First Validated Electrical Resistance Tomography System

Feb. 25, 2009 - PRLog -- Process consistency and product quality are key to the pharmaceutical industry from drug development research through to manufacturing scale-up.

To ensure better quality and efficiency, the validation of the equipment used to monitor and control these processes is crucial. Validation relates to demonstrating that instrumentation has been tested and that the information reported corresponds to what is being measured.      

Industrial Tomography Systems (ITS), as part of its commitment to working with the life science and other regulated markets has introduced a validated version of its popular electrical resistance tomography p2000 system. ITS has invested in conducting a pre-validation exercise with ABB Life Sciences.  This effectively tests the use of ITS technology against criteria set out in GAMP 4 and also relates closely to GAMP 5.

The p2000 is able to help characterise complex processes such as crystallisation. As well as determining concentration variations through a vessel.

ITS is also able to provide information on key unit processes such as mixing, filtration and liquid-liquid separation. This offers the benefit of reducing batch cycle times and improving batch to batch consistency.

This work includes assessment against ITS’s
•   ensuring that instrumentation meets users requirement specification (URS)
•   risk based approach to current and new applications
•   CFR Part 11 Code 21 approach to software testing and validation
•   change management procedures

Quality Management System

•   Validation Policy, QMS Document Register, Approach to Validation Procedure

Specification Phase

•   Validation Plan, User Requirement Specification, Functional Specification, 21 CFR Part 11 Assessment, Requirement Traceability Matrix

Design Phase

•   Configuration Spec, System Hardware Build

Testing Phase

•   FAT Spec, FAT Execution & Reporting, Site Installation, User’s Manual

Qualification Phase

•   IQ, OQ & PQ Protocols, IQ, OQ & PQ Execution and Reporting, SOP – Normal Operation, SOP – System Administration, SOP – Maintenance & Calibration, SOP – Backup & Restore, Training, Validation Report


At present, the standard applications for process tomography which have been validated through to factory acceptance testing are:

•   interface detection with linear sensor
•   homogeneity measurement with linear sensor
•   two phase flow visualisation with circular sensor

If you are interested in further details on ITS’s approach to validation or would like to use tomography in a validated environment please contact:

Michael Dunne
Industrial Tomography Systems Plc
Speakers House,
39 Deansgate,
Manchester
M3 2BA

Tel: +44 161 838 9086
E: michael.dunne@itoms.com

For more information, please visit:

http://www.itoms.com/p2000_validation_iq_oq_pq_quality_by...

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Industrial Tomography Systems are the leading supplier of electrical tomography instrumentation, sensors and software. The technology is currently used in a wide range of process industries including petrochemicals, mining and the nuclear sectors.