1288950 S01 .pdf


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Sponsor:
André Daigle
8509239 Canada, Inc.
2247 chemin de Deauville
Saint-Adèle, J8B 2B1
CANADA

Bacterial Filtration Efficiency (BFE) Final Report
Test Article:

Study Number:
Study Received Date:
Testing Facility:

Test Procedure(s):
Deviation(s):

Face Mask UCHUU-CV-19
Meltblown (1-ply)
Meltblown (2-ply)
1288950-S01
15 Apr 2020
Nelson Laboratories, LLC
6280 S. Redwood Rd.
Salt Lake City, UT 84123 U.S.A.
Standard Test Protocol (STP) Number: STP0004 Rev 18
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
3
flow rate and fixed air pressure. The challenge delivery was maintained at 1.7 - 3.0 x 10 colony forming
units (CFU) with a mean particle size (MPS) of 3.0 ± 0.3 μm. The aerosols were drawn through a sixstage, 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:

Face Mask: Inside
Meltblown: Either Side
2
Face Mask: ~7.1 cm
2
Meltblown: ~40 cm
28.3 Liters per minute (L/min)
85 ± 5% relative humidity (RH) and 21 ± 5°C for a minimum of 4 hours
3
Face Mask: 1.7 x 10 CFU
3
Meltblown: 2.3 x 10 CFU
<1 CFU
Face Mask: 2.9 µm
Meltblown: 2.8 µm

BFE Test Area:
BFE Flow Rate:
Conditioning Parameters:
Positive Control Average:
Negative Monitor Count:
MPS:

Reid Jones electronically approved for
Study Director

801-290-7500

|

nelsonlabs.com

|

sales@nelsonlabs.com

James Luskin

15 May 2020 17:14 (+00:00)
Study Completion Date and Time

hmm

FRT0004-0001 Rev 22

Page 1 of 2
T hese results apply to the samples as received and relate only to the test article listed in this report. Repo rts may not be reproduced except in their entirety. Subject to NL terms and conditions at www.nelsonlabs.com.

Study Number 1288950-S01
Bacterial Filtration Efficiency (BFE) Final Report

Results:
Face Mask:
Test Article Number

Percent BFE (%)

1

99.3

2

99.7

3

99.6

4

99.6

5

>99.9

Test Article Number

Percent BFE (%)

1

>99.9

2

>99.9

3

>99.9

4

>99.9

Meltblown (1 ply):

a

a

5
99.8
There were no detected colonies on any of the Andersen sampler plates for this test article.

Meltblown (2 ply):

a

Test Article Number

Percent BFE (%)

1

>99.9

a

There were no detected colonies on any of the Andersen sampler plates for this test article.

The filtration efficiency percentages were calculated using the following equation:
C = Positive control average
𝐶−𝑇
T = Plate count total recovered downstream of the test article
% 𝐵𝐹𝐸 =
𝑥 100
𝐶
Note: The plate count total is available upon request

801-290-7500

|

nelsonlabs.com

|

sales@nelsonlabs.com

hmm

FRT0004-0001 Rev 22

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