White Papers

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  • 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
  • Model Predictive Control of Batch Temperature

    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
    06/23/2008
  • Multiple Products in a Monoclonal Antibody S88.01 Batch Plant

    The most successful biotech companies have multiple products approved for market and must make the use of existing manufacturing capacity to produce them. Often times this requires rapid changeover from one product to the next. This paper addresses the challenges with bringing new products into an existing S88.01 facility and the challenges involved in maintaining the standard as well as implementing a change in an operating plant with a minimum of downtime. It was found that the S88 concept is enormously helpful in implementing changes within the equipment capability but that challenges arise when the equipment capability must be changed also. The recommendation is to standardize the manufacturing process and build the necessary capability into the plant upfront to avoid costly downtime during product changeover.

    Mahasti Kheradmand, John O’Connell, WBF
    06/23/2008
  • Production Performance Ratings

    Key Performance Indicators (KPIs) are used in batch processing industries as measurements of production performance. Their use is one element in the current trend of real-time performance management. A single KPI used as the primary measurement of production can cause other dimensions of production performance lose importance. When multiple KPIs are used to measure a batch’s production performance it can be difficult to reconcile differences between them for individual batches or for groups of batches. KPIs based upon meeting a target, or specification, measure absolute performance yet do not provide relative information regarding how a batch performed against its peers. The peer comparisons are important for monitoring variability of production performance, which is a critical factor in documenting ROI.

    David Emerson, WBF
    06/23/2008
  • Retrofit of an Existing Process Cell with S88

    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.

    Brian N. DeHaan, WBF
    06/23/2008
  • 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
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