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Several of West’s experts will be featured speakers at The Universe of Prefilled Syringes and Injection Devices organized by 2013 PDA Europe, which will be held November 5-6, 2013, in Basel, Switzerland. West’s representatives will report on the latest trends in the world of prefilled syringes and innovations in the field of self-injection devices.
West’s experts will participate in two sessions related to advances in self-injection:
Next Generation Plungers for Enhanced Functionality: An Ideal Combination with Self-Injection Devices – Christa Jansen-Otten, Director Prefillable Syringe Platform, Europe, will discuss recent developments in plungers for improved and reliable performance. (Breakfast Session 2, November 5, 2013, 7:45 a.m.)
West & Janssen Biotech Discuss A Novel Self-Injection Technology and Unique Partnership – Bart Burgess, Director, Business Development, Self-Injection Systems, West and Peter Krulevitch, Engineering Director, Packaging, Devices & Delivery, Janssen Biotech, will present a case study of the development of an integrated drug delivery solutions designed to ease self-injection. (Track 1, November 5, 2013, 4:45 p.m.)
Christa Jansen-Otten also will present on Elastomeric Components for Prefilled Syringes during the Hands on Training Course, Development of Prefilled Syringes. West’s Nicolas Brandes, Business Development Manager Daikyo Crystal Zenith Europe, will present at the Pre-Conference Workshop Polymer as a Container Material for Prefilled Syringes on November 4, 2013.
Additionally, West Vice President of Global Marketing for Pharmaceutical Packaging Systems Mike Schäfers will serve as co-moderator for the session, “Trends in Pharmaceutical Development and Manufacturing of Prefilled Syringes” on November 5 from 11:30 a.m. until 1:15 p.m. The session highlight challenges and innovations in the rapidly growing prefilled syringe market.
Visit West in booth #64/65 at PDA Europe to find out about the latest from the world of prefilled syringes and West drug delivery and packaging solutions that enable safe, effective administration to patients.
<p><em>West is pleased to welcome guest blogger Dr. Marla Phillips, Director</em><em>, Xavier University.</em></p><p>Materials and products used to serve the drug and device industries are supplied from areas all over the world. From raw materials such as sand to highly processed components for delivery systems, the materials that are used to create packaging systems are presumed to be safe. But how can pharmaceutical manufacturers be sure that incoming materials used in these products are consistently safe and reliable?</p>
In 1987, the International Organization for Standardization (ISO) issued the first version of ISO 9001, a standard intended to define the basic requirements, structure, responsibilities, and procedures required to implement an effective quality management system for manufacturing organizations in general. In 1996, the International Organization for Standardization issued the first version of ISO 13485, “Quality Systems—Medical Devices—Particular Requirements for the Application of ISO 9001,” to specify, in conjunction with the application of ISO 9001, the Quality Management System (QMS) requirements for medical device manufacturers. Today, ISO 13485 is used internationally by many regulatory authorities as the foundation for defining regulatory QMS requirements for medical device manufacturers and is utilized in regulatory harmonization programs such as the Medical Device Single Audit Program (MDSAP).
Known for a commitment to excellence in elastomeric components, West has complemented its vial closure portfolio with the Flip-Off® seal brand. Particularly in its ability to provide solutions for aseptic and clean crimping, the Flip-Off seal demonstrates potential to become an industry standard.
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