Viral Filtration Efficiency (VFE) Final Report
Test Article: ...........................Nano Fiber Mask B, REF 1230500529
Purchase Order: .....................NR21000017
Study Number:.......................1385914-S01
Study Received Date:............ 03 Feb 2021
Testing Facility: ....................Nelson Laboratories, LLC, 6280 S. Redwood Rd. Salt Lake City, UT 84123 U.S.A.
Test Procedure(s): ................Standard Test Protocol (STP)
Number: ..............................STP0007 Rev 16
Deviation(s):......................... None
Summary: The VFE test is performed to determine the filtration efficiency of test articles by comparing the viral control counts upstream of the test article to the counts downstream. A suspension of bacteriophage ΦX174 was aerosolized using a nebulizer and delivered to the test article at a constant flow rate and fixed air pressure. The challenge delivery was maintained at 1.1 - 3.3 x 103 plaque forming units (PFU) with a mean particle size (MPS) of 3.0 μm ± 0.3 μm. The aerosol droplets were drawn through a six-stage, viable particle, Andersen sampler for collection. The VFE test procedure was adapted from ASTM F2101.
All test method acceptance criteria were met. Testing was performed in compliance with US FDA good
manufacturing practice (GMP) regulations 21 CFR Parts 210, 211 and 820.
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