bacterial filtration efficiency (bfe) and differential

Bacterial Filtration Efficiency (BFE)and Differential Pressure (Delta P) Final Report

Test Article:

Study Number:Study Received Date:

Testing Facility:

Test Procedure(s):Deviation(s):

SURGICAL FACE MASK

1276505-S01

12 Mar 2020

Nelson Laboratories, LLC6280 S. Redwood Rd.

Salt Lake City, UT 84123 U.S.A.Standard Test Protocol (STP) Number: STP0004 Rev 18None

Summary: The BFE test is performed to determine the filtration efficiency of test articles by comparingthe bacterial control counts upstream of the test article to the bacterial counts downstream. A suspensionof Staphylococcus aureus was aerosolized using a nebulizer and delivered to the test article at a constantflow rate and fixed air pressure. The challenge delivery was maintained at 1.7 - 3.0 x 10^ colony formingunits (CFU) with a mean particle size (MPS) of 3.0 ± 0.3 pm. The aerosols were drawn through a six-stage, viable particle, Andersen sampler for collection. This test method complies with ASTM F2101-19and EN 14683:2019, Annex B.

The Delta P test is performed to determine the breathability of test articles by measuring the differentialair pressure on either side of the test article using a manometer, at a constant flow rate. The Delta P testcomplies with EN 14683:2019, Annex C and ASTM F2100-19.

All test method acceptance criteria were met. Testing was performed in compliance with US FDA goodmanufacturing practice (GMP) regulations 21 CFR Parts 210, 211 and 820.

Test Side:

BFE Test Area:

BFE Flow Rate:

Delta P Flow Rate:

Conditioning Parameters:

Test Article Dimensions:

Positive Control Average:Negative Monitor Count:

MPS:

Inside

~40 cm^28.3 Liters per minute (L/min)8 Liters per minute (L/min)85 ± 5% relative humidity (RH) and 21 ± 5°C for a minimum of 4 hours-160 mm X -150 mm

2.1 xlO^<1 CFU

3.3 pm

CFU

ACCREDITED

TESTING UkBORATORY

Study Director

1276505-S01

801-290-7500 | nelsonlabs.com | [email protected]

James W. Luskin Study Completion Date

hmm FRT0004-0001 Rev 22

of 2

These results apply to the samples as received and relate only to the test article listed In this report. Reports may not be reproduced except in their entirety. Subject to ML terms and conditions at www.nelsonlabs.com.

5 Nelson Labs.A Sotera Health company

Study Number 1276505-801Bacterial Filtration Efficiency (BFE)

and Differential Pressure (Delta P) Final Report

Results:

Test Article Number

1

2

3

4

Percent BFE (%)

>99.9

>99.9

99.8

ga

5 >99.9

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

Test Article Number Delta P (mm H20/cm Delta P (Pa/cm'

1 7.2 70.9

2 6.7 65.5

3 7.1 69.6

4 7.0 1 68.2

5 7.1 69.3

The filtration efficiency percentages were calculated using the following equation:C = Positive control average

„ T = Plate count total recovered downstream of the test article^ Note: The plate count total is available upon request

C-T% BFE = X 100

801-290-7500 nelsonlabs.com | [email protected] Rev 22

of 2

Flammability of Clothing Textiles Final Report

Test Article:


Testing Facility:


SURGICAL FACE MASK

1277395-S01

16 Mar 2020



Summary: This procedure was performed to evaluate the flammability of plain surface clothing textilesby measuring the ease of ignition and the speed of flame spread. The parameter of time is used toseparate materials into different classes, thereby assisting in a judgment of fabric suitability for clothingand protective clothing material. The test procedure was performed in accordance with the test methodoutlined in 16 CFR Part 1610 (a) Step 1 - testing in the original state. Step 2 - Refurbishing and testingafter refurbishing, was not performed. All test method acceptance criteria were met. Testing wasperformed in compliance with US FDA good manufacturing practice (GMP) regulations 21 CFR Parts 210,211 and 820.

Test Article Side Tested:

Orientation:

Outside Surface

Cross

Test Criteria for Specimen Classification (See 16 CFR Part 1610.7):

1

2

3

Burn time ̂ 3.5 seconds

Not applicable to plain surface textile fabric§.f

Burn time <3.5 seconds

The 16 CFR Part 1610 standard specifies that 10 replicates are to be tested if, during preliminary testing,only 1 test article exhibits flame spread and it is less than 3.5 seconds or the test articles exhibit anaverage flame spread less than 3.5 seconds. Five replicates are to be tested if no flame spread isobserved upon preliminary testing, if only 1 test article exhibits flame spread and it is equal to or greaterthan 3.5 seconds, or if the average flame spread is equal to or greater than 3.5 seconds. In accordancewith the standard, 5 replicates were tested for this study.

OV'I"///

CCREOITeO

TCSTINO LABORATORY

9 7 ^7^study Director

1277395-801


Curtis Gerow, B.S. Study Completion Date

ks FRT0073-0001 Rev 9

Page 1 of 2

These results apply to the samples as received and relate only to the test article listed in this report. Reports may not be reproduced except in their entirety. Subject to ML terms and conditions at www.nelsonlabs.com.

Nelson Labs^ A Sotera Health company

Study Number 1277395-801Flammability of Clothing Textiles Final Report

Results:

Replicate Number

IBE = Test Article ignited, but extinguished

Time of Flame Spread

IBE

IBE2-

BE

- ̂

IBE

801-290-7500 | nelsonlabs.com [email protected] FRT0073-0001 Rev 9

Page 2 of 2

Robert Putnam electronically approved

01 Apr 2020 20:20 (+00:00)

Study Director Robert Putnam Study Completion Date and Time


bsm FRT0036-0010 Rev 10

Page 1 of 2

These results apply to the samples as received and relate only to the test article listed in this report. Reports may not be reproduced except in their entirety. Subject to NL terms and conditions at www.nelsonlabs.com.

Microbial Cleanliness (Bioburden) of Medical Masks Final Report

Test Article: SURGICAL FACE MASK

Study Number: 1276507-S01

Study Received Date: 12 Mar 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: STP0036 Rev 15

Customer Specification Sheet (CSS) Number: 202001488 Rev 01

Deviation(s): None

Summary: The testing was conducted in accordance with EN 14683:2019, with the exception of approximate volumes of eluent used when performing the extraction procedure and a temperature range of 30-35°C used for aerobic incubation.

When bioburden results are calculated using a software program, manual calculations may differ slightly due to rounding. The counts determined on products are colony forming units and may not always reflect

individual microorganisms. The sponsor performs any statistical analysis and determines the acceptable limits. Testing was performed in compliance with US FDA good manufacturing practice (GMP) regulations 21 CFR Parts 210, 211 and 820.

Results:

Unit Number Weight (g) Aerobic Fungal Total

Bioburden (CFU/mask)

Total Bioburden (CFU/g)

1 3.8 23 <3 26.5 7.0

2 3.9 15 3a 18.0 4.6

3 3.9 21a 3

a 24.0 6.2

4 3.8 27a 3

a 30.4 8.0

5 3.9 24 3a 27.8 7.1

Recovery Efficiency 57.6%

< = No Organisms Detected Note: The results are reported as colony forming units (CFU) per mask. a Spreader. Count is considered a minimum estimate due to swarming of certain colonies on the membrane.

Study Number 1276507-S01 Microbial Cleanliness (Bioburden) of Medical Masks Final Report

801-290-7500 | nelsonlabs.com | [email protected] bsm FRT0036-0010 Rev 10

Page 2 of 2

Method Suitability:

Organism Percentage

Bacillus atrophaeus 90%

Test Method Acceptance Criteria: If applicable, anaerobic controls are acceptable for the bioburden

test results. The number of masks to be tested shall be a minimum of 5 or more to meet an acceptable quality level of 4%. The bioburden of the medical mask shall be < 30 CFU/g tested.

Procedure:

Positive Controls/Monitors: Bacillus atrophaeus

Extract Fluid: Peptone Tween®

Extract Fluid Volume: 300 mL

Extract Method: Orbital Shaking for 15 minutes at 250 rpm

Plating Method: Membrane Filtration

Agar Medium: Tryptic Soy Agar

Potato Dextrose Agar

Recovery Efficiency: Exhaustive Rinse Method

Aerobic Bacteria: Plates were incubated 3 - 7 days at 30-35°C, then enumerated.

Fungal: Plates were incubated 5 - 7 days at 20-25°C, then enumerated.

Latex Particle Challenge Final Report

Test Article:


Testing Facility:


SURGICAL FACE MASK

1276503-S01

12 Mar 2020



Summary: This procedure was performed to evaluate the non-viable particle filtration efficiency (PFE) ofthe test article. Monodispersed polystyrene latex spheres (PSL) were nebulized (atomized), dried, andpassed through the test article. The particles that passed through the test article were enumerated usinga laser particle counter.

Three one-minute counts were performed, with the test article in the system, and the results averaged.Three one-minute control counts were performed, without a test article in the system, before and aftereach test article and the counts were averaged. Control counts were performed to determine the averagenumber of particles delivered to the test article. The filtration efficiency was calculated using the averagenumber of particles penetrating the test article compared to the average of the control values.

The procedure employed the basic particle filtration method described in ASTM F2299, with someexceptions; notably the procedure incorporated a non-neutralized challenge. In real use, particles carry acharge, thus this challenge represents a more natural state. The non-neutralized aerosol is also specifiedin the FDA guidance document on surgical face masks. All test method acceptance criteria were met.Testing was performed in compliance with US FDA good manufacturing practice (GMP) regulations 21CFR Parts 210, 211 and 820.

Test Side:

Area Tested:

Particle Size:

Laboratory Conditions:Average Filtration Efficiency:

Standard Deviation:

Inside

91.5 cm^0.1 pm20°C, 24% relative humidity (RH) at 0921; 2rC, 23% RH at 114399.67%

0.373

VACCREOITEO

TESTINC LABOiMTOAY

Study Director

801-290-7500

^7Curtis Gerow, B.S. Study Completion Date

1276503-S01

nelsonlabs.com | sales(S>nelsonlabs.comks FRT0005-0001 Rev 6

Page 1 of 2

These results apply to the samples as received and relate only to the test artide listed in this report. Reports may not be reproduced except in their enUrety. Subjed to NL terms and conditions at www.nelsonlabs.com.

NelsonA Sotera Health

Labs.company

Study Number 1276503-801Latex Particle Challenge Final Report

Results:

Test Article Number | Average Test Article Counts | Average Control Counts | Filtration Efficiency (%)1

3

4

5

75

6

15

115

12,896

13,076

12,997

i-i:09613,351

Bf®-

99.42

99.962

99.951

99.14

801-290-7500 nelsonlabs.com sales@)nelsonlabs.com FRT0005-0001 Rev 6

Page 2 of 2

Synthetic Blood Penetration Resistance Final Report

Test Article: SURGICAL FACE MASKStudy Number: 1276504-S01

Study Received Date: 12 Mar 2020Testing Facility: Nelson Laboratories, LLC

6280 S. Redwood Rd.

Salt Lake City, UT 84123 U.S.A.Test Procedure(s): Standard Test Protocol (STP) Number: STP0012 Rev 09

Deviation{s): None

Summary: This procedure was performed to evaluate surgical facemasks and other types of protectiveclothing materials designed to protect against fluid penetration. The purpose of this procedure is tosimulate an arterial spray and evaluate the effectiveness of the test article in protecting the user frompossible exposure to blood and other body fluids. The distance from the target area surface to the tip ofthe cannula is 30.5 cm. A test volume of 2 mL of synthetic blood was employed using the targeting platemethod.

This test method was designed to comply with ASTM F1862 and ISO 22609 (as referenced inEN 14683:2019 and AS4381:2015) with the following exception: ISO 22609 requires testing to beperformed in an environment with a temperature of 21 ± 5°C and a relative humidity of 85 ± 10%. Instead,testing was performed at ambient conditions within one minute of removal from the environmentalchamber held at those parameters.


Numberof Test Articles Tested: 32

Number of Test Articles Passed: 29Test Side: Outside

Pre-Conditioning: Minimum of 4 hours at 21 ± 5°C and 85 ± 5% relative humidity (RH)Test Conditions: 21.7°C and 22% RH

James W. LuskinStudy Direct

" IWICWrACCREDITED

I, T6STINC LABORATORY

Study Completion Date

1276504-S011 i „ I 1 . _ hcb FRT0012.0002Rev13801-290-7500 | nelsonlabs.com j [email protected] 1 of 2

hese results apply to the samples as receiveO and relate only to the test artirde listed In this report. Reports may not he reproduced except In their entirety. Subject to NL terms and conditions at wvro.nelsonlabs com.

Nelson Labs.A Sotera Health company

Study Number 1276504-801Synthetic Blood Penetration Resistance Final Report

Results: Per ASTM F1862 and ISO 22609, an acceptable quality limit of 4.0% is met for a normal singlesampling plan when >29 of 32 test articles show passing results.

Test Pressure: 160 mmHg (21.3 kPa)

Test Article Number

1-11, 13-23, 25-28, 30-32

12, 24, 29

Synthetic Blood Penetration

None Seen

Yes

801-290-7500 | nelsonlabs.com [email protected] FRT0012-0002 Rev 13

Page 2 of 2

Viral Filtration Efficiency (VFE) Final Report

Test Article:


Testing Facility:


SURGICAL FACE MASK

1276506-S01

12 Mar 2020



Summary: The VFE test is performed to determine the filtration efficiency of test articles by comparingthe viral control counts upstream of the test article to the counts downstream. A suspension ofbacteriophage 0X174 was aerosolized using a nebulizer and delivered to the test artide at a constantflow rate and fixed air pressure. The challenge delivery was maintained at 1.1 - 3.3 x 10 plaque formingunits (PFU) with a mean particle size (MPS) of 3.0 pm ± 0.3 pm. The aerosol droplets were drawnthrough a six-stage, viable particle, Andersen sampler for collection. The VFE test procedure wasadapted from ASTM F2101.


Test Side:

Test Area:

VFE Flow Rate:

Conditioning Parameters:

Positive Control Average:Negative Monitor Count:

MPS:

Inside

~40 cm^28.3 Liters per minute (L/min)85 ± 5% relative humidity (RH) and 21 ± 5°C for a minimum of 4 hours1.8x 10'

<1 PFU

3.0 pm

PFU

Study Director

ACCREDITEO

TESTINC LASOAATOnV

"2-1 toiO

1276506-801


James W. Luskin Study Completion Date

dh FRT0007-0001 Rev 16

Page 1 of 2

9 results apply to the samples as received and relate only to the test artide listed In this report. Reports may not be reproduced except in their entirety. Subjed to NL terms and conditions at vwm.neisonlabs.com.

5/ Nelson Labs.A Sotera Health company

Study Number 1276506-801Viral Filtration Efficiency (VFE) Final Report

Results:

Test Article Number

1

2

3

4

5

Percent VFE (%)

>99.9®

>99.9

99.9

>99.9

>99.9®

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

The filtration efficiency percentages were calculated using the following equation:

C-T% VFE = —— X 100

C = Positive control average

T = Plate count total recovered downstream of the test articleNote: The plate count total is available upon request

801-290-7500 | nelsonlabs.com | [email protected] FRT0007-0001 Rev 16

Page 2 of 2

bacterial filtration efficiency (bfe) and differential

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