Eurotherm’s Flexible and scalable solutions for the Pharmaceutical and Biopharma Industry |
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Eurotherm continues to offer a most complete set of flexible & scalable control and data acquisition products and solutions with features designed specifically to meet the requirement of the pharmaceutical industry. This ranges from signal conditioners, data recorders, industrial controllers, Unit Controllers, to full DCS systems. 21 CFR Part 11 compliance -- A quick way to meet 21 CFR Part 11 is Eurotherm's model 5180V or 5100V, 5000B data recorder products. The audit trail and electronic signature features provide compliance with 21 CFR Part 11. Data is secure and yet easily viewable using Eurotherm Review Software or standard applications like Excel® or Acrobat®. Interested in process control with 21 CFR Part 11 built in features -- The T800 Visual Supervisor offers an ideal Unit solution combining process control, Batch with recipe and sequence control, and a touch screen display in one unit. It can log data, audit trails, Electronic signatures and accept operator notes with time / date information in "tamperproof" files. If you require high availability for saving your valuable products then the T940 Process Supervisor with bumpless redundancy feature is available. Requiring central and remote monitoring and control system with 21 CFR Part 11 -- The EurothermSuites' family of Supervisory systems including Operations Viewer and Server with built in 21 CFR Part 11 provide a central repository for logging data, audit trails and electronics signatures in "tamperproof" files. Eurotherm's line of process controllers also includes models 2704 and 2604, 1/4 DIN controllers and models T630 and T640. These units control from one to four loops and feature redundant sensors, digital communication and power-fail recovery strategies. With "lockout" front panel keys they can be used in conjunction with Eurotherm's wide range of 21 CFR Part 11 operator displays. The well-established and comprehensive range of paper recorders, circular recorders, process alarm units, process indicators, Web View I/O web enabled signal conditioners, and a wide range of sensors complement Eurotherm's control and data management range of solutions. Lower cost of ownership Eurotherm products and solutions not only allow you to meet regulatory requirement at a lower cost but also our world class training and services can significantly lower the cost of ownership. Our world wide presence allows successful implementation in one location to be effortlessly repeated in other plants around the world with our local support teams. More than 30 Years experience Eurotherm's products and solution has been uses in a wide range of pharmaceutical and biotechnology applications, in both standalone and as part of an integrated system, that have been successfully validated by the regulatory bodies around the world including FDA, EMEA .. Eurotherm's long established Quality Management System is approved by Lloydds Register Quality Assurance to ISO9001:2000 and the TickIT guide Issue 5. Our Tick-IT and ISO 9001 Quality Management System ensures all products and solutions are designed and manufactured with built in quality. Successful "supplier audit" by major pharmaceutical and biotechnology corporations testifies to this. Eurotherm's teams of pharmaceutical experts around the world with numerous years of experience offer a complete life cycle support including:
Many of our pharmaceutical, biopharma and medical devices customers request work to the GAMP, Guide for Validation of Automated Systems - guidelines which have become the de facto standard for Good Automated Manufacturing Practice in the healthcare industries. Eurotherm has a long history of projects successfully validated to GAMP guidelines including many which are now operating in FDA regulated environments Documents:
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| Last updated December 19, 2003 |
