Visit us at Booth #1663
We’re excited to be exhibiting at Interphex. Eurotherm is a global supplier of instrumentation for precision process control applications, and high integrity data management solutions. This year Eurotherm, recognized for precision process control, will be showcasing our Environmental Monitoring Solutions, which are designed to help our customers who need to meet regulatory requirements for achieving or maintaining 21 CFR part 11 compliance. Visit us at booth 1663 to discuss in detail about your GAMP5 validation requirements and how we might assist you. We also invite you to join us for Rick Jarrell’s informative technical session titled “Reducing Business Risk and Improving Data Integrity Through cGMP and Meeting FDA/ALCOA(+) Requirements”.
Eurotherm by Schneider Electric designs and manufactures products and systems to enable excellence in Precision Process Control, Secure Data Recording and Advanced Power Control. 3000+ customers over the last 50 years have relied on our expertise in improving control and providing solutions for the Life Science, Heat Treatment, Glass and Semiconductor industries.
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Control and monitoring of storage and production environments are very important within the Pharmaceutical Industry. The FDA, MHRA, EMEA and other regulatory bodies require accurate measurement and storage of environmental parameters and, if the storage medium is electronic, the methods used must comply with FDA 21 CFR Part 11.
Over the last ten years however, there has been a shift to separate the BMS from the EMS as suggested by the ISPE. The immediate benefits include:
nanodac™ Recorder / Controller
The ultimate in graphic recording combined with PID control and setpoint programs
The nanodac™ recorder/controller offers the ultimate in graphical recording combined with PID control for a box of its size. The compact ¼ DIN panel mount unit offers four high accuracy universal inputs for data recording and PID control. This secure data recording device with accurate control is enhanced by a full color, ¼ VGA display to bring a crystal clear operator interface to even the smallest of machines. The significance of the nanodac is its ease of integration into existing and new building automation systems, an overall hardware cost reduction by reducing the number of required components, and it includes an integrated color display to make data easy for the operator to both view and understand.
Eurotherm PAC System
The Eurotherm® Programmable Automation Controller (PAC) System consists of a high-availability T2750 automation controller and I/O subsystem combined with an easy-to-use Wonderware® based Human Machine Interface (HMI) extended by Eurotherm for optimum integration.
The Eurotherm T2750 controllers provide cost-effective process control redundancy options and a highly distributed control and monitoring architecture with tamper-resistant data recording at point of measurement.
These characteristics enable the Eurotherm PAC to optimize control performance and system availability, helping to maximize your return on investment.
Eurotherm PAC provides a highly scalable solution using the same hardware for small applications up to plant-wide solutions, combining the performance of a Distributed Control System (DCS) with the price point of a Programmable Logic Controller (PLC).
The Eurotherm PAC System includes our highly developed control with auto tuning algorithms and regulatory compliant data recording capabilities. The Eurotherm PAC solution also facilitates data integration and production efficiencies that span both your production operations and your business systems.
Reducing Business Risk and Improving Data Integrity Through cGMP and Meeting FDA/ALCOA(+) Requirements.
Thursday, April 4, 10:00 AM – 10:45 AM Stage 1, Booth 1076 Exhibit Hall
Rick Jarrell Business Development Manager | Life Science and Food & Beverage
Pharmaceutical/biotechnology manufacturing and engineering businesses have largely moved data collection to a practice of digitized record management. There is a large range of systems to choose from that can help businesses validate the quality of their products more efficiently, and comply to safety regulations, such as the FDA’s 21 CFR Part 11, as well as guidelines offered by MHRA, WHO, and other organizations worldwide. However, data integrity remains one of the greatest challenges within the Life Science industry. Duplicate data, missing data, inaccurate data, or incorrect data all fall into the category of bad data. Thankfully, there is significant alignment, and an international conversion on data and metadata integrity requirements. This conversion is summarized nicely with the FDAs guidance and the ALCOA+ guidelines. It is required that there be a significant understanding of the risks and remediation associated with the individual components of ALCOA+.Add ti Calendar