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.
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 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.
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 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.
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 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.
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.