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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. Choosing an optimized container closure early for your drug application can improve yield, reduce line downtime, influence lyophilization performance and speed time to market.

This webinar will provide insights on different stopper designs and elastomer formulations having different chemical, physical and functional characteristics. The choice of stopper and vial combination contribute not only to the ease of manufacturing, but also to product quality and stability. 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, and extractables and leachables.

Key Takeaways:

  1. Insights on inherent risks to lyophilized drug product quality.
  2. Primary packaging selection based on chemical, physical and functional testing.
  3. Comprehensive analytical strategy through expanded study design.

Prabhaharan Sankaran

Sankaran, Prabhaharan,

Technical Account Specialist, India

Prabhaharan has more than 14 years of experience in the medical/pharmaceutical industry. In his role as the Technical Account Specialist, he provides technical support to pharmaceutical companies in India, providing product recommendations, technical trainings and advices to ensure smooth and easy uptake of West’s wide product portfolio as required for customer’s drug product application. He has rich experience in the areas of technical customer support and medical device verification and development