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.
The COTS (commercial, off the shelf) revolution has changed commercial computing, created personal computing, impacted telecommunications, and made huge changes in the industrial environment. Most of these changes have been incredibly beneficial, while some have been problematic and some have caused FUD (Fear, Uncertainty and Doubt). This white paper discusses the COTS revolution and all the FUD that can come with it.
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
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.
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.
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.
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.
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.
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 OEMs (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 OEMs, built using control system hardware and software from various technology providers. PackMLs 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.
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.
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 todays 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
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
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
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.
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
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.