E&L testing involves investigating extractables from the product related to its materials of construction or trace impurities that may come from … [Read more...] about Reducing Relative Response Factor Variation in E&L Testing

Risks assessments are a key element in extractables and leachables testing. There are many factors involved in ascertaining the specific risks and how … [Read more...] about Risk Assessment Strategies in Extractables and Leachables

Extractables and leachables testing – E&L testing for short – is the process of identifying and quantifying the molecules which can be released … [Read more...] about E&L Testing: Methods of Chemical Characterization

An important step in determining the biological compatibility and safety of a medical device as required by ISO 10993 is chemical characterization. … [Read more...] about Common Mistakes in Extractables and Leachables Analysis

Extractables and leachables are compounds that can be extracted from a product either in the presence of a solvent or simply over time through direct … [Read more...] about How to Measure Extractables and Leachables