STATEMENT OF NO DATA CONFIDENTIALITY …r-water.com/docs/lab-reports/r-water-epa-glp-study.pdfStudy...

Study ID: GLP1014-A1 Client: R-Water, LLC Protocol Number: P1012

STUDY TITLESTUDY TITLESTUDY TITLESTUDY TITLEGLP AOAC Germicidal Spray Products Test

Study Identification NumberStudy Identification NumberStudy Identification NumberStudy Identification NumberGLP1014-A1

Protocol NumberProtocol NumberProtocol NumberProtocol NumberP1012

Product IdentityProduct IdentityProduct IdentityProduct IdentityTK60

Test MicroorganismsTest MicroorganismsTest MicroorganismsTest MicroorganismsStaphylococcus aureus ATCC 6538

Pseudomonas aeruginosa ATCC 15442

Data RequirementsData RequirementsData RequirementsData RequirementsU.S. EPA 40 CFR § 158

AuthorAuthorAuthorAuthorNicole Goulding, B.S.

Study Director

Study Completion DateStudy Completion DateStudy Completion DateStudy Completion Date10 DEC 2014

GLP1014-A1 Reported on 15 DEC 2015

Main Test FacilityMain Test FacilityMain Test FacilityMain Test FacilityMicrochem Laboratory 1107-C S. Airport Circle

Euless, TX 76040

Study SponsorStudy SponsorStudy SponsorStudy SponsorRayne GuestR-Water, LLC

2061 Clovis Barker Rd., Ste. 4-BSan Marcos, TX 78666

Page 1 of 29Microchem Laboratory • 16713 Picadilly Ct. • Round Rock, Texas 78664 • (512) 580-1342


STATEMENT OF NO DATA CONFIDENTIALITY CLAIMSSTATEMENT OF NO DATA CONFIDENTIALITY CLAIMSSTATEMENT OF NO DATA CONFIDENTIALITY CLAIMSSTATEMENT OF NO DATA CONFIDENTIALITY CLAIMS

No claim of confidentiality, on any basis whatsoever, is made for any information contained in this document. I acknowledge that information not designated as within the scope of FIFRA sec. 10(d)(1)(A), (B), or (C) and which pertains to a registered or previously registered pesticide is not entitled to confidential treatment and may be released to the public, subject to the provisions regarding disclosure to multinational entities under FIFRA 10(g).

Company: ___________________________________________

Agent/Submitter: ___________________________________________

Title: ___________________________________________

Date: ___________________________________________

Signature: ___________________________________________



GOOD LABORATORY PRACTICE COMPLIANCE STATEMENTGOOD LABORATORY PRACTICE COMPLIANCE STATEMENTGOOD LABORATORY PRACTICE COMPLIANCE STATEMENTGOOD LABORATORY PRACTICE COMPLIANCE STATEMENT

This study meets U.S. Environmental Protection Agency Good Laboratory Practice Standards and requirements for 40 CFR §160 with the following exception:

• Records concerning test substance characteristics (i.e. composition, purity, stability, strength,solubility) are maintained by the Study Sponsor.

Study DirectorStudy DirectorStudy DirectorStudy Director

Company: Microchem Laboratory

Name: Nicole Goulding, B.S.

Title: Study Director

Study SponsorStudy SponsorStudy SponsorStudy Sponsor

Company: R-Water, LLC

Name: Rayne Guest

Title: Study Director

Signature: _______________________________ Date: _____________________

SubmitterSubmitterSubmitterSubmitter

Company:

Name:

Title:

Signature: _______________________________ Date: _____________________


12/18/2015


QUALITY ASSURANCE STATEMENTQUALITY ASSURANCE STATEMENTQUALITY ASSURANCE STATEMENTQUALITY ASSURANCE STATEMENT

Study Title: GLP AOAC Germicidal Spray Products Test

Study ID#: GLP1014

The following quality assurance audits were conducted in accordance with Good Laboratory Practice Standards outlined in 40 CFR § 160 and reported to management and the Study Director:

Main Test FacilityMain Test FacilityMain Test FacilityMain Test Facility

Phase Inspected Date InspectedDate Reported toStudy Director

Date Reported toManagement

In Phase 07 NOV 2014 07 NOV 2014 20 NOV 2014Draft Report 19 NOV 2014 21 NOV 2014 21 NOV 2014Final Report 03 DEC 2014 04 DEC 2014 04 DEC 2014

Amended Final Report 14 DEC 2015 14 DEC 2015 15 DEC 2015

Quality Assurance Unit:

Note: Sarah Knight performed all quality assurance audits, other than amended final report audit.



PERSONNEL INVOLVED IN THE STUDYPERSONNEL INVOLVED IN THE STUDYPERSONNEL INVOLVED IN THE STUDYPERSONNEL INVOLVED IN THE STUDY

Study DirectorStudy DirectorStudy DirectorStudy DirectorName: Nicole Goulding, B.S.Company: Microchem Laboratory, LLCTitle: Study Director

Scientific DirectorScientific DirectorScientific DirectorScientific DirectorName: Benjamin Tanner, Ph.D.Company: Microchem Laboratory, LLCTitle: Scientific Director

Assisting PersonnelAssisting PersonnelAssisting PersonnelAssisting PersonnelName: Towanda Ebron, B.S.Company: Microchem Laboratory, LLCTitle: Technician

Name: Tucker Burke, B.S.Company: Microchem Laboratory, LLCTitle: Technician



TABLE OF CONTENTSTABLE OF CONTENTSTABLE OF CONTENTSTABLE OF CONTENTS

STUDY TITLE..................................................................................................................................1

STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS....................................................................2

GOOD LABORATORY PRACTICE COMPLIANCE STATEMENT...........................................................3

QUALITY ASSURANCE STATEMENT.................................................................................................4

PERSONNEL INVOLVED IN THE STUDY..........................................................................................5

TABLE OF CONTENTS...................................................................................................................6

FINAL STUDY REPORT SUMMARY...................................................................................................7

FINAL STUDY REPORT....................................................................................................................8

PROTOCOL CHANGES..................................................................................................................9

CONTROLS.................................................................................................................................10

STUDY ACCEPTANCE CRITERIA....................................................................................................12

CALCULATIONS AND STATISTICAL ANALYSIS...............................................................................13

STUDY RECORD AND TEST SUBSTANCE RETENTION....................................................................14

RESULTS......................................................................................................................................15

STUDY CONCLUSION.................................................................................................................18

REFERENCES...............................................................................................................................19

PROTOCOL.................................................................................................................................20

PROTOCOL AMENDMENT...........................................................................................................29



FINAL STUDY REPORT SUMMARYFINAL STUDY REPORT SUMMARYFINAL STUDY REPORT SUMMARYFINAL STUDY REPORT SUMMARY

Study TitleStudy TitleStudy TitleStudy TitleGLP AOAC Germicidal Spray Products Test

Study Identification NumberStudy Identification NumberStudy Identification NumberStudy Identification NumberGLP1014

Protocol NumberProtocol NumberProtocol NumberProtocol NumberP1012

Test MicroorganismsTest MicroorganismsTest MicroorganismsTest MicroorganismsStaphylococcus aureus ATCC 6538

Pseudomonas aeruginosa ATCC 15442

Study SponsorStudy SponsorStudy SponsorStudy SponsorRayne GuestR-Water, LLC

2061 Clovis Barker Rd., Ste. 4-BSan Marcos, TX 78666

Main Testing FacilityMain Testing FacilityMain Testing FacilityMain Testing FacilityMicrochem Laboratory1107-C S. Airport Circle

Euless, TX 76040

Study DirectorStudy DirectorStudy DirectorStudy DirectorNicole Goulding, B.S.

Study Completion DateStudy Completion DateStudy Completion DateStudy Completion Date10 DEC 2014

GLP1014-A1 reported on 15 DEC 2015

Study ObjectiveStudy ObjectiveStudy ObjectiveStudy ObjectiveTo determine, using the AOAC Germicidal Spray Products Test Method, the antimicrobial efficacy of three lots of TK60, prepared at approximately 200 ppm free available chlorine (FAC), against S. aureus ATCC 6538 and P. aeruginosa ATCC 15442 in the presence of a 5.0% artificial soil load.

Study ConclusionStudy ConclusionStudy ConclusionStudy ConclusionTK60 when prepared at approximately 200 ppm free available chlorine, met the protocol-specified disinfection success criteria when tested against S. aureus ATCC 6538 and P. aeruginosa ATCC 15442supplemented with a 5.0% artificial soil load at a 60 seconds contact time.



FINAL STUDY REPORTFINAL STUDY REPORTFINAL STUDY REPORTFINAL STUDY REPORT

Important DatesImportant DatesImportant DatesImportant DatesStudy Initiation Date: 07 NOV 2014Experimental Start Date: 07 NOV 2014Experimental End Date: 12 NOV 2014Study Completion Date: 10 DEC 2014Study Amended Date: 15 DEC 2015

Test Test Test Test SubstanceSubstanceSubstanceSubstance Information Information Information InformationTest Substance: TK60Lot Number(s): Batch1, 2, and 3Active Ingredient: Hypochlorite/Hypochlorous Acid (200 ppm FAC)Date Received: 07 NOV 2014Date of Manufacture: 06 NOV 2014Expiration Date(s): Not Provided by Study SponsorStorage Conditions: 5±5°CForm: Liquid

Test Parameters Test Parameters Test Parameters Test Parameters Test Systems (Microorganisms): Staphylococcus aureus ATCC 6538

Pseudomonas aeruginosa ATCC 15442Number of Daily Cultures: 1 Daily Culture Transferred Before Test CultureNumber of Test Carriers: 60 Carriers/Test Microorganism/Test Substance LotCarrier Type: Glass cover slips, 22x40 mmContact Time: 60±3 SecondsTest Temperature: Ambient temperatureNeutralization Broth: Dey Engley Medium (D/E)Organic Soil Load: 5% Bovine Calf SerumCarrier Dry Time: 40±2 MinutesCarrier Dry Temperature: 36±1°CIncubation Temperature: 36±1°CTest Culture Incubation Time: 48–54 Hours

Test MethodTest MethodTest MethodTest MethodThe test was conducted according to the attached protocol.



PROTOCOL CHANGESPROTOCOL CHANGESPROTOCOL CHANGESPROTOCOL CHANGES

Protocol Amendment(s)Protocol Amendment(s)Protocol Amendment(s)Protocol Amendment(s)

1. The protocol was amended on 11 DEC 2015 to change the name of the test substance from DS-200 to TK60. The Study Sponsor communicated that the test substance name was changed internally but that the formulation of the test substance was not altered in any way.

2. The protocol was amended on 11 DEC 2015 to change the name of the Study Director from Towanda Ebron to Nicole Goulding. Microchem Laboratory's Scientific Director and Test Facility Management Benjamin Tanner, Ph.D. assigned Nicole Goulding as the new Study Director to GLP1014 for the purposes of incorporating the revised test substance name.

Protocol Deviation(s)Protocol Deviation(s)Protocol Deviation(s)Protocol Deviation(s)

1. Phosphate Buffered Saline (PBS) was replaced with sterile Deionized water (DIW) as the dilution medium for the test culture and neutralization verification inoculum. This deviation is not thought to impact the study outcome since adequate carrier concentrations were recoveredfrom carrier enumerations and the neutralization verification inoculum was demonstrated to be between 10 and 100 CFU for each microorganism.

2. A deviation from the approved protocol occurred wherein inoculated and untreated test carriers selected to determine the number of microorganisms present on the carriers were vortexed from 30 seconds, rather than the 120±5 second vortexing prescribed in the approved protocol for S. aureus inoculated carriers, and the 60±5 second vortexing time prescribed in the approved protocol for P. aeruginosa inoculated carriers. Because adequate carrier concentrations were recovered from elutions of test carriers, it was thought that this deviation did not jeopardize the study outcome.



CONTROLSCONTROLSCONTROLSCONTROLS

Enumeration of Inoculated Test CarriersEnumeration of Inoculated Test CarriersEnumeration of Inoculated Test CarriersEnumeration of Inoculated Test CarriersFollowing the conclusion of the dry time, dried inoculated carriers were assayed in two sets of three; one set of three immediately prior to conducting the test, and one set immediately following the test. Each carrier was aseptically transferred individually to a sterile subculture/neutralization test tube. These test tubes were vortex mixed for 30±5 seconds. Within 2 hours of vortex mixing, each set of three test tubes (pre-test and post-test) was enumerated using standard dilution and plating techniques.

Viability ControlViability ControlViability ControlViability ControlTwo inoculated test carriers were placed in individual subculture/neutralization broth tubes and incubated alongside the test to confirm test system viability.

“Soil” Sterility ControlSoil” Sterility ControlSoil” Sterility ControlSoil” Sterility ControlAn aliquot of the test “soil” was plated using an appropriate growth agar to confirm sterility.

Neutralization ControlNeutralization ControlNeutralization ControlNeutralization ControlA sterile uninoculated carrier was treated with the test substance in accordance with efficacy testing. After the specified contact time had elapsed, the carrier was transferred, without allowing excess fluid to drain off of the carrier, to a sterile subculture/neutralization broth test tube. After transfer, the test tube was inoculated with 10-100 CFU of test microorganism (obtained by serial dilution in sterile deionized water) and incubated along with the other test tubes. The inoculum was plated in duplicate to verify the number of CFU added and incubated alongside the remainder of the test.

Subculture/Neutralization Sterility ControlSubculture/Neutralization Sterility ControlSubculture/Neutralization Sterility ControlSubculture/Neutralization Sterility ControlA test tube containing only the subculture/neutralization broth was incubated alongside the other test tubes to confirm sterility.

Carrier Sterility ControlCarrier Sterility ControlCarrier Sterility ControlCarrier Sterility ControlAn uninoculated carrier was transferred to a sterile test tube containing the subculture/neutralization broth to confirm carrier sterility.

Dilution Media Sterility ControlDilution Media Sterility ControlDilution Media Sterility ControlDilution Media Sterility ControlAliquots of sterile deionized water (DIW) and Dey Engley Medium (D/E) were plated using sterile growth medium and incubated alongside test tubes to verify sterility at the time of test.

Plating Media Sterility ControlPlating Media Sterility ControlPlating Media Sterility ControlPlating Media Sterility ControlA plate containing only growth medium was incubated alongside test tubes to verify sterility at the timeof test.



CONTROLS (cont.)CONTROLS (cont.)CONTROLS (cont.)CONTROLS (cont.)

Test Microorganism Purity ControlTest Microorganism Purity ControlTest Microorganism Purity ControlTest Microorganism Purity ControlA loopful of each test microorganism used in this study was subcultured to an appropriate growth agar medium and incubated alongside enumeration plates to morphologically confirm the presence of a pure culture at the time of test.



STUDY ACCEPTANCE CRITERIASTUDY ACCEPTANCE CRITERIASTUDY ACCEPTANCE CRITERIASTUDY ACCEPTANCE CRITERIA

The experimental success (controls) criteria follow:The experimental success (controls) criteria follow:The experimental success (controls) criteria follow:The experimental success (controls) criteria follow:1. The carrier enumeration must demonstrate a mean log10 density of at least 5.0

and not greater than 6.5 for both test microorganisms.2. The media sterility control test tube is negative for growth.3. Both of the viability growth control test tubes are positive for growth.4. The neutralization control subculture/neutralization test tube is positive for growth.5. The neutralization control inoculum demonstrates between approximately 10 and

100 CFU.6. The “soil” sterility control agar plates are negative for growth.7. The test microorganisms purity streaks show pure culture for growth.8. Additional media sterility controls are negative for growth.

The EPA performance criterion for disinfection follows:The EPA performance criterion for disinfection follows:The EPA performance criterion for disinfection follows:The EPA performance criterion for disinfection follows:1. The carrier enumeration must demonstrate a mean log10 density of at least 5.0

and not greater than 6.5 for both test microorganisms.2. Fifty-nine (59) out of 60 carriers are negative for growth of the test microorganism

for each lot of test substance within the specified contact time.

Retesting Guidance Retesting Guidance Retesting Guidance Retesting Guidance1. When a test passes and the log10 density of the test carriers is above 6.5, no

retesting is necessary.2. When a test fails and the log10 density of the test carriers is below 5.0, no retesting

is necessary.3. When a test fails and the log10 density of the test carriers is above 6.5, retesting is

necessary.



CALCULATIONS AND STATISTICAL ANALYSISCALCULATIONS AND STATISTICAL ANALYSISCALCULATIONS AND STATISTICAL ANALYSISCALCULATIONS AND STATISTICAL ANALYSIS

Test Carrier EnumerationTest Carrier EnumerationTest Carrier EnumerationTest Carrier Enumeration

CFU = (A)(B)

Where: A= number of colonies counted on pour plate (between 30-300) B= dilution factor of the pour plate with 30-300 colonies.

Log10 Density = Log10(CFU/Carrier)

Available Chlorine TitrationAvailable Chlorine TitrationAvailable Chlorine TitrationAvailable Chlorine Titration

mg/ml Free Available Chlorine (FAC) = (A+B)(N)(35.450) ml of sample

Where: A = ml of 0.01N sodium thiosulfate required for sample B = ml of 0.01N sodium thiosulfate required for blank sample (- or +) N = normality of sodium thiosulfate

To get ppm = (mg/ml)(1000)(D)

Where: D = dilution of sample



STUDY RECORD AND TEST SUBSTANCE RETENTIONSTUDY RECORD AND TEST SUBSTANCE RETENTIONSTUDY RECORD AND TEST SUBSTANCE RETENTIONSTUDY RECORD AND TEST SUBSTANCE RETENTION

Study Record RetentionStudy Record RetentionStudy Record RetentionStudy Record RetentionThe study report and corresponding data sheets will be held in the archives of Microchem Laboratory for at least 2 years after the date of the final report and then may be destroyed, unless used by the Study Sponsor in support of a label claim, in which case they will be returned to the Study Sponsor for archiving at Sponsor’s expense.

Test Substance RetentionTest Substance RetentionTest Substance RetentionTest Substance RetentionThe test substance may be returned to the Study Sponsor at Sponsor’s request and expense within 30 days of study completion. If the Study Sponsor does not request the sample, it may be destroyed 30 days after study completion.



RESULTSRESULTSRESULTSRESULTS


07 NOV 2014

Batch 1 202 ppm 202 ppm 3.76

Batch 2 199 ppm 198 ppm 3.73

Batch 3 199 ppm 198 ppm 3.81

10 NOV 2014

Batch 1 202 ppm 202 ppm 3.82

Batch 2 199 ppm 198 ppm 3.71

Batch 3 199 ppm 198 ppm 3.77

Table 3. Observation of Free Available Chlor ine Concentration of Received TK60 Table 3. Observation of Free Available Chlor ine Concentration of Received TK60 Table 3. Observation of Free Available Chlor ine Concentration of Received TK60 Table 3. Observation of Free Available Chlor ine Concentration of Received TK60 Test SubstanceTest SubstanceTest SubstanceTest Substance

Date of Date of Date of Date of Titrat ionTitrat ionTitrat ionTitrat ion

Test Test Test Test Substance Substance Substance Substance

LotLotLotLot

Free Available Free Available Free Available Free Available Chlor ine Chlor ine Chlor ine Chlor ine

Concentration Concentration Concentration Concentration Reported by Study Reported by Study Reported by Study Reported by Study

SponsorSponsorSponsorSponsor

Measured Free Measured Free Measured Free Measured Free Available Available Available Available Chlor ine Chlor ine Chlor ine Chlor ine

ConcentrationConcentrationConcentrationConcentration

pH pH pH pH MeasurementMeasurementMeasurementMeasurement

Batch 1

60 seconds

60 0

Batch 2 60 0

Batch 3 60 0

Table 1. TK60 Product Performance and Carr ier Enumeration Results from Testing Conducted on Table 1. TK60 Product Performance and Carr ier Enumeration Results from Testing Conducted on Table 1. TK60 Product Performance and Carr ier Enumeration Results from Testing Conducted on Table 1. TK60 Product Performance and Carr ier Enumeration Results from Testing Conducted on 07 NOV 201407 NOV 201407 NOV 201407 NOV 2014

Test Test Test Test MicroorganismMicroorganismMicroorganismMicroorganism

Test Test Test Test SubstanceSubstanceSubstanceSubstance

Contact Contact Contact Contact TimeTimeTimeTime

Pre-Test Carr ier Pre-Test Carr ier Pre-Test Carr ier Pre-Test Carr ier Enumeration Enumeration Enumeration Enumeration (CFU/Carrier)(CFU/Carrier)(CFU/Carrier)(CFU/Carrier)

Post-Test Post-Test Post-Test Post-Test Carr ier Carr ier Carr ier Carr ier

Enumeration Enumeration Enumeration Enumeration (CFU/Carrier)(CFU/Carrier)(CFU/Carrier)(CFU/Carrier)

Number of Number of Number of Number of Negative Negative Negative Negative Carr iersCarr iersCarr iersCarr iers

Number of Number of Number of Number of Confirmed Confirmed Confirmed Confirmed Positive Positive Positive Positive Carr iers Carr iers Carr iers Carr iers

S. aureusATCC 6538

2.55x106

(6.41 LD)2.26x106

(6.35 LD)

Batch 1

60 seconds

60 0

Batch 2 60 0

Batch 3 60 0

Table 2. TK60 Product Performance and Carr ier Enumeration Results f rom Testing Conducted on Table 2. TK60 Product Performance and Carr ier Enumeration Results f rom Testing Conducted on Table 2. TK60 Product Performance and Carr ier Enumeration Results f rom Testing Conducted on Table 2. TK60 Product Performance and Carr ier Enumeration Results f rom Testing Conducted on 10 NOV 201410 NOV 201410 NOV 201410 NOV 2014


Test Test Test Test SubstanceSubstanceSubstanceSubstance

Contact Contact Contact Contact TimeTimeTimeTime

Pre-Test Carr ier Pre-Test Carr ier Pre-Test Carr ier Pre-Test Carr ier Enumeration Enumeration Enumeration Enumeration (CFU/Carrier)(CFU/Carrier)(CFU/Carrier)(CFU/Carrier)

Post-Test Post-Test Post-Test Post-Test Carr ier Carr ier Carr ier Carr ier

Enumeration Enumeration Enumeration Enumeration (CFU/Carrier)(CFU/Carrier)(CFU/Carrier)(CFU/Carrier)

Number of Number of Number of Number of Negative Negative Negative Negative Carr iersCarr iersCarr iersCarr iers

Number of Number of Number of Number of Confirmed Confirmed Confirmed Confirmed Positive Positive Positive Positive Carr iers Carr iers Carr iers Carr iers

P. aeruginosaATCC 15442

2.48x106

(6.39 LD)2.34x106

(6.37 LD)


RESULTS (cont.)RESULTS (cont.)RESULTS (cont.)RESULTS (cont.)


Test CultureTest CultureTest CultureTest Culture Transfer Date / TimeTransfer Date / TimeTransfer Date / TimeTransfer Date / Time

04 NOV 2014 / 0915

Test Culture 05 NOV 2014 / 0915

Table 4. Test Culture Incubation Information for the Test Culture Used for Testing Conducted on Table 4. Test Culture Incubation Information for the Test Culture Used for Testing Conducted on Table 4. Test Culture Incubation Information for the Test Culture Used for Testing Conducted on Table 4. Test Culture Incubation Information for the Test Culture Used for Testing Conducted on 07 NOV 201407 NOV 201407 NOV 201407 NOV 2014


Incubat ion Incubat ion Incubat ion Incubat ion Temperature Temperature Temperature Temperature

RangeRangeRangeRange

Culture Culture Culture Culture Incubat ion Incubat ion Incubat ion Incubat ion

Time Time Time Time

S. aureus ATCC 6538

Initial Culture from Microbial Library Frozen Stock(Daily Transfer)

36±1°C

24 hours, 0 minutes

48 hours, 0 minutes

Test CultureTest CultureTest CultureTest Culture Transfer Date / TimeTransfer Date / TimeTransfer Date / TimeTransfer Date / Time

07 NOV 2014 / 0900

Test Culture 08 NOV 2014 / 0900

Table 5. Test Culture Incubation Information for the Test Culture Used for Testing Conducted on Table 5. Test Culture Incubation Information for the Test Culture Used for Testing Conducted on Table 5. Test Culture Incubation Information for the Test Culture Used for Testing Conducted on Table 5. Test Culture Incubation Information for the Test Culture Used for Testing Conducted on 10 NOV 201410 NOV 201410 NOV 201410 NOV 2014


Incubat ion Incubat ion Incubat ion Incubat ion Temperature Temperature Temperature Temperature


Culture Culture Culture Culture Incubat ion Incubat ion Incubat ion Incubat ion

Time Time Time Time


Initial Culture from Microbial Library Frozen Stock (Daily Transfer)

36±1°C

24 hours, 0 minutes

48 hours, 0 minutes

Table 6. Sterility Control for Test ing Conducted on 07 NOV 2014 and 10 NOV 2014Table 6. Sterility Control for Test ing Conducted on 07 NOV 2014 and 10 NOV 2014Table 6. Sterility Control for Test ing Conducted on 07 NOV 2014 and 10 NOV 2014Table 6. Sterility Control for Test ing Conducted on 07 NOV 2014 and 10 NOV 2014

Growth Growth No Growth No Growth No Growth No Growth Pure Growth

Neutralizat ion Neutralizat ion Neutralizat ion Neutralizat ion Verificat ion Verificat ion Verificat ion Verificat ion ControlControlControlControl

Tes t System Tes t System Tes t System Tes t System Viability Viability Viability Viability ControlControlControlControl

Neutralizat ion Neutralizat ion Neutralizat ion Neutralizat ion Broth SterilityBroth SterilityBroth SterilityBroth Sterility Plat ing Media Plat ing Media Plat ing Media Plat ing Media

Sterility ControlSterility ControlSterility ControlSterility ControlSoil Sterility Soil Sterility Soil Sterility Soil Sterility ControlControlControlControl

Dilut ion Media Dilut ion Media Dilut ion Media Dilut ion Media Sterility ControlSterility ControlSterility ControlSterility Control

Test System Test System Test System Test System Purity Streak Purity Streak Purity Streak Purity Streak

ControlControlControlControl


RESULTS (cont.)RESULTS (cont.)RESULTS (cont.)RESULTS (cont.)


Table 7. Neutralization Ver ification Control ResultsTable 7. Neutralization Ver ification Control ResultsTable 7. Neutralization Ver ification Control ResultsTable 7. Neutralization Ver ification Control Results

Test Substance LotTest Substance LotTest Substance LotTest Substance Lot

07 NOV 2014

Batch 1

82 CFU

Growth

Passed

Batch 2 Growth

Batch 3 Growth

10 NOV 2014

Batch 1

90.5 CFU

Growth

Batch 2 Growth

Batch 3 Growth


Date Testing Date Testing Date Testing Date Testing ConductedConductedConductedConducted

NV Inoculum NV Inoculum NV Inoculum NV Inoculum ConcentrationConcentrationConcentrationConcentration

Observation of Observation of Observation of Observation of Neutralization Neutralization Neutralization Neutralization Ver if ication Ver if ication Ver if ication Ver if ication Test TubeTest TubeTest TubeTest Tube

Neutralization Neutralization Neutralization Neutralization Ver if ication Ver if ication Ver if ication Ver if ication

Control ResultControl ResultControl ResultControl Result

S. aureus ATCC 6538


Test Mater ialsTest Mater ialsTest Mater ialsTest Mater ials

07 NOV 2014

10 NOV 2014

Table 8. Incubation of Testing Mater ials from Testing Conducted on 07 NOV 2014 and Table 8. Incubation of Testing Mater ials from Testing Conducted on 07 NOV 2014 and Table 8. Incubation of Testing Mater ials from Testing Conducted on 07 NOV 2014 and Table 8. Incubation of Testing Mater ials from Testing Conducted on 07 NOV 2014 and 10 NOV 201410 NOV 201410 NOV 201410 NOV 2014


Date Testing Date Testing Date Testing Date Testing ConductedConductedConductedConducted

Incubation Incubation Incubation Incubation Temperature Temperature Temperature Temperature


Incubation Incubation Incubation Incubation DurationDurationDurationDuration

S. aureus ATCC 6538

Neutralizer Tubes, Study Controls, and Enumeration Plates

36±1°C

48 hours, 0 minutes


Neutralizer Tubes, Study Controls, and Enumeration Plates

48 hours, 0 minutes


STUDY CONCLUSIONSTUDY CONCLUSIONSTUDY CONCLUSIONSTUDY CONCLUSION

The three lots of TK60 evlauated in this study passed the AOAC Germicidal Spray Products Test success criteria defined in the approved protocol when evaluated against S. aureus ATCC 6538 and P.aeruginosa ATCC 15442 supplemented with 5.0% artificial soil at a 60 second contact time.

The study was carried out in compliance with the approved Protocol Number P1012.



REFERENCESREFERENCESREFERENCESREFERENCES

1. "Association of Official Analytical Chemists, International." AOAC Official Method 961.02 Germicidal Spray Products as Disinfectants. Revised 2012. Official Methods of Analysis.



PROTOCOLPROTOCOLPROTOCOLPROTOCOL



PROTOCOL (cont.)PROTOCOL (cont.)PROTOCOL (cont.)PROTOCOL (cont.)
























PROTOCOL AMENDMENTPROTOCOL AMENDMENTPROTOCOL AMENDMENTPROTOCOL AMENDMENT


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