Determining when a product is safe for release can be difficult due to various factors impacting Ethylene Oxide (EO) residual levels: packaging type, sterilisation cycle, material composition, and load density. Without the right test protocol, residual levels can be unpredictable, making it difficult to determine if a product is truly safe. Failure to demonstrate compliance for residual sterilant levels can result in delayed launches, regulatory setbacks, and supply chain disruption. Navigating these regulations requires specialised knowledge and expertise. 

The Eurofins BioPharma Product Testing (BPT) network of laboratories provides expert EO residuals testing services to help you navigate these complexities. Our laboratories support validation of your EO sterilisation and verification efforts with speed, precision, and deep regulatory insight. We test in accordance with Ph. Eur. 2.4.25, USP <228>, and ISO 10993-7 standards. Compendial methods are routinely performed for raw materials, with custom method development and validation available for specific matrices. For primary packaging, polymeric devices and single-use systems, we follow ISO 10993-7 to validate extraction protocols, prior to gas chromatographic analysis of EO and its byproducts (ethylene chlorohydrin, ethylene glycol etc.). 

Our comprehensive testing services establish the appropriate extraction methods and assess ethylene oxide residuals to confirm levels are below toxicological risk limits. This includes analysis of degradation byproducts and verification of sterility. Eurofins BPT is equipped to test a wide range of material types and complex packaging designs. Our experienced analysts can develop custom test protocols, accelerate scheduling, and provide tailored reporting packages suitable for regulatory submission. By involving us early, you can reduce the risk of repeat testing, minimise cost and workload, and avoid compliance-related delays.