With the growing desire for end users to self-administer pharmaceutical products to treat chronic illnesses, the need for pre-filled syringes and autoinjectors has increased, compared to the traditional vial and syringe delivery. While companies are keenly focused on developing the product that goes inside the syringe, this growing trend requires companies to navigate a complex landscape of testing requirements of syringes in order to comply with FDA and international health and safety regulations. Therefore, developing an appropriate test plan for syringe functionality testing is of utmost importance with the globalization of the Medical Device and Pharmaceutical products to ensure patient safety.

During this webinar, we will share insights, testing requirements, commonly performed tests, and test plan rationales to save you time and avoid delays in your product development cycle, including:

• Overview of various testing standards required to get your product to market
• The current status and expectations of regulatory agencies
• How to design a test plan for design verification or lot release of the product
• Answers to common syringe testing questions

Presenter:

Sunny J. Modi, Ph.D. Director, Package Testing Eurofins BioPharma Product Testing

Dr. Sunny J. Modi is a Director of Package Testing for Eurofins BioPharma Product Testing with many years of experience focusing on creating and testing packaging materials. He specializes in syringe testing, transport simulation, and mechanical testing with a thorough understanding of ASTM, ISTA, and ISO protocols for package integrity testing. Dr. Modi participated in the technical review committee for International Safe Transit Association (ISTA) and a member of Institute of Packaging Professionals (IoPP) and the Association for the Advancement of Medical Instrumentation (AAMI).  Dr. Modi earned his Ph.D. and M.S. degrees from The Ohio State University focusing in packaging and composite applications.