The Next Generation Approach to Elastomeric Closures for Sterile Products

The current pharmaceutical market has faced a variety of challenges, including increasing expectations for quality from end-users and regulatory agencies driven by concern for patient safety. While pharmaceutical companies are working to assure that new quality and compliance paradigms are met, a balance must be achieved between the reality of managing costs to provide a [...]

Schaefers to Speak at Prefilled Syringe Conference – Jan. 18-19, 2012

West’s Mike Schaefers, Vice President, Marketing Europe, will present “Next Generation Quality Syringe Components and Systems” at the 4th Annual European Prefilled Syringes Conference.  The conference will be held in London on January 18-19, 2012. Customer expectations related to quality, functionality and compatibility of syringe components and systems are steadily increasing.  As trends toward home [...]

Vacuum Retention in Vial-Stopper Systems: A Study on Component Compatibility

Jeff Smythe, Lynn Lundy, and Amy Miller The pharmaceutical industry faces challenges when choosing packaging components for lyophilized products. The European Commission Guide to Good Manufacturing Practice, Annex 1, Section 89 states, “Containers sealed under vacuum should be tested for maintenance of that vacuum after an appropriate, pre-determined period.” Selecting optimal components for the lyophilization [...]

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; [...]

Jansen-Otten to Present “Innovations for Elastomeric Components for Prefillable Syringes” – November 9, 2011

 Christa Jansen-Otten, Director, Prefillable Syringe Platform, Europe, will present “Innovation for Elastomeric Components for PFS”  at the Universe of Prefilled Syringes & Injection Devices – Device Usability and Compliance” conference on November 9, 2011.  The conference will be held on November 8-9 in Basel, Switzerland. This presentation will lead attendees through the innovations on elastomeric [...]