Ensuring accuracy, reproducibility, and traceability through a methodical validation protocol aligned with ISO requirements to ensure accuracy, reproducibility, and traceability of results. This technique is widely applied across pharmaceutical, food, and materials science sectors to characterize particle size, shape, and distribution in real time. To meet ISO compliance, particularly under the ISO 13322 family of standards for particle sizing and ISO, organizations must establish a comprehensive validation framework.
Initiate validation by specifying the method’s purpose and defining measurable performance targets. This includes identifying the parameters to be measured, such as size distribution, shape factors, 粒子形状測定 roundness, and particle clustering, and determining acceptable tolerances for each. The method must be fit for purpose, meaning it should reliably produce results within specified limits under normal operating conditions.
Subsequently, calibrate the system with NIST-traceable or ISO-certified reference particles. For dynamic image analysis, this often involves using particles with known size and shape, such as standardized glass microspheres and synthetic polymer spheres, to verify the system’s ability to accurately capture and measure images. Calibration should be performed regularly and documented, with records maintained for audit purposes.
Precision and accuracy must be evaluated through repeated measurements under controlled conditions. Reproducibility testing should be conducted across varied personnel, equipment units, and experimental dates to assess within-laboratory variability. Accuracy can be verified by comparing results against a reference method, such as laser diffraction or microscopy, where appropriate. The difference between the dynamic image analysis results and the reference values should fall within predefined acceptance criteria.
Equally vital is the assessment of method robustness. This involves deliberately introducing small variations in method parameters—such as illumination levels, suspension flow speed, or lens focal distance—to determine how sensitive the method is to operational changes. A robust method will produce consistent results even when minor deviations occur, indicating reliability in routine use.
The method’s range and limit of detection must also be established. This includes determining the smallest and largest particle sizes the system can reliably measure, as well as the lowest concentration at which particles can be detected without interference from background noise or artifacts.
Documentation is essential throughout the validation process. All protocols, raw data, calculations, and conclusions must be recorded in a clear, auditable format. A validation report should summarize the objectives, methods, results, and conclusions, and include statements of compliance with applicable ISO standards. Any deviations or anomalies encountered during testing must be analyzed and corrected before the method is approved for routine use.
Training personnel in proper sample preparation, instrument operation, and data interpretation is also required. Human error can significantly affect outcomes, so competency assessments and standard operating procedures must be in place. Continuous monitoring and regular re-assessments must be planned to ensure the method remains valid over time, especially after instrument maintenance, software updates, or changes in sample matrix.
Finally, laboratories seeking ISO. This ensures that validation is not a one-time event but a ongoing dedication to excellence.
Adopting these validated procedures in accordance with applicable ISO requirements, organizations can confidently validate dynamic image analysis methods, ensuring their results are scientifically sound, legally defensible, and suitable for use in regulated environments.