Critical Airflow Visualization tests (CAV), or Smoke Studies, are a key activity in the qualification, maintenance, and monitoring of an aseptic facility. These studies are typically performed under both static and dynamic conditions. Smoke studies are conducted to confirm unidirectional airflow in a medical clean room. These studies should be well planned, documented with written conclusions, and include an evaluation of the impact of aseptic manipulations and equipment design. The results are objective evidence that is used to demonstrate the ability of the facility to maintain the proper manufacturing environment to internal and external regulators. Whereas a well-designed facility can successfully complete static testing, it is the evaluation under dynamic conditions (using the facility as intended) that will demonstrate the facility, equipment, and operators can function together to maintain the required aseptic conditions.
The PV team of experts help our clients to identify and correct errors as they arise and train their team to properly execute industry best practices to guarantee an aseptic facility which operates as intended to always deliver the best quality products.
While working with our clients, PV gains an understanding of the operations and interventions. Combining that with our expertise and experience with critical smokes studies, we can communicate potential risks and provide solutions before the initial smoke study activities begin. Our expertise also allows us to visually identify potential airflow problems before beginning the qualification testing, allowing us to work even with a short window of availability. By providing the proper deliverables, our clients can be confident that their critical airflow meets or exceeds regulatory requirements.
With the extensive experience of the Performance Validation (PV) team, we can aid in consulting, planning, and execution of the airflow visualization project. PV will bring in a team of experts, along with our own fogging equipment to coordinate the study.
By owning our own CRF4 Fogger, it allows our team of experts to respond quicker to our customer needs. The CRF4 fogger provides a dense fog allowing a better visualization of airflow turbulence and clearer recording of the smoke study outcomes.
Critical Airflow Services include:
- Study Director/ Project Management
- Protocol Development
- Digital Recording
- Data Analysis
- Summarization of Each Intervention
- Remediation Solutions
- On-site Support
- Daily Review.
Lyophilization Loading/Unloading Areas
Locally Controlled Environments
Stopper Processing Equipment
All Grade A Classified Areas