Pharma News

• New solutions for Data Acquisition management: Innovative Remediation Solutions, PAT Solutions, Central Password Entry (Security Manager), Email Calibration & Process Alarm Capability, Report 5000 (directly from encrypted data)
• Process control solutions through dedicated control systems for the following applications: Water Purification / Fermentors / Freeze Dryers / Tablet Coaters / Environmental and Stability Chamber Monitoring / Time Synchronization / Redundant Inputs (save the batch)

Eurotherm has introduced a process control system specifically designed for the Fermentation Process. The system uses the T800 Visual Supervisor. A control system must provide flexibility so that accurate and repeatable control of the fermentation environment can be achieved: Eurotherm’s T800 provides such a single integrated unit solution for fermentation applications.

Eurotherm, a leading manufacturer and supplier of industrial instrumentation for the process control and data acquisition industries, and a unit of Invensys plc, has introduced a process control system specifically designed for the freeze drying process using the T800 Visual Supervisor. The freeze drying process is used in regulated industries and extracts dry product from an aqueous solution. The T800 Visual Supervisor controls all facets of this slow batch process.

A new 'state-of–the-art' Pharmaceutical Manufacturing Unit (PMU) at Moorfields Eye Hospital NHS Trust (London, United Kingdom), features sophisticated Water for Injection (WFI) and Clean Steam generation systems for cleaning and sterilization purposes. The system, designed and engineered by specialist consultants Honeyman Group, uses a Eurotherm T800 (Visual Supervisor) based control solution for all supervisory control functions. The system meets the demanding requirements of FDA 21CFR Part 11 with respect to electronic records.

Eurotherm has been awarded a contract valued "approximately $875,000" to supply AstraZeneca with a 21CFR Part 11 compliant control and data acquisition system for their new Large Scale Lab Facility at the Macclesfield site. The large Scale Laboratory (LSL) is multi-purpose and manufactures kilo scale quantities of primary pharmaceutical products for use in clinical trials. LSL comprises of 18 independent Production units, which include heat cool reactors, Cryogenic reactors, Hydrogenator & chromatographic units.

The system is required to be validated and to provide 21CFR Part 11 compliance

The control system provides local operator visualisation and control for 18 production units each utilising Eurotherm's T800 Visual Supervisor. A central supervisory system with redundant EurothermSuite Operation Servers provides operator visualisation and all long term tamper proof logged data and audit trails. Distributed Operations Viewer nodes allow lab-wide view of overall facility.

Validation CD saves over 70 hours of work

One of Eurotherm's customers just performed GAMP / FDA validation on a 5180V recorder using Eurotherm's validation CD. The IT Manager and the Process Chemist spent 20 hours validating their system. They had nothing but good words to say about the validation documentation from Eurotherm. It saved them over a weeks work in preparation alone before they even sat down with the recorder. They estimated it would have taken over 70 hours of work for two people without the Eurotherm validation documentation.

Eurotherm meets with FDA