29 Sep UND Office of Safety and the SMHS develop in-house program to certify biosafety cabinets
Jeffrey Voigt was in a lab, testing the air circling through a biological safety cabinet. This is crucial for a piece of equipment that facilitates work with biohazardous agents. But Voigt, safety assistant at University of North Dakota’s Office of Safety, at first could not figure out why the air flow was off.
Eventually, he found the culprit: a major leak in the high-efficiency particulate air (HEPA) filter.
“Any work that would be done in a biosafety cabinet not functioning according to manufacturer specifications can compromise the containment needed to safely work with biohazardous agents in a laboratory environment,” said Voigt.
Biological safety cabinets – or biosafety cabinets – are indispensable pieces of high-tech furniture for research labs. Composed of a box-like work area topped with a hood, they provide a sterile, secure setting where scientists can study various pathogens without posing a risk to either the researcher or the environment.
Currently, across various labs, UND has about 90 biosafety cabinets, more than half of which belong to the School of Medicine & Health Sciences.
There are several types of biosafety cabinets, but all function on the principle of regulating air flow in and out. The volume and velocity of that air flow – as well as any particles in it – must meet a strict protocol set by the National Sanitation Foundation (NSF) – the so-called NSF/ANSI Standard 49 – that governs the current specifications regarding design, materials, construction, and testing of biosafety cabinets.
Because any mechanical imperfections could distort the air flow and, thus, contaminate a sample, leak harmful materials into a lab or even expose a researcher to a biohazardous agent, the cabinets need to undergo certification tests every year.
“The HEPA filter leak test is the most important test we have to do because most of these biosafety cabinets utilize HEPA filters that remove 99.97% or more of airborne particles that are sized 0.3 microns and larger,” said Sumit Ghosh, former biological safety officer at UND and current Associate Director of Research Safety at the Abigail Wexner Research Institute at Nationwide Children’s Hospital in Columbus, Ohio. “And one of the reasons for that is because most biohazardous agents are in that size range.”
The NSF recommends that the technicians who conduct cabinet checks – the accuracy of which hinges on correct measurements and precise calculations – be accredited by the foundation. The NSF has led the field since the 1970s, when it developed the NSF Standard 49 – one of the most stringent in the world.
In far-flung regions such as North Dakota, however, contracting a NSF-vetted specialist presents a challenge whenever a biosafety cabinet needs to be certified, repaired or re-inspected after a move.
Two years ago, the closest NSF-approved cabinet certifiers for UND, NDSU and independent labs and hospitals in the state were in Minneapolis. The distance made for time delays in service that stretched for weeks and hampered research. It also made certifications and repairs quite costly.
“We had some real problems when we moved to the new Med school,” said UND Director of Safety Terry Wynne. “A lot of the biological safety cabinets were transferred over; they had to be decontaminated and recertified. When we called up one of the contractors to do it, it was going to take us three weeks. They said, ‘Well, we can come up there tomorrow, but that’ll be an extra $1,000.’ We can’t afford that. That just doesn’t work.”
So, the Office of Public Safety acted, and today UND has its own NSF-approved certification program for biosafety cabinets. And, the man inspecting – and fixing – cabinets is Voigt.
For a year, Voigt trained under Ghosh, who carries NSF accreditation and established the University’s in-house personnel accreditation and cabinet certification program.
To earn NSF’s accreditation, Ghosh had to enroll in special courses and take practical exams at the Eagleson Institute in Sanford, Maine, and at ENV Services in Hatfield, Pa., two of only five approved test sites in North America.
Today, Voigt is a few step away from himself becoming a full-fledged NSF cabinet certifier. What separates him from the designation is a 120-question written test and an eight-hour long practical exam. Until he sits for – and passes – them, Voigt must submit all his accreditation reports to Ghosh, who oversees his work.
“My background as a firefighter, and dealing with fluid transfer, kind of crosses over to doing movement of the air,” said Voigt. “So a lot of it wasn’t new. It was just a matter of adapting to that. And it went fairly well, once we got the mechanics and everything else squared away.”
Voigt’s and Ghosh’s training – including NSF’s test fees and the purchase of specialized equipment – cost about $20,000. This expense proved an obstacle.
Terry Nelson, Associate Director for Budget and Facilities Management at the SMHS, helped the Office of Safety leap over this financial hurdle.
“We were fortunate that we [at the SMHS] had some funding that we could use to help support the additional education and equipment [at the Office of Safety],” said Nelson. “In return, we got the benefits of getting some reduced prices for our cabinets to be certified.”
In 2018, UND saved more than $30,000 over what it would have cost to have an outside NSF certifier come in. On top of that, the Office of Safety generated nearly $6,000 in revenue from Voigt’s services to labs at North Dakota State University in Fargo.
Through the Office of Safety, a cabinet certification could cost North Dakota-based researchers only a quarter of what an out-of-state certifiers would command – and this excludes the out-of-state certifiers’ charges for travel expenses.
“We’re definitely making marks at the University – biology, chemistry, mechanical engineering, chemical engineering,” said Wynne. “They’re starting to see the pluses of it.”
A model for others
So are other higher-education, research-focused institutions. In August, Ghosh outlined UND’s efforts at the Midwest Area Biosafety Conference, where he said “so many” universities reached out for further details.
Such a positive reaction is what Ghosh and the rest have hoped for. After all, they set up UND’s in-house certification program not only to save time and money for the University but also to offer a how-to guide, especially to small organizations with limited access to NSF-vetted certifiers.
To that end, this summer, Ghosh, Wynne, Voigt and Nelson published a paper on this topic in the Journal of Applied Biosafety.
“We just wanted to have a template for other organizations, because biosafety cabinets are not just used in United States,” said Ghosh. “They are used throughout the world.”