92 | Chapter 6: Instrument Qualification
Overview
This chapter contains BioTek Instruments’ recommended Installation Qualification (IQ),
Operational Qualification (OQ), and Performance Qualification (PQ) procedures for all
models of the Synergy HTX Multi-Mode Microplate Reader.
Every Synergy HTX reader and external dispense module is fully tested at BioTek prior to
shipment and they should operate properly upon initial setup. If you suspect that a
problem occurred during shipment, if you have received the equipment after returning it
to the factory for service, and/or if regulatory requirements dictate that you qualify the
equipment on a routine basis, you should perform the procedures outlined in this chapter.
A Product Qualification Package (PN 1340508) for the Synergy HTX
is available for purchase. The package contains complete procedures
for performing Installation Qualification, Operational Qualification,
Performance Qualification, and Preventive Maintenance procedures.
Microsoft Excel spreadsheets are provided for performing the
calculations, and checklists, data sheets, and logbooks are provided for
recording results. Contact your local BioTek dealer for more
information.
IQ/OQ/PQ
Installation Qualification confirms that the reader and its components have been
supplied as ordered and ensures that they are assembled and configured properly for your
lab environment.
• The recommended IQ procedure consists of setting up the instrument and its
components as described in
Chapter 2, Installation and performing the System
Test. For models with injectors, a quick “Injector Test” is also performed, to ensure
that the dispense module is properly installed and there are no leaks.
• The IQ procedure should be performed initially (before the reader is used for the
first time).
• The successful completion of the IQ procedure verifies that the instrument is
installed correctly. The Operational Qualification procedure should be performed
immediately following the successful IQ.
BioTek Instruments, Inc.
To Next Page
Loading...
Need help?
General
