Instruction manual

7. Hardware Validation
7-2
RF-20A/20Axs
7.1 Overview of Hardware Validation
7.1.1 Hardware Validation
Hardware validation is the work of inspecting whether the LC system is running correctly and the instrument is
suitable for the intended analysis, and of documenting this process. The performance of the LC system
deteriorates with age, reflecting the wear of consumable parts. Hardware validation must therefore be
performed periodically from the time of installation until the system is retired. Although aspects of validation
related to analysis, such as method validation and system suitability tests should also be performed, hardware
validation is a prerequisite for these aspects.
7.1.2 Types of Hardware Validation
A high performance liquid chromatograph consists of a number of LC components including pump(s), an
autosampler, column oven, and detector(s). For this reason, hardware validation is divided into the inspection
of individual components and system validation as a whole, and both these types of validation must be
performed.
The validation reports obtained during the production of each Shimadzu product are supplied with the product.
This chapter describes the inspection procedures and guidelines for the inspection pass criteria for this
component and, separately, for the HPLC system, to assist the user in validating the performance of this
instrument. Refer to each instruction manual for each component for the method of hardware verification for
that specific component.
To inspect whether each LC component runs correctly.
To inspect items that cannot be inspected as a single
component and also inspect the entire LC system for
proper function.
Hardware validation
Component validation
System validation