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 Genentechs 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.
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 PLCs 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
Talk integration to a vendor and a customer and youre 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
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
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.
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.
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 companys 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.
Distillation, both batch and continuous, is the most often used separation technique in the Specialty Chemical Industry. While continuous distillation has historically received the most attention, batch distillation has suffered from some public neglect. This paper will present a summary of design basis criteria and control strategies for a multi-purpose batch still. Given the multiple product and flexible processing requirements of batch manufacturing, optimization of a batch distillation process is generally very equipment and process specific, unless the equipment was designed and is used for manufacturing a single product. The concepts presented here are suitable for processing over 80% of the Crude encountered in the industry and the design features and control strategies shown have accounted for 15-30% improved yields and throughputs.
Manuel R. Florez, Senior Engineer, Millennium Chemicals, Inc.
Batch management 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.
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
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)
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
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
Investments in process control systems will claim a large percentage of capital investments in modern manufacturing facilities. In order to maximize return on these investments, automation concepts must be developed at the early stages of the project and detailed in parallel with the process, equipment, and facility components as the engineering work progresses. However, it is difficult to illustrate control strategies for complex batch operations on PFDs and P&IDs, therefore the control system Functional Specification must come to life early and be used more effectively as a living document which is developed together with the process design.
This paper presents a case study on the application of S88.01 in the design of a multi-product biotech manufacturing facility, where flexibility, modularity, and CGMP compliance were major objectives. It shows how the models presented in the standard can be applied to develop automation concepts, which are defined in a Functional Specification that supports effective review and input by all members of the project team. This approach ensures that the automation strategy meets the project objectives, and that important concepts are not lost or mistranslated in the transition from concept through detailed design and final implementation.
Henkel Surface Technologies has significantly increased plant throughput and capacity utilization - resulting in substantial savings in terms of infrastructure investment and cost per pound produced. The program, TIP (throughput improvement program), is an employee-driven integrated cost management effort that has had corporate-wide impact in operations, finance and marketing/sales.
In manufacturing operations, the systemized daily report of operations (DRO) provides floor communications between employees and management to drive improvement. Captured metrics include attainment to schedule, attainment to standard, operator noted opportunities, and others. Reporting from the DRO identifies and prioritizes improvement opportunities.
In finance, the captured information forms the foundation for benchmark reporting that tracks improvements by trending selected process metrics. This in turn is used to develop detail product-byproduct costs for more than 6,000 individual sku's. Database reporting allows the information to be analyzed in a variety of formats with an emphasis on product complexity and its impact on operations. The cost information is then communicated corporate-wide through the product cost and financial reporting systems.
In marketing and sales, cost information, accessed through margin reports and profit and loss statements impacts business area decisions, while also influencing product rationalization decisions. Rationalization decisions, formerly primarily volume-based, now incorporate complexity factors that directly impact operations.
Rick Luedecke, Mfg Development Mgr, Henkel SurfaceTechnologies; Doug Sanders, Mfg Development Spvsr, Henkel SurfaceTechnologies; Dean D. Baker,
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.