Extractables & Leachables

We offer comprehensive Extractable and Leachable (E&L) testing solutions for pharmaceutical, healthcare, and packaging industries, providing reliable and thorough analysis.

Product categories we test

We specialise in conducting E&L testing on various products including orally inhaled and nasal drug products (OINDPs) such as:

• Metered dose inhalers (MDIs)
• Dry powder inhalers (DPIs)
• Parenteral and ophthalmic drug products (PODPs) — prefilled syringes, bags, tubing, vials, filters, closures, and bottles

Our testing follows the guidelines in the "Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products" published by the Product Quality Research Institute (PQRI).

Specialist sub-services

• N-Nitrosamines Testing — detection of potentially carcinogenic compounds in rubber closures and pharmaceutical products, ensuring compliance with safety regulations.
• Migration Testing for Food Contact Materials — assessment of potential transfer of substances from packaging or utensils into food, in line with EU and UK food contact legislation.

Most of our methods hold accreditation from the United Kingdom Accreditation Service (UKAS). As a Testing Facility listed on the Generic Drug User Fee Amendment listings (GDUFA), we fulfil the registration requirements for the Food and Drug Administration (FDA).