Event Summary

Regulatory agencies are requiring stricter standards for environmental monitoring systems, facility cleaning and disinfectant qualification, aseptic cleanroom operations, filtration, sterilization, and aseptic process simulation (or media fill). This two-day summit features comprehensive coverage of best practices in barrier, containment, and aseptic manufacturing and processing technologies.

Featuring In-Depth Coverage On:

• A Risk Based Approach to an Environmental Monitoring Assessment
• Annex 1—What You Need to Know
• Using Scientific Data to assess the Risk of Sterilizing Filter Flaw Masking and the Need for Pre-use, Post-Sterilization Integrity Testing
• Designing a Risk Based Cleaning and Disinfection Program
• Continuous Microbiological Environmental Monitoring for Aseptic Manufacturing
• Innovations in Aseptic Processing-Opportunities & Challenges for Implementation
• Single Use Manufacturing Systems – Practical Considerations
• Aseptic Compounding in 503b Industry: Challenges and Mitigation
• Terminal Sterilization or Bioburden Reduction Processes using Ionizing Radiation
• Isolators for Cell and Gene Therapy: Closing the Process for ATMPs
• NextGen Now-The Future of Advanced Therapy Medicinal Products (ATMP) Facilities 
• New Developments in Lyophilization and Automatic Vial Loading/Unloading
• Single-Use Technologies Used for Aseptic Processing and Final Filling Applications
• Media Fills/Aseptic Process Simulation and Validation
• Clinical and Small-Scale Aseptic Manufacturing, a Modular Filling System Approach

Past Sponsors of Pharma Ed’s Aseptic Processing Summit Include:

Silver Sponsor

Event Sponsors