Performance Validation provides critical airflow visualizations (ie, smoke studies), which are used to demonstrate proper airflow to protect product sterility. These studies reflect actual aseptic practices. Even the best systems can be invalidated through poor aseptic technique, improper gowning, lack of maintenance, or failure to follow procedures. Performance Validation helps users identify issues and offers guidance on remediation, having successfully performed multiple critical airflow visualization studies in aseptic areas. Studies can be designed to validate aseptic processing and identify any necessary interventions. In addition, Performance Validation can execute, document, and film the study to meet regulatory expectations.
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