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 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 are the ANSI/ISA 88s 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.
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
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
As batch processes are automated, it is common to leave certain less essential field devices without automatic actuators. Thus, the initial control design must accommodate both automated and manual activities. Later, the manual field devices may be automated, either one-at-a-time or in related groups as equipment modules. These field changes, often occurring over a period of years, each require rework of the batch control logic, which can easily exceed the cost of the actuator. In response to this undesirable situation, a technique has been developed which permits the batch design to automatically modify itself, or evolve, to accommodate changes in field automation. This approach yields significant benefits:
Initial design treats all field devices as if they are automated,
Recipe includes logic for both automatic and manual devices,
Batch Journal logs manual device actions,
Field devices may be automated over any time period,
Virtually zero modification time for batch logic,
No redesign, patches, or work-around,
No dead code or wasted engineering.
This paper describes the problem, illustrates a practical solution, and explores the resulting benefits.
David A. Christie, Consulting Batch Applications Engineer, Yokogawa Corporation of America
The migration of an existing Batch application, either by replacement or upgrade of the batch engine, or the entire replacement of the control system, raises many issues. This paper covers the work involved, and the benefits and pitfalls expected, in contemplating a replacement of the batch engine or the entire control system, and the analysis and justification necessary for a migration to realise potential benefits.
Examples will be used where a validated pharmaceutical plant converted to a new S88 aware batch engine and chemical plants replaced the entire control system. In both cases the benefits and problems and techniques used to ensure a successful conversion and achieve the potential benefits, including increased yield and quality and reduced cycle times, will be discussed.
Also covered will be applications (batch reactor), with examples, where a batch engine was not necessary but the provision of this solution on a new plant did produce many primary and secondary benefits.
The paper will conclude with a breakdown of the main technical and engineering issues involved and the justification and benefits that may be attained.
The upgrade of an existing operational plant to a new control system can be full of uncertainties, especially in the areas of operability, downtime, and benefit. Cabot Corporation recently upgraded their Treated Silica operations in Tuscola, Illinois to Batch software, new PLC processors, and an upgrade of the existing HMI's to the latest version of the vendors software. The previous system was using older PLC's with HMIs in a semi-automatic configuration. The system relied heavily on the operators to make critical batch decisions and mechanical equipment adjustments. Cabot utilized the services of a batch software provider/developer, who developed the new system using S88 standards. The system started up with minimal downtime and has delivered as promised.
The Units have seen as much as 30% increased throughput, production record keeping has become more accurate, and the product has become more consistent. These gains were achieved by the automation of a great majority of the operators former manual tasks, which included the use of batching technology and the addition of more automation equipment in the field. Additionally, to speed production and fulfill Cabot's production needs for greater throughput, recipe entry onto the batch list is now handled using specialized campaign software.
Tom Branch, Senior Project Engineer, Application Systems Engineering, Rockwell Automation; Todd Ray, Senior Process Engineer, Cabot Corporation
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.
Batch manufacturing, for specialty products, offers a unique challenge to e-commerce systems. The ability to electronically define unambiguous customer requirements, using S88.01 general recipes, supports new Internet business processes. These processes support the collaborative development of the product definitions, leading to automatic generation of process manufacturing instructions. Collaborations occur within a company, between a company and its supply chain partners, between a company and its customers, or even in an open marketplace. Multi-company, roll-based processes define the collaborative workflow required to convert product requirements to process descriptions (general recipes), and process descriptions to manufacturing instructions (master recipes). These collaborative processes are substantially different from the auction and reverse auction workflows that occur in typical MRO procurement e-commerce solutions. This paper illustrates several different ccommerce models that apply to batch manufacturing. These models include intra-company coordination and inter-company collaboration around general recipes for product development and manufacturing deployment using the ISA S88 and ISA95 models.
Michael Saucier, Founder and Chief Technology Officer, Sequencia
In todays global environment, a true competitive advantage can be attained for companies by designing their batch systems to integrate with technologies for e-Manufacturing. Through proper planning, design, and implementation, organizations not only have a means to efficiently automate batch operations, they now have an opportunity to optimize their operations. A properly integrated control domain / enterprise management system provides real time information needed for making timely management decisions. Interoperability of these systems for e-Manufacturing requires electronic data flows dependent upon such issues as production requirements, timing considerations, quality assurance results, resource allocation, and report generation. In addition, conformance with emerging U.S. Federal legislation such as the E-Sign Act (effective October 1, 2000), and FDAs 21 CFR Part 11 (E-Records; E-Signatures, effective March 20, 1997) can be addressed as an integral part of project design. The importance of understanding the electronic requirements of e-Manufacturing provides a basis for designing new systems and upgrading legacy systems to meet each organizations own enterprise demands. This paper provides insight into the design and requirements of batch process systems for integration with manufacturing and business systems for todays e-Manufacturing environment.
Kenneth S. Kovacs, V. P.- Pharmaceutical and Healthcare, Real Enterprise Solutions
This paper analyzes two methods of deferring costs associated with the installation of batch automation systems. The first defers cost by postponing the configuration of recipes and batch management until after start-up. With this method operations personnel manually coordinate the execution of phases and maintain a paper batch record. Often this leads to a design that uses larger and more specialized phases since the execution of the recipe is not automated. A batch management package and recipes can be added at some later time to create a fully automated process. The alternative design implements the batch management package up-front, postponing the configuration of automatic phases until later. Operations personnel would then use the batch management package to guide them through the process as they manipulate the control modules at the direction of the batch management package. Automated phases are implemented in stages deferring costs over time. This implementation can be carried out in a prioritized order, based on operator input, specifying which process operations are the most time consuming and difficult. The two methodologies are examined for potential pitfalls and benefits of each. Compromises that must be made, as well as the functional advantages and deficiencies of each approach will be discussed.
Thomas E. Crowl, Principal Application Engineer, Siemens Moore; James V. Heckmanski, Sr. Project Engineer Batch Solutions, Siemens Moore
When presented with the problem of having to increase capacity 25% for a $100M/yr DuPont fluorochemical business, the solution was to fully automate the bottleneck of its supply chain, a batch process. Although the process already had a DCS, it was not nearly used to the potential it could be if additional instrumentation and automation software were installed. The journey taken to complete this solution taught us a lot about how to properly run a batch automation project.
Upon completion of the project, we were presented another challenge. DuPonts largest competitor withdrew from the market dramatically increasing product demand. With no additional capital, we were able to further increase capacity another 40%.
John W. W. Wood Jr, Technical Engineer, DuPont; Vernon F. Morenas, R&D Engineer, DuPont
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
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.
The benefits of applying the S88.01 standard have been well proven in the industry, although most users have only scratched the surface on achieving these benefits. Some of this dilemma can be attributed to poor application of the standard by users; much can be traced to deficiencies in current tools that are available to the user. The S88.01 batch control standard has been around for five years. Ample time has been available to allow the appropriate tools to be developed that will allow users to take full advantage of the S88.01 standard. Most tools still do not provide enough needed features and flexibility. This paper will discuss ways of improving user application of the S88.01 standard and some of the deficiencies of currently available tools.
Thomas G. Fisher, Operations Technology Manager, The Lubrizol Corporation
This paper discusses the current status and developments in integrated batch automation. The idea of todays batch automation is the integrated automation of the supply chain as a whole. Because many systems are involved in the supply chain, a homogenous integration is one of the biggest problems in integrated batch automation. Key factors for success are mentioned. In theory, with S88 as a well established standard and S95 in the pipeline, there are good guidelines for an automation project. But the experience shows that there is still a difference between theory and practical experience.
The basic issue in business control systems is the coverage of required functionality. In this level, there are complicated resource and planning activities. Especially in a net of integrated plants, standard software systems cant cover all the required functionality. Some of these functions may be standard functions in the future, but they are not by now.
Even in DCS with state-of-the-art batch systems, some functions are often missing. These are some batch-related functions and the matter of standardized interfaces. But at large, most of the required functionality is available. However, in DCS, stability is much more important than in the ERP world, and in IT based DCS systems sometimes a critical subject.
It is shown that the only way to improve batch automation solutions is the development of standards and standardized interfaces. A typical system will be composed of standard systems and enhanced by jobspecific extensions as opposed to pure custom systems. These standard interface solutions are still in an early stage of development. Some attractive standard systems will emerge and boost the batch automation business, while less successful solutions may deter companies from further projects. Therefore, the development of best practice systems and solutions may be an elusive objective, but seems to be the only way to success.
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.
Implementation of ISA S88.01 Standard has delivered many benefits including improved control, reusability and a common language. Yet, many processes are unreliable, fragile and inconsistent. Some batch processes are seen as black art, and surrounded by myths. Why? The question is Even if we are designing batch process control to specification, but is the specification correct?
This paper describes a systematic design methodology that ensures commissioning and project success, shortens time to market, and makes your process delivers consistently and reproducibly. Control and Operability Study (C&O) defines your process, from chemistry to automation sequences. It is a rigorous method for discovering the fundamental factors that affect performance, quality and operability, and delivering real benefits to batch operations. A trained moderator directs the study, breaks the barrier between chemists and engineers, and brings in knowledge of best practices.
C&O has been applied to a wide range of batch processes. It has slashed the time to market for a finechemicals company, and resulted in 60% capacity increase and $1M profits for a personal-care company.
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.