A QbD Approach Towards Manufacturing of Parenteral Packaging Components with First Line USA

10:10 - 10:45

  • Key considerations to select the appropriate parenteral packaging components.
  • A QBD approach to design a facility for pharmaceutical components with a focus on particulate reduction
  • Risks that face the pharmaceutical industry today from a drug packaging perspective, and strategies to mitigate these risks.

Visible particles are a concern for the pharmaceutical industry. In the last few years, a quarter of all sterile injectable drug recalls were linked to particulate found in finished drugs. This poses a significant challenge to address Quality requirements, and to comply with regulatory authorities in various geo-regions. This presentation will focus on innovations in the manufacturing of parenteral packaging components to address the demanding needs for packaging sensitive drug molecules, such as biologics. Advancements in products and processes to achieve best-in-class specifications, with a focus on 'zero-defects' will be discussed.

Rahul Thakar, Technical Key Account Manager, Datwyler Pharma Packaging, Inc.