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ROXY qualification procedures

roxy qualification procedures





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.