Airflow Pattern Visualization (AFPV)
Airflow pattern visualization provides a visual record of actual airflow patterns in a pharmaceutical facility. It is currently the most widely accepted method of demonstrating that airflow patterns in critical processing areas meet regulatory expectations. In addition, airflow pattern visualization allows multiple functional organizations to discover the effectiveness and significance of the airflow design and functionality, especially in critical areas. This online course provides a unique opportunity to explore the requirements for airflow pattern visualization and to see different video examples of actual airflow pattern visualization results. The course provides a comparison of different types of airflow patterns, but focuses primarily on unidirectional airflow patterns in critical areas (ISO 5).
Course Modules/Learning Objectives
- Module 1: Introduction to Airflow Pattern Visualization
- Explain why Airflow visualization testing is important and how this process is used to demonstrate compliance with associated regulatory requirements.
- Review the regulations, regulatory and industry guidance and associated Standards.
- Module 2: Principles of Airflow Types
- Discuss the types of airflow patterns as a result of the design of the controlled environment
- How airflow patterns can be affected in a unidirectional coverage area
- Recognize and assess risk areas of non-UAF airflow
- Module 3: People as the Issue
- Review problems with operator motion and its effect on unidirectional flow
- Choosing the correct aerosol for your application
- Identify common problems in facility and equipment, design and layout
- Review problems.
- Module 4: Practical Advice and Application
- Discuss established testing criteria and requirements, along with the challenges associated with them.
- Review the current velocity measurement standards and discuss how this can lead to inconsistency.
- Review Operational Airflow requirements and look at examples of good and bad Airflow Pattern Tests.
- Discuss guidance for testing and planning.
Interactive Course includes:
- A downloadable presentation for note-taking.
- Engaging graphics.
- Reference materials and links to regulatory information.
- Assessments to measure your comprehension.
- The ability to start and stop at any time, beginning where you left off.
CEUs are provided once you achieve an 80% passing grade and complete the evaluation.
Attendance suggested for
- Engineering
- Facilities and Utilities Qualification
- Fill/Finish
- GMP Compliance
- HVAC
- Mechanical Services
- Microbiology
- Operations
- Quality Assurance
- Technical Services
- Validation
Instructors
