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.

	PQ kit pn 250.3040 contains column, sample and mobile phase.
	OQ kit pn 250.3050 contains test cables and plugs.

• Installation Qualification: 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.
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• Performance Qualification: the PQ checks the most crucial criteria for performance. The PQ starts with a dummy cell test, followed by a HPLC test using a test substance. Repeatability, linearity & peak height is measured and for GC electrodes only: I-cell, noise & s/n ratio.
  The PQ kit pn 250.3040 contains a column (DCC kit: 2), test sample and concentrated buffer for 1L mobile phase. Two pieces of standard bore tubing are included in case the PQ is done on a micro LC system. The PQ for DCC has an additional vial set. Every DECADE II and ROXY has its own dummy cell already.
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• Operational Qualification: the OQ is a check of performance specifications and calibration parameters of a device. There is no chromatography involved and the flow cell is not included in this test.
  The OQ kit pn 250.3050 contains 2 test cables, 2 I/O test plugs, and 1 cell test plug. For a DCC kit 2 additional plugs and 1 dummy cell are included for the second channel. This is also the content of the extention kit pn 250.3054.
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We have one document 180_0028 which describes the PQ procedure for all Antec systems, EC detectors or potentiostat. It applies to DECADE II, ROXY and also for INTRO and DECADE I, for systems with glassy carbon and gold cells. Our Dialogue software uses a script and an Excel template for PQ and OQ measurements.

Software is not included in the below mentioned parts and should be ordered separately. For distributors we advise a Dialogue OQ/PQ/ROXY license pn 171.9002.

For more details on qualification procedures see our documentation (scroll down to section Qualifiction Procedures).