White Papers

521-540 of 810 < first | | | last >
  • Composite Batch Report and 21 CFR 11

    New technologies bring a step change in the availability, flexibility and quality of data for reporting. Batch reporting can be considered to be made up of three elements (1) automated actions by the control system, (2) manual actions and records by an operator and (3) process values. Windows technology has made the combination of (1) and (2) routine but combining (1), (2) and (3) into a single report has been elusive. In addition within the regulated industries the integrity of such a report has to be assured.

    Chris Morse, WBF
    08/23/2008
  • IR Automation Guidebook: Temperature Monitoring and Control with IR Cameras

    This handbook is intended to help those considering the creation or improvement of production automation or monitoring systems to take advantage of what IR cameras have to offer. Numerous application examples will be presented, with explanations of how these IR vision systems can best be implemented.

    FLIR Systems
    07/29/2008
  • The Fundamentals of Refractory Inspection with Infrared Thermography

    Thermography has been used to inspect the condition of refractory lined vessels and piping for many years now. It is a proven and accepted method for locating damaged and missing refractory material. Most companies however, do not fully understand the full benefits of performing refractory surveys. They mainly use thermography only before a plant turnaround to determine the extent of refractory damage in order to estimate the materials and labor needed for the repairs. This paper discusses the fundamentals of refractory inspection and how Thermal Diagnostics Limited has been using Infrared thermography in Trinidad and Tobago as an effective means of predicting areas of future refractory problems in addition to pre-turnaround surveys.

    Sonny James, Managing Director Thermal Diagnostics Ltd
    07/29/2008
  • The Project Management Office

    The purpose of this paper is to explain the general concepts, purposes, specific responsibilities and requirements associated with an effective project management office.

    Thomas B. Clark, Project Success, Inc. (formerly YCA)
    07/14/2008
  • Applying S88, S95 and B2MML in Dairy Enterprise

    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.

    Arne Svendsen, WBF
    06/23/2008
  • Control and Automation Maturity Models in Brewing

    How do we choose the correct level of automation for a specific process area within the production facility? How does that facility drive a migration of its control systems to meet increasing business requirements while taking into account very real constraints around skills levels, existing equipment configuration and materials availability? These are very real questions confronting all of us today irrespective of how basic or advanced our manufacturing facilities are. This paper will present the concept of simple maturity models with regard to manufacturing control systems. It will illustrate the use of the concept through the typical stages of brewing control system complexity found within a brewing process area – from the completely manual to the fully automated configurations. It will further explore the typical business drivers which would require the move from one level to the next as well as the impacted factors to be addressed when driving a migration of the control system. Relevant international standards like S95 and S88 will also be put into context as helpful models and terminology in support of the business needs of SABMiller.

    Willie Lotz, WBF
    06/23/2008
  • Control Room Information for Batch Processes

    The way information is displayed in control rooms in the process industry has developed a long way from the original gauges, chart recorders and lamps to the sophisticated windows based Graphical User Interfaces (GUI) of today. But does the increased ability to acquire and to display more data mean that better information is conveyed than before? This paper describes how the technology available recently has not been used to its full potential in control rooms. A methodology is then developed to make use of the available technology in order to assist in the delivery of information to control room operators. In particular the paper addresses the problems in the presentation of plant data in the context of batch processes.

    Milton Crofts, WBF
    06/23/2008
  • ISA 95 Integration Between SAP R/3 And Batch In Pharmaceutical Applications

    The ISA 95 Enterprise to Manufacturing integration model is used to structure the integration processes between business systems and the plant floor. Through the use of the ISA 95 “structures, a “common denominator” business model was established for integrating SAP’s R/3 PP-PI transactions and data structures with an ISA 88 batch automation data structure.

    Stephan Van Dijck, WBF
    06/23/2008
  • Modeling Batch Process Using Virtual Variable

    Batch processes include many steps or phases related to each other, either sequentially or in parallel, in order to achieve a final outcome. The final outcome of such a process is measured using quality and quantity targets. However, in many cases, the outcomes of intermediate steps/phases are not measured even though their values may significantly affect the final outcome. In some cases the measurement of such intermediate outcomes is not possible. This paper will present a methodology that applies “Virtual Variables” in order to predict and qualify the intermediate outcome. With this qualification and modeling, the final outcome of the whole batch can be targeted better. The paper will present data from an actual project where such a methodology has been applied.

    Dr. Eyal Brill, WBF
    06/23/2008
  • Modular Turnkey Concept for Pharmaceutical Sterile Formulation

    Sterile parental drugs are produced or formulated in GMP critical batch processes. These automated process installations are submitted to a lot of regulations applying to the pharmaceutical industry. The formulation installations have moved away from being just utilities’ extensions and have become speciality installations requiring a high degree of technical skills but also knowledge about regulations and qualification/validation strategies. As a result of this, specialised suppliers offer a turnkey approach for concept design, detailed engineering, realisation and qualification of these installations. Nowadays, there is a move towards modular skid concepts, allowing prefabrication and pre-qualification.

    Geert Roggeman, WBF
    06/23/2008
  • Monitoring Multi-Recipe Batch Manufacturing Performance

    Quality and consistency are key factors in determining business success. Manufacturing products that satisfy product quality and consistency specifications first time result in increased productivity and lower overall manufacturing costs. Approaches to achieving consistently high quality production and enhanced manufacturing performance include Statistical Process Control (SPC) and Six Sigma with increasing attention now being paid to Multivariate Statistical Process Control methodologies (MSPC) or perhaps better termed “Process Performance Monitoring”. In today’s process manufacturing environment, a number of issues arise which can challenge the application of MSPC based process performance monitoring technologies. For example, most applications of MSPC have tended to focus upon the manufacture of a single product, i.e. one grade, one recipe, etc. with separate models being developed to monitor individual product types. However, with process manufacturing trends being influenced by customer demands and the drive for product diversification, there has been an increase in flexible manufacturing. Thus with many companies now producing a wide variety of products, there is a real need for process models which allow a range of products, grades or recipes to be monitored using a single process representation. Three industrial case studies are presented to demonstrate the application of the multi-group performance monitoring approaches.

    Julian Morris, Elaine Martin, WBF
    06/23/2008
  • The Price of the Split Between S88 and S95

    There is a split between the S88 and S95 models. In the physical model of S95 procedures are not implemented. Why not use PFC for logistic procedures instead of BPML? Your engineers have to learn only one model. You can combine S88 and S95 to one physical model for batch, continuous and discrete processing including storage units.

    Siem Broersen, WBF
    06/23/2008
  • Applying S88 – The Human Factor

    Automating manufacturing using S88 concepts across all of the operational manufacturing boundaries has become the “standard” way of doing business. The current states of the technologies used in these automations require individuals with unique capabilities, or success is not always certain. Each operational area has its own unique needs, and not only requires a high minimum capability in that area, but the ability to coordinate across areas as well. This paper will address what it takes to identify levels of capability, and the benefits of taking advantage of this capability. What to look for in evaluating an organization’s capability in delivering automation will also be discussed, as well as the results of not knowing your automation supplier’s real capabilities.

    David A. Chappell, WBF
    06/23/2008
  • Tight Integration of Process Control with ERP

    For a new built multi purpose batch plant the DCS with batch control was linked to the ERP-system of the company to ensure consistent and up-to-date data in all systems. As part of the engineering project of the plant the part process control using a standard DCS with the manufacturers batch extension was configured to meet the needs resulting from the task to exchange data and information with the company-wide used ERP-system. Nevertheless a direct link between DCS and ERP-system could not be established due to misfit of data models. Therefore a „Middleware“ was configured and programmed. The Middleware takes relevant material information from the ERP-system and sends it to the batch control system, takes master recipes from the batch control system and creates planning recipes within the ERP-system, takes orders from the ERP and generates control recipes within the batch control system, and reads current data from the DCS about process status and material consumption and production and creates messages for the ERP. The Middleware translates between DCS and ERP generating fast and reliable information-update in all systems and comprehensive documentation of the production process with low personnel efforts.

    Martin Zeller, WBF
    06/23/2008
  • 21 CFR Part 11 Compliant Recipe and Batch Management - What’s Missing?

    In this paper (and associated presentation), the requirements to manage various levels of batch recipe within the pharmaceutical and other sectors within the Life Sciences sectors industry will be discussed, as well as the requirements to maintain secure batch records, including compliance with various electronic records and electronic signatures guidance. Examples of how this can be achieved within an ERP solution (without the need for a separate MES level batch or recipe management solution) will also be discussed.

    David Stokes, WBF
    06/23/2008
  • Batch Manufacturing in the Biopharmaceutical Environment

    The operations and manufacture of biopharmaceuticals is a complex process combining the capabilities of multiple systems that extend the boundaries of batch processing. The Manufacturing Execution System (MES) receives information from the Enterprise Resource Planning (ERP) system and creates the necessary production orders, maintains material tracking/genealogy and coordinates key manual activities. The automated batch control system sequences the phases, controls the devices and captures the necessary history. These systems come together in the operation of Biopharmaceutical production plants, which require a very specific architecture that leverages standard batch products that are tightly integrated with MES capabilities. This is driven by the upstream and downstream processing specifications of such plants, the detailed compliance requirements and the benefits achieved in maximizing automated functionality. This paper explores the unique requirements of batch manufacturing in the biopharmaceutical environment.

    Torsten Winkler, WBF
    06/23/2008
  • Communication Through B2MML – Is That Possible?

    Many of you have certainly heard about the ISA S95 standard, and you know that it treats the subject of how Enterprise/business systems should be integrated with manufacturing and control systems You might also be aware that of B2MML (Business to Manufacturing Markup Language), a set of XML schemas corresponding to the S95 object models, is intended to be used for data exchange between a business system and a manufacturing system. This paper describes experiences of using the B2MML schemas in real applications. What happens if the Business system does not export the data in a format compliant with the schemas? What about reliability for the data being exchanged? Were extensions or restrictions needed on the schemas? Which are the reasons for choosing to use B2MML? Is it practically possible to communicate using B2MML? Benefits, difficulties, compromises, challenges etc of using the B2MML schemas in practical applications will be described in the paper.

    Heike Schumacher, Charlotta Johnsson, WBF
    06/23/2008
  • Coriolis Mass Flow Meters in Batching Applications – The Good, the Bad and the Ugly

    Coriolis mass flowmeters are the most accurate of the industrial flow measurement technologies, and the only flowmeter that claims to measure true liquid mass flow directly. They are widely used in both continuous and batch processes. They are often used in batch processes as a less-expensive alternative to load cell weighing systems (the good). As with any other flow metering technology, Coriolis has its own application “watch outs,” including a requirement that the flowmeter be totally and completely full of non-aerated liquid during the measurement.

    James R. Reizner, WBF
    06/23/2008
  • Functions Need to be Considered for Batch Material Transfer Controls

    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.

    Charlie Fu, WBF
    06/23/2008
  • Implementing B2MML with SAP

    The Procter & Gamble MES organization is implementing B2MML with SAP. When starting, we found several obstacles including; Lack of examples of B2MML; No desire from the SAP company to pursue a B2MML interface; Our lack of XML skills; Missing automatic interfaces in SAP. Several factors in our favor included: Support for B2MML at management level in our Information Exchange, Material Movement/Warehouse, SAP Production Execution, and MES organizations; we could use an existing SAP Business Connector infrastructure; our key MES vendor was actively developing a B2MML interface; The WBF XML working group was willing to exchange information.

    David Cornell, WBF
    06/23/2008
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