Best Practices for Glass Primary Containers - Training / Workshop von PDA Europe gGmbH

Inhalte

Glass vials, ampoules, syringes and cartridges are commonly used in packaging of parenteral pharmaceuticals. Good glass handling practices are essential to assuring glass-based container performance as intended in maintaining the safety and efficacy of the drug product. The two-day course will offer insights into the science of glass and its inherent properties. It will review container design and dimensioning, cover glass strength and fracture mechanics as well as review the fundamental principles of good glass handling and inspection. The course will follow step-by-step the processes for packaging of parenterals in vials, ampoules, cartridges and syringes. Further insights into glass breakage including an overview of fracture analysis using fractography will be presented.

Lernziele

Prerequisites

  • Technical aptitude
  • Some familiarity with pharmaceutical fill/finish processes

 

Learning Objectives

  • Understands the nature of glass
  • Knows what glass breakage causes
  • Is aware of regulatory requirements and how to perform QC incoming inspection
  • Knows how to inspect glass containers for breakage-relevant defects
  • Is able to apply the knowledge to avoid glass breakage in the filling line
  • Is able to apply a structured way of evaluating in case of glass breakage
  • Is able to ‘read’ from the splinters and broken glass

Zielgruppen

  • Packaging engineers
  • Quality personnel
  • Filling line technicians
  • Supervisors and engineering support
  • Those responding to failure complaints
  • Root cause investigators

SG-Seminar-Nr.: 1785790

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