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Lyophilization is a complex, time intensive and often challenging process. It has become a common manufacturing practice for parenteral pharmaceuticals that are unstable in aqueous solution. The process itself poses critical demands on primary packaging. Often the selection of packaging materials is considered too late in the development cycle of a lyophilized drug product to fully evaluate these complexities. Choosing an optimized container closure early for your drug application can improve yield, reduce line downtime, influence lyophilization performance and speed time to market.

Different stopper designs and elastomer formulations have different chemical, physical and functional characteristics. In the case of a lyophilized product, the choice of stopper and vial combination contribute not only to the ease of manufacturing, but also to product quality and stability. This free webinar will explore considerations of primary packaging selection and review potential risks based on chemical, physical and functional testing. The discussion will cover container closure challenges such as:

  • Feeder bowl clumping and twinning
  • Continuous feed along the rails
  • Stability in the vented position
  • Sticking to the lyo shelves
  • Pop-up
  • Residual moisture content
  • Drying and sterilization
  • Extractables and leachables

Ed Trappler

President, Lyophilization Technology Inc.

Edward Trappler has over 40 years of experience that includes product development, toxicology and clinical supply manufacturing, and parenteral production. In 1992 he founded Lyophilization Technology, Inc. as a source of scientific and technical services, with the ambition of expanding the knowledge and understanding of lyophilization throughout the healthcare product industry. Ed has contributed to six books, authored and presented numerous papers and courses internationally. He is an active member of the Parenteral Drug Association, serving as chairperson of the Lyophilization Interest Group, Validation Task Force, and Education Advisory Board. He has lectured for the AAPS, ISPE and PDA. He has received numerous recognitions and the PDA awarded him the Gordon Personeous Award for his contribution to the PDA and the James Agalloco Award for Education.

Diego Zurbriggen

Technical Account Manager, TCS, NA West Pharmaceutical Services

Mr. Zurbriggen has over 20 years of analytical lab experience, 10 of which focused on inorganic trace level analysis. As Technical Account Manager within the Technical Customer Support group of West, the focus of his role is to provide technical support relating to West’s packaging components and delivery systems for injectable drugs and healthcare products. He serves as the West subject matter expert on Extractables & Leachables, including elemental impurities. Prior to this role, he was Supervisor of the Leachables/Stability group in the Analytical Labs division of West Pharmaceutical Services, Inc., the focus of his role was to develop and validate leachables methods. Mr. Zurbriggen holds a Bachelor of Science/Chemistry degree from the Gewerbliche Berufsschule Visp – Visp, Valais, Switzerland.