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Technical Summary: GFS BioProtectTM Hand Gel with Aloe Vera:
IntroductionAntiseptic Hand Rub or Hand Sanitizer: GFS BioProtectTM Hand Sanitizer gel with Aloe Vera is a unique antimicrobial technology that not only kills on contact, but also has persis-tent activity designed to help prevent healthcare associated infections in hospitals, clinics, and nursing homes. It is also useful in other industry segments where hand transmission of infectious diseases can occur. The core of the technology lies in a highly effective proprietary blend of quaternary amines in revolutionary film forming formulation that is highly effective in healthcare environments with specific issues of antibiotic resistant pathogens and frequent glove use is involved. The antimicrobial agents are compliant with FDA regulations and CDC guidelines for non-alcohol hand sanitizer products. Safe, water-based alcohol-free, it is faster acting and longer lasting than traditional hand sanitizers. As a proprietary antimicrobial blend it is unsurpassed in its ability to kill germs using a new technology with a unique chemo-electro-mechanical mode of action. GFS technology described above is available as a hand gel, foam or hospital grade disinfectant spray.
A. Efficacy Testing1. Rapid Broad Spectrum Kill
The GFS BioProtect TM hand sanitizer gel product offers rapid, broad-spectrum kill and persistence. Within 15 seconds, the product killed more than 99.99% FDA-specified organisms, included in Table 1. Shown in this table is time kill test data (Quantitative Suspension Test) as specified in FDA 1994 for the 25 Microbes listed in the OTC Topical Antimicrobial Drug Monograph as well as additional strains and species of public health significance. Test methods include ASTM 2315, European EN 1276 and EN 1040 for Bacteria as well as EN 1275 for Fungi.
Methods: The products were evaluated according to standard Time-Kill protocol and against 45 different microorganisms, listed in the section below, 25 of which are specified in the FDA Tentative Final Monograph. Each test product was evaluated at a 99% concentration, and the percent (%) and log reductions were determined following exposure times of 15,30, and 60 seconds. All agar-plating was performed in duplicate. A combination of clinical isolates and lab strains were used in the testing.
Neutralization studies of each test product were performed to ensure the neutralizing solution employed (Butterfield’s Phosphate Buffer solution with product neutralizers) was effective and non-toxic to each of the representative challenge species.
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1.Acinetobacter baumannii 15 sec >6.02(ATCC #19606) 5 (99.999%) 30 sec >6.02 (99.999%) 60 sec >6.02 (99.999%)-------------------------------------------------------------------------------------------------------------------2. Bacteroides fragilis 15 sec >6.03(ATCC #25285) 4 (99.999%) 30 sec >6.03 (99.999%) 60 sec >6.03 (99.999%)-------------------------------------------------------------------------------------------------------------------3. Haemophilus influenzae 15 sec >6.12(ATCC #33930) 5 (99.999%) 30 sec >6.12 (99.999%) 60 sec >6.12 (99.999%)-------------------------------------------------------------------------------------------------------------------4. Enterobacter aerogenes 15 sec >6.02(ATCC #13048) 5 (99.999%) 30 sec >6.02 (99.999%) 60 sec >6.02 (99.999%)-------------------------------------------------------------------------------------------------------------------5. Escherichia coli 15 sec >6.01(ATCC #11229) 3, 5 (99.999%) 30 sec >6.01 (99.999%) 60 sec >6.01 (99.999%)-------------------------------------------------------------------------------------------------------------------6. Escherichia coli 15 sec >6.58(ATCC #10536) 5 (99.999%) 30 sec >6.58 (99.999%) 60 sec >6.58 (99.999%)-------------------------------------------------------------------------------------------------------------------7. Escherichia coli 30 sec >5.0(ATCC #25922) 4 (99.999%) 60 sec >5.0 (99.999%)
Time Log 10 Microorganism (Seconds) % Reductions
Rapid Broad Spectrum Antimicrobial Activity:
Table 1: Time-Kill Testing Results: GFS BioProtect™ Hand Sanitizer gel withAloe Vera Meets or Exceeds Efficacy Standards in Applicable Regulations
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8. Escherichia coli 15 sec >4.0(O157:H7) 1 (99.999%)-------------------------------------------------------------------------------------------------------------------9. Klebsiella oxytoca 15 sec >6.03(ATCC #13182) 5 (99.999%) 30 sec >6.03 (99.999%) 60 sec >6.03 (99.999%)-------------------------------------------------------------------------------------------------------------------10. Klebsiella pneumoniae 15 sec >5.0(ATCC #51504) 4 (99.999%) 30 sec >5.0 (99.999%) 60 sec >5.0 (99.999%)-------------------------------------------------------------------------------------------------------------------11. Klebsiella pneumoniae 15 sec >6.04(ATCC #4352) 5 (99.999%) 30 sec >6.04 (99.999%) 60 sec >6.04 (99.999%)-------------------------------------------------------------------------------------------------------------------12. Pseudomonas aeruginosa 15 sec >6.58(ATCC #9027) 7 (99.999%) 30 sec >6.58 (99.999%) 60 sec >6.58 (99.999%)-------------------------------------------------------------------------------------------------------------------13. Pseudomonas aeruginosa 15 sec >6.23(ATCC #27853) 5 (99.999%) 30 sec >6.23 (99.999%) 60 sec >6.23 (99.999%)-------------------------------------------------------------------------------------------------------------------14. Pseudomonas aeruginosa 15 sec >5.0(ATCC #27853) 4 (99.999%) 30 sec >5.0 (99.999%) 60 sec >5.0 (99.999%)-------------------------------------------------------------------------------------------------------------------15. Pseudomonas aeruginosa 15 sec >5.0(ATCC #15442) 2, 3 (99.999%) 30 sec >5.0 (99.999%) 60 sec >5.0 (99.999%)--------------------------------------------------------------------------------------------------------------------------------------------------------------------
Table 1 (continued)
Time Log 10 Microorganism (Seconds) % Reductions
16. Proteus mirabilis 15 sec >6.12(ATCC #7002) 5 (99.999%) 30 sec >6.12 (99.999%) 60 sec >6.12 (99.999%)-------------------------------------------------------------------------------------------------------------------17. Serratia marcescens 15 sec >6.12(ATCC #14756) 5 (99.999%) 30 sec >6.12 (99.999%) 60 sec >6.12 (99.999%)-------------------------------------------------------------------------------------------------------------------18. Salmonella enferica 60 sec >5.0GFS-(ATCC #10398) 3 (99.999%)-------------------------------------------------------------------------------------------------------------------19. Salmonella typhimurium 1 15 sec >4.0 (99.999%)-------------------------------------------------------------------------------------------------------------------20. Staphylococcus aureus 15 sec >6.06(ATCC #6538) 3, 7 (99.999%) 30 sec >6.06 (99.999%) 60 sec >6.06 (99.999%)-------------------------------------------------------------------------------------------------------------------21. Staphylococcus aureus 15 sec >6.11(ATCC #29213) 4, 5 (99.999%) 30 sec >6.11 (99.999%) 60 sec >6.11 (99.999%)-------------------------------------------------------------------------------------------------------------------22_ Staphylococcus epidermidis 15 sec >6.22(ATCC #12228) 5 (99.999%) 30 sec >6.22 (99.999%) 60 sec >6.22 (99.999%)-------------------------------------------------------------------------------------------------------------------23. Staphylococcus hominis 15 sec >6.21(ATCC #27844) 5 (99.999%) 30 sec >6.21 (99.999%) 60 sec >6.21 (99.999%)-------------------------------------------------------------------------------------------------------------------24. Staphylococcus haemolyticus 15 sec >5.0(ATCC #43253) 4 (99.999%) 30 sec >5.0 (99.999%) 60 sec >5.0 (99.999%)-------------------------------------------------------------------------------------------------------------------25. Staphylococcus haemolyticus 15 sec >6.12(ATCC #29970) 5 (99.999%) 30 sec >6.12 (99.999%) 60 sec >6.12 (99.999%)
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Table 1 (continued)
Time Log 10 Microorganism (Seconds) % Reductions
26. staphylococcus saprophyticus 15 sec >6.11(ATCC #35552) 5 (99.999%) 30 sec >6.11 (99.999%) 60 sec >6.11 (99.999%)-------------------------------------------------------------------------------------------------------------------27. Micrococcus luteus 15 sec >6.22(ATCC #7468) 5 (99.999%) 30 sec >6.22 (99.999%) 60 sec >6.22 (99.999%)-------------------------------------------------------------------------------------------------------------------28. Streptococcus pyogenes 15 sec >6.03(ATCC #19615) 3. 7 (99.999%) 30 sec >6.03 (99.999%) 60 sec >6.03 (99.999%)-------------------------------------------------------------------------------------------------------------------29. Enterococcus faecalis 15 sec >6.01(ATCC #29212) 5 (99.999%) 30 sec >6.01 (99.999%) 60 sec >6.01 (99.999%)-------------------------------------------------------------------------------------------------------------------30. Enterococcus hirae 15 sec >6.56(ATCC #6057) 7 (99.999%) 30 sec >6.56 (99.999%) 60 sec >6.56 (99.999%)-------------------------------------------------------------------------------------------------------------------31. Streptococcus pneumoniae 15 sec >6.06(ATCC #8043) 5 (99.999%) 30 sec >6.06 (99.999%) 60 sec >6.06 (99.999%)-------------------------------------------------------------------------------------------------------------------32. Candida albicans 15 sec >5.22(ATCC #10231) 6 (99.999%) 30 sec >5.22 (99.999%) 60 sec >5.22 (99.999%)-------------------------------------------------------------------------------------------------------------------33. Aspergillus niger 15 sec >5.04(A TCC# 16404) 6 (99.999%) 30 sec >5.04 (99.999%) 60 sec >5.04 (99.999%)
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Table 1 (continued)
Time Log 10 Microorganism (Seconds) % Reductions
2. Healthcare Hand Rub Efficacy Testing (EN 1500)EN 1500 testing is used as the European standard method for qualifying hand rubsthat are to be used in healthcare settings. 20 test subjects are used in each test groupand performance of test product is compared to a standard reference alcohol rub, inthis case Propan-2-o. 60% (v/v) as per test method was used. Hands were contaminated with 2 x 10 8 of Escherichia coli strain # K 13 NCTC 10538. For bothreference alcohol and test product 6 mL applied -3.0 ml for 30 seconds, a further3.0 mL for another 30 seconds totaling 60 seconds rubbing time and hands aresampled and compared to control inoculum levels. To be EN 1500 compliant testproduct must surpass reference alcohol by a convincing margin or via statisticalanalysis of results. Data from this testing is presented in Table 2 below.
Table 2: GFS BioProtect™ Hand Sanitizer with Aloe Vera antimicrobial activity on hands using BS EN 1500:2013 Test Method (EN 1500 Compliant)
3. Long Term Sustained Activity when Neededa. GFS BioProtectTM Hand Sanitizer with Aloe Vera: Sustained kill against Gram-Positive & Gram-negative bacteria when not removed from the skin.
As shown in Figure 1 (with data in Table 3), in an ex-vivo test using a pigskin model(using ASTM E2897-12 & ASTM WK36911), GFS BioProtect™ Hand Sanitizer gelwith Aloe Vera was applied to the skin. After the specified amount of time, the skinsamples were challenged with S. aureus (ATCC #12600)9. From the data presentedin Table 3, GFS AV killed more than 98% of both the gram-positive and gram-negativeantibiotic resistant bacteria introduced at 1 hour after application, and around 90% at4 hours. Activity against all three antibiotic resistant strains MRSA, VRE and CRE isconsistent with testing on S. aureus that showed continued killing even after 24 hoursafter application. GFS BioProtect™ Hand Sanitizer gel with Aloe Vera testing wasconducted at an independent laboratory, Eurofins Microbiology Laboratory in Lancaster, PA.
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Healthcare Hand Reference BioProtect TM
Rub Testing 8 Alcohol Hand Sanitizer w/Aloe
Pre Log 10 Inoculum Values (SD) 6.43 (0.51) 6.58 (0.46)Post Treatment 10 Values (SD) 2.55 (0.21) 2.37 (0.22) Log 10 Reduction Values 3.89 4.22
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34. Methicillin-Resistant S.aureus (MRSA: ATCC #33592) 10
35. Vaneomycin-ResistantEnterococcus (VRE; ATCC#51575) 10
36. Carbapenem-ResistantEnterobacteriaceae(CRE; Klebsiella pneumoniaeA TCC #BAA-1705) 10
37. Staphylococcus aureus(ATCC #12600) 9
Data presented in Figure 1 above
GFS BioProtect AV Time Post % Reduction Hand Rub (Log 10 Reduction) 2 min. >99.9 (>3.0) 1 hr. 99.2 (2.1) 2 hr. 97.4 (1.6) 4 hr. 95.2 (1.3) 2 min. >99.9 (>3.0) 1 hr. 99.4 (2.2) 2 hr. 98.1 (1.7) 4 hr. 90.9 (1.0) 2 min. 99.6 (2.4) 1 hr. 98.3 (1.8) 2 hr. 93.0 (1.2) 4 hrs. 87.9 (0.9) 2 min. >99.9 (3.2) 1 hr. 99.0 (2.0) 2 hr. 98.3 (1.8) 4 hr. 96.9 (1.5) 8 hr. 84.9 (0.8) 16 hr. 79.5 (0.7) 24 hr. 54.1 (0.3)
Figure 1. GFS BioProtectTM Sustained Kill Shown up to 24 Hours 9
b. Sustained Activity of GFS BioProtectTM Hand Sanitizer Gel with Aloe Vera (AV) Against Antibiotic Resistant Strains
Table 3. Persistent Activity as an Adjunct to Frequent Hand Hygiene
Time Period Post Skin Treatment w/GFS BioProtect AV
100
80
60
40
20
02 min.
% R
educ
tion
1 hr.. 2 hr. 4 hr. 8 hr. 16 hr. 24 hr.
Microorganism
ATCC 1st Inoculum 2nd Inoculum Strain Counts (28 day Counts (28 day # duration) duration) 11229 2x10 6 3x10 6
4352 2x10 6 5x10 6
15442 2x10 6 5x10 6
6538 2x10 6 3x10 6
10231 2x10 6 5x10 6
25416 2x10 6 6x10 6
6051 2x10 6 5x10 6
1015 2x10 6 5x10 6
10466 2x10 6 1x10 6
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c. Sustained Activity of GFS BioProtectTM AV on Hands and when Gloves are Worn (ASTM E1115)11
To access persistent activity on hands when used in clinical settings incorporatingperiods of glove use, ASTM Test method E 1115-11 was used with 20 humanvolunteers. This method is typically used to evaluate surgical hand scrub formulations.When tested in accordance with ASTM E1115-11, GFS BioProtectTM Hand SanitizerGel with Aloe Vera possesses Immediate Activity and Persistent Activity. Immediateactivity results demonstrated that bacterial reduction of hand flora after using theproduct was greater than a 5.8 Log10 reduction factor. Persistent activity suppressingregrowth of skin bacteria was shown to be in the same order of magnitude (5.8 Log10)at 3 hours and 6 hours post treatment. Even at 12 hours after product application withhands kept occluded within surgical gloves, only a minimal lowering of antibacterialactivity (suppression of growth) was observed. Persistent activity at 3 and 6 hours was> 99.999 % (>5 Log10) while geometric mean persistent antibacterial reduction valueat 12 hours was seen to be 99.99% (4.0 Log10). This is consistent with data obtainedin the ex-vivo studies demonstrating 24-hour activity and persistent activity againstantibiotic resistant strains.
4. Challenge Testing as Further Proof of Wide Spectrum Activity12
Challenge testing of products regulated by FDA as over-the-counter antimicrobialdrugs is the ultimate test of effectiveness of individual formulations as here instead ofjust killing germs on hands or in suspension tests, multiple high count inoculation andlong term incubation is used. Thus both biocidal (bacteriacidal and fungicidal) activityand preservative effectiveness is determined. Table 4 provides results of testing inaccordance with ASTM E640-06 (Reapproved 2012). As a variation of this a widerange of microbial strains and types were selected. As shown in Table 4, GFSBioProtectTM Hand Sanitizer Gel with Aloe Vera possesses bactericidal and fungicidalreduction of microbial species in double challenge testing and thus satisfies therequirements of the test standard ASTM E640-06(2012)12.
Micromorganism 5. Escherichia coli 11. Klebsiella pneumoniae 15. Pseudomonas aeruginosa 20. Staphylococcus aureus 32. Candida albicans 38. Burkholderia cepacia capacia 39. Bacillus subtilis 40. Aspergillus niger 41. Penicillium luteum
Table 4. Efficacy Testing as per ASTM E640-12 a Double 28 Day Challenge12
5. Antiviral Activitya. Norovirus Ex-Vivo Testing of GFS BioProtectTM AV Hand Gel
Norovirus is the leading cause of gastroenteritis, causing diarrhea, vomiting, andsevere abdominal pain. Alcohol sanitizers have been shown to be somewhat ineffectiveagainst the Norovirus. In an ex-vivo test using porcine skin (using ASTM E2897-12 &ASTM WK36911) against a Norovirus surrogate, murine norovirus 1 (MNV-1), GFSBioProtect TM AV hand sanitizer was demonstrated to reduce the Norovirus by 2.0 log 10
(99 %) during the time required for the gel to dry on porcine skin (1-2 minutes) 13, 14.
b. GFS BioProtectm Hand Sanitizer Gel Demonstrated Effective Against other Viruses 15
GFS BioProtect Alcohol hand sanitizer gel can be declared as virucidal againstRhinovirus cause of the common cold (ATCC VR-482), Influenza virus (ATCC VR-17 41) and Enterovirus 71 (Hand: Foot & Mouth Disease Virus). GFS BioProtect HandSanitizer Gel with Aloe Vera demonstrated effectiveness as dilute 80% solutionsagainst Rhinovirus (common cold), Influenza virus and Enterovirus 71 a cause ofHand, Foot & Mouth Disease (ATCC VR-1775) using BS EN 14476:205 with anexpected 4 Log10 reduction after a contact time of 60 minutes. Testing demonstratedactivity meant to establish the 4 Log 10 benchmark allowing the disinfectant virucidalclaim to be made. It should be noted that formulas of hand sanitizer using the sameactive ingredients (at similar concentrations) as in GFS BioProtectTM products havebeen shown to be effective against numerous virus family groups including the HumanCoronavirus family 16. For a full list of viruses that GFS BioProtectTM AV activeingredients have been shown to be active against, please contact GFS US.
B. Clinical Trials1. Hospital Associated Infection Rates - Clinical Trail 17
To test product practical value in healthcare a pilot clinical study was conducted overan 8-day period, in surgical and orthopedic wards of a US hospital. Microbial surveysof healthcare workers hands (~40) were obtained with 624 microbial cultures takenrandomly for 4 days using standard alcohol hand sanitizer and for 4 days using GFSBioProtectTM Hand Sanitizer Gel with Aloe Vera (GFS AV). The use of GFS AV wasdemonstrated to reduce the frequency of commonly identified opportunistic pathogensresponsible for hospital-associated infections on hands for each ward by around 50%when compared to standard alcohol hand sanitizer use. This efficacy is a direct resultof the persistent activity demonstrated in testing described earlier.
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C. Lack of Skin Irritation-Safe for Repeated ApplicationThe active ingredient of GFS BioProtect™ Hand Sanitizer Gel with Aloe Vera,Benzalkonium Chloride is a mixture of alkylbenzyldimethylammonium chlorides withthe following chain lengths 50% C12, 30% C14, 17% C16, 3% C18 18. The ingredientis used in cosmetic products as a foaming cleansing and bactericidal agent atconcentrations up to 5.0%. The compound was found to be non-mutagenic in severaldifferent cell assays. It has been found to be an ocular irritant at concentrations greaterthan 0.1%. This cosmetic ingredient is not a sensitizer to normal humans atconcentrations of 0.1 %, but may be to individuals with diseased skin. It is concludedthat Benzalkonium Chloride can be safely used as an antimicrobial agent atconcentrations up to 0.1% 18. Benzalkonium chloride (0.1.1 %-0. 13%) is generallyrecognized as safe (GRAS) and effective by the US FDA for use in topically appliedanti-bacterial products such as hand sanitizers.
At time of formula creation every precaution was taken to develop a product that didnot irritate the skin with repeated use. Qualified skin care product experts reviewedevery aspect of the formulation. Now with several years successfully manufacturingand distributing these products in the US, Australia and New Zealand, a clinical trial ina healthcare facility, low irritation potential of GFS BioProtect alcohol-free HandSanitizer with Aloe Vera is well established for both gel and liquid products. The GFShospital trial also demonstrated skin compatibility in a well-monitored population ofhealthcare professionals. Numerous school trials of similar hand sanitizer formulatedwith the same active ingredient, benzalkonium chloride, have shown skin compatibilitywhere hand and skin monitoring clearly demonstrated this to be a positiveendpoint. The various production runs of the product represent positive experiencesby 70,000 to 90,000 individuals using these products in a wide variety of settings fromhouseholds, schools and healthcare to prisons 18.
D. Glove CompatibilityNumerous Benzalkonium Chloride based hand sanitize formulations are advertised asideal for environments where a non-alcohol hand sanitizer is required and compatiblewith vinyl, nitrile and latex gloves 18.
E. Product RegistrationsThe GFS BioProtect™ hand sanitizer gel with Aloe Vera has been registered with theUS National Library of Medicine18 and with the New Zealand Ministry of Agricultureand Forestry for use in government regulated facilities processing animal products 18.The GFS BioProtect Hand Sanitizer with Aloe Vera liquid solution is registered withthe Canadian Food Inspection Agency for use for hand sanitizer applications ingovernment regulated facilities processing food products 18.
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References:
1. Stainback L. 2011. BioProtectTM Hand Sanitizer Evaluation. Unpublished Report-Triad Forensics Independent Services Laboratory (Winston-Salem, North Carolina, USA) test report dated 2-24-2011.
2. Rex A. 2010. Suspension Time-Kill Study Report- GFS Hand Sanitizer Aloe Vera Gel. Unpublished Antimicrobial Test Laboratories (Round Rock, Texas, USA) test report dated 8-23-2010.
3. Drabble D. 2012. Effect of Hand Sanitizer on Selected Organisms- Report. Unpublished Marble Laboratories LLC. (Winston-Salem, North Carolina, USA) test report TP015 dated 10-14-2012.
4. Drabble D. 2013. Effects of GFS BioProtect™ Hand Sanitizer Aloe Vera on Selected Organisms- Report. Unpublished Marble laboratories LLC. (Winston-Salem, North Carolina, USA) test report TP021 dated 6-2-2013.
5. Walsh T. 2014. Testing of 3 GFS BioProtect™ Alcohol Hand Sanitizer Gel, Hand Sanitizer Gel with Aloe and Hand Sanitizer Liquid with Aloe using Test method BS EN 1040:2005 a Time/Kill Suspension test. CNT Laboratories Testing and Certification Ltd. (Guangzhou, China), Test Report Nos. CNT14011201013, CNT14011201014, & CNT14011201015, dated 1-20-2014.
6. Walsh T. 2013. Testing of 3 GFS BioProtect™ Alcohol Hand Sanitizer Gel, Hand Sanitizer Gel with Aloe and Hand Sanitizer Liquid with Aloe using Test method BS EN 1275:2005. Time/Kill Suspension test - Fungi. CNT Laboratories Testing and Certification Ltd. (Guangzhou, China), Test Report Nos. CNT13011211034, CNT13011211036, & CNT13011211037 dated 1-25-2013.
7. Walsh T. 2013. Testing of 3 GFS BioProtect Alcohol Hand Sanitizer Gel, Hand Sanitizer Gel with Aloe and Hand Sanitizer Liquid with Aloe using Test method BS EN 1276:2005. Time/Kill Suspension test-Bacteria under clean & dirty conditions. CNT Labs Testing and Certification Ltd. (Guangzhou, China), Test Report Nos. CNT1311251042, CNT1311251043, & CNT1311251044, dated 1-25-2013.
8. Adenaver J, Walsh T. 2014. GFS BioProtectTM Hand Sanitizer Gel with Aloe Vera BS EN 1500:2013 Testing. CNT labs Testing and Certification Ltd. (Guangzhou, China), Test Report No. CNT1401271184.
9. Centrella W, Marshall D. 2014. Persistence of Activity (<24 hrs) of Hand Sanitizers against Staphylococcus aureus using ASTM E2897 -12 & ASTM WK36911 porcine skin test methods (2-17 -14). Eurofins Microbiology Laboratories, Inc. Lancaster, PA.
10. Centrella W, Marshall D. 2014. Persistence of Activity of Hand Sanitizers against Antibiotic Resistant Microorganisms using ASTM E2897-12 & ASTfvl WK36911 porcine skin test methods (2-17-14). Eurofins Microbiology Laboratories, Inc. Lancaster, PA.
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11. Adenaver J, Walsh T. 2014. GFS BioProtect™ Hand Sanitizer Gel with Aloe Vera ASTM E1115-11 Standard Test Method for Evaluation of Surgical Hand Scrub Formulations. CNT Labs Testing and Certification Ltd. (Guangzhou, China}, Test Report No. CNT1401241112 (1-28-2014).
12. Adenaver J, Walsh T. 2014. GFS BioProtect™ Hand Sanitizer Gel with Aloe Vera Tested using ASTM E640-06(2012) Standard Test Method for Preservatives in Water-Containing Cosmetics (Bactericidal Reduction & Peservative Adequacy-Challenge Testing. CNT Labs Testing and Certification Ltd. (Guangzhou, China). Test Report No. CNT1401241116 (1-27-2014).
13. Drabble D. 2013. Effect of GFS BioProtect™ Hand Sanitizer on Murine Norovirus 1 (MNV-1) on Porcine Skin. Unpublished Marble Laboratories LLC. (Winston-Salem, North Carolina, USA) test report TP016.1 dated 5-7-2013.
14. Michaels B. 2013. Norovirus Efficacy Report based on Marble Labs Test Report TP016.1 (Issued Sept 5, 2013).
15. Adenaver J, Walsh T. 2014. GFS BioProtect™ Hand Sanitizer Gel with Aloe Vera BS EN 14476:205 Virucidal quantitative suspension test for human medicine. CNT Labs Testing and Certification Ltd. (Guangzhou, China), Test Report No. CNT1402281220.
16. Saknimit M, lnatsuki I, Sugiyama Y, Yagami K. Virucidal efficacy of physicochemical treatments against coronaviruses and parvoviruses of laboratory animals. Jikken Dobutsu. 1988;37:341-5.
17. Anon. 2013. A Comparison Study Showing the Effectiveness of GFS BioProtect™ vs. a Leading Alcohol-based Hand Sanitizer. Unpublished report.
18. Michaels B. 2014. Dermal Compatibility: GFS BioProtect™ Hand Sanitizer with Aloe Vera. (Report on File).
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