We offer comprehensive Extractable and Leachable (E&L) Testing Solutions for Pharmaceutical, Healthcare, and Packaging Industries.
Our testing services encompass a wide range of industries, including pharmaceuticals, healthcare, and packaging, offering reliable and thorough E&L testing. 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) like prefilled syringes, bags, tubing, vials, filters, closures, and bottles.
Following the guidelines outlined in the 'Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products (OINDPs)' published by the Product Quality Research Institute (PQRI), our E&L testing ensures compliance with industry standards and provides valuable insights into potential chemical interactions.
In addition to E&L testing, our comprehensive range of analytical methods aids in drug delivery failure analysis, contamination issues, and component quality control testing.
Most of our methods hold accreditation from the United Kingdom Accreditation Service (UKAS), guaranteeing the highest level of accuracy and reliability. Moreover, 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), further ensuring regulatory compliance.
With our expertise and commitment to quality, we provide comprehensive E&L testing solutions and analytical services to support the safety and quality of pharmaceutical, healthcare, and packaging products.
N-Nitrosamines testing involves the analysis and detection of these potentially carcinogenic compounds in various products, ensuring compliance with safety regulations and mitigating potential health risks.
Migration Testing for Food Contact Materials
Migration testing for food contact materials is a crucial analysis to assess the potential transfer of harmful substances from packaging or utensils into food, ensuring compliance with food safety regulations and protecting consumer health.