White Papers

541-560 of 823 < first | | | last >
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
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