White Papers

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  • 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
  • Predictive Control of Batch Reactors

    Continuous control of batch reactors is now feasible with Model Based Predictive Control. First Principles modeling allows the solution of difficult problems of non linear, integrative, constrained, cascaded end split range control, with no lag error on ramping set points. This has been implemented in DCS control boards and PLC,s.Diverse industrial applications are described. Linking Sequential Control and Continuous Control is made easier if both control schemes are implemented in the same generic control library.

    J. Richalet, ADERSA; Eric Vitté, Schneider Electric
  • Project Management of Batch Control Projects: How to avoid the Pitfalls

    Batch control projects have tended to be software intensive and often overrun substantially. In most cases this is due to a lack of foresight and planning in the early stages. The “S88 Era” has tried to alleviate this situation by providing a structured methodology – but again the flexibility of current control systems and a lack of planning can produce the same effect as having no structure at all. This paper aims to highlight some potential problems and pitfalls and how they may be contained without adversely affecting the outcome of the project.

    Dr. Maurice J. Wilkins, Director of Process Automation and Control Systems, Millennium Specialty Chemicals
  • Seamless Project Execution, from URS to Implementation and Maintenance

    Since ISA S88 is widely used within the process industry, process engineers and automation engineers from the DCS vendors use a common terminology and structure to describe batch processes and production. Why not use this common language to create a DCS independent relational database, mapping the S88 plant model supporting the life-cycle of the project from (Unit Requirements specification (URS) to maintenance? Starting with the URS, data are entered in the database and over the subsequent project phases more and more details are added by the control engineers. The consequent use of types and instances together with the possibility to define rules for the later generation of software reduces the necessary input to a minimum. As just one database exists instead of several documents, data inconsistency is impossible. Later the DCS specific solutions are referenced to the system independent types in the database. The software for the DCS is generated, applying the rules set for the project. The implementation time and the number of faults is reduced dramatically. The content of the database is documented automatically through several standardized reports according to GMP guidelines, providing a secure way to fully comply with FDA requirements. Test documents are generated in a similar way.

    Steffen Uebler, Dipl. Ing., SIEMENS AG
  • Building MES-applications with S95

    In modern manufacturing processes the usage of automated systems is inevitable. Whether for production control, scheduling, or reporting, computers are used. The capturing of data out of the production process and transforming these data into information is one of the objectives of MESsystems. This paper describes the recent development and introduction of several MES-modules in a manufacturing plant. The role of the S95 standard in the project will be highlighted. After a short introduction of the production process, the business goals for the project are briefly discussed. Then the functional and technical architecture will be presented. The results and the benefits of the project will be discussed as well as the benefits of using the S95 standards during the project. The paper ends with the lessons learned.

    Ing. Erwin Winkel MBA, WBF
  • Business Driven Systems Migration

    Traditional approaches all have one thing in common, they are exciting for engineers but not the business. The problems we are typically faced with are that, despite the age of equipment, it works and the latest technology in itself does not have sufficient benefit.

    Ian Allan, Billy Melvin, Peter Iles-Smith, WBF
  • Composite Batch Report and 21 CFR 11

    New technologies bring a step change in the availability, flexibility and quality of data for reporting. Batch reporting can be considered to be made up of three elements (1) automated actions by the control system, (2) manual actions and records by an operator and (3) process values. Windows technology has made the combination of (1) and (2) routine but combining (1), (2) and (3) into a single report has been elusive. In addition within the regulated industries the integrity of such a report has to be assured.

    Chris Morse, WBF
  • IR Automation Guidebook: Temperature Monitoring and Control with IR Cameras

    This handbook is intended to help those considering the creation or improvement of production automation or monitoring systems to take advantage of what IR cameras have to offer. Numerous application examples will be presented, with explanations of how these IR vision systems can best be implemented.

    FLIR Systems
  • The Fundamentals of Refractory Inspection with Infrared Thermography

    Thermography has been used to inspect the condition of refractory lined vessels and piping for many years now. It is a proven and accepted method for locating damaged and missing refractory material. Most companies however, do not fully understand the full benefits of performing refractory surveys. They mainly use thermography only before a plant turnaround to determine the extent of refractory damage in order to estimate the materials and labor needed for the repairs. This paper discusses the fundamentals of refractory inspection and how Thermal Diagnostics Limited has been using Infrared thermography in Trinidad and Tobago as an effective means of predicting areas of future refractory problems in addition to pre-turnaround surveys.

    Sonny James, Managing Director Thermal Diagnostics Ltd
  • The Project Management Office

    The purpose of this paper is to explain the general concepts, purposes, specific responsibilities and requirements associated with an effective project management office.

    Thomas B. Clark, Project Success, Inc. (formerly YCA)
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