement on the way the process will function, is the starting point for a detailed functional specification, and can be the basis for defining what should be automated – and, perhaps more important, what should not.

    Lynn W. Craig, President, Manufacturing Automation Associates, Inc.
    08/26/2008
  • A DuPont Batch Automation Project Experience

    When presented with the problem of having to increase capacity 25% for a $100M/yr DuPont fluorochemical business, the solution was to fully automate the bottleneck of its supply chain, a batch process. Although the process already had a DCS, it was not nearly used to the potential it could be if additional instrumentation and automation software were installed. The journey taken to complete this solution taught us a lot about how to properly run a batch automation project. Upon completion of the project, we were presented another challenge. DuPont’s largest competitor withdrew from the market dramatically increasing product demand. With no additional capital, we were able to further increase capacity another 40%.

    John W. W. Wood Jr, Technical Engineer, DuPont; Vernon F. Morenas, R&D Engineer, DuPont
    08/26/2008
  • E-Business Will Change Manufacturing Strategies

    Initially E-Business was surrounded by much hype, but, eventually, E-Business will enable new business models in manufacturing. Collaboration processes, touted in E-Business, are only possible if manufacturing is an agile component of the extended supply chain. A product must be made to a demand signal or accurate forecast to fulfill the order and ensure a satisfied customer. However, EBusiness has not yet been adequately translated by the business into actionable manufacturing priorities. E-Business Trading Exchanges will eventually move from procurement buy side to sell side processes. In the automation process, more inventories will be eliminated from the supply chain. Reliable delivery from manufacturing will become more critical as the margin for error diminishes. Manufacturers must focus on consistency and delivery to demand. Integration of plant information processes and product specification management as part of managing the product lifecycle is important manufacturing foundations for E-Business. S88 and SP95 provide a useful framework to support these strategies. Most manufacturers are still translating business strategies into coordinated IT and business initiatives. They are trying to do too much and many IT initiatives are still disconnected. This will constrain E-Business initiatives dependent on integrated back end IT and business processes. To prepare for E-Business manufacturers must build organizational readiness and governance, manage integration, and integrate information across the extended supply chain against priorities set by the business strategy. This paper will discuss industry trends, pitfalls, and make pragmatic recommendations for manufacturers confronted with the challenge of moving manufacturing to align with emerging EBusiness Strategies.

    Roddy Martin, Service Director- CPG and Lifesciences Manufacturing, AMR Research
    08/26/2008
  • Emerging Trends In The Petrochemical Industry

    Changing market conditions are forcing batch-manufacturing facilities to modify the way they conduct business. The demand for software and hardware vendors to provide a higher level of batch automation is increasing. This demand is being fueled by a shortage of knowledge-workers coupled with the demand for flexible manufacturing environments. Industry standards for software and batch-control are emerging rapidly. These standards are helping to improve the interconnectivity of many products. E-commerce will be the area for growth during this decade. Many companies are already buying and selling products through business-to-business portals on the Internet. The ability for a company to respond to ever changing manufacturing demands will determine their success or failure in the future. The purpose of this paper is to discuss these business trends along with the impact of new standards on the batch industry. The paper describes several examples of companies that have been able to leverage infrastructure investments while successfully applying these emerging standards.

    Tom Hosea, Batch Applications Specialist, OSI Software Inc.
    08/26/2008
  • Implementing A Manufacturing Execution System At Chevron Chemical Oak Point Plant

    In the past, manufacturing facilities with extensive automation opportunities, such as those around continuous processes, have been able to achieve a high level of integration. The integration has typically broken at the points where manual intervention is needed in an otherwise automated process, such as in the product movements areas, and on smaller batch processes. This partial integration at the manufacturing facility has made integration to an enterprise resource planning system fragile at best, and unsuccessful in the majority of cases. To get around the challenges of a mixed initiative operation, manufacturers have had to make large capital investments in automating the manual tasks. These capital investments often involved long lead times, process unit shutdowns, and could be only marginally profitable in smaller facilities. This paper describes how the Chevron Chemical Oak Point plant is using production and batch management software and the S88 methodology to implement a manufacturing execution system (MES) to manage the full life-cycle of production work orders, including manual, semi-automatic and automatic processes. The solution combines Web technology and several commercial software packages.

    Dave Blosser, IT Manager, Chevron Chemical; Darrell Tanner, Batch Consultant, Honeywell Hi-Spec Solutions
    08/26/2008
  • MES-DCS Integration Case Study

    This paper addresses the design and implementation of a real time, batch scheduling and material reporting interface between MES and DCS applications in a good manufacturing practice (GMP) environment. Included is a discussion of the process functionality and data model applied to successfully implement such an interface. The design approach applies standardized technologies where possible to help ensure inter-application compatibility, data integrity, and continued expandability.

    Richard E. Parapar, Principal Systems Architect- Operations Systems, Genentech, Inc.
    08/26/2008
  • Operations Excellence

    Our premise is that functional organizations, namely Production, Quality and Information Technology, have traditionally solved problems by rapid problem definition, solution design and implementation of automated controls or other computer systems. The new economy represents a new set of challenges to that approach. These challenges take the form of worldwide production and distribution, cost pressures, site consolidation and more stringent FDA requirements. Meeting these challenges requires a new method of problem solving in the areas of manufacturing and quality control. This will also have a significant impact on the roles and responsibilities of the Information Technology (IT) organization in supporting these two organizations. This paper is based on consulting work that dealt with the overall business transformation associated with management and control of batch records while improving operating efficiency and reducing risk.

    Patrick Hurley, Principal, Cap Gemini Ernst & Young
    08/26/2008
  • Product Life Cycle Management and the General Recipe a Case Study

    To adapt to today's shifting market and customer requirements, an enterprise must be increasingly agile to redefine its products. Organizational barriers introduce delays and inconsistencies in the transfer of this information. At the same time, a global enterprise needs to ensure that products are manufactured consistently, wherever they are developed or made in the supply chain . This paper presents a case study of the development and implementation of an electronic Product Lifecycle Management application to successfully address these challenges, for a premium brand food manufacturer. The business requirements are defined and mapped against the capabilities of commercial software products. To ensure that the application can evolve, as business needs change, the use of existing and emerging standards, recommendations and technologies is evaluated. The organization and project approach to involve all disciplines, redefine the product development processes and successfully introduce this new technology is described. In the conclusion a brief overview is given of the scope and uses of the application, the expected benefits are illustrated and recommendations are made to improve batch standards.

    John Delhez, Sr Product Manager, Honeywell-POMS Corp.
    08/26/2008
  • Repeated S88 Success Yields Cost Reductions at Large Consumer Products Company

    A large consumer products company was faced with implementing multiple new product lines to meet product demands. Using S88 models for batch process control across the multiple process and product lines this company was able to achieve a high degree of engineering re-use. Key elements in this success were teaming with the automation provider to achieve requirement definition and applying object-oriented design techniques. The state transition documentation allowed for ease of understanding and repeated application. The S88 models, applied to the process resulted in improved product quality and consistency, recipe flexibility and increased productivity. Engineering re-use allowed a significant reduction in the time to production for repeated application. Project Design and Implementation time also showed a significant reduction. Additional business benefit has been realized, through the application of S88 principles. This has come from capital cost and project risk reduction through reuse of tried-andtrusted components and improved manufacturing flexibility and faster introduction of new products.

    Mark P. Givens, Project Engineer, Rockwell Automation; Andrew McDonald, Control Engineer, Unilever Research
    08/26/2008
  • S88.01 Models and Commissioning / Qualification Mapping

    The following paper makes a link between ISA-S88.01 Batch Control Models and Terminology, and key features and terminology, used in ISPE Baseline Pharmaceutical Engineering Guide: Commissioning and Qualification. The problem is how to extend effects of modular design, based on S88.01 models, to other activities: application software development, FAT, commissioning, qualification & validation. The solution is the linkage between different islands of terminology, knowledge, experiences and views: design, user, control system vendor, package unit vendor, quality assurance and maintenance. S88.01 physical model, procedural control model and process model provide consistent definition of commissioning, qualification and validation scope. Implementing the proposed method results in reduction of manpower, expenses of documentation and project implementation time.

    Marin Klaric, Manager of Department for Designing, PLIVA
    08/26/2008
  • Six Sigma and S88 Unite for Batch Automation Productivity Improvement

    Six Sigma is a quality improvement methodology applied to improving any type of process. It is a methodology endorsed by and heavily integrated into several major chemical companies. This paper outlines how the program works with regard to performing process studies for the purpose of improving batch productivity through automation within a manufacturing environment.

    Bruce Jensen, Systems Marketing and Sales Support Manager, Yokogawa Corporation of America
    08/26/2008
  • Use of Web Technologies in Batch Management

    Genentech Inc.’s bulk manufacturing facility in Vacaville, CA has been in production for the past two years. Application of S88 design concepts has provided the needed flexibility for multi-product manufacturing. Furthermore, the DCS has provided the integrated manufacturing environment necessary to trace and track the multitude of process activities required for the production of a single batch. To meet increasing manufacturing capacity requirements, there is an effort underway to maximize yield and plant throughput. There is an increasing recognition that these goals may be realized by decreasing the time for postproduction analysis of batch production data and the generation of a Batch Assay History Report prior to its market release. Yields may be maximized by real time preemption of deviations in batch quality while the batch is in production. Such time demanding requirements are met by using the Web to deploy raw data and processed information to fulfill users’ data needs; when, where and how they need it. This paper discusses benefits realized through the use of Web technologies for supervisory batch control, batch production data analysis and batch report generation.

    Chinmoy Roy, Manager- Automation Engineering, Genentech Inc.; Leonard Johnson, DCS System Administrator, Genentech Inc.
    08/26/2008
  • A User’s Wishlist for Batch

    The benefits of applying the S88.01 standard have been well proven in the industry, although most users have only scratched the surface on achieving these benefits. Some of this dilemma can be attributed to poor application of the standard by users; much can be traced to deficiencies in current tools that are available to the user. The S88.01 batch control standard has been around for five years. Ample time has been available to allow the appropriate tools to be developed that will allow users to take full advantage of the S88.01 standard. Most tools still do not provide enough needed features and flexibility. This paper will discuss ways of improving user application of the S88.01 standard and some of the deficiencies of currently available tools.

    Thomas G. Fisher, Operations Technology Manager, The Lubrizol Corporation
    08/26/2008
  • Using XML with S88.02

    The eXtensible Markup Language (XML) was released by the World Wide Web Consortium (W3C) in 1998 and has experienced rapid worldwide acceptance. When the SP88 committee started work on the S88.02 exchange tables XML technology was not available for consideration and relational database table technology was used as a basis for batch data exchange. As applications come to market based on S88.02 it is important to examine the newer XML technology for suitability for batch data exchange. This paper provides a brief overview of XML and discusses how it can be used for batch data exchange. As an example an application that converts a control system's proprietary master recipes to and from XML is discussed. Lessons learned about the use of XML versus relational database technology are presented as well as possibilities for future uses of XML with batch control.

    David Emerson, Sr. System Architect, Yokogawa Corporation of America
    08/26/2008
  • Batch Manufacturing: Status and Future Challenges

    This paper discusses the current status and developments in integrated batch automation. The idea of today’s batch automation is the integrated automation of the supply chain as a whole. Because many systems are involved in the supply chain, a homogenous integration is one of the biggest problems in integrated batch automation. Key factors for success are mentioned. In theory, with S88 as a well established standard and S95 in the pipeline, there are good guidelines for an automation project. But the experience shows that there is still a difference between theory and practical experience. The basic issue in business control systems is the coverage of required functionality. In this level, there are complicated resource and planning activities. Especially in a net of integrated plants, standard software systems can’t cover all the required functionality. Some of these functions may be standard functions in the future, but they are not by now. Even in DCS with state-of-the-art batch systems, some functions are often missing. These are some batch-related functions and the matter of standardized interfaces. But at large, most of the required functionality is available. However, in DCS, stability is much more important than in the ERP world, and in IT based DCS systems sometimes a critical subject. It is shown that the only way to improve batch automation solutions is the development of standards and standardized interfaces. A typical system will be composed of standard systems and enhanced by jobspecific extensions as opposed to pure custom systems. These standard interface solutions are still in an early stage of development. Some attractive standard systems will emerge and boost the batch automation business, while less successful solutions may deter companies from further projects. Therefore, the development of “best practice” systems and solutions may be an elusive objective, but seems to be the only way to success.

    Dr. Thomas Hauff, BASF AG
    08/26/2008
  • Benefits of Advanced Engineering Methodologies for the Design and Support of Batch Projects in the Pharmaceutical Industry

    A cost breakdown of any major batch project reveals that the a major part of the engineering effort is spent on the coding of the logic and sequences. This applies to the initial purchase price and more so to the ongoing support cost for maintenance, upgrades and modifications. Specifically for the pharmaceutical industry, where procedures must meet Regulatory Compliance (FDA approval), measurable economic benefits can be derived from advanced design methodologies. Based on the experience of a very large Batch project for a pharmaceutical company, the methodology used to reduce the engineering effort and to support validation and hence obtain Regulatory Compliance are explained. The methodology is based on the generation of prototype software modules and a subsequent copy process to generate the actual software modules for the various parts of the plant. All steps are validated to meet FDA requirements. This methodology resulted in significant savings during the engineering process. Even higher savings were achieved during a later modification to accommodate a plant change, as the process down time could be minimized.

    A.M . Verhagen, Senior Consultant Production Automation, Akzo Nobel Engineering B.V.; H. Stapper, Manager Applications, Foxboro Nederland N.V.
    08/26/2008
  • C&O Methodology: Delivering Batch Plant Project Right First Time

    Implementation of ISA S88.01 Standard has delivered many benefits including improved control, reusability and a common language. Yet, many processes are unreliable, fragile and inconsistent. Some batch processes are seen as black art, and surrounded by myths. Why? The question is “Even if we are designing batch process control to specification, but is the specification correct?” This paper describes a systematic design methodology that ensures commissioning and project success, shortens time to market, and makes your process delivers consistently and reproducibly. Control and Operability Study (C&O) defines your process, from chemistry to automation sequences. It is a rigorous method for discovering the fundamental factors that affect performance, quality and operability, and delivering real benefits to batch operations. A trained moderator directs the study, breaks the barrier between chemists and engineers, and brings in knowledge of best practices. C&O has been applied to a wide range of batch processes. It has slashed the time to market for a finechemicals company, and resulted in 60% capacity increase and $1M profits for a personal-care company.

    Dr Phillip Cheng, Lead Consultant, Eutech
    08/26/2008
  • Exception Handling – A Practical and Manageable Approach

    This paper is based on the practical experiences implementing batch projects on both new build and control system replacement projects. In particular, a technical and management framework specifically for exception handling is essential to ensure a known, proven, safe and maintainable validated batch system is delivered. The practical challenges are significant, projects following the classic specification lifecycle either fail to deliver the quality of information or the safety assessment tasks are conducted in parallel and therefore not available at the early stages. Working methods must be defined to allow the batch control system to accommodate exceptions with a high degree of transparency and flexibility.

    Alistair Ross, Alba Controls Limited
    08/26/2008
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