What’s the best strategy to create a holistic syringe-based combination product performance testing program? Start with the fundamentals - ISO and USP considerations.

In recent years, patient-related safety incidences have occurred due to glass syringe misconnections from incompatibility among interfacing components. To combat the issue, in 2013 the FDA created draft guidance: Technical Information … (ISO) Standard 11040-4. The guidance was designed to ensure syringe connection integrity to reduce potential for patient harm. Assessing product risks properly, early and continuously is critical to help ensure patient safety.

Since the release of the draft guidance, several additional ISOs and guidances have been published – such as the Prefilled Syringe User Requirements PDA TR73:2015, Luer ISO standard 80369-7:2016 and Finished Prefilled Syringe ISO 11040-8:2016. These publications outline test strategies and annexes to assess fundamental syringe performance.

Join West packaging and performance experts Daniel Bantz and Jennifer Riter as they explain how fit-for-purpose syringe-based combination product packaging involves holistic consideration and testing for:
  • Qualification of packaging components involving drug protection
  • Materials compatibility
  • Patient safety
  • Product performance 

Featured Speakers

Jennifer L. Riter

Sr. Director, Analytical Services
West Pharmaceutical Services, Inc.

Jennifer blends knowledge of pharmaceutical systems and components with hands-on experience with delivering technical support and analytical solutions for packaging and delivery systems. Jennifer has presented at symposiums on analytical testing of parenteral packaging components and systems. She is a member of the Board of Directors for the Lock Haven University Foundation, AAPS, PDA, and HBA. She earned a B.S. in Biology/Chemistry from Lock Haven University and an MBA in Pharmaceutical Business at the University of the Sciences in Philadelphia.


Daniel Bantz

Technology Manager, Packaging & Performance
West Pharmaceutical Services, Inc.

Daniel Bantz brings experience in product performance testing to West’s pharmaceutical systems and components to his position as Packaging and Performance Technology Manager. He’s competent in fluidics systems development and combination product testing. Daniel implements testing technologies meeting ever-changing regulations in conjunction with customer needs. He earned an associate’s in Electromechanical Technology from Allegany College of MD, a bachelor’s degree in Business Management from the University of Northwestern St. Paul and an MBA in Operations and Technology from Aurora University.


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