SG US Technology Excellence Center presents a Webinar on:
Glass Delamination: Holistic approach for characterization and control
- Date: Thursday, May 28th
- Time: 12pm ET / 9am PT / 6pm CEST
- Duration: 1 hour
Drug stored in glass primary containers risk losing efficacy and safety when not properly tested for corrosion or delamination. These phenomena occur when a drug interacts with the inner glass surface over time, causing glass matrix dissolution. In 2011, the FDA issued an industry warning leading to aggressive and extensive testing. We at Stevanato Group leverage our expertise as a leading glass container manufacturer and as an independent laboratory investigating delamination to present:
- The science and manufacturing factors related to glass corrosion and delamination
- Fundamental identification techniques and the methods in the regulatory-required USP <1660>
- Cases where you can improve product quality and reduce testing with our risk-based approach:
- Choosing the correct glass container early in development and when dual sourcing.
- Optimizing downstream processes to minimize the likelihood of delamination.
Key Learning Objectives:
- What are glass delamination and corrosion
- Identification methods in USP <1660>
- Contributing manufacturing factors
- Selecting the glass based on the drug
- Risk-based process optimization
Who Should Attend:
Recommended attendees include those who are:
- Conducting pre-formulation or container closure selection studies
Facing delamination issues during development or commercial phases
- Looking to enhance the stability and shelf life of their product continuously
About the speakers:
Lab Advanced Technology Analyst, Stevanato Group US Technical Excellence Center (TEC)
Alan Xu is leading key initiatives at Stevanato Group’s new US TEC in Boston, MA, by leveraging his background in developing pharmaceutical combination devices. Alan was previously an Engineering Manager leading the development, design transfer, and production verification of a novel primary container in a medical device start-up partnering with large pharmaceutical companies. Alan’s specialty is in medical device development and characterization, CMO management, and root cause investigations. Alan holds a degree in Mechanical Engineering from the Massachusetts Institute of Technology (MIT).
SG Lab Analytics Researcher
Serena Panighello is a researcher at SG Lab Analytics. Her role is mainly related to studying glass corrosion mechanisms and container-drug interaction consultancy. She holds a Ph.D. in Chemical Sciences from Ca' Foscari University-Venice featuring a joint research program with the National Institute of Chemistry-Slovenia. During the Ph.D., she was awarded a Paul Award at the New Researchers Forum during the SGT (Society of Glass Technology) annual conference in the UK.