Following the entry into force of the new Annex 1, airflow visualization studies like Smoke Studies and Computational Fluid Dynamic (CFD) studies, have become one of the key aspects of a company’s contamination control strategy (CCS).
The importance of these studies is not only limited to the qualification of clean rooms and clean air equipment, but if properly executed they can also be used for other evaluations, such as the definition of the environmental monitoring plan, the training of personnel and the definition of the positions of biological and chemical indicators for the validation of the VHP cycle.
But what does “properly executed studies” mean? There are several requirements that must be met not only to comply with regulatory requirements, but also to generate a scientific-sound study that allows a careful examination of airflow patterns and any related risks.
In this webinar, all these aspects will be explored, with particular focus on the interpretation and use of the information generated by these studies in order to build a holistic and effective contamination control strategy (CCS).
What you’ll learn:
- the role of smoke studies within a Contamination Control Strategy
- how to document a flow visualization
- the requirements for the proper execution of smoke studies
- how to determine the frequency of smoke studies
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