The Effect of a Barrier Film on Elastomeric Extractables in a Parenteral Packaging System

Amy Miller and Jennifer Riter Extractables from elastomeric components become an issue even before a pharmaceutical drug makes contact with the elastomeric component. The suitability of the elastomer and the drug product needs to be taken into consideration at the development stage of the packaging and delivery system for the drug product. The potential for [...]

West Authors Contribute Chapters to New Leachables and Extractables Handbook

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. The Handbook offers a practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated [...]

Impact of Steam and Gamma Processing on Elastomers

To further understand the impact of typical sterilization methods on elastomeric components, West Pharmaceutical Services, Inc. conducted a study that evaluated extractables, physical properties and functional properties of common elastomer formulations after exposure to steam and gamma irradiation. The processing of any component can have an impact on extractable profiles, physical properties and functional properties; [...]

Validation of a Method to Determine Extractable Content in Polypropelene

Validation of a method for determination of extractable additives from a polypropylene material of known composition was performed.  A test method was developed based on results of studies outlined in a protocol written by the PQRI Leachable and Extractable Working Group titled “Experimental Protocol for Controlled Extraction Studies on Plastic Test Articles.”  The method quantitates [...]