Introduction
Page 8 of 60
M1393R0
OQ/PQ Operating Instructions
1.3
General Notes and Recommendations
•
After the validation of the different modules, a cytochrome C separation should be
performed according to the LC Packings factory qualification protocol (as described in
the user’s manual).
•
For Ultimate Dual Gradient system configurations, the gradient accuracy test
(Section 4.10 ) must be performed on both pumps.
•
Channel C & D should only be tested on customer request.
•
If the customer ordered a system with two configurations (e.g. a NAN configuration
and a CAP upgrade kit), the OQ/PQ should be performed for the system configuration
that the customer will be using on a routine basis.
•
If required, test any other configuration according to the factory qualification protocol
(cytochrome C digest separation).
•
After the instrument has been validated via the protocols described in this document,
the analyst should perform a validation of the assay with standards of the compounds
of interest.
1.4
How this Manual is structured
This manual describes the Operation and Performance Qualification for the LC Packings
UltiMate Systems in its different configurations (including the FAMOS Microautosampler
and the Switchos Advanced Microcolumn Switching Unit) and provides the following
information:
Requirements for a Successful OQ/PQ
provides an overview of the parameters
to be tested, a short description of the tests and lists the required acceptance limits for OQ
and the recommended limits for PQ.
lists all required materials, standards and solvents that are necessary
to perform the OQ/PQ test procedures. In addition, it describes how to prepare
CHROMELEON and the UltiMate system to perform the tests.
provides step-by-step instructions about how to perform and
evaluate the various OQ/PQ tests.
discusses how the operator can determine the cause of a
difficulty in the performing of the OQ/PQ.
provides the listings of all CHROMELEON programs
used to perform the QQ/PQ test procedures on an UltiMate system in NAN configuration.
1.5
For Additional Information
For more detailed information about the operation, maintenance or troubleshooting of the
instruments of the UltiMate system or how to use the CHROMELEON software package,
please refer to the documentation provided with these products and to the online help of
CHROMELEON (F1 key).
