Challenging Air Change Rate Guidelines in GMP Facilities
Jason Rifkin, Equilibrium
Patrick Goetz, JennErik Engineering
As research and development of biotechnology progresses to marketable products, those products must first be manufactured within a controlled environment. This environment is regulated by the U.S. Food and Drug Administration as well as the European Medicines Agency (for drugs intended for European sale) and the attributes of the facility design are codified in regulations and guidelines. The focus of these regulations is to ensure a controlled, clean, and (where applicable) sterile environment to mitigate the risk of potential contaminates to biologically derived products.
Different levels of clean production space are classified by the maximum particulate counts allowable within a volume of air (measured as particulates greater than 0.5 µm within a cubic foot or meter of air), as well as other factors. Associated with these classifications are air change rates to obtain the various levels of particle-free air. Our premise is to challenge these air change rates as necessary to achieve the associated classifications of "clean rooms" and to propose active controls to modulate the air change rates based on activity within a production space at any given time.
In our experience and as empirical data will show, the air change rates set forth by government regulations and industry standards, coupled with current room construction practices, results in much "cleaner" air than the room classifications would dictate.
Air change rates drive first costs in equipment selection and continued operating costs associated with elevated utility bills from the fan energy and cooling required to move that much air through these regulated facilities. By reducing the air change rates with actual data in conjunction with modulating the air change rates down, when the facility is not in production, first costs and continued operating expenses in production facilities can be greatly reduced.
Biographies:
Jason Rifkin has worked in the life science industry for the past 17 years and brings extensive experience in the biotechnology and life science sector previously working for Celera Genomics as a quality control supervisor and at NeuralStem as a researcher and laboratory manager. Mr. Rifkin has worked with Turner Construction Company as a life sciences construction market consultant and for Scheer Partners as a senior vice president in charge of development and construction of life science facilities.
Mr. Rifkin holds a Bachelor of Science in biology from the University of Maryland at Baltimore County, a Master of Science in neurobiology from Montana State University, and a Masters of Business Administration from the University of Baltimore.
Patrick Goetz has 22 years of experience in the life sciences industry where he has prepared master plans; prepared energy analyses; prepared contract documents; and estimated and provided construction, commissioning, and project management services for single buildings as well as campus facilities. His projects have ranged from research and development to manufacturing facilities for research, biotechnology, and pharmaceutical clients. His experience includes both the design and design-build management for mechanical, electrical, and plumbing (MEP) systems for multiple clean room and biosafety level (BSL)-3 facilities.