Battelle CCDS Critical Care Decontamination System™ Being Deployed to Meet Urgent Need for Personal Protective Equipment fo...
28 Marzo 2020 - 12:48PM
Business Wire
Battelle announced today that it has begun rapid manufacturing
of a system to decontaminate N95 respirator masks and other medical
protective equipment.
Each Battelle CCDS Critical Care Decontamination System™ is
capable of decontaminating up to 80,000 masks per day at full
capacity. Because it is scalable, the system is capable of
processing even more pieces of personal protective equipment (PPE)
each day. Battelle CCDS™ uses concentrated, vapor phase hydrogen
peroxide (VPHP) and works by exposing used respirator masks to the
validated concentration level for 2.5 hours to decontaminate
biological contaminates, including SARS-CoV-2.
Battelle has a fully operational system at its West Jefferson,
Ohio facility that has processed test batches of previously worn
PPE received from Central Ohio hospitals. Battelle is working
closely with the U.S. Food and Drug Administration to obtain an
Emergency Use Authorization (EUA) to begin processing previously
worn PPE for reuse in a clinical setting.
This past week, Battelle started building systems at one of its
manufacturing operations in Columbus for shipment to sites around
the country. The first completed system is in transit and will be
placed at an undisclosed location in the New York metropolitan area
to address that city’s critical shortage of PPE needed by
healthcare workers and first responders.
“The Battelle team mobilized to begin acquiring parts and
developing manufacturing processes to deploy systems to help those
on the frontline who need essential protective equipment,” said
Matt Vaughan, Battelle’s Contract Research President. “We are
building the next units and are in discussions with health
officials across the country to determine where to best place
them.”
For decades, Battelle has served the military in protecting
troops from chemical and biological hazards. The company operates
Biosafety Level 2 and 3 labs where research is performed on live
viruses, including SARS-CoV-2. Battelle also has a full medical
device development team that works with the FDA on a regular
basis.
Battelle CCDSTM is based on research that Battelle performed for
the FDA in 2015 (Richter et al., 2016) to assess the feasibility to
decontaminate N95 respirator masks in the event of a PPE shortage
resulting from a pandemic. In that FDA study VPHP decontamination,
using the same system parameters and critical end points as the
current system, was shown to result in 6-log reduction of G.
stearothermophilus while not degrading the filter performance of
N95 respirators for multiple decontamination cycles. Battelle is
currently conducting research to validate that other equipment,
including surgical masks and ventilator components, can be
decontaminated using this process.
Once the EUA is in place, Healthcare systems that are enrolled
in the Battelle CCDSTM program will collect worn respirator masks
daily in accordance with an approved procedure and courier them to
one of the active Battelle CCDS Critical Care Decontamination
SystemTM locations. The PPE will be labeled with a barcoded serial
number for tracking the chain-of-custody throughout the process.
This ensures that a hospital system receives its own masks back.
Each respirator mask will be marked with the number of times that
mask has been processed.
To learn more about Battelle CCDSTM, please visit
www.battelle.org/decon or www.battelle.org/covidnews.
About Battelle
Every day, the people of Battelle apply science and technology
to solving what matters most. At major technology centers and
national laboratories around the world, Battelle conducts research
and development, designs and manufactures products, and delivers
critical services for government and commercial customers.
Headquartered in Columbus, Ohio since its founding in 1929,
Battelle serves the national security, health and life sciences,
and energy and environmental industries. For more information,
visit www.battelle.org.
For more information contact Katy Delaney at (614) 424-7208 or
at delaneyk@battelle.org or contact T.R. Massey at (614) 424-5544
or at masseytr@battelle.org.
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version on businesswire.com: https://www.businesswire.com/news/home/20200328005013/en/
Katy Delaney, (614) 424-7208 delaneyk@battelle.org or T.R.
Massey, (614) 424-5544 masseytr@battelle.org