Implementing a structured and meticulous validation process for 粒子径測定 dynamic image analysis under ISO guidelines to ensure accuracy, reproducibility, and traceability of results. Industries including pharma, food manufacturing, and materials research routinely employ dynamic image analysis to characterize particle size, shape, and distribution in real time. To meet ISO compliance, particularly under ISO 13322 series for particle size analysis and IEC 17025 for testing and calibration laboratory competence, 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 size distribution, shape factors, 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.
Next, the instrument must be properly calibrated using certified reference materials that are traceable to national or international standards. For dynamic image analysis, this often involves using particles with known size and shape, such as glass or polystyrene 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.
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 dry sieving or optical 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 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.
The method’s range and limit of detection must also be established. This includes determining the lower and upper particle size limits detectable with confidence, as well as the lowest concentration at which particles can be detected without interference from background noise or artifacts.
All validation activities require meticulous and traceable documentation. All protocols, raw data, calculations, and conclusions must be recorded in a well-organized, reviewable, and compliant documentation. A validation report should summarize the intended purpose, execution steps, outcomes, and final assessment, 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.
Training personnel in proper sample preparation, instrument operation, and data interpretation is also required. Human error can significantly affect outcomes, so regular skill verification and documented work instructions are required. Continuous monitoring and ongoing validation checks need to be implemented to ensure the method remains valid over time, especially after equipment servicing, firmware upgrades, or altered sample properties.
Accreditation requires that validation processes be fully incorporated into the organization’s quality framework. This ensures that validation is not a one-time event but a ongoing dedication to excellence.
Implementing this structured approach in alignment with ISO guidelines, organizations can confidently validate dynamic image analysis methods, ensuring their results are robust, compliant, and appropriate for regulated applications.
