Thermo Scientific UltiMate - Requirements for a Successful OQ;PQ

OQ/PQ Operating Instructions M1393R0 Page 9 of 60
CHAPTER 2
Requirements for a Successful
OQ/PQ
2.1 Overview
The Operational Qualification (OQ) and Performance Qualification (PQ) procedures are
system-specific procedures. The procedures provided with this document apply for the
components of the LC Packings UltiMate Capillary HPLC system listed in TABLE 2-1:
TABLE 2-1 List of UltiMate System Components with available OQ/PQ Procedures
Instrument Version Option
UltiMate [Plus] Nano- and
Capillary HPLC System (b)
Standard / Inert - Flow Sensor
- Without UV Detector (a)
- Manual Injection Valve
UltiMate [Plus] Dual Gradient
Nano- and Capillary HPLC
System (a) (b)
Standard / Inert - Flow Sensor(s)
FAMOS Well Plate
Microautosampler
Standard / Inert - Sample Cooling
FAMOS Carousel
Microautosampler
Standard / Inert - Sample Cooling
Switchos II Advanced
Microcolumn Switching Unit
Standard / Inert N/A
Notes: (a) If no UV Detector is installed, an extra detector is required to perform the OQ/PQ procedures.
(b) For test procedures regarding the MIC versions of the UltiMate system, contact LCP.
Note: The OQ/PQ procedure are identical for LC Packings UltiMate and UltiMate Plus
Capillary- and Nano HPLC Systems. When the LC Packings UltiMate system is mentioned,
the reader should assume that the material applies to both systems.
Note: If the system does not include an UltiMate UV Detector, a standalone UltiMate UV
Detector is required to perform the OQ/PQ procedures.
The instruments should be controlled by CHROMELEON® 6.6 SP1 or higher (previous
versions will have compatibility problems with the CHROMELEON report file). All necessary
CHROMELEON programs and sequences are provided on the CD ROM ‘IQOQPQ on
UltiMate™ (Plus) Systems’ (P/N 163935). If a different software package (e.g. Xcalibur™,
Analyst™, HyStar™, MassLynx™, UltiChrom™, etc.) is used to control the instruments, all
programs will need to be prepared manually. Some limitations may apply due to different
or limited control capabilities of these software packages.