After an extractable study, the data is reviewed by a toxicologist to ascertain whether a leachable study is required. It’s important to use analytical methods based on the extractables techniques/methods and establish a comprehensive correlation between extractables and leachables profiles.
The methodology leads to a routine extractables testing method, which is necessary for the future. Depending on the final application, the leachable study and routine extractable studies should be fully validated.
Where applicable, the duration of a leachable study is linked to the shelf life of the product. For other products (e.g. tubing, production line elements, etc) bespoke leachable studies should be defined to assess the appropriate requirements.
It is critical 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 are completed, the data can be used to ensure ongoing product conformance, reducing future problems and costs.
Leachable studies are frequently conducted alongside stability studies. This synergy saves time, effort, and money.
Ultimately, it is the manufacturer’s responsibility to ensure their products are safe and we’re here to ensure this compliance.