Critical airflow (Smoke Studies) is used to maintain aseptic conditions when manufacturing sterile products under aseptic conditions. Smoke studies, the visualization of critical airflow, is used to demonstrate unidirectional airflow and sweeping action over and away from the product. These studies are typically performed under both static and dynamic conditions.
The studies should be well planned, documented with written conclusions, and include evaluation of the impact of aseptic manipulations (e.g., interventions) and equipment design. Videotape or digital recording is used to provide a documented visual record of each test. These records are the objective evidence that is used to demonstrate the ability of the facility to maintain the proper manufacturing environment to internal auditors 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.
Performance Validation has extensive experience in performing Critical Airflow Visualization studies. We have completed over 33 studies ranging in size from a single hood, to an entire aseptic manufacturing line, we have over 5,500 hours of combined experience in the planning, development and execution/documentation of these studies and can provide assistance in consulting, planning and execution of your next airflow visualization project. In addition, Performance Validation recently purchased an Applied Physics CRF4 CleanRoom Fogger so we know have our own fogging equipment, and are not service limited based on the availability of rental equipment.
Critical Airflow Services provided by Performance Validation include:
Have a question on Critical Airflow Visualization? Need to schedule a Smoke Study? Please contact Dalton Pierson, Performance Validation’s Subject Matter Expert on Critical Airflow or use our Contact Us form and we will be happy to help.
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