Validation Support

Supporting the pharmaceutical and biotechnology industry throughout the entire system validation process, including Equipment Qualification.

Equipment Qualification and training are performed and carried out by GMP-trained, qualified Biacore personnel when the system is installed in its selected operating environment.

In addition, to keep the system in a validated state, a re-qualification service, PM GxP, is provided. This supports the on-going qualification process and ensures correct function and maintenance throughout the entire lifetime of the system.

The on-going qualification, monitoring and maintenance process in the laboratory.

IPQ is a validated test tool for Biacore A100, Biacore T100, Biacore 3000 and Biacore C. This tool verifies that the system functions according to operational specifications under conditions similar to those used by the customer. The IPQ enables regular assessment and verification of system performance with an independent test kit.

IPQ is performed during OQ and every PM GxP visit.

The IPQ test is an interactive method using Biacore software together with the quality assured IPQ test kit. The test is performed by means of a biochemical assay, using a biotin antibody and a pre-immobilized biotin sensor chip. The kit is designed to test critical functions in the system, including:

After completion, the results are evaluated and presented in an IPQ report that is attached to the OQ documentation.