If you’re in the pharmaceutical or medical device industry, then you’ve probably heard about Extractables and Leachables (E&L). But what are they, exactly? And what do you need to do to make sure your products are compliant?
What is E&L?
Extractables are chemicals that can be extracted from a material or product under specific conditions. Leachables are chemicals that can leach out of a material or product under specific conditions. In the context of pharmaceuticals and medical devices, Extractables and Leachables refer to any chemical compounds that could potentially end up in the patient’s body.
Why is E&L important?
Because Extractables and Leachables can potentially end up in the patient’s body, it’s important to make sure that they’re safe. That’s why Extractable/Leachable studies are an important part of the development and manufacturing process for pharmaceuticals and medical devices.
We hope this information has been useful to you.