Extractables and leachables testing

Extractables and leachables testing is an analysis of harmful, or potentially harmful, components from the device or packaging of a product, following a specific period of controlled storage conditions. The length of time can be tailored to suit specific needs, usually one to three months.

America’s FDA defines the two terms as follows:

Extractables are compounds that can be extracted from the container closure system when in the presence of a solvent.
Leachables are compounds that leach into the drug product formulation from the container closure system as a result of direct contact with the formulation.

Our other compliance services include:

What our quality service offers:

results in one to three months
ISO/IEC 17025:2017 accredited laboratory
state-of-the-art instruments
analysis by scientists in the UK.

Book your compliance today

Phone our friendly team on +44(0)1302986088 or email hello@adactmedical.com.

We look forward to speaking with you soon.

Contact ADACT Medical

Ready to discuss your unique testing needs? Contact us today to find out how our services can help you achieve your goals.