sterilizationqualitycontrol

Sterilization quality control refers to the activities and procedures used to verify that sterilization processes achieve the required sterility assurance level for medical devices, pharmaceuticals, and related equipment. It encompasses process validation, ongoing monitoring, and post-sterilization verification to ensure products remain sterile until use and that deviations are detected and corrected.

Key elements include validation of sterilization cycles according to applicable methods (steam, moist heat; dry heat; ethylene oxide; radiation; vaporized hydrogen peroxide; ozone). Validation establishes parameter ranges (temperature, time, humidity, gas concentration, dose) that reliably achieve SAL 10^-6 under defined loading conditions. Routine quality control uses indicators: biological indicators containing resistant spores, chemical indicators that react to critical parameters, and physical indicators embedded in packages or loads. A BI test is used to confirm load sterility; chemical indicators provide immediate pass/fail; physical indicators verify process conditions.

Monitoring and documentation: equipment qualification (IQ/OQ/PQ), control charts, calibration, and record-keeping; per-load or per-batch BI results and cycle parameters; packaging integrity testing and post-sterilization residue assessment. Sterility testing of manufactured lots may be performed when appropriate, with quarantined lots until release criteria are met. Any nonconformities trigger CAPA and investigations.

Standards and regulatory context: international standards include ISO 11135 (ETO), ISO 17665 (steam sterilization), ISO 11137 (radiation), plus quality management systems such as ISO 13485 and FDA/European regulatory guidance. Risk assessment and continuous improvement are integral, often incorporating HACCP or FMEA.

Sterilization quality control aims to balance safety, product functionality, and efficiency, providing traceability from load identification to final disposition and ensuring compliance with applicable regulatory and customer requirements.