Smoke Studies and Sterility Assurance: Understanding the Impact of Annex 1

Advertising and Promotion
Business Support
Events, Conferences and Webinars

With the recent implementation of the revised Annex 1, airflow visualization studies, such as Smoke Studies and Computational Fluid Dynamics (CFD), have become indispensable tools in a company’s Contamination Control Strategy (CCS).

These studies are no longer confined to the qualification of cleanrooms and clean air equipment. When conducted rigorously, they offer valuable insights for a range of applications, including:

  • Environmental Monitoring Plan Development:  Optimizing sampling locations for accurate risk assessment.
  • Personnel Training: Enhancing understanding of airflow patterns and their impact on contamination control.
  • Validation of VHP Cycles: Precisely positioning biological and chemical indicators for reliable cycle validation.

But what constitutes a “properly executed study”? To meet regulatory standards and generate scientifically sound data, several key requirements must be met.

Register here for the free webinar!

What you'll learn:
  • The Role of Smoke Studies in Contamination Control: Understanding their significance within a comprehensive CCS.
  • Documentation Best Practices: Ensuring clear and accurate records of airflow visualization studies.
  • Key Requirements for Rigorous Studies: Adhering to industry standards and regulatory guidelines.
  • Optimizing Study Frequency: Determining the optimal schedule for effective monitoring.

By the end of this webinar, you’ll gain a deeper understanding of how to leverage airflow visualization studies to build a robust and effective contamination control strategy.

Don't forget to register! Link here.

Who should attend:
  • Quality Assurance
  • Quality Control
  • Compliance and Validation Specialists
  • Bioprocess Engineers
  • Regulatory Affairs Specialists
  • Manufacturing and Operations Managers
  • R&D Personnel
  • Pharmaceutical Researchers, Scientists and Consultants