Extractables are compounds forcibly extracted from user or product contact materials using a range of solvents in conjunction with a number of extraction techniques. The observed compounds are potential leachables, although generally found at much higher levels than in a leachable study. The information is then used to determine patient/user risk and leachable method development.
The types of materials used will therefore affect the levels and types of leachables observed.
The source of extractable compounds can usually be traced to the raw materials used in the device component manufacture. Experience of handling and analyzing raw materials is a significant advantage in extractable studies.
The planning of an extractable study has to anticipate the leachable study and how the device will be used.
As such, before starting an extractable study, consider the following:
- What is the intended use of the material and product?
- The analytical sensitivity required
- What scientific instrumentation should be used
- How should the extract be prepared
We follow the most appropriate regulatory guidelines and use our knowledge of the subject matter alongside the latest scientific principles to design the most appropriate studies for your product.
As products and materials can cover a very broad range of applications, we would strongly recommend discussing your specific requirements with our dedicated team.