Industrial Tomography Systems (ITS), as part of its commitment to working with life science and other regulated markets, has introduced a validated version of its electrical resistance tomography p2000 system. ITS has invested in conducting a pre-validation exercise with ABB Life Sciences which will effectively test 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 characterize complex processes such as crystallization, 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’

• 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