PDA Asia Pacific Aseptic Processing of Biopharmaceuticals

Join us during PDA Asia Pacific Aseptic Processing of Biopharmaceuticals Virtual Conference - Fill finish technology and patient-friendly devices.

Speech:

Wednesday, October 14th - from 11.30 am to 12.00 pm (GMT+9)

Serena Panighello - SG Lab Analytics Researcher

"Integrated Development Approach: From Glass Science to Glass Primary Container Selection"

Panel Discussion:

Wednesday, October 14th - from 1.15 to 1.45 pm (GMT+9)

Session "Container Closure Components" 

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.