Blogs

At West, we often get asked “What extractable compounds are present in your products?”, “What are the current requirements for Extractable and Leachable testing?” and “How do I make sense of all of this data and get the regulatory authorities what they want?”

Beginning in 1998, when an increase in the incidence of pure red cell aplasia (PRCA) was observed in patients with chronic renal failure and associated with the subcutaneous use of Eprex^® (epoetin alpha), the U.S Food and Drug Administration (FDA) and European regulatory agencies have paid special attention to leachables in drug products especially resulting from uncoated primary elastomer components.

A scientific poster by: Clara Goodfield, Eugene Polini, Amy Miller and Wayne Curry

The ideal sterilization process destroys all microorganisms rapidly with minimal adverse impact on the chemical and physical properties of the elastomeric closure. Developing and validating an acceptable sterilization process is critical to the drug product quality. This study served to help understand the potential deterioration of physical and chemical properties, the possible impact to functionality and the potential changes to the extractable/leachable profile as a result of sterilization

West authors Diane Paskiet, Kim Miller, Laura Stubbs and Diego Zurbriggen contributed to several chapters in the new “Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products” available from Wiley Scientific.