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  • 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.
  • RFID Helps Track Assets, Manage Safety

    In this paper we discuss a solution to implement this safety requirement using RFID technology and advanced location sensing algorithms.

  • 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
  • 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
  • S88: The Good, The Bad and The Ugly!!

    As S88 becomes widely adopted within the batch industries operating companies are increasingly looking for reliable transfer of recipes between systems from different vendors. This makes sense for industry as operator companies seek to use best in class components to reduce design and implementation times as well as integrate effectively with existing systems. However, whilst the standard is now well proven for implementation of projects within a vendor's suite of tools, it is far less common to find real transfer of recipes between systems from different vendors.

    Alistair Gillanders, WBF
  • 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
  • Batch Control Application Frameworks and Reuse

    ABB Automation has adopted elements of object-oriented analysis and design in their batch control projects in order to take advantage of the reuse potential inherent in the ISA S88.01 model. Here are some architectural and process tradeoffs that anyone should consider before doing their first project: 1) Define modules at a level of granularity that optimizes reuse without obscuring the process. 2) Be prepared to manage significantly smaller and more numerous modules as compared with traditional procedural decomposition. 3) Give careful attention to module interfaces and communications between modules. 4) Begin with solution patterns that have proven to work in the real world. 5) Think beyond code reuse to design and test documentation reuse for quicker payback. The goals of this paper are: 1) provide a common perspective and terminology for discussions on application reuse, 2) discuss examples of object-oriented analysis and design in batch control and 3) show how most batch control products can be made to support this model, even if they do not utilize object-oriented application languages.

    Allen D. Benton, Consulting Application Engineer, ABB Automation Inc.
  • Analyse, Design, Develop and Validate-Fast

    This paper describes an approach to the production of the process automation systems for large-scale pharmaceutical processes using S88.01. The context is the development of highly automated systems concurrently with the project design engineering on a fast-track project.

    Andrew Knott, Francis Lovering, WBF
  • Definition and Format of Recipes for the Packaging of Consumer Packaged Goods

    The S88 standard has delivered significant cost savings benefits to the batch industry worldwide. This has been achieved through standard terminology and models as well as inherent reusability of recipes and equipment phases. The PackML subteam of the OMAC (Open Modular Architecture Controls) Packaging Working Group is a diverse group of end users, technology suppliers and packaging machine OEM’s (Original Equipment Manufacturers) committed to the development of industry guidelines which will deliver Plug-and-Pack functionality. Their objective is to significantly simplify the integration of packing machinery from different OEM’s, built using control system hardware and software from various technology providers. PackML’s work has used the state model within S88.01 as one of its foundations. It has further been discovered that there is significant potential to nhance and transfer models, terminology and principles used in batch manufacturing into the discrete world of packaging. The process, physical and procedural models, which appear in S88.01, have direct analogues in the packaging domain. It is also possible to design, in general terms, a recipe which defines both batch and discrete components of a consumer product. The principal advantage to be gained from this approach is the ability to more rapidly deploy and roll out product definition, in a consistent format, to many global manufacturing facilities. This is essential for those global Consumer Packaged Goods (CPG) companies who are committed to ensuring consistency and quality of their products irrespective of where they are manufactured.

    Andrew McDonald, WBF
  • Applying S88, S95 and B2MML in Dairy Enterprise

    This paper describes an end-user project at Arla Foods with the use of the B2MML schemas as a corporate standard for communication between business systems and ES systems. This presentation presents the real-life experiences using the B2MML schemas. The focus is on the Schedule and Performance schemas. A short introduction on the general use of S88 and S95 within Arla Foods is also included.

    Arne Svendsen, WBF
  • Maximizing the Potential of Batch Process Control

    In the recent years, batch process optimization has made significant advances. The efforts that went into the development of ISA-S88/IEC 61512 batch control standard has helped us in this direction. However, in today’s highly competitive environment, optimization of individual manufacturing plants is not enough. In order to maximize the return on investments, control engineers must turn their attentions to site and company wide optimization along with the optimization of the supply chains. Typically, batch processes use many different raw materials to produce various products and grades of products. Market demands require frequent changes in product mix under short notice. Thus, batch processes offers greater opportunities than typical continuous processes for the optimization of raw material and intermediate supplies, production scheduling, and upstream and downstream transportations. For the last five years, the ISA-SP95 committee has been developing the standards for integration of control systems with business systems. This effort is significantly helping site and company wide optimization of manufacturing processes. Additionally, the recent developments in Internet and intranet technologies are increasing the feasibility of supply chain optimization. Today, the challenge for control engineers is to broaden their focus from narrow control issues to wider aspects of enterprise-wide optimization.

    Asish Ghosh, Vice President, ARC Advisory Group
  • Model Predictive Control of Batch Temperature

    Control modules used for critical phases of reactor operation such as heating, cooling and reacting can be optimized using advanced process control technology to reduce batch cycle time. Temperature control of batch reactors is difficult for conventional proportional-Integral-Derivative (PID) controllers due to the open loop instability of these processes coupled with the long time delays and large time constants. These dynamics are present on various reactor designs involving heating or cooling with jackets, internal coils, or recirculation loops through external heat exchangers. Model Predictive Control (MPC) provides an alternative to PID for use in these control modules to dramatically improve temperature set point tracking, improve product consistency, and reduce batch cycle time. This paper describes the design of an MPC controller that is built to specifically handle the dynamics found on batch reactors as well as the large process disturbances that occur due to exothermic reactions. The results of an application example will be discussed.

    Bill Gough, Sava Kovac, Lynne DeVito, David Quick, WBF
  • 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
  • Retrofit of an Existing Process Cell with S88

    Retrofitting a working process cell that must manufacture medicine using the S88 standard presents unique challenges. Engineering solutions are not simply driven by cost-benefit analyses when working in a GMP environment. Gathering true user requirements for a system that has been in use for 10 years is not nearly as simple as one would expect and educating developers, management, and engineering technicians on the effective implementation of the standard in a design that is user-friendly requires more time than engineering the solution. Configuration management and revision control of nearly 70 modules in the development process while working with multiple vendors requires careful planning and a defined set of processes before starting the project. The business realizes many benefits from the delivered flexible system, but there is a price in ongoing documentation management.

    Brian N. DeHaan, WBF
  • 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
  • Functions Need to be Considered for Batch Material Transfer Controls

    Batch processes depend heavily on the speed and repeatability with which each material transfer is completed for every recipe executed. Each and every transfer generally requires precise cut-off control over the valves, screw feeders or pumps, as those transfers directly impact the annual profitability of a manufacturing facility. Therefore it is very important to have a cost-effective material transfer control system that consistently improves process quality and throughput while reducing raw material waste and operating costs. This paper presents some main factors to impact speed and accuracy of batch material transfers. In addition to functions to reach the goals of speed and accuracy for batch material transfers, many other either must-have, should-have or beneficial functions are explained. Where those functions should be built? Some considerations are presented to answer the question in this paper.

    Charlie Fu, WBF
  • Batch Processing in a Wider Perspective

    With the “new economy” comes new requirements on all manufacturing and processing activities, including batch processing. The entire chain of activities – from order placement to delivery – must work seamlessly. This implies that batch processing must be dealt with in a wider concept. In batch systems of today there are generally no means for synchronization or coordination of activities outside the scope of the batch. The solution presented in this paper is to have a flexible but yet tructured component-based system where the batch-processing system will constitute one part – nevertheless an important part - of the entire system. The entire system corresponds to a MES system, which can be structured according to the standard ISA S95. A framework is used to synchronize and coordinate the activities of the different components. The execution of a batch is handled by the batch-execution-component, which is S88 compliant. The batch execution component can be synchronized with other components at the stop and start of a batch but also during the execution in a sequential or parallel way. Examples are given in the paper. The benefits of this approach are vital in the “new economy”, where quicker “time-to-market” and “production-agility” become even more important. A system with well designed components and a flexible and user-friendly framework will shorten the project design time, the project implementation time, and the required time for introducing a new product on the market. By having a well-organized MES system in which the execution of the different cells can be synchronized, the production capacity of the area can increase.

    Charlotta Johnsson, Product Manager Cube-XBatch, Orsi-Group
  • 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.
  • 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.
  • 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.
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