Demand for extractables and leachables studies increases as industry and regulatory bodies adopt the ISO 10993 approach to Biological Evaluations. Similar to the role materials characterization plays in device design and development, extractables and leachables studies play a role in pre-submission, medical device safety testing.
All medical devices should consider extractables and leachables studies. When determining the test strategy, there are discussions regarding whether or not a study is necessary. The device classification and indication for use: intended population, route of administration, and clinical application all have a role in evaluating the need for extractables and leachables studies.
Once there is a decision that extractables and leachables studies would be appropriate for your device, it is imperative you select the best partner to conduct those studies.
This partner will understand the complexity of the analytical chemistry and identification of the compounds. For example, chemistry data derived from thorough extractables and leachables studies supplies a toxicologist the chemicals extracted for the device for a risk assessment. This chemistry data is also a pool of data a toxicologist may use to leverage in the event a color change or particulate present within a biocompatibility extract. In addition, a regulatory trend — most commonly with blood contacting, permanent implants — is exhaustive extractions. This is scientifically complicated, and increases the complexity of identification within the extractables study.
These examples demonstrate how our extractables and leachables studies support a pre-submission device safety testing.
WuXi AppTec offers the industry-leading analytical chemistry department and access to our toxicologists for consultation, regulatory guidance and toxicological risk assessments. Our extractables and leachables program has conducted more than 4500 projects, and our program stands out, because of our commitment to complete chemical characterization.
Contact us to discuss your project further: email@example.com or 651-675-2000.