Extractables are compounds that can be extracted from a packaging component, a delivery system or a manufacturing surface via laboratory manipulation, such as exposure to solvents or heat. Extractables can be potential leachables.

Leachables are compounds that passively migrate into the medicinal product over time from the packaging system, components in use or a manufacturing surface as a result of direct contact.

Extractables and Leachables (E/L) studies are important in identifying and quantifying potentially harmful leachables that may migrate from the container, equipment and packaging, thereby contaminating the pharmaceutical products as this may pose a risk to the patient's health and result in significant problems in terms of quality.

That is why all our single-use components come with full documentation - including E/L and BPOG, which is the strictest standard in the field.