Manufacturing of Sterile Medicinal Products Enabled by RTU Packaging

Zielsetzung

This seminar is designed to provide participants with a comprehensive understanding of the latest innovations and best practices in the manufacturing of sterile medicinal products, with a special focus on Ready-to-Use (RTU) packaging solutions.
Key topics include:

• Agile Aseptic Manufacturing & Decentralized Production
  Gain insights into the benefits of decentralized manufacturing and fleet/sister site concepts, including the role of automation, alternative microbial monitoring, and regulatory considerations.
• Annex 1 and Modern Manufacturing Techniques
  Understand the key aspects of Annex 1 (2022) and its implications for aseptic material transfer, automation, and robotics in sterile medicinal product manufacturing.
• Interaction of Packaging Material and Machinery
  Explore critical factors influencing packaging material and machine compatibility, with a focus on pre-sterilized syringes, robotic solutions, and gloveless isolators.
• Standardization of RTU Primary Packaging
  Learn about DIN/ISO standardization efforts for prefillable syringes, vials, and cartridges, including considerations for both glass and plastic containers.
• Commercial Use of RTU Packaging
  Examine the current market landscape, implementation challenges, and evolving responsibilities in cGMPcompliant RTU processing versus bulk sterile manufacturing.
• Advanced Processing and Inspection of RTU Containers
  Discover innovative processing techniques such as 100% check-weighing, specialized priming/end-of-batch programs, and unique inspection steps to maximize product yield.
• Development of CSTD-Compliant Components
  Gain insights into the successful development of snap-on caps for robotic and non-robotic fill & finish systems in compliance with CSTD guidelines.
• Sustainability in RTU and Reusable Device Product
  Explore sustainable strategies in RTU packaging and the development of reusable device solutions.
• Sterilization Methods and Validation Excellence 
  Review key sterilization techniques, validation principles, and the unique challenges associated with ensuring sterility in pre-crimped RTU cartridges

This seminar aims to equip professionals with the knowledge and tools needed to navigate the complexities of sterile medicinal product manufacturing, fostering innovation and compliance in an ever-evolving industry.