White Papers

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  • 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.
  • 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
  • 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.
  • 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
  • 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
  • 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
  • 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.
  • 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
  • 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
  • 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
  • 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.
  • 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
  • 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
  • WBF XML Schemas

    This paper provides background on, and an overview of, the soon to be released WBF XML batch and enterprise-control system schemas. The schemas consist of two sets, one is intended to provide for the exchange of batch data and is based upon the ANSI/ISA 88 standard. The second is intended to serve as a basis for exchanging data between enterprise and control systems and is based upon the ANSI/ISA 95 standard. The organization of each set is described along with examples on how they can be used.

    David Emerson, Senior Systems Architect, Yokogawa
  • 21CFR11 Compliance and Automated Manufacturing

    21CFR11 took effect in August 1997 with little observed regulatory activity. However, that has changed and increasing numbers of FDA warning letters are being generated for software used for GMP, GCP, or GLP (GxP) purposes. This presentation addresses the impact of 21CFR11 on automated manufacturing systems and processes. Included is an overview of 21CFR11, a discussion of the processes needed to reach compliance including 21CFR11 interpretation, assessment and remediation activities, and some issues for legacy automated manufacturing systems. It will speak to the compliance issues for hybrid systems where there is a multiplicity of options between totally paper based and totally electronic systems.

    Kathleen Waters, Manager - Automation IT, Genentech Inc.
  • Advanced Control of Batch Reactor Temperature

    This paper describes the application of an advanced model predictive adaptive controller to the problem of batch reactor temperature control. Although a great deal of work has been done to improve reactor throughput using batch sequence control, the control of the actual reactor temperature remains a difficult problem for many operators of these processes. Temperature control on these systems is difficult for conventional Proportional-Integral-Derivative (PID) controllers because the response is characterized bynan open loop integrator with long delay and time constant. Temperature control is important as many chemical reactions are sensitive to temperature for formation of desired products and reaction rates can be highly temperature dependent. The applications discussed in this paper include a PVC reactor and an Ethoxylated fatty acid reactor. In each case, the variability of the reactor temperature was reduced by 60% or more. Improved temperature control permitted operation at higher reaction temperatures with higher sustained feed rates of reactants and catalysts while remaining within product temperature limits. Batch cycle times were reduced by as much as 35% due to the higher sustained reaction rates. The applications demonstrate the attractive economics for optimization of batch reactors with model predictive controls and highlight the opportunity for tremendous improvements in batch consistency, reduced batch cycle times, and improved productivity.

    Mihai Huzmezan, University of British Columbia, Pulp and Paper Centre; Bill Gough, Sava Kovac, Universal Dynamics Technologies Inc.
  • From a Corporate Product Specification to a Control Recipe: It's not a Transatlantic Trip…

    Corporate Product Specification Management is fairly new in batch processing industries. Up to now, it lived a low profile life in the form of spreadsheets, word docs and paper, but with the increasing supply chain dynamics specifications become more than ever the focal point as the indispensable backbone. Automotive, electronics and assembly businesses have known the theme for a number of years as PDM (Product Data Management). AMR defines its variant for the process industries as PLM: Product Lifecycle Management. Welcome to the world of acronyms!

    Leo Zwijns / Eric Thieren, Product Manager, Siemens
  • General Recipe: Multiproduct Facility Design; Technology Transfer

    The crucial task for engineers involved in designing manufacturing facilities is to determine the most efficient way to dimension process cell equipment to achieve the required production capacity when beginning with general recipes. In case of technology transfer, the challenge is the assessment of facility production capability to perform the process requirements, being defined in the general recipe. This paper suggests a useful method for determining process cell equipment and equipment functionality based on number of products, their quantity and general recipe data. In case of technology transfer to other sites or cells, it is suggested how to assess available production capability, based on general recipe data and installed equipment capability. The suggested method can be useful during multiproduct facility dimensioning and, in case of technology transfer, the assessment of existing facilities. The result of implemented method is the best way to optimal price/performance ratio, in case of investment decisions, and reduction of life-cycle engineering efforts.

    Marin Klaric, Business Development Specialist, PLIVA
  • Modular & Concurrent Design Using Standardized Interfaces for Accelerating Design Process

    The successful execution of an accelerated project from Concept to Process Qualification within 1 year with extensive usage of multiple Vendors requires a paradigm change for the Batch and Automation part of the project. Traditionally one Automation supplier has delivered and configured the complete Batch & Control system and a number of Skid Vendors has supplied only equipment,machinery & piping. To accelerate the project execution to meet the 1 year goal requires a Modular approach, where the Design, Implementation, Construction and Validation are done concurrently and where the Validation is planned from day one and included in the design. Skid Vendors must take responsibility of the Batch & Control system as well as the mechanical part and deliver a complete package that is validated to the extend possible before installation on-site. The different Skid Vendors may use different Batch and Control system products, and thus demand a very high level of standardization, especially regarding structuring (S88) and interfacing (OPC, S95 etc.). The Batch and Control system products on the market today do enable this high level of standardization, but when it comes to things like Material tracking and local inventory, there is still a need to have oneMaster system managing this. Initiatives like BatchML & B2MML published by WBF for the S88 & S95 standards will ease the integration, but the Systems available today still have too much formatting information that needs to be included to really make the integration easy.

    Frede Vinther, Specialist in Automation, Novo Nordisk Engineering
  • My Plant is Manual, Why do I need S88?

    Many manufacturers do not feel confident in designing new facilities incorporating full automation and want to retain manual control of the process. For these users, good modeling of the plant to achieve the required functionality is even more important. Most manual facilities still incorporate a degree of automation for those functions that are difficult to control manually. These functions must be accessible to the operators and easy to use in both normal and emergency situations. This paper will examine why the use of good structured design, following the principals of S88, will provide major benefits to these users. A structured analysis will identify common modules in the design and may even indicate where reuse of predefined modules is possible. This approach speeds up both the design and validation of the new facility. The user can decide the level of automation that they feel comfortable with and this may vary with the functions provided. E.g. Process operations may be performed by manually selecting equipment modules, but cleaning may be fully automatic to ensure that it is effective. In all these situations a structured model is the key to understanding the functionality of the plant.

    Keith Morris, Automation Consultant, Kvaerner E&C
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