Extractables and leachables are two of the most important topics in pharmaceutical manufacturing today.
Extractables are chemicals that are extracted from a material, while leachables are chemicals that leach out of material. Both can have a serious impact on the quality of a product, so it is essential to understand them and how to control them.
There are three main ways to control extractables and leachables: material selection, manufacturing process, and packaging.
Material selection is the most important factor, as it determines which chemicals will be in contact with the product.
The manufacturing process can also influence extractables and leachables, as certain processes may create or release more chemicals.
Lastly, packaging can also play a role in controlling these chemicals.
It is important to control extractables and leachables because they can have a serious impact on the quality of a product.
