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Session 1—Tuesday MorningSession Chair: Chris Monshinski, Automated ControlsUsing ISA-95 as an Analysis Tool to Design the Integration of ERP, MES and AutomationPerry Hailey, James Bellars, Tony Ryan, Julian Ward and Marcus Massingham, Glaxo Smith Kline Reducing the total time needed to introduce a new chemical entity into the market is an important key performance indicator in pharmaceutical manufacturing. This requires a combination of effective batch management, automation, and operations management. Batch management systems are traditionally composed of two subparts, one managing the creation and configuration of the recipes, and the other managing the execution of the recipes. The execution part of the batch management system must obviously work efficiently; however, if it works in isolation from other systems, then it will be insufficient. Personnel, materials, scheduling, and maintenance information sent from an ERP system must be managed in an efficient way. Traditional batch management systems are not intended to, nor capable of, handling this type of information. Rather than extending a batch management system beyond its core role as defined by the ISA88 standard, an MES system that is designed to handle this information and other operations management functions must be part of a complete solution. An approach based on the ideas and models presented in the ISA95 standard will be presented. This paper and presentation cover, in detail, the interfacing between ISA95 Level 2/Level 3 and Level 3/Level 4, and the design of both a Workflow and Electronic Batch Record System as applied to a Pharmaceutical Secondary Manufacturing environment. Back to sessions and abstracts list. Mapping SAP PP-PI, ISA-95 Production Schedule and ISA-95 Production PerformanceClaudia Melissa Ordonez Lizcano, Javier Mauricio Mina Trochez and Oscar Amaury Rojas Alvarado, University of Cauca Nowadays, business management systems and manufacturing control systems are separated—not necessarily a technological gap—by a conceptual gap. The flow of information to be interchanged by these two systems is essential for companies to achieve their goals of guaranteeing the fulfillment of quality standards, increasing their levels of productivity, and improving the performance of their processes. In that sense, the ISA95 standard and the Business to Manufacturing Markup Language (B2MML) documents proposed by WBF are useful tools for the development of new technologies for this flow of information because they correspond to generic and common models that do not depend on proprietary solutions. In this paper the information exchange using the PP-PI interface is illustrated using a recipe control form from the MES level and reports generated by the MES level sent as Production Performance reports to the ERP. These serve as a base of the common information mapped between the execution level and the planning and scheduling level. Therefore, in this paper the generic mapping carried out between the proprietary forms of the PP-PI interface of the SAP and the B2MML documents are exposed. This will show that when submitting to the integration standards, apart from facilitating the structured organization of the company information, an efficient exchange of information between the business level and the manufacturing level is carried out, obtaining a reduction in the engineering time and an interoperability among the applications. Back to sessions and abstracts list. Independence Day for Equipment Modules: Case Study of How a Flexible Batch Application Can Save CostsGordon Roney, Noramco, Inc.; Andrew Blankenship, Innovative Controls, Inc. This paper is a case study of the implementation of batch capable equipment modules at an existing facility that manufactures Active Pharmaceutical Ingredients (APIs) that can be used with or without a batch manager application. In 2004, we started the process of expanding a recently installed process control system. We desired the ability to re-use equipment modules in order to save costs on system configuration, qualification, and new recipe configuration. Additionally, we wanted the capability to use these equipment modules independently from the batch manager application. The equipment modules reside in the controllers instead of at the batch management level, which allowed us to configure and qualify them independently from any higher-level recipe manager. The cost savings came from being able to qualify them once, and then use them in multiple instances and recipes. The cost of configuring new recipes is also lowered because the equipment modules are already installed and qualified, which reduces the time to write and qualify the new recipe. Monitoring of process upset conditions and the response to these conditions is implemented directly at the equipment module instance instead of through the batch application manager. The improved response time lowers risks and costs. This paper will show:
Back to sessions and abstracts list. The Challenge of Integrating Multiple Batch Systems to Global Business SystemsFrede Vinther, NNE Pharmaplan A/S Integration of Batch Systems to the Business System is key to enabling the business to manage and respond to the manufacturing of products. This integration has been assisted by ISA95 and most recently, ISA95.00.05, which describes business to manufacturing transactions. This paper is based on a number of Integration Strategy and Concept consultancies performed for various clients over the last year. The focus is on the challenges that have to be addressed and covered to enable a successful integration in world biotech and pharmaceutical manufacturing where new manufacturing methods and technologies are introduced on a daily basis. One major challenge to overcome is to look at Manufacturing and Automation as a whole, and not as a MES–DCS system function. Overcoming this is not solely a technical issue, but just as much a cultural/personal preference issue. These issues and others are described in this paper, which also addresses the ongoing Standardization work on ISA88 Technical Report on Batch Control Transactions that is to complement the ISA95.00.05 transactions with similar methodology for the Batch world. Back to sessions and abstracts list. Becoming Green: The Next Level of Manufacturing OptimizationJames Parshall, Eli Lilly For many years, progressive companies have been very environmentally conscious for all the right reasons, even sometimes incorporating the act of “social responsibility” into their purpose. As awareness of environmental issues grows and material and energy economics become larger factors in cost equations, global companies are realizing that going green is not only good for the environment, but also good for business. Firms that understand and embrace this concept will see opportunities to reduce costs, which translates into higher profits. Mainstream companies that assume associated risks by acting as leaders in this movement may also enjoy increased market awareness due to their green efforts, most likely translating into increased sales. While no effort for recycling, energy conservation, or car pooling should be discarded as insignificant; there is a huge responsibility in becoming more efficient in manufacturing globally. Driving to a sustainable or even carbon-neutral process is an admirable goal, but companies should also realize that there are many opportunities to reduce energy consumed or waste produced. During the past 10 years, WBF has sponsored initiatives, hosted the sharing of successes, or otherwise evangelized the rise of very influential global manufacturing standards and practices, including ISA88, ISA95, and PackML/Make2Pack. For WBF, there is no better way to shape the future of manufacturing than showing companies how to apply these standards and practices for enabling greener manufacturing, resulting in more socially-responsible processes that also improve companies’ top and bottom-lines. Back to sessions and abstracts list. Session 2—Tuesday AfternoonSession Chair: Scott Sommer, Jacobs Engineering GroupGetting an Organization Ready for S95—Designing and Implementing Plant Models within Enterprise ApplicationsJack Greene, Alkermes, Inc. The ISA95 approach to Business to Manufacturing application integration defines a scalable cross-systems architecture linking applications at the business layer with applications at the control layer. These architectures can be used to streamline a wealth of business workflow models to facilitate lean manufacturing. Implementation of these systems is challenging because of the level that they affect all aspects of plant workflow. One of the prerequisites is to build a plant model following the ISA88/ISA95 hierarchy and to implement a version of it within each of the applications at the business layer. This facilitates the downstream integration work and improves the utility of each individual business application. This paper is a case study of how a plant model was developed for a pharmaceutical manufacturing plant and how the model was implemented within a series of business applications. Each implementation required customization of the model to account for the strengths and limitations of each business application package as well as the data reporting needs of the users and is listed below:
Even without the MES built, the implementation of the model in each of these applications significantly streamlined the business process by helping users to extract information that is more meaningful. Back to sessions and abstracts list. Should Operators Speak ISA-95Bianca Scholten, Ordina Technical Automation Recently I overheard a conversation that was not meant for my ears. Two people were discussing a graphical user interface of an MES system. ISA95 terminology was used in this interface. They agreed that this was a typical technical engineering solution and that more attention should have been paid to the user friendliness for the operators. Were they right? Should the use of ISA95 terminology be avoided in MES user interfaces? This paper is about the feasibility of ISA-95 as a standard manufacturing language. It answers questions like:
Back to sessions and abstracts list. Applying ISA-88 to Polyethylene ProductionsChris Morse, Honeywell The production of polyethylene is considered a classic continuous process; however, a number of the manufacturing challenges are common to batch manufacturing. Common factors include raw materials management, traceability, and production control. On more detailed analysis of the typical automation requirements, many principles of ISA88 can be applied to this process with some complicating factors. The paper considers a real example applied to a newly constructed polyethylene plant. To ensure flexibility, future supportability, and to provide certain business benefits, ISA88 was applied to the automation system. The overall solution, challenges, and differences from classic batch processes are considered. Back to sessions and abstracts list. Make2Pack ISA-88 Part 5 Overview and UpdateDavid Chappell, CMAa-LLC This paper will provide an overview of the WBF Make2Pack workgroup’s ISA88 Part 5 standard, which will lead to a formalized approach in creating modular factory floor automation applications. How the evolving concepts of both control and operational modes can be used to support the many different control strategies existing on the factory floor will be shared. The spectrum of ISA88 equipment control components and the proposed methods for separating custom control from industry-provided, reusable components of control will be shared. How to use all of these concepts to create the lowest cost and most functional automation that is both modular and supportable will be shared. The details of a standardized way to interact with the resultant automation allowing dissimilar control systems that interact without specialized applications will be shared. And finally an overview of the personal roles found in manufacturing and how they drive automation will be shared along with an overview of the benefits these concepts provide. Back to sessions and abstracts list. Batch Process Automation Executed on the PLC PlatformGiovanni Godena, Jozef Stefan Institute; Igor Steiner, INEA A new concept was developed for recipe-based control of batch processes according to the ISA88.01 standard. Normally, recipes are created on a batch server—usually industrial PC—which acts as a batch execution engine. Within real time, a control loop batch server communicates with a PLC during recipe execution. Phase logic and basic control of the process are performed by the PLC. Since PCs are inherently unreliable, redundancy of execution engine and communication lines is used to increase safety and reliability of the operation. PLCs are one of the most reliable equipment components within production process. They are becoming more and more capable. Based on these facts, the new concept for batch execution was developed. Within the new approach, editing of recipes and equipment is done on a PC and then downloaded to a PLC. The PLC itself becomes the batch execution engine while still taking care of phase logic and basic control of the process. The need for real time communication loops and the need for an industrial PC are eliminated. The need for redundancy is drastically reduced. The new concept is simple, cost effective, reliable, and understandable, yet sufficiently powerful for most cases of batch process control. Back to sessions and abstracts list. ISA S88.01 Updated for Today's Best Bath PracticesPaul Nowicki, Rockwell Automation The original landmark work in batch control systems models and terminology is in the final steps of an update effort, aimed to clarify issues that have come up over the past 10 years. Learn important clarifications and alignments that have been incorporated into this standard to help make it even more useful as the foundation for batch control implementations. Back to sessions and abstracts list. Implementing ISA-88 across Life Science Development OperationsLouis Ciabattoni, California Software Implementing ISA88 may be perceived as a challenge in most industries. The benefits of the ISA88 standard test this notion—reducing the time to reach full production levels for new products, making recipe development straightforward, and reducing life-cycle engineering efforts, as well as enabling vendors to supply appropriate tools for implementing batch control. Even with new FDA recommendations for Pharmaceutical cGMP for 21st Century, the Pharmaceutical Industry has been slow in accepting the standard. Imagine the added complications in implementing ISA88 in the pilot plant development area, where recipes are constantly evolving. This paper will discuss the strategies used in implementing an ISA88–compliant electronic development record application for small and large molecule drug substance and drug product development. As an observing member of the ISA88 Workgroup, combined with the QbD, ICH Q8 and Q9 insights from the FDA-Conformia CRADA project (Docket number 2005N-0353), and our work with the top 20 life science companies, Louis Ciabattoni, Senior Product Manager at Conformia, will describe a strategy to rollout ISA88 in your company, present new ISA88 concepts found only in development, and outline a straightforward mechanism for technology transfer of a FDA approved product to commercial manufacturing. Back to sessions and abstracts list. Seven Steps in Creating a Highly Effective Alarm Management SystemEddie Habibi, PAS Abnormal situations at processing plants directly impact profitability, endanger plant personnel and the public, cause harm to the environment, and create bad publicity for the corporation. Abnormal situations range from minor upsets to major industrial accidents, such as BP Texas City in 2005. In almost every case, the root cause of abnormal situations can be traced back to human error; hence the safety axiom: all accidents are preventable. Such human errors include those introduced during the design, construction, operation, or maintenance of a plant. Human error can be minimized through proper application of human factors engineering in every phase of the lifecycle of a processing plant. This presentation provides an overview of human factors that impact the ability of a process plant console operator in managing abnormal situations. Alarm management is one of the factors that significantly impact an operator’s ability to safely run a plant especially during abnormal situations. This paper provides a summary of root causes of the current alarm management crisis in the industry and seven specific steps toward creating a highly effective alarm management system. Back to sessions and abstracts list. Session 3 – S95—Wednesday MorningSession Chair: Lynn Craig, Former Chairman of ISA-88 CommitteeWhat’s Above a Master Recipe – Area Work Definitions?Dennis Brandl, BRL Consulting The ISA88 standard provides a powerful model for effective operations and control at the Process Cell and Master Recipe level, but says nothing about the levels above. The ISA95 standard provides activity models and data exchange models, but does not tie these into the ISA88 model. This paper discusses how the new models in the ISA95 updated standard, Work Segments and Work Definitions, can bridge the gap between the ISA95 models and the ISA88 models, providing an easy to understand and well integrated solution to the ISA88 problem: what is above the master recipe. The paper proposes the use of Work Definitions to define the routing of batches between process cells, production lines, storage, and production units. It shows how each of the elements within a Work Definition are used to define product (or general work) specific instructions for an MES area level work flow engine. The paper proposes a natural progression and hierarchy of activities that relate the well defined ISA88 structures to the well defined ISA95 structures, and defines a robust work flow instruction model. Back to sessions and abstracts list. The ISA-88 Area Model: More than Just a Pretty FaceDoug Bourgeois, Complete Systems Automation; Scott Sommer, Jacobs Engineering Group Hundreds of major manufacturing projects begin every year, many of which will require some level of batch automation and control. ISA88 principles will be employed on almost all of these batch automation projects due to its acceptance as the prominent framework for defining batch automation. From the authors’ experience, following an ISA88 approach provides benefits from project conception through startup and validation. It is also the authors’ experience that most of these projects advance too far before the definition of the Batch Area Model is begun. Often, the project decisions made prior to Area Model definition place limits on the ability of the Systems Integrators and Batch Automation Professionals to provide the most efficient, value-added batch automation configurations. The full benefits of ISA88 are not realized if project managers do not include the definition of the Area Model as a required document during the BOD phase of a project. The authors will present case studies and actual project data that will demonstrate that the definition of the ISA88 Batch Area Model in the BOD phase of a project is vital for:
Throughout the presentation, the benefits and value for defining the ISA88 Batch Area Model during the BOD phase of a project will be identified. Back to sessions and abstracts list. Batch Management Modernization: Case Study of Upgrading and Adding S88 Features to a Legacy System at LanxesKent Wolcott, Lanxess, Ken Keiser, Siemens Energy & Automation This paper will present the benefits and financial cost justifications of adding ISA88 batch system to a legacy DCS system. An ISA88 structured batch management system was added to two different existing legacy control systems. This resulted in one unified HMI and Batch management system managing both legacy systems’ controllers, reducing engineering and validation costs by 25%. The plant experienced outdated hardware and software in two areas which were controlled by two different control systems. Additionally, both batch management systems were not ISA88 compliant and did not communicate with each other. The existing HMI software and hardware was also reaching the end of its life for both systems. The plant opted to change the HMI and Batch management level for each system to a unified system rather than replace the entire system. This allowed for keeping the existing controllers and the batch code saving considerable amount of engineering and validation costs. Topics discussed in this paper include:
Back to sessions and abstracts list. Leveraging the ISA-88 Standard in a Multi-Station Dipping ProcessesMarcus Tennant and John Parraga, Rockwell Automation Multi-station dipping such as anodizing or parts cleaning is a critical application in many industries. In this paper, we will outline applying ISA standards to the requirements of this application by showing:
Back to sessions and abstracts list. Three Principles for Reducing the Time It Takes to Implement Software SystemsJohn Roach, Advanced Automation In today’s manufacturing climate, the ability to respond quickly to changing markets and regulations is essential for gaining a competitive advantage. When a need for new software is identified, how quickly are your operations or IT organizations able to respond? When an implementation is planned, manufacturing personnel, engineering, IT, and management all have their own frame of reference and expectations. Discord often leads to frustration, as project schedules become drawn out when the software falls short of these expectations. How can you create synergy and thereby increase your implementation speed? By following these three principles: Principle 1: To speed up, slow downWriting the code once takes a lot less time than writing it over and over. We will look at how to perform a thorough requirements analysis so that all of the stakeholders understand what to expect. Principle 2: Use iterations to increase perceived speedWWhat if instead of delivering the entire system all at once, the most important elements are delivered first and relatively quickly. Let the more time consuming elements wait for version 2.0 or 3.0.We will look at how to decide what comes first and what can wait. Principle 3: Brace for impactWhether the software is changing manufacturing processes or changing the business, you are impacting people. Resistance to change is inevitable. There is a price to pay to generate real business benefit, and it may cost you dearly if you are not prepared. Back to sessions and abstracts list. Session 4—Wednesday AfternoonSession Chair: Maurice Wilkins, YokogawaMapping ISA-95 Production Schedule, ISA-95, Production Performance and ISA-88Hernan Felipe Bolanos Cruz, Juan Manuel Velasquez Velez and Oscar Amaury Rojas Alvarado, University of Cauca The automation concepts have spread to all levels of organizations within the industrial sector, expanding the concepts and requirements beyond the control reach and the machines, to the point of affecting the business procedures of the entire company. Therefore, to achieve an integral automation production process, it is necessary to keep in mind various aspects such as the process itself, the company’s organizational structure and equipment, and the management of supplies. The specification and the definition of such aspects turn out to be even more complex due to economic policies and globalization, making it imperative to get the most out of the information flow of the company’s business processes in order to achieve productivity and to remain competitive. In this paper the study of the information exchange revealed by a Batch manager software in a Batch Markup Language (BatchML) to MES level in a Business to Manufacturing Markup Language (B2MML) and vice versa is presented, having as a base the common information mapping between the manufacturing execution levels and the control level. In this paper the definite BatchML fields related to the information represented by the B2MML according to the Production Performance Model and the Production Schedule Model are identified. The relationship between the Production Schedule Model and the Batch manager information is presented as well, along with the information delivered by the Batch manager to the MES level in the Production Performance model. The information flow for the scheduling activities and the production programming, and the production performance existing between the manufacturing and the control level are defined under the structure proposed by the ISA88/ISA95 standard, contributing to the information exchange problem between the Batch manager systems and the MES systems in the combination company-control. Furthermore, throughout the conducted mapping, obtaining a generic standard interface can be guaranteed through the dynamic document exchange in B2MML and BatchML formats. Back to sessions and abstracts list. Manufacturing Science Model Extensions to Address Product and Process SustainabilityVelumani Pillai and Rob Burrows, Pfizer; Dennis Brandl, BR&L Consulting Innovation in manufacturing with faster development, faster new product release, robust process understanding, and vastly improved quality by design is critical for advanced manufacturing organizations. Sustainability awareness (the environment impact of the product and production processes) is also permeating into consumers’ minds in evaluating products. Manufacturing science is the body of scientific knowledge, regulations, and principles involved in the transformation of materials and information into products. We proposed Manufacturing Science Informatics (MSI) as the new information model framework to support Process and Product Knowledge discovered, shared, retained, and applied over a product’s entire life-cycle. MSI framework enables established business processes such as production sourcing, material sourcing, new product introduction, continuous process improvement, process optimization, and product investigations, but can also be extended to address new business processes. MSI Framework uses ISA88 General Recipes as one of the foundational information entities. Emerging sustainability and green directives (such as EU Directive 2005/32/EC) are placing new reporting and assessment demands, like total and actual energy use and greenhouse gas emissions being tracked and reported not only during design but also manufacturing of a product. Sustainability criteria is increasingly finding its way into development and sourcing decisions. Here we propose extensions to the ISA88 General Recipe model and other product and process information entities in the ISA95 standards to handle these evolving needs. Back to sessions and abstracts list. Use of ISA-88 Techniques in a Semi-Continuous ApplicationsWayne Gaafar, Honeywell Process Solutions In most continuous processing plants, there is at least one process area that acts as a semi-continuous process. Whether it is a water treatment facility, a set of carbon filters, or a set of reactors that foul over time, these processes all use sequences of steps to make it appear to the overall process that they act continuously. Setting up control systems designed to work for continuous operations for semi-continuous or batch operations can be difficult to program and then later difficult to maintain. By using ISA88 batch conventions, semi-continuous processes can be easily implemented and maintained in modern controllers. A simple three column semi-continuous operation will be used to demonstrate how the ISA88 techniques can be applied. Back to sessions and abstracts list. Traveling with ISA-S88: Leveraging the ISA-88 Standard in a complex Assembly ProcessBruce Henne, EaglePicher Technologies; Marcus Tennant, Rockwell Automation Battery manufacturing for the aerospace and defense industries is a complex and highly regulated assembly process. By applying the models and methods of the ISA88 standard, EaglePicher technologies has enhanced assembly workflow, decreased variability, reduced waste in their assembly operations, and have improved the efficiency of the approval process. In this paper we will overview the requirements of this complex assembly process and the concept of a traveler—the document that defines the sequence of the manufacturing operations and the test/ inspection points. Applying elements of the equipment model to the traveler concept and utilizing the procedural model has enabled EaglePicher to:
We will conclude with operational metric improvements seen after this standards based system was implemented. Back to sessions and abstracts list. Advanced Process Control for Chemical Batch ProcessesWim Van Brempt, IPCOS Advanced Process Control (APC) has become widespread and even a commodity tool for certain continuous processes. APC encompasses model based control solutions, where control and on-line optimization go hand in hand, and a Model Predictive Controller is often used for this purpose. The advantage of this technology is straightforward: while delivering a significantly improved process control result, it enables you to optimize your process on-line, taking operational constraints into account. However, until recently these tools could not be applied to chemical reaction batch processes. The reasons for this are twofold: on the one hand, the general APC tools as applied in continuous processes cannot deal with the more complex nature of batch processes (changing dynamics, nonlinear responses). On the other hand, the modeling effort and related cost would also be prohibitive to implement an APC project on batch processes with a reasonable return on investment. This would be truer in a multi-product multi-reactor environment. Therefore, a new strategy has been developed for chemical batch processes. A hybrid modeling solution is proposed which needs limited engineering input, and delivers a high precision representation of the process. This non-linear model is then used within the Model Predictive Control solution. As such, the reaction phase of the batch is minimized while keeping the process within the allowable constraints (available heat exchange duty, adiabatic temperature, quality aspects). The above mentioned APC methodology has now been applied to several industrial processes. An example will be shown. |