Extractables and leachables testing

A pharmaceutical manufacturer engaged in switching from a vial to a prefilled syringe sought Chimera’s guidance on extractables and leachables testing strategy and setting limits when a new elastomeric component was introduced into the packaging system. Chimera reviewed technical specifications and testing reports provided by the elastomeric component manufacturer in order to establish a written justification which was submitted to FDA for not conducting additional extractables/leachables testing to support the change.