White Papers

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  • Definition and Format of Recipes for the Packaging of Consumer Packaged Goods

    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 OEM’s (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 OEM’s, built using control system hardware and software from various technology providers. PackML’s 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.

    Andrew McDonald, WBF
    06/23/2008
  • General to Master Recipe Transformation, Capturing Best Engineering Practices in Recipe Generation

    This paper discusses various strategies and methods that may be used to convert equipment independent general and site recipes, as defined in the ISA-88 Part 3 draft standard, into equipment specific master recipes, as defined in ISA-88 Part 1. The methods described have been used in multiple companies and examples of use are included in the paper. These methods allowed the companies to gain economic advantages from general recipes, reducing the engineering time and cost for new product deployment. General recipe transformation can use each site’s best engineering practices in the transformation process. This results in more consistent master recipes, fewer trial batches, and improved multi-site product consistency. The methods for general recipe transformation can be performed manually, semi-automated, or completely automated. Automation requires strict conformance to the ISA-88 Part 3 procedure definitions models. The relationship between the models and the transformation strategies is covered in the paper.

    Dennis Brandl, WBF
    06/23/2008
  • How New Technologies Can Improve Compliance

    While U.S. drug products are of high quality, there has been an increasing trend towards manufacturing problems, resulting in recalls, disruption of operations and drug shortages. Companies are missing billions of dollars of potential additional revenue, and necessary medications are sometimes unavailable to the public. By enforcing 21 CFR Part 11 and introducing additional new quality-related initiatives, the FDA is signaling a need for better compliance to ensure consistency and safety. The industry wants to comply, but many manufacturers lack the necessary capabilities, or are unaware that new technologies are available to meet the beefed-up regulatory demands and still operate efficiently and profitably.

    Justin O. Neway, Ph.D., WBF
    06/23/2008
  • How to Establish a Batch Best Practice

    All over the world, small and medium sized plants in the chemical, foods and beverage industries operate in manual or "manumatic" mode. For a small batch process operation to achieve the same level of excellence as larger companies, it must establish batch best practices. Batch manufacturing is a sequential processing activity at the level of process cells. In these cells, control modules are applied to equipment modules to run a recipe in a specific unit. To establish a best practice it is necessary to link it to a determinate Process Cell and make the right choice in process modularization. An example process cell is postulated and a possible process material selection control module discussed. Some alternatives are compared and some fundamental parameters identified to be optimized in the best batch sense.

    Paulo Ignacio Fonseca de Almeida, WBF
    06/23/2008
  • Impact of Batch Software Upgrades on Validated Batch Applications

    Batch software upgrades on validated batch applications raises many issues. This paper talks about guidelines on how much revalidation evidence is needed to meet regulatory requirements for validated batch applications, if changes made to software that is utilized in developing these automated applications. In addition, the benefits and liabilities expected after making upgrades to batch software. Often, it is difficult to estimate the level of testing effort needed to perform on a production system after implementing software upgrades. The outcome of this testing/documentation should provide sufficient data to demonstrate that software upgrades have no negative impact on equipment/product/process performance and the system has been restored to its validated status. This is the absolute requirement for Pharmaceutical Companies and should meet the guidelines required by FDA and internal company standards.

    Shri Mariyala, WBF
    06/23/2008
  • Is It Possible to Build a Pharmaceutical Plant in 18 Month (Or Even in 12 Month) Using S88

    S88 is an important factor when reducing time in both design phase, construction phase & in Commissioning & Qualification. But is it enough? Will s88 give an answer to the question or is there a need for Modular Engineering unseen to the business. This presentation will give different perspectives on this subject and try to give overview of the lifecycle of the modular approach in terms of thinking the methods into early development and ending up with a plant producing the product. The presentation will also outline some of the requirements for the Control Systems so they fit into the modular approach & give overview of the different disciplines and how they need to comply with s88 & standardization to reach the goal.

    Lars Petersen, WBF
    06/23/2008
  • One Link at a Time: A Supply Chain Success Story for a Process Industry

    Optimizing the supply chain is a hot issue in the race for global competitiveness. Defining the perfect end-state is easy. Getting there while you have a business to run is not. To achieve dramatic and sustainable results, it is necessary to put in place a process for improvement rather than a one-time project for improvement. One DuPont business accomplished this between 1991 and 1995 by tackling one real-world problem at a time.

    Jane B. Lee, WBF
    06/23/2008
  • Protecting Process Control Systems and Networks From Cyber Attack

    Business information systems and process automation systems that support the manufacturing enterprise have evolved from individual isolated applications utilizing proprietary operating systems and networks, to interconnected systems and applications employing “open” architectures and standard protocols. These manufacturing computer systems are now being integrated into Enterprise Resource Planning (ERP) systems through site and corporate communication networks.

    Lawrence Falkenau, P.E., WBF
    06/23/2008
  • Real Time Batch Control and Materials Management in Perfume Production

    This paper discusses the automation of the batch process and raw materials warehouse functions at a large perfume manufacturing facility. Many items no longer met the business needs of the facility, including: manual processes, insufficient reporting, and minimal information distribution.

    Mike Hunter, WBF
    06/23/2008
  • System Configuration Management and Version Control in an FDA Regulated Environment

    Managing the genealogy of database configuration and its life cycle is critical to following 21 CFR Part 11. In addition to recipes and equipment model configurations, phase logic and control strategies residing in automated control systems are an integral part of automated batch execution. Typical configuration management systems do not provide the capability to implement and guarantee a standard development procedure for the database configuration. With a set of enforced qualification states and GAMPbased transitions, a strategy that has been properly tested and approved with signatures can be installed on a process system. For control systems operating in validated environments, this procedure is paramount. This paper explores the life cycle management requirements for batch phase logic and control strategies executing in a validated environment.

    Steve Zarichniak, WBF
    06/23/2008
  • Targeting Batch Outcome using Predictive Control

    The paper will present a new methodology for using predictive control to improve batch process outcomes. Predictive control refers to a situation in which data collected during the execution of earlier process stages are used to retarget controllable variables during later process stages. Improvement is measured either by increasing output yield or by shifting the distribution of product outputs towards higher bin values, thereby increasing the value of a given output quantity. The technology includes a graphical method of presenting the logical flow of causality and functionality along a process. The paper describes how this methodology has been used in order to improve production outcomes in a batchbased system. The first part of the paper will present the technology, its pros and cons relatively to the traditional S88 without predictive control, and how the adaptive system is integrated within control systems. The second part of the paper will present results from a specific case study in which this technology has been implemented.

    Dr. Eyal Brill, Mr. Oren Yulevitch, WBF
    06/23/2008
  • Using S88 Batch Techniques to Manage and Control Continuous Processes

    Have you ever thought of using batch sequencing and S88 recipe management techniques to control a continuous process? This paper will discuss the great similarities and subtle differences found in such applications. At Procter & Gamble we have successfully created several such “hybrid” process control applications. The results of these adventures greatly exceeded expectations. These systems benefited from an adaptation of the modular approach described in the S88.00.01 standard with some significant differences in the states of their Equipment Modules and Phases. The necessary modifications will be presented in detail.

    David A. Chappell, WBF
    06/23/2008
  • Analyse, Design, Develop and Validate-Fast

    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.

    Andrew Knott, Francis Lovering, WBF
    06/23/2008
  • Batch Control Analysis

    Batch control analysis is one of steps in the design of plants executing batch process - an S88-based analysis of batch process from the control point of view. It is between the conceptual design of the batch process (PFD or P&I) and the start of the design of the control system (design of instrumentation, control hardware and software). Its objective is to fill the gap almost always found between the formulation of requirements and the specification of the actual implementation. It transforms user requirements into “process-based” detailed functional requirements. It has several advantages if these problems are handled, not by software engineers, rather by batch control analysts who are closer to the plant and know the process better.

    Ferenc Molnár, Tibor Chován, Tibor Nagy, WBF
    06/23/2008
  • Batch Control Systems Market and User Requirements

    Standards for batch control systems continue to be developed and incorporated into many current and new automation products. This effort is having significant impact on the increased growth of the global batch control systems market and the automation architecture of the next generation of process control systems. This paper will include current market sales, forecasts, and strategic issues involved in continuation of this growth. It also will include a discussion of additional user requirements obtained from a survey of users in the food, beverage, pharmaceutical, and chemical industries. It will offer recommendations to address these issues, as highlighted in ARC studies, "Batch Control Systems Market Study 2001" and "Batch Control Systems Market Study 2002." The papers also will address how batch standards, traceability, event management, and change control will become core functions “designed into” future automation systems architectures rather than incomplete add on functions to current systems.

    John E. Blanchard, WBF
    06/23/2008
  • Batch Modeling in Pharma Industry: The Role of the Engineering Company

    The S88.01 rule is today a well accepted standard all over the world: all qualified engineers involved in the design of a batch control system are getting familiar with the terminology and models therein described. The focus is now on the implementation. As a matter of fact, the S88.01 standard is not a prescriptive guideline. This means that engineers must define, for each project, which documents are to be produced, by whom and with which formalisms.

    Valerio Sala
    06/23/2008
  • "Collaborate-Breakthrough-Profit:" A Myth, Minefield or Treasure Chest?

    The objective of this paper is to provide an outlook on emerging Collaborative Production Management (CPM) tools. It will discuss these CPM tools in relation to material transfers (ingredient addition) in Batch manufacturing. Illustrating what collaborative initiatives these tools are likely to support, why they are required and how they may be deployed. The concept of collaborating is an old concept, but Collaborative Production Management, and the notion of CPM tools is a relatively new manufacturing trend. One that has been revitalized by the internet and the advent of more open manufacturing systems. Today global measurement and control suppliers find they are being pushed hard by manufacturers to increase their development momentum in this emerging area of “collaborative production management tools”.

    Rodger W. Jeffery, WBF
    06/23/2008
  • Exception Handling for Optimal Batch Production

    This paper supports the application of an “Intelligent” exception handling strategy, which helps to provide maximum business benefit and optimum batch production. Incorrect or incomplete design of the exception handling philosophy for a batch control system can have a detrimental effect to the batch process performance, including both the batch quality and processing time. Even though most people would agree with this, exception handling is often an area of batch control system design not always given the level of attention it duly requires, even though it can have such a significant impact.

    Paul J. Marriott BEng, CEng, MIEE, WBF
    06/23/2008
  • Personnel Tracking in Citect

    Personnel safety in heavy industries such as metals, mining and mineral processing is of paramount priority. This paper discusses the value proposition of having Citect possess the ability to deliver in real time, information about personnel that are present at or around the process that is currently being viewed on screen. Although the main driver is around safety, there are also potential benefits from a maintenance and support perspective.

    Yong, The National Account Manager, Citect
    06/12/2008
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