NewswireToday - /newswire/ -
Manchester, Lancs, United Kingdom, 2009/02/25 - 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.
• Validation Plan, User Requirement Specification, Functional Specification, 21 CFR Part 11 Assessment, Requirement Traceability Matrix.
• Configuration Spec, System Hardware Build.
• FAT Spec, FAT Execution & Reporting, Site Installation, User’s Manual.
• 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.
About Industrial Tomography Systems Plc (ITS)
Industrial Tomography Systems plc (itoms.com) is a leading supplier of process tomography instrumentation. The company provides a range of electrical and acoustic-based tomography systems for research and process applications. Our systems are widely used in the pharmaceutical and FMCG industries to characterise and monitor processes such as mixing and crystallisation.