Test Article: ......................... NANO FIBER MASK B, REF 1230500529, lot 20117175
Purchase Order:..................NR20000432
Study Number:................... 1376718-S01
Study Received Date:........ 30 Dec 2020
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: .................................STP0004 Rev 18
Deviation(s):.......................... None
Summary: The BFE test is performed to determine the filtration efficiency of test articles by comparing
the bacterial control counts upstream of the test article to the bacterial counts downstream. A suspension
of Staphylococcus aureus 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 1.7 - 3.0 x 103 colony forming
units (CFU) with a mean particle size (MPS) of 3.0 ± 0.3 μm. The aerosols were drawn through a six- stage, viable particle, Andersen sampler for collection. This test method complies with ASTM F2101-19 and EN 14683:2019, Annex B.
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.
Test Side: Inside
BFE Test Area: ........................~40 cm2
BFE Flow Rate:....................... 28.3 Liters per minute (L/min)
Conditioning Parameters: ........85 ± 5% relative humidity (RH) and 21 ± 5°C for a minimum of 4 hours
Test Article Dimensions:........ ~178 mm x ~172 mm
Positive Control Average:........ 2.1 x 103 CFU
Negative Monitor Count: ........<1 CFU
MPS:........................................2.9 μm
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