Analytical Instruments Categories
In contemporary laboratories, a diverse array of instruments is employed, ranging from basic tools to advanced automated systems. It is imperative for users to determine the requisite qualification level for each instrument, with reference to the guidelines outlined in USP 31, specifically Section <1058> - Analytical Instrument Qualification. These instruments are classified into three distinct groups: A, B, and C, in accordance with user-specific needs, and it is important to acknowledge that this categorization may differ from one user to another.
Group A:
Basic equipment with no calibration requirements; user requirements align with the manufacturer's specifications. Verification can be visual. Examples: nitrogen evaporators, stirrers, vortex mixers, centrifuges.
Group B:
Instruments providing measured values and those controlling physical parameters requiring calibration. User requirements match manufacturer specs. Conformance is determined using standard procedures during Installation Qualification (IQ) and Operational Qualification (OQ). Examples: balances, pH meters, thermometers.
Group C:
Instruments and computerized analytical systems with specific user requirements for functionality and performance. These may require specialist assistance and undergo a full qualification process, as outlined in USP 31, Section <1058>. Examples include mass spectrometers, atomic absorption spectrometers, gas chromatographs, HPLC, UV/Vis. Spectrometers, etc.
Note: The exact instrument grouping should be determined by users based on their specific needs and applications, and reference to USP 31, Section <1058> Analytical Instrument Qualification should guide this process.