Critical Airflow Visualization (CAV) tests, also known as smoke studies, offer a visual representation of real airflow patterns within a facility. These tests are crucial in qualifying, maintaining, and monitoring aseptic environments. Conducted under static and dynamic conditions, these studies are essential for ensuring the optimal performance of the facility. Partner with Performance Validation (PV) for compliant CAV testing you can rely on.
Why CAV Tests Matter to Aseptic Environments
CAV tests are conducted to confirm unidirectional airflow in a clean room. Therefore, 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 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, the evaluation under dynamic conditions (using the facility as intended) will demonstrate that the facility, equipment, and operators can function together to maintain the required aseptic conditions.
Our CAV Process for Meeting Regulatory Requirements
CAV tests are the most widely accepted method of demonstrating that airflow patterns in critical processing areas meet regulatory requirements. Throughout the process, our team of experts helps you identify and correct errors as they arise and trains your team to properly execute industry best practices to guarantee an aseptic facility that operates as intended to always deliver the best quality products.
A Game-Changing Approach to Smoke Studies
PV is revolutionizing smoke studies in the FDA-regulated industry by introducing a groundbreaking approach that addresses past technological limitations. Traditionally, live streaming smoke studies faced obstacles like cost, reliability, and security, requiring a cumbersome process involving multiple cameras and data transfers. PV’s innovative method transforms the smoke study experience by promoting image sync and other benefits.
- Seamless integration of technology is achieved by mounting four cameras in a fixed position, allowing a single PC to record all tracks simultaneously, thereby eliminating synchronization challenges and the need for manual adjustments. This also ensures image stability throughout the recording process, enhancing the accuracy and reliability of critical airflow visualization.
- Real-time collaboration facilitated by PV’s partnership with your IT departments enables live streaming within their network, allowing stakeholders worldwide to actively participate, collaborate, and contribute to smoke studies regardless of time or location.
- Enhanced data security is ensured by recording all four tracks as a single file on a PC, eliminating cumbersome file transfers, preserving original data integrity by editing the images on-site, and minimizing the risk of data breaches, enhancing the study’s integrity.
- Innovative mobility is attained through implementing a custom mobile rolling desk by the PV team, simplifying transportation and setup of the new approach.
Identify & Fix Airflow Problems with Ease
PV understands your operations and interventions. Combining that with our expertise and experience with critical smoke 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, you can be confident that your critical airflow meets or exceeds regulatory requirements.
Improve Airflow Visualization with Fogging Equipment
With the extensive experience of the PV team, we can aid in consulting, planning, and executing your airflow visualization project. PV will bring in a team of experts, along with fogging equipment, to coordinate the study. By owning our own CRF4 Fogger, our team of experts can respond quickly to your needs. The CRF4 fogger provides a dense fog, allowing better visualization of airflow turbulence and clearer recording of the smoke study outcomes. If your SOP mandates the utilization of a particular fogger, rest assured that our team will readily accommodate this requirement.
Critical Airflow Services to Maintain Aseptic Conditions
Ensure the effective management and maintenance of airflow in sensitive environments with our critical airflow services:
- Study director/project management
- Protocol development
- Digital recording
- Data analysis
- Summarization of each intervention
- Remediation solutions
- On-site support
- Daily review
Effective Area & Equipment Testing
Get your environments and equipment tested by our experts to ensure your CAV needs are met:
- Filling lines
- Lyophilization loading/unloading areas
- Locally controlled environments
- Stopper processing equipment
- All Grade A classified areas
Your Reliable Partner for Compliant CAV Studies
Our SMEs have extensive experience in performing Critical Airflow Visualization studies. We have completed studies ranging in size from single hood to an entire aseptic manufacturing line and experience in the planning, development and execution.