White Papers

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  • Batch Process Development - An Information Supply Chain

    This paper reviews the information requirements throughout the development lifecycle across different sectors of the batch industries. It then discusses the challenges facing software seeking to enable smarter working through this lifecycle. Aspects considered include the creation, analysis, manipulation and retrieval of process information in ways that enable more effective decision support, eliminate transcription and work cooperatively allowing users to choose “the right tool at the right time”. Some of the issues addressed are: • Uncertainty and data quality/rigor • Risk vs. consequences including the business context • Resource constraints…addressing “what should we do next?” • Multi-disciplinary synergies and frictions (especially chemist & chemical engineer) • Supporting/competing standards…where does ISA/S88 fit? • The differing needs of simulation, design and recipe execution systems Benefits from an effective IT environment are discussed covering both tactical (direct cost and time savings) and strategic (“picking the winners”, time to market, more efficient, robust and flexible processes) benefits. The paper draws conclusions regarding the classes of software needed, the essential nature of fully supporting information sharing, the impact of existing and developing standards, the current “state of the art” available and some ideas on how the future might look.

    Alistair Gillanders, Senior Consultant – Batch Processing, AEA Technology Engineering Software
  • Batch Schedules and Production Schedules Which Should You Use?

    The integration of scheduling and control systems invariably involves custom programming or the use of proprietary formats to enable the transfer of production schedules. Currently there are two ISA standards committees developing standard schedule formats. The ISA SP88 committee's S88.02 draft 14 presents a batch schedule object model and a set of relational database tables for the exchange of schedule data. At the time this paper was written the ISA SP95 committee was finishing work on the S95.01 Enterprise/Control Integration standard1. S95.01 defines a production schedule object model. The SP95 committee is continuing work on this model as part of the S95.02 development effort. The committee is expected to develop attributes for the objects. This paper analyzes the two committee's work and proposes a mapping between the different sets of work. The mapping shows how the S88.02 schedule object model and exchange tables can fit into the S95.01 production schedule model and the on-going S95.02 work.

    David Eme
  • Bringing the Benefits of the Batch Control Standard (S88.01) to the Flat Sheet Industries

    During the last several years, the ISA Batch Standard (S88.01) has become a commonly understood way of communicating batch system requirements. Traditional batch manufacturing industries such as Food and Beverage, Consumer Products and Pharmaceuticals have realized the benefits of this model. However, non-traditional batch manufacturing applications such as Pulp and Paper, Steel and Plastics can also realize significant productivity benefits by applying the S88.01 model. This paper examines some of these "non-traditional" batch manufacturing applications and outlines the benefits that S88.01 can provide. It also provides a discussion of the usefulness of batch standard terminology for these nontraditional applications. In some instances, the use of actual terminology provides real benefit to the manufacturing process; in others, the application of the standard in principle only is the most appropriate and beneficial.

    Rick Salisbury, Batch Development Manager, ABB Automation Inc.
  • Building the Perfect Beast Batch

    The ISA S88.01 Standard for Batch Control, Part 1: Models and Terminology has had a significant impact on the implementation of industrial control systems since its inception in the early 1990’s. One need only examine all the batch management products available in today’s marketplace to recognize the affect S88 has had in standardizing the look and feel of batch applications. While the terms and structures used to describe batch applications are now generally well understood, many users still struggle with the complexities associated with actually building batch control systems. This paper addresses one approach to the ‘how’ of implementing S88. It presents a proven software development methodology that takes the beast out of batch, and allows users to realize many additional benefits by applying the S88 Standard.

    Richard E. Parapar, Principal Systems Engineer, Genentech Inc; William N. Gracely P.E., Principal Technical Consultant, The Foxboro Company; Alan Karner, Applications Manager, APV
  • Comprehensive Decision Support Solutions for Improving Operations Management in the Batch Industry Supply Chain

    Many business and process operational decisions ultimately determine the yield, quality and throughput of batch product operations. Improving operations therefore requires analysis of the process starting at the top of the supply chain down to the plant floor. A comprehensive approach to this problem is presented which applies multiple technologies to clearly identify, characterize and deploy solutions for improving batch operations. Impact modeling identifies and quantifies supply chain improvement opportunities that can be explored through “what if” scenarios. By drilling down from the enterprise level into the production environment, opportunities for process improvements and optimization are identified. The benefits of implementing process improvements through knowledge capture and deployment and advanced monitoring, control and optimization systems become clear. Analyzing the global impact of interacting local issues within the context of the entire supply chain and using a suite of technologies to solve local issues leads to comprehensive decision support solutions for improving yield, quality and throughput of batch product operations.

    Bonnie Haferkamp, Business Development Manager, Gensym Corporation; John Wilson, Sales Manager, Gensym Corporation
  • Coordinated Batch Execution is the Key Theme of the New Plant Architecture……..…….. A Status Update

    Manufacturers consolidating production facilities around contract manufacturing and outsourcing models are reducing noncore activities so that costs can be decreased and responsiveness to market dynamics increased. While most manufacturers made integrated Enterprise Resource Planning business system and Advanced Planning and Scheduling supply chain system decisions, they have not catered for the detailed production coordination requirements in the plant. This will become evident as E-Business dynamics get closer to directly influencing manufacturing operations in operations such as food, beverage, and consumer packaged goods manufacturing. Plants are still grappling to find software packages to support process based architectures that enable coordinated operations both within the manufacturing site, and externally with the business and supply chain. Market research indicates trends in plant software packages towards model based applications for example MES, in which the model becomes the application. Model based application architectures make it easier to manage the change of migrating from data centric product architectures to the processes represented on the AMR Research REPAC model. This paper examines trends in software products and user manufacturing architectures towards a manufacturing coordination infrastructure that supports requirements emerging from S88 and SP95. The paper addresses the question as to whether manufacturers and software vendors are ready for this change and what it requires to be successful.

    Roddy Martin, Research Director , CPG and Lifesciences Manufacturing, AMR Research
  • Costs Abound with Regulatory Noncompliance: Lessons Learned on ERP Implementation

    Over the past several years, the pharmaceutical industry has plunged headfirst into ERP systems implementation. This broad-based effort motivated by Y2K and aging legacy systems created an opportunity for our business to execute several large-scale GMP system projects. All the efforts achieved some level of success; however, all suffered avoidable setbacks. In addition, the ERP vendors always assume that all the solutions lie within their "license." This is a dangerous assumption, in that lower cost GMP compliant solutions exist readily. The purpose of this paper is to discuss several projects in the context of "lessons learned" in an effort to provide guidance for future efforts. The paper will focus on: 1. Development time and control of costs 2. Regulatory compliance and the cost of noncompliance 3. The use of prepackaged systems to offset ERP development expense © 2000-2001 World Batch Forum. All rights reserved. Page 2 4. Functionality (i.e., given time and money, anything can be built) 5. Testing and validation – why they never get together 6. Validation and why it is still a problem 7. Documentation – why it is always created late and wrong 8. Methodologies – are great in sales presentation The paper and its presentation will be a lively but brutally honest discussion of ERP implementations. This paper is geared for IT, QA, and manufacturing professionals involved with or planning to implement an ERP or manufacturing system project in a GMP environment.

    Herman Bozenhardt, Vice President, Foster Wheeler Corporation
  • Establishing Compliance of Batch SCADA Systems with FDA cGMP 21 CFR Part 11

    FDA enforcement of a 1997 cGMP regulation, 21 CFR Part 11, for electronic records and signatures, is imminent. Compliance policy Guidelines were issued May 1999 to clarify the agency’s expectations of pharmaceutical and medical device manufacturers. FDA scrutiny of system implementations is anticipated to be extensive. The popular use of “open” architectures and commercial-off-the-shelf software products for automated batch control and data management has introduced many challenges to compliance with this regulation. In addition, legacy systems are not exempt and verification of data integrity compliance is expected to be retroactive. Batch SCADA systems have the proven ability to reduce costs and improve product consistency and the industry is heavily dependent upon their continued application in the manufacturing environment. Regulatory requirements shall be reviewed, with real-world examples of assessment and compliance resolution for Batch SCADA Systems. System functionality requirements shall be stressed without direct reference to product or service brand names.

    Stanley L. Whitman, Consulting Project Manager, Raytheon Consulting & Systems Integration Inc.
  • Implementing Automated Batch Control of a Biotechnology Manufacturing Facility using S88.01 concepts – A Case Study

    Genentech Inc. recently completed the design, construction and automation of a new, multipurpose, biotechnology drug, bulk-manufacturing facility in the United States. This project accomplished many first-time implementations for Genentech. This paper presents a case study discussing factors involved in the conceptualization of automation requirements and the challenges posed in designing and implementing them. Along the way, it highlights the efficiencies gained in using S88.01 principles of partitioning and modularity. Also addressed are the challenges posed to “Change Management” personnel involved in the startup, commissioning, qualification and validation of an S88.01 based system under the Good Manufacturing Practices guidelines of the Food and Drug Administration (FDA). It is Genentech’s desire to maximize plant output. To meet this goal, project teams are currently involved in devising schemes to ready the facility for a product changeover while the plant is in operation. The changeover involves some minor physical modifications along with control software changes. The challenges encountered and methods employed to meet them without compromising the Validated production environment of the control system will be highlighted.

    Chinmoy Roy, Senior Automation Engineer, Genentech, Inc; Geoffrey Wyshak, Senior Automation Engineer, Genentech, Inc.
  • Integrated Automation of Filling Line for Parenteral Products

    Integration of batch process and pharmaceutical production equipment (OEM) towards MES and Business System in a sterile manufacturing About 40 Filling, Inspection and Packaging machines from 20 different suppliers and a formulation batch process have to be controlled from a central control room with a limited amount of operators in such a way that the operator interface is similar for every machine. Data communication from and to the equipment PLC’s over SCADA and MES towards Business System in order to have electronic tickets with data storage. An identical hard and software platform for each control unit creates a structural and uniform communication platform between different equipment. SCADA gives the operator a HMI with the same look and feel. MES offers the operator an interactive production ticket. Use of client server technology in order to have the same information on different places. Use of a common data base as storage and communication medium.

    Paul De Smet, Manager Automation Global Engineering, Pharmacia & Upjohn
  • Integrated Batch Solution for Pharmaceutical Rubber Production: The IPS Approach

    Talk integration to a vendor and a customer and you’re likely to get two very different points of view, despite the emergence of standards designed to reconcile these differences. By too carefully defining the limitations of software packages, we risk limiting the functionality of the very manufacturing operation we intended to improve. A responsive, integrated Batch Solution must be capable of positioning itself in the context of the Enterprise Production System, responsible not only for executing a planned sequence of operations, but also for the wider repercussions of its actions. This paper describes the implementation of an Integrated Plant System (IPS) for a major multi-national pharmaceutical company. Of particular interest from a Batch perspective, the asynchronous manual and automatic activities of over 100 recipes are tied to stock movements to ensure raw material is available at the right place and time. This illustrates the point that synchronization is integration, both at the Batch and Enterprise level. The production facility in Milan, Italy, was modeled using the IPS paradigm, and now coordinates all operational activities from equipment maintenance through inventory management to order scheduling and MRP.

    Alastair Orchard, Application Technology Manager, ORSI Group
  • An Integrated System with Batch functions And Front-End Scheduling based on S88 - Application to Beverage Plant -

    The case study in this paper illustrates the value of integrating front-end scheduling with a batch control system. Recipe changes, and addition of recipes, occur frequently in the target process. However, since both scheduler and batch packages were designed with the ISA-S88.01 model in mind, these packages could be tightly coupled (well integrated) – and, as a result, it is easy to add or change recipes. The frontend scheduler is not limited to performing scheduling; it also provides an easy-to-grasp real-time production status display which can help enhance efficiency and productivity.

    Ryoichi Himono, Yokogawa Electric Corporation; Kenichi Takahata, Suntory Limited; Kiyokazu Mano, Suntory Limited
  • Integrating Batch Automation with New Product Development: Meeting the Challenge

    A major cosmetics manufacturer had just finished the first production run of a brand new skin cleanser, when the error was discovered – an ingredient in the cleanser was wrong. Upon investigating, it was discovered that a data entry person had accidentally keyed not the final approved formula, but a previous unapproved version into MES/ERP. The entire production run, including bottles and labels, was disposed of at a $250,000 loss. Traditionally, it has been difficult for product developers to share information not just with manufacturing, but even among themselves. Formulas, and other product development data has been scattered across the enterprise in various R&D labs, and isolated in spreadsheets, legacy systems, disorganized file cabinets or lab notebooks. Due to the lack of a centralized product development information system linked to MES/ERP, formulas have usually been manually keyed, inevitably creating batch errors. A new breed of product development software has emerged that centralizes all product development data, automates the product development process and creates a seamless link between R&D and MES/ERP, ensuring accurate and timely communication not only of new product formulas, but also of modifications to existing formulas. This presentation will highlight this software and detail how it can be used to improve integration of batch automation with new product development.

    Steve Phelan, Senior Vice-President, Formation Systems Inc.
  • Assuring Industrial Control System (ICS) Cyber Security

    Joe Weiss, Control's Unfettered blogger, was asked by CSIS to prepare a white paper on cybersecurity for Industrial Control Systems. CSIS is the Center for Stategic and International Studies, which was tasked in a bipartisan manner to form a blue ribbon committee to prepare cybersecurity recommendations for the next administration. This white paper is posted by permission of CSIS and Joe Weiss.

    Control and Joe Weiss are posting this white paper as a pro bono public service. The registration is solely to keep track for security purposes of who downloads the white paper and will not be used for commercial purposes.

    Joe Weiss PE, CISM
  • Identifying Benefits for S-88 and S-95 Based Systems

    System Architectures using S-88 and S-95 standards are being used in system implementations across the plant floor. These systems include batch management, MES, process control and ERP integration. For regulated industries, electronic record keeping and system validation must be addressed in these new initiatives. When implemented as applications, these architectural components are designed to provide benefits that support the company’s business drivers. These benefits often overlap as the interfaces between applications become blurred as application vendors are changing functionality. Using S-88 and S-95 standards and an architectural approach, system requirements can be related directly to benefits. This paper presents system life cycle architecture for implementing pharmaceutical automation projects. Primary, secondary and strategic benefit sources for measurable economic benefits in each functional area of regulated and non-regulated operations. Realized benefits are presented for actual implementations across the plant floor.

    Joseph F. deSpautz, Aurora Biosciences Corporation; Baha U. Korkmaz, Automation Vision Inc.
  • Batch Distillation: Practical Aspects of Design and Control

    Distillation, both batch and continuous, is the most often used separation technique in the Specialty Chemical Industry. While continuous distillation has historically received the most attention, batch distillation has suffered from some public neglect. This paper will present a summary of design basis criteria and control strategies for a multi-purpose batch still. Given the multiple product and flexible processing requirements of batch manufacturing, optimization of a batch distillation process is generally very equipment and process specific, unless the equipment was designed and is used for manufacturing a single product. The concepts presented here are suitable for processing over 80% of the Crude encountered in the industry and the design features and control strategies shown have accounted for 15-30% improved yields and throughputs.

    Manuel R. Florez, Senior Engineer, Millennium Chemicals, Inc.
  • Batch Management in the Supply Chain

    Batch management systems are traditionally composed of two subparts, one assuring the creation and configuration of the recipes, and the other assuring the execution of the recipes, i.e., driving the equipments to make a product. By reducing the total time needed for producing a product, the market can be reached quicker and more money can (hopefully) be earned. Time to market is an important key competitive performance indicator. So, how can time to market be reduced? The execution part of the batch management system must obviously work efficiently, but this alone will not be enough. Personnel, materials, scheduling and maintenance information sent from the ERP system must also be managed in an efficient way. The problem is that traditional batch management systems are not intended to or capable of handling this information. Neither are they intended to handle information concerning warehouses, packaging or material receiving. Rather than extending the batch management system beyond its core role, the importance of the MES system and its capabilities should be stressed. An approach based on the ideas and models presented in ISA S95 is believed to be successful. Dedicated cross industry components manage the functions that are decidedly non-batch. Similar to a traditional batch management system that coordinates and synchronizes the recipe execution, a MES system should do the same for the functions of the components. Applying this approach, the batch management system can truly work in the context of the supply chain!!!

    Charlotta Johnsson, System Architect, Siemens Orsi Automation S.p.A.
  • Electronic Batch Records and Flexible Batch Reporting

    S88.01 defines batch history as 'a collection of data relating to one batch'. This is expanded by S88.02 to show that a batch history is an aggregation of both common and batch specific elements. A batch history may be made up of data collected by several systems and held in multiple locations. From this collection of data it may be required to produce for different purposes several batch reports. This paper reviews with the aid of case studies some methods of implementing flexible batch historian and batch reporting systems and discusses some of the issues faced such as 21CFR part 11 compliance and the integration of time series data and batch event data.

    Eur Ing C. M. Marklew BSc CEng FinstMC MIEE, Aston Dane plc
  • Exception Handling in S88 using Grafchart

    Exception handling constitutes a large part of the design and implementation effort in batch production, but so far little work has been carried out to specify this area. This paper proposes an internal model approach for equipment unit supervision using Grafchart. It also discusses exception handling at the recipe level.

    Rasmus Olsson and Karl-Erik Årzén, Department of Automatic Control, Lund Institute of Technology
  • General Recipes As Contracts With Manufacturing

    General recipes are the ANSI/ISA 88’s definition of how to document the way a product is manufactured without specifying the exact production equipment. General recipes are transformed through an engineering process into master recipes, and they can often map to a wide range of physical equipment layouts. The target equipment often varies in unit layout, level of automation, physical properties, and process control capability. Usually, local engineers with a deep understanding of the target process cell layout do the transformation from a general or site recipe to a master recipe. The general recipe thus becomes the controlling document that is exchanged between sites. The general recipe can be considered a “contract” document between Research & Development (R&D) and manufacturing, defining the chemistry and physics that must be performed to manufacture the product. Because this document must be unambiguous, the elements that make up the general recipe must also have an unambiguous definition. In the ANSI/ISA 88 model these elements are process actions and equipment constraints. The actions and constraints are used during master recipe creation to identify master recipe unit procedures and operations and to bind the master recipe unit procedures to equipment. This paper defines the rules and considerations in defining corporate-wide process actions and equipment constraints so that they can become the complete and unambiguous definitions required by manufacturing.

    Dennis Brandl, BR&L Consulting
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