You can use the search box below to locate specific speakers or sessions.
View Sub-Track: Automation
Wednesday, March 26, 2008
T-1: The Role of Industrial Automation in Qualified & Non Qualified Building Automation Solutions 9:00AM - 10:00AM (Wednesday, March 26, 2008)
A paradigm shift has occurred; The building has become part of the process, and,conversely, the same equipment that manages your manufacturing process today can also manage your facility's environment. What if you could lower your cost of ownership through a more integrated approach to BAS/QBAS? By managing the environment using the same control platform as the process, you could make better use of your training budget,eliminate "locked in" long term support agreements in favor of a more flexible "Menu Selection" of support services, and improve your bottom line. In addition, validation of any system can be a challange. Regulatory compliance is not easy. But if the same approach is adopted in terms of control to the environment, as is the process, you will create an element of commonality in respect of the documentation and protocols employed. Learn more about integrating your environmental management into your production process in this session and become the master of your domain!
T-2: Benefits of Integrating Production and Quality Information 10:15AM - 11:15AM (Wednesday, March 26, 2008)
This session case study will review a successful integration of real time quality results from laboratory information systems to production systems. The case study will stress the importance of using ISA standard S88 and S95 in concert to achieve successful interoperability. Today's manufacturing execution system platforms offer an opportunity to integrate data from production and quality systems resulting in improved productivity and traceability. Genealogy tracking of production ingredients in manufacturing is a common requirement for production MES systems; however, the linkage of product data to laboratory test results is often lacking or not in real time. A key goal of any MES implementation should be to optimize laboratory operations to support production. Industry standards have emerged as guidelines to understanding how this data should be exchanged in a real time production
T-3: WORKSHOP: Automation of 'Plug and Play' Process Skids and Components in a Biopharm Facility 2:00PM - 4:00PM (Wednesday, March 26, 2008)
To enhance the flexibility and usability of biopharma pilot, clinical, and production facilities, moveable and portable process skids, tanks, chromotography units, and other modular process components are employed. The integration of these components into a process control system can be challenging and difficult. With proper planning, development of detailed user requirements, and an in-depth knowledge of S88, the proper automation strategy can be developed. The author will develop the automation strategy for a "prototype" biopharm process during this session. An interactive approach will be taken with the attendees, with the goal of identifying the major considerations of defining an automation strategy for "plug and play" components.
T-8: The Next Generation of Process Automation - The User's Requirements 9:00AM - 10:00AM (Thursday, March 27, 2008)
In the 1970's, the Programmable Logic Controller revolutionized the machine control industry. In the early 1980's, proprietary Distributed Process Control systems and microprocessor-based sensors and actuators facilitated large-scale digital plant automation for the first time. Later that decade, the personal computer made application-based automation and control inexpensive and scaleable. The S88 and S95 standards, in conjunction with GAMP4 guidelines, has given a framework for developing, documenting, and maintaining automation and process control systems for the pharmaceutical industry. Over the past ten years, however, while the industry has seen the introduction of new applications and smarter sensors and actuators, the author feels, as do a large percentage of end users, that a new paradigm in automation and process control is needed. The recent “advances” in automation have mostly come from vendors who have created different flavors of existing technologies in order to maintain market share and sales targets. In the process, application spaces have become crowded, “data” has been generated by the terabyte without much focus on “information”, and there has been a slow, but noticeable shift back to proprietary hardware platforms and software applications. It is time that end users voice their User Requirements for this next generation of automation and process control. This session will highlight the requirements of end users specifically, independent of any vendor or automation platform. The author has developed a survey and will conduct interviews which will target hundreds of end users in the pharmaceutical industry asking for input as to what this new generation of automation and process control system should look like. This session will reflect the results of this industry-wide interviews and survey, not those of the author. This session will focus on the user's perspective for the next generation of I/O subsystems, automation controllers, information processors, data historians, batch execution engines, and manufacturing execution systems.
T-9: cGMP Informatics: IT Infrastructure Design for 21st Century Pharmaceutical QC Operations 10:15AM - 11:15AM (Thursday, March 27, 2008)
Pharmaceutical R&D and Manufacturing has not changed its fundamental paper-based infrastructure in decades. The principle reason is that science by nature and regulatory requirements resist change. Recently, industry and FDA have been more aligned with respect to utilizing innovation and technology to bring manufacturing processes into the 21st century. Leading companies are adopting a new approach to automating the non-value added tasks associated with paper processes in QC and batch record management. The dominate strategy is utilizing innovative technologies (such as Electronic Notebooks) and building quality into the research, quality and compliance infrastructure. The paper will discuss the current situation in cGMP lab and production floor operations relative to FDA initiatives in manufacturing and the broad opportunity for electronic notebook processes. The paper will profile an innovative “method and SOP-centric” software platform, designed to electronically execute and manage laboratory protocols, and production batch records, yielding significant reductions in overall method execution cycle times and electronically capture all data and metadata in a common repository. In addition the GMP Electronic Notebook System provides a Lab Execution System (LES) layer within the GMP IT infrastructure to provide seamless integration of the data capture steps in operating a lab or batch record process to LIMS and ERP systems.
John Helfrich - Director, GMP Lab Automation Programs, VelQuest Corporation
Quick Search
You can use the search box below to locate specific speakers or sessions.
