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Airflow Pattern Visualization (AFPV)
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. The 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.
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.
Attendance Suggested for:
  • Engineering
  • Facilities and Utilities Qualification
  • Fill/Finish
  • GMP Compliance
  • HVAC
  • Mechanical Services
  • Microbiology
  • Operations
  • Quality Assurance
  • Technical Services
  • Validation

Biographies

David Brande brings 28 years of experience in the cleanroom industry. David was a founder and President of Contamination Control Technologies, Inc., for 19 years. The company specialized in providing cleanroom and biological containment certifications, as well as international consulting services, to the pharmaceutical, medical device and biomedical research industries until purchased by nnepharmaplan in August of 2005. David left nnepharmaplan in 2007 and is currently Lead Consultant for Cleanroom Project Management, Inc.

Nick Haycocks, a Chartered Mechanical Engineer with over 20 years experience in the Pharmaceutical industry, Nick has worked for GSK, Schering Plough, and Amgen in their technical organizations as well as on site supporting projects in various locations including China and Singapore. In both Glaxo and Schering Plough he was an internal specialist for Critical Utility systems, writing internal guidance documents, and specifications. He is the co chair of the Guidance Documents Executive Committee in ISPE, and chair of the HVAC and Sustainability COP committee, and has contributed to the HVAC, Process Gas, and Good Engineering Practice good practice guides.

Peter Meginnis is a Consultant Engineer at Eli Lilly and Company and is responsible for the design, installation, qualification and maintenance of all unidirectional airflow systems at the company’s parenteral manufacturing operations in Indianapolis, Indiana. Since 1994, Pete has filled project engineer, manager and consultant roles in parenteral Engineering and Quality.
Discounted member price: 400.00
500.00
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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. The 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).  The student will also learn how to avoid some of the problems that can occur when creating the visual recording how the results of airflow pattern visualization can be evaluated objectively.

 

This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessments to measure your comprehension and the ability to start and stop at any time, beginning where you left off.

ISPE CEUs are provided once you achieve an 80% passing grade and complete the evaluation.

Approximate Course Duration: 2 Days (this is a self-paced course)

*NOTE* You will have 14 calendar days to access and complete this course from time of purchase

ISPE CEUs: 1.20 ISPE CEUs will be awarded upon successful completion of grading requirements

Member Price: $ 400.00
Non Member Price: $ 500.00
Item #: WEBTRAFPVUS