After an extractable study, the data is often reviewed by a toxicologist to ascertain whether a leachable study is required. It’s important to be able to establish a comprehensive correlation between extractables and leachables profiles.
Depending on the final application, the leachable study should be fully validated.
Where applicable, the duration of a leachable study is linked to the shelf life of the product.
It is critical to consider the addition of blank and control samples when performing leachables studies as they will help discount any analytes related to the product.
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.