White Papers

561-580 of 826 < first | | | last >
  • S88: The Good, The Bad and The Ugly!!

    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.

    Alistair Gillanders, WBF
    06/23/2008
  • Transfer Lines As Units In An S88 Framework

    Traditional process models typically view a transfer line between Units either as a physical extension of the batching vessel or as a shared equipment module. The valves in the transfer line are then convenient places to establish the boundary of the upstream or downstream Unit.

    Todd A. Brun, WBF
    06/23/2008
  • Application of S88 Model in the Control of Continuous Distillation Facilities

    A recipe control of a continuous distillation plant was a challenge in its design, simulation, validation and successful exploitation. The plant was used for solvent recovery in an Active Pharmaceutical Ingredients Production Facility (API). Following S88 models, which were used as tools in structuring a specific process cell, which had several trains with batch operating units, it was decided to apply and extend the same approach on the continuous processes as well.

    Franjo Kralj, WBF
    06/23/2008
  • Applying MPC to a Batch Process

    The application of Model Predictive Control (MPC) is often considered for multi-variable continuous processes. However, the benefit of applying MPC to a batch process can often be just as significant as a continuous process. In this presentation we will show how MPC is being applied in a pharmaceutical manufacturing facility for the control of one cut of a batch distillation column. The primary benefit of using MPC is to reduce batch cycle time. The performance that can be achieve with MPC vs. traditional techniques for this application will be examined.

    Noel Pérez, Dan Lorenzo, WBF
    06/23/2008
  • Automated Batch Scheduling and MES Integration Using a Hierarchical Based, Batch Control Software Architecture

    After years of advancement in the batch control industry--particularly within the area of standardization using S-88 and S-95--today’s automated batch control systems offer end users many features which have enabled improvements in product quality, reduced cycle time, and overall return on investment. However, the area of automated batch scheduling and MES integration has to date gone largely untapped on a relative basis when comparing features incorporated into the actual control system. In general, the problem of batch scheduling and MES integration has been left to customized, one-off solutions developed on a site-by-site basis (due to both plant variability and lack of support in the underlying control system). This paper will address recently developed technologies that begin to incorporate the batch scheduling and integration layers into the control system itself, while still maintaining the flexibility required for customization of the already present hierarchical architecture. Along with a description of the solution, real world case studies will be discussed, including both results and lessons learned.

    Nathan Pettus, Dieter Wolf, WBF
    06/23/2008
  • Automating the Manufacture of Highly Energetic Organics using the S88 Model

    The manufacture of highly energetic organics consists of three distinct and physically separated process steps. The steps are Reaction, Filtration and Crystallization. Due to the reactive nature of the products produced each step is performed in separate and isolated manufacturing areas. In 2000, a project was initiated to automate the complete production of the manufacturing process and to install state-of-the-art automation in all three of the manufacturing steps. The effort was completed in late 2001 and has been in use for almost six months at the time of this paper. One of the most visible signs of success of the new system has been the reduction of off-specification products from 15-20% to less than 2% of the batches produced. This paper addresses some of the lessons learned, trials, tribulations, and issues involved in bringing batch automation to a process that has been traditionally handled manually. Some of the issues revolve around process measurements, control problems, replacing human action with computer actions, and resistance to change. The paper will discuss how S88 concepts were applied in the manufacture of highly energetic organics.

    John Arnold, Dennis Brandl, WBF
    06/23/2008
  • Batch XML Interfacing

    The ability to share information between batch control systems and Manufacturing Execution Systems (MES) or Enterprise Resource Planning (ERP) systems has become a critical parameter in adapting to the expanded requirements for agile manufacturing. Traditionally, batch data and execution control has been the domain of control engineers. MES and ERP Systems have lived in the information technology environment with data exchanged manually with the plant floor. This increases the chance of data entry errors and slows down access to process information needed for effective scheduling, material tracking, reporting and decision-making.

    Pamela Mars, WBF
    06/23/2008
  • Centralized System Approach For Part 11 Compliancy

    The paper presents a case study on how the world’s largest pharmaceutical tablets manufacturing site achieved 21 CFR Part 11 compliancy on their manufacturing equipment by using a central information system. The paper shows the development of User Requirements Specification and Information System Design. It shows the Information Systems Implementation and how the project organized to be able to work with a large number of machines and against a tight time schedule. The technical solutions to fulfill the 21 CFR Part 11 requirements was the primary goal of the project but it also gives an added value to AstraZeneca since the system can and will be used for production optimizations and planning purpose.

    Per Westerberg, Göran Eriksson, WBF
    06/23/2008
  • 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
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