ISO-Compliant Validation of Dynamic Image Analysis for Particle Characterization > 자유게시판

Implementing a structured and meticulous validation process for dynamic image analysis under ISO guidelines 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.

The first step is to define the intended use of the method and establish clear performance criteria. This includes identifying the parameters to be measured, such as PSD, elongation ratio, sphericity, and aggregate formation, and 動的画像解析 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 at defined intervals with full recordkeeping, with records maintained for audit purposes.

Evaluate both precision and accuracy by conducting repeated trials under standardized operational settings. Reproducibility testing should be conducted across multiple operators, instruments, and days to assess within-laboratory variability. Accuracy can be verified by comparing results against a reference method, such as static image analysis or sieve analysis, where appropriate. The difference between the dynamic image analysis results and the reference values should fall within predefined acceptance criteria.

Another indispensable phase is evaluating method ruggedness. This involves deliberately introducing small variations in method parameters—such as lighting intensity, flow rate, or focus settings—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.

It is essential to define the operational range and detection threshold. This includes determining the the minimal and maximal particle dimensions the instrument can resolve, as well as the minimum detectable particle density free from noise or false signals.

Documentation is essential throughout the validation process. All protocols, raw data, calculations, and conclusions must be recorded in a well-organized, reviewable, and compliant documentation. 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 examined and remediated before the method is approved for routine use.

Competent training in sample handling, device operation, and analytical interpretation is mandatory. Human error can significantly affect outcomes, so competency assessments and standard operating procedures must be in place. Continuous monitoring and periodic revalidation should be scheduled to ensure the method remains valid over time, especially after equipment servicing, firmware upgrades, or altered sample properties.

Finally, laboratories seeking ISO. This ensures that validation is not a one-time event but a continuous emphasis on reliability and conformity.

Adopting these validated procedures in accordance with applicable ISO requirements, organizations can confidently validate dynamic image analysis methods, ensuring their results are reliable, audit-ready, and fit for compliance-driven industries.