Analytical instrument qualification in capillary electrophoresis

Area of Science:

• Analytical Chemistry
• Pharmaceutical Technology

Background:

• Capillary electrophoresis (CE) is a vital technique in pharmaceutical quality assurance.
• Analytical instrument qualification (AIQ) is essential for robust quality management, preceding method validation and quality control.
• Operational qualification (OQ) and performance qualification (PQ) are critical daily laboratory activities.

Purpose of the Study:

• To introduce a novel concept for OQ and PQ of CE systems.
• To detail the significance, testing methods, and acceptance criteria for key CE qualification parameters.
• To offer a practical and efficient AIQ strategy for pharmaceutical laboratories.

Main Methods:

• Development of a new AIQ concept for CE systems, focusing on OQ and PQ.
• Detailed examination of critical parameters including temperature control, voltage supply, detector performance (noise, wavelength accuracy, linearity), and injection characteristics (linearity, accuracy, precision).
• Implementation and testing of the proposed procedures on five CE instruments from three manufacturers.

Main Results:

• The proposed AIQ procedures are easy to implement and validated across multiple CE instruments.
• A continuous PQ method was developed, leveraging system suitability tests (SSTs) for time and cost efficiency.
• The holistic concept ensures continuous monitoring of critical parameters for sustained instrument suitability.

Conclusions:

• The new AIQ concept effectively assures the correct function of CE systems.
• This approach enhances the reliability of pharmaceutical analysis by ensuring instrument suitability.
• The continuous PQ strategy reduces instrument downtime and optimizes laboratory workflow.