Antec developed procedures and kits for Installation Qualification (IQ), Performance Qualification (PQ) and Operational Qualification (OQ) for ALEXYS and ROXY systems and system components. An IQ consists of a list of requirements prior to installation, and a checklist covering the delivery and instructions for use. The IQ is nothing more than a document that needs to be signed upon succesful installation. The PQ checks the most crucial criteria for performance. It starts with a dummy cell test, followed by a test using a test substance. The OQ is a check of performance specifications and calibration parameters of a device. There is no chromatography involved and the reactor cell is not included in this test.
It is advisable to do an OQ followed by a system PQ after preventive maintenance of wear and tear parts, preferrably once a year.