Extractable – Compounds that migrate from a given component under aggressive conditions. What can come out.
Leachable – Compounds that migrate from a given component under normal operating conditions. What does come out.
We can carry out E&L testing on a wide range of products including OINDPs (orally, inhaled and nasal drug products) such
as MDIs (metered dose inhalers) and DPIs (dry powder inhalers) and PODPs (parenteral and ophthalmic drug products),
eg. prefilled syringes, bags, tubing, vials, filters, closures, bottles etc.
Our E&L testing is carried out to the PQRI “Safety Thresholds and Best Practices for Extractables and Leachables in OINDPs”.