What are the analytical instruments’ categories as per USP General Chapter: <1058> Analytical Instrument Qualification?
Analytical Instruments Categories of instruments are divided into three groups: A, B, and C.
1. Analytical Instruments Group A
- Group A contains standard equipment with no measurement ability or usual requirement for calibration, where the manufacturer’s main functioning specifications are considered as user requirements
- Visual inspection of Group A equipment’s functioning can be used to verify and document its compliance with user requirements.
Examples:
- Nitrogen evaporators
- Magnetic stirrers
- Vortex mixers
- Centrifuges
2. Analytical Instruments Group B
- Group B contains standard equipment and instruments providing measured values in addition to equipment controlling physical parameters (such as temperature, pressure, or flow) that required calibration, where the user’s functional and operational needs are often the same as the manufacturer’s specifications.
- The conformance of Group B instruments or equipment to user requirements is determined using the instrument or equipment’s standard operating procedures (SOP) and documented during IQ and OQ.
Examples:
Instruments:
- Balances
- Melting Point Apparatus
- Light Microscopes
- Ph Meters
- Variable Pipets
- Refractometers
- Thermometers
- Titrators
- Viscometers
Equipment:
- Muffle Furnaces
- Ovens
- Refrigerator-Freezers
- Water Baths
- Pumps
- Dilutors
3. Analytical Instruments Group C
- Instruments and computerized analytical systems in Group C are those in which the user specifies the analytical application’s functionality, operating, and performance restrictions.
- Specific function and performance testing establish whether Group C instruments comply with user requirements. Installing this equipment is a difficult task that may necessitate professional assistance.
- A full qualification process should require for these instruments.
Examples:
Instruments:
- Atomic Absorption Spectrometers (ATS)
- Differential Scanning Calorimeters (DSC)
- Dissolution Apparatus
- Electron Microscopes
- Flame Absorption Spectrometers (ABS)
- High-Pressure Liquid Chromatographs (HPLC)
- Mass Spectrometers (MS)
- Microplate Readers
- Thermal Gravimetric Analyzers
- X-Ray Fluorescence Spectrometers
- X-Ray Powder Diffractometers
- Densitometers
- Diode-Array Detectors (DAD)
- Elemental Analyzers
- Gas Chromatographs
- IR Spectrometers (IR)
- Near-IR Spectrometers (NIR)
- Raman Spectrometers
- Uv/Vis Spectrometers (UV)
- Inductively coupled plasma-emission spectrometers (ICP)
What is the difference between equipment and instrument?
- Instruments are used to measure units such as flow, pressure, and weight, among others. The instrument is a section of equipment.
- Equipment is made up of one or more instruments that can be used to accomplish a variety of tasks. Weight balance, Moisture analyzer, for example, is a piece of equipment.
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Reference:
1. As per USP General Chapter :<1058> Analytical Instrument Qualification