Broughton has launched a new Extractables and Leachables (E&L) testing service with a fully integrated approach that will combine technical and analytical services, in-house toxicology consulting and regulatory compliance support.
 
The E&L service is aimed at both pharmaceutical and consumer companies and is available for all stage of product development lifecycles: early-stage innovation, product development through to commercialization and post-market surveillance. It will include study design, leachables method development and validation, leachables shelf-life studies, leachables toxicology evaluation, extractables toxicology assessments and extractables studies. Customers will have access to toxicology support, analytical method development and validation, analytical testing, study design, and on-site stability storage. 
 
Broughton CEO Chris Allen said, “extractable and leachable studies are an essential part of the product development to ensure safety and manage risk. With the implementation of new ICH guidance on approaches to E&L, it is essential pharmaceutical manufacturers have an up-to-date understanding of the evolving regulatory requirements on the impact of organic compounds and elemental impurities that leach into their product from the manufacturing process, the container closure system (CCS) or packaging materials, and even the delivery mechanism. This is important as leachables can cause health issues over time, environmental population or adversely impact the active ingredient’s efficacy.”
 
The company will offer a new ICH guidance, which covers harmonizing E&L study design and implementing ICH Q14 quality-by-design method for developing best practices. Services covered are material characterization screens for raw materials, parenteral ophthalmic drug products (PODPs), orally inhaled and nasal drug products (OINDP), combination products, medical devices, single-use systems for potential leachables from container closure systems, manufacturing and processing equipment, pre-filled syringes, and packaging. 
 
“Our scientific experts and toxicologists have years of combined experience conducting E&L studies across a range of pharmaceutical drug product and service categories. A wide range of analytical techniques is employed in E&L studies to ensure the dedication of all potential leachables. These are then screened to understand their potential toxicological impact on the user and environment,” Allen added. By offering a one-stop solution for E&L studies, we can ensure a fully integrated approach across study design, extractables study delivery, leachables method development, and toxicology assessment with our specialized consultants available to troubleshoot, problem solve and develop analytical solutions to issues that may arise.”