Once the extractable study has been performed, and the data reviewed by a toxicologist, the next stage may be to perform a leachable study (depending on your risk assessment based on the device/product to be tested).
It is important to use Analytical methods based on the extractables techniques/methods and should establish a “comprehensive correlation” between extractables and leachables profiles.
The methodology employed will also lead to a routine extractables testing method (necessary for the future). Depending upon the final application, it may be that the leachable study and routine extractable studies should be fully validated.
The duration of a leachable study is linked to the shelf life of the product (when applicable). For other specific products (e.g. tubing, production line elements.. etc), bespoke leachable studies should be defined to assess the appropriate requirements.
One critical point is to consider the addition of blank and control samples when performing leachables studies as this will help the generation of useful data and make the final report more concise when delivered to the regulating authorities. This needs to be considered before samples are sent to storage.
Once the extractables and leachables studies have been performed, the data can be used to ensure on-going product conformance reducing future problems and costs.
Leachable studies are frequently conducted alongside stability studies, hence allowing a saving in time, effort and money.