White Papers

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  • 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
    08/28/2008
  • 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
    08/28/2008
  • 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
    08/28/2008
  • 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.
    08/28/2008
  • 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.
    08/28/2008
  • 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
    08/28/2008
  • 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
    08/28/2008
  • 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
    08/28/2008
  • 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.
    08/28/2008
  • 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
    08/27/2008
  • 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.
    08/27/2008
  • 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.
    08/26/2008
  • 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.
    08/26/2008
  • 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
    08/26/2008
  • 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
    08/26/2008
  • 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
    08/26/2008
  • Integrating Intermediate Bulk Containers (IBCs) Within An S88 Structure

    An S88.01-aware automation system covers the control & management of activities carried out within plant equipment directly connected to it via hardwired, serial or fieldbus links. Batches begin and end within these confines. Plant managers see a wider picture; eg Process fluid, the batch with its ID, maybe transferred from conventional reactors to Intermediate Bulk Containers (IBCs) and later returned to the piped plant. This application uses soft (PC) phases within the S88 operation to deal with transfers to & from IBCs. Rather than implementing sequence logic in a plant controller the soft phases interface with an SQL database which tracks the batch ID as process fluid is transferred ‘out of the piped plant’. The SQL server database interfaces in turn with radio barcode scanners, which identify IBCs, reactors, operators & IBC storage rooms used in each transfer. Batch ID is preserved between transfers and the operator view from the automation system is of a batch held in a unit (the IBC). The status of any IBC, eg clean, batch ID inside, may be instantly determined via the barcode scanner. The following benefits are realised: Cycle time reduction, Reduction in abnormal occurrences, Production capacity increase, Improved safety

    Nick Taylor, Manager, Business Pursuit Lead Engineer, Emerson Process Management; Pete Davies, Integration Projects, Emerson Process Management
    08/26/2008
  • Process Modeling & Efficient Engineering

    The modelling of a Batch Process and breaking down into S88 modular components is key to an easy and cost effective control software solution. This paper looks at the issues involved with engineering a batch control system, in relation to modelling, unit acquisition and transfers of material, including the use of generic coding techniques and ‘multiplexing’ or unit relative design. There are many ways to engineer a batch application even using S88 concepts. Real case studies will be used, where two batch applications have been engineered on the same site over the last 5 years. The first placed a high emphasis on control station coding and complexity within the phase and sequences. The later case was designed to fully use the capability of the Batch Supervisor to optimise engineering and maintenance and provide the functionality required. A comparison of these two methodologies provides a good insight into the benefits and disadvantages of each, in relation to engineering, testing and on-going maintenance.

    Paul Wilson, Batch Consultant, Invensys Software Systems (Foxboro)
    08/26/2008
  • 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, Managing Director, Breakthrough Process Consulting
    08/26/2008
  • Synthesis of Optimal Batch Distillation Sequences

    After the original design is completed, optimum Batch Distillation Sequencing/Operation in a chemical plant is usually a matter of trial and error that evolves as operators gain experience with the system. Some predictive tools exist for simulating batch separation systems, and they have been used with success in designing new separation systems and in analyzing existing systems. However, these tools require the user to define all the operation steps for each cut. The number of case studies required to approach an optimum scenario is very large, and is almost impossible to accomplish. Optimal design and operation, however, is the ultimate goal. In this paper we propose how to truly optimize a batch separation sequence. Combining the flowsheeting and modeling features of a process simulator provides an advantageous way to analyze and optimize operating scenarios for optimum batch separation sequencing. This approach is demonstrated with the optimization/debottlenecking of several batch distillation scenarios to separate and recover a heavy product, a partially water-miscible solvent, and water from a batch reactor effluent. Simulations identified a 25% increase in capacity with a minimum capital investment.

    Matthew J. Engel, Senior Process Engineer, Air Products and Chemicals Inc.; Bradley H. Cook, Craig S. Landis, Steven J. Tedeschi, Anthony J. Zehnder
    08/26/2008
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