Pharmaceutical primary packaging sterilised with Ethylene Oxide gas must be tested to ensure any residual sterilant or degradation byproducts are below limits that may pose a toxicological risk to the end users. Many factors can impact the levels of Ethylene Oxide Residuals following sterilisation, such as packaging type, material of components, sterilisation cycle parameters, and load density, thus it can be difficult to predict when a product would be safe for release to the public.

Consequently, it is required by regulatory bodies, that primary packaging cannot be released until testing is performed and the quantities of these residuals confirmed. Failing to provide proof of the completion of such testing can delay the launch of your pharmaceutical and create supply chain issues for the manufacturer.

Eurofins BioPharma Product Testing’s (BPT) network of laboratories offers Ethylene Oxide Residuals Testing to provide clients with one source for all necessary residual and sterility tests on primary packaging. Our team has extensive experience in testing for Ethylene Oxide Residuals and working with clients to navigate the ISO 10993-7 testing requirements.

Your company will have direct communication with our laboratory to guarantee your packaging is tested to the appropriate standards.

Choose Eurofins BPT to help you:

  • Utilise one source for sterility testing and residuals testing.
  • Navigate ISO 10993-7 to determine appropriate specifications for your product.
  • Determine appropriate extraction methods and testing of Ethylene Oxide Residuals
  • Use platform methods to test most products quickly and efficiently with little time needed for establishment.
  • Develop and validate Ethylene Oxide Residual methods for packaging that require specialised treatment, have unique specifications, or present interferences with routine residual levels.
  • Perform Ethylene Oxide Residual testing for validation of sterilisation cycle and products.
  • Ensure residuals from your Ethylene Oxide Sterilisation are not harmful to a patient.