Analytical Instrument Categories
Users are establishing the level of qualification needed for an instrument. On the basis of the level needed, it is to categorize instruments into three groups: A, B, and C, as for detail defined below.
Examples of instruments in each group are provided.
Note that the list of instruments provided here is for illustration only and is not meant to be exhaustive. It does not provide the exact category for an instrument at a user site. That category should be determined by users for their specific instruments or applications.
The exact grouping of an instrument must be determined by users for their specific requirements. Depending on individual user requirements, the same instrument may appropriately fall into one group for one user and another group for another user. Therefore, a careful selection of groups by users is highly encouraged.
Group A includes standard equipment with no measurement capability or usual requirement for calibration, where the manufacturer’s specification of basic functionality is accepted as user requirements.
Conformance of Group A equipment with user requirements may be verified and documented through visual observation of its operation.
Examples of equipment in this group are nitrogen evaporators, magnetic stirrers, vortex mixers, and centrifuges.
Group B includes standard equipment and instruments providing measured values as well as equipment controlling physical parameters (such as temperature, pressure, or flow) that need calibration, where the user requirements are typically the same as the manufacturer’s specification of functionality and operational limits.
Conformance of Group B instruments or equipment to user requirements is determined according to the standard operating procedures for the instrument or equipment, and documented during IQ and OQ.
Examples of instruments in this group are:
Melting point apparatus,
Examples of equipment in this group are:
Group C includes instruments and computerized analytical systems, where user requirements for functionality, operational,and performance limits are specific for the analytical application.
Conformance of Group C instruments to user requirements is determined by specific function tests and performance tests.
Installing these instruments can be a complicated undertaking and may require the assistance of specialists. A full qualification process, as outlined in this document, should apply to these instruments.
Examples of instruments in this group include the following:
• Atomic absorption spectrometers
• Differential scanning calorimeters
• Dissolution apparatus
• Electron microscopes
• Flame absorption spectrometers
• High-pressure liquid chromatographs
• Mass spectrometers
• Microplate readers
• Thermal gravimetric analyzers
• X-ray fluorescence spectrometers
• X-ray powder diffractometers
• Diode-array detectors
• Elemental analyzers
• Gas chromatographs
• IR spectrometers
• Near-IR spectrometers
• Raman spectrometers
• UV/Vis spectrometers
• Inductively coupled plasma-emission spectrometers
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Reference – USP General Chapter <1058> Analytical Instrument Qualification