Medi9 Technical Data - UD Jan 15

Medi9

T e c h n i c a l R e p o r t

Nin

e G

ro

up

In

te

rn

atio

na

l

What is Medi9?

Medi9 is a new biocide technology. It combines conventional biocides with a polymer backbone to produce a

highly effective, food safe, non toxic, non tainting product that can be used to sanitise both skin and surfaces

around the home, factory, gym, car and office. It can also be used to clean and sanitise machinery. Is highly

effective in clinical and non-clinical environments.

What is different about Medi9?

For biocides to work effectively against microorganisms they must be found in a product above a level known as

the minimum inhibitory concentration (MIC). For example the MIC of Sodium Hypochlorite (bleach) is around

2500mg/L. The polymer technology used in Medi9 means that the mixture of biocides in the product can be at

concentrations below their individual MIC yet still produce an effective biocidal product.

Many biocides when used on their own are extremely toxic to humans and there are many health and safety issues

to consider, especially when dealing with the higher end disinfectants. Medi9 is classified as Non Hazardous due

to the relatively low amounts of these biocides. Therefore Medi9 is a safer product.

How Does Medi9 Work?

Medi9 is not a biocidal chemical. It is a biocide technology. It could be said that the whole is greater than the sum

of its parts. This is due to the synergy between the Polymer and the biocides attached to it. The polymer effectively

coats the surface it is applied to and spreads. It not only coats the surfaces in need of cleaning but anything that

is adhered to it including the microorganisms.

Bacteria, when left to colonise a surface, form what is known as a biofilm. This is made up of the millions of

bacteria within the colony plus their secretions. This film means that the bacterial colony has produced its own

habitat in which it can control the amounts of oxygen, nutrients and other factors which the bacteria needs to

metabolise. Medi9 coats this biofilm and stops reproduction in the colony. As the colony becomes older it

becomes more susceptible to biocides and at this point the biocide in Medi9 can enter the cell and destroy it.

This mode of action means that Medi9 is also effective against spores. By coating the bacteria in its spore state it

stops the spore from germinating and the changing from an endospore to a vegetative cell

Medi9 has a cumulative and residual effect. The polymer coating leaves a monomolecular layer that will work for

a time after the initial application; it also combats redeposition of soil and the formation of biofilms. This means

that over time the incidences of reinfection will reduce.

What is Medi9 effective against?

Medi9 has been tested to a number of European Standards:

EN1276 Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants.

EN13704 Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants.

EN1650 Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants.

EN1500 Hygienic Hand Rub Standard Test

Medi9 has also been tested for virucidal activity. This test involved applying Medi9 to a Surface onto which a

known number of viral phages had been inoculated. This simulated the cleaning of a surface with a wipe for

example.

These tests asses Medi9 against of number of bacterial and fungal strains to see if the product has the broad-

spectrum antibacterial capability that is needed for a disinfectant /sanitiser in modern health care and food

production areas. These tests are not exhaustive and we will be constantly testing Medi9 against other bacterial

strains to give concrete proof to our claims.

Medi9 has been tested against the following bacteria:

Bacteria tested to EN1276:

Pseudomonas aeruginosa

E.coli

Enterococcus Hirae

Staphylococcus aureus

Staphylococcus aurues (methicillin resistant strain) MRSA

These include both gam negative and gam positive organisms. E.coli and Enterococcus Hirae are Enterobacteria

that are found in the gut and in areas of faecal contamination. Pseudomonas and Staphylococcus are opportunistic

pathogens that colonise skin and wound sites, Pseudomonas are also found in water.

Bacteria

gram –ve/+ve

Associated Infection

Staphylococcus

Positive

Impetigo, skin and wound Infections

Psuedomonas

Negative

Wound Infection, abscesses, UTI, conjunctivitis

E.coli

Negative

Urinary tract infections, wound infection, Sickness Diarrhoea

Enterobacter

Negative

Bactereamia, UTI, sickness & Diarrhoea

Listeria

Negative

Enteric Infection, Septicaemia

Legionella

Negative

Legionnaires disease, Pontiac fever

Salmonella

Negative

Gastroenteritis


Bacillus subtilis

Geobacillus stearothermophillus

Clostridium difficile Clostridium difficile

All of these bacteria are spore formers. This means that should the environmental conditions not be right for the

bacteria to grow e.g. low nutrients. They form an endospore and enter a dormant state. These endospores are

very difficult to remove without the use of very toxic chemicals and high temperatures. Some spores have been

germinated after nearly 100000 years in their dormant state.

Bacteria

gram –ve/+ve


Bacillus (spp)

Positive

Septicaemia, food poisoning,

Clostridium

Positive

Diarrhoea, Tetanus, Botulism

Aspergillus niger Candida albicans

Bacteria

Gram –ve/+ve


Aspergillus

N/A

Wound infection, Aspergillosis, Respiratory infections

Candida

N/A

Thrush, skin infections, dermatitis


Aspergillus niger

Candida albicans

Aspergillus niger is an environmental mould

Candida albicans is a yeast.

Norovirus

SARS

Virus

Enveloped / Non-enveloped

Associated infection

Norovirus

Non-enveloped

Winter vomiting sickness

SARS

Enveloped

Severe acute respiratory Syndrome

Hepatitis A-E

Non enveloped

Liver Damage

HIV

Enveloped

Human Immunodeficiency virus, AIDS

Influenza type A

Enveloped

Bird Flu

Medi9 has been tested against viruses:

Norovirus is a non-enveloped virus, this means that is consists

of single or double stranded DNA or RNA, and it does not have

a protein coat. These types of virus are quite stable within the

environment and therefore harder to destroy than the enveloped

type of virus.

SARS is an enveloped virus. This means that its DNA is

encapsulated within a lipid membrane. These types of virus are

not a hardy as the non-enveloped viruses as the protein coat

can be affected quite readily rendering the virus useless.

Medi9 product range and potential markets?

Medi9 can be used in many different areas. With its broad spectrum of antibacterial properties it provides an

answer to many questions that may be asked by customers and infection control specialists interested in cleansing

and sanitising their products and workspace.

The table detailed below shows a range of products, uses and potential industries for Medi9.

Product

Use

Industry

Medi9 Antibacterial Hand Foam

Cleansing and sanitising hands

Healthcare, Food

Medi9 Waterless Hand Sanitiser

Cleansing and sanitising hands

Healthcare, Food

Medi9 Cleansing Sanitiser Spray

Cleansing and sanitising hard surfaces

Healthcare, Food, Defence

Medi9 Sanitising Solution

For use through Sanitising System for vehicles and rooms

Healthcare, Food, Defence

Medi9 Medical Device Wipes

For medical equipment and technical devices

Healthcare, Defence

Medi9 Sanitising Wipes

Hard surfaces, gym equipment, scientific apparatus

Healthcare, Food, Leisure, Care

The virucidal properties of Medi9 mean that Medi9 can be supplied to the cruise industry, residential schools and

care homes where Norovirus is particularly prevalent.

The anti redeposition element of Medi9 means that the areas cleaned appear cleaner for longer.

In certain markets such as care homes it is possible for the Medi9 range to be a one stop cleaning shop offering

hand wash, cleansers, sanitisers and wipes.

Further information is available from:-

www.medi9.com

Tel: 0845 643 9109

Email: [email protected]

http://www.medi9.com/




Medi9 Independent

Test Data


Quantitative suspension test for the evaluation of bactericidal activity of

chemical disinfectants and antiseptics

used in food, industrial, domestic and

institutional areas

Nine Group International Medi9 Solution

EN 1276 June 1997

1.0 Aim

The aim of the test is to evaluate the bactericidal activity of the Medi9 Solution received from Nine Group International.

2.0 Media and Materials

• Tryptone soya agar

• Tryptone soya broth

• Tryptone sodium chloride solution

• Neutralising solution

• Sterile water

• Bovine albumin solution

• Incubator 37oC

• Water bath 20oC

• Stopwatch

• Vortex mixer

• Variable pipette and sterile tips

• 90mm triple vent petri dishes

3.0 Test Organisms

Pseudomonas aeruginosa ATCC 15442

Escherichia coli ATCC 10536

Staphylococcus aureus ATCC 6538

Enterococcus hirae ATCC 10541

Staphylococcus aureus NCTC 12493 MRSA

Salmonella butantan NCTC 7831

Listeria Monocytogenes NCTC 11994

The test organisms were kept frozen using Pro-lab micro bank beads. One bead was taken and used to inoculate a 10ml

universal of TSB. The universals were then incubated at 37oC for 24 hours. Serial dilutions of each organism were then

performed using Tryptone Sodium Chloride Solution to give inoculum levels of approximately

1.5 x108- 3.0 x108.

4.0 Test Method

The selected conditions for the tests were:

Temperature: 20oC

Contact Time: 1min and 5min

Interfering Substance: Bovine Albumin Solution (3g/l) to simulate dirty conditions.

Product concentrations: Neat, 1/25, 1/250

1ml of interfering substance was added to 1ml of bacterial test suspension (Approximately x108) and placed in a water

bath at 20oC for 2 minutes. At the end of this time 8ml of the product test solution was added and placed in the water

bath for a further 1 minute. After a contact time of 1 minute and 5 minutes, a 1ml aliquot was pipetted into 8ml

neutraliser and 1ml of water. 1 ml of this mixture was then plated in duplicate into a petri dish and poured with 12-15mls

of Tryptone Soya Agar. This step was repeated using all product concentrations and test organism strains.

Test Organism Inoculum Level Cfu/ml Recovery After 1 minute

Pseudomonas aeruginosa ATCC 15442 2.6x108 <1.5x102

Escherichia coli ATCC 10536 2.2x108 <1.5x102

Staphylococcus aureus ATCC 6538 2.6x108 <1.5x102

Enterococcus hirae ATCC 10541 2.4x108 <1.5x102

Salmonella butantan NCTC 7831 2.9x108 <1.5x102

Listeria monocytogenes 2.6x108 <1.5x102

Staphylococcus aureus NCTC 12493 MRSA 2.8x108 <1.5x102

5.0 Conclusion

The results indicate that the Medi9 liquid has the required bactericidal effect on the test organisms used under the agreed

test conditions, contact times and temperatures. The Medi9 solution produces at least a 105 reduction in numbers of viable

organisms when used neat and at a 1/25 dilution.

5.1 Test Results After 1 Minute Contact Time

Test Organisms Validation Test Results Bacterial Test Suspen

sion

Test Procedures at Contact time 1

minute

Bacterial Suspension

Experimental Conditions 6.0.1

Neutraliser Toxicity 6.0.2

Dilution Neutralisation 6.0.3

Neat Test Solution

Non

Active

Pseudomonas

aeruginosa

ATCC 15442 1.2x103 1.0x103 9.4x102 6.8x102 2.6x108

<1.5x102 <1.5x102 >3.0x103


8.4x102 7.4x102 5.8x102 4.8x102 2.2x108

<1.5x102 <1.5x102 >3.0x103

Staphylococcus aureus ATCC 6538 6.4x102 5.8x102 4.6x102 3.3x102 2.6x108

<1.5x102 <1.5x102 >3.0x103


9.8x102 8.8x102 7.6x102 4.9x102 2.4x108

<1.5x102 <1.5x102 >3.0x103

Salmonella

butantan

NCTC 7831 1.3x103 1.0x103 9.2x102 7.4x102 2.9x108

<1.5x102 <1.5x102 >3.0x103

Listeria Monocytogenes NCTC 11994

2.8x103 1.1x103 9.5x102 7.4x102 2.6x108

<1.5x102 <1.5x102 >3.0x103

Staphylococcus

aureus (MRSA)

NCTC 12493 2.6x103 1.1x103 9.8x102 6.4x102 2.8x108

<1.5x102 <1.5x102 >3.0x103

5.2 Test Results After 5 Minutes Contact Time

Test Organisms Validation Test Results Bacterial

Test Suspen

sion

Test procedures at contact time of 5

minutes

Bacterial Suspension




Neat Test

solution Non

Active

Pseudomonas

aeruginosa

ATCC 15442 1.2x103 1.0x103 9.4x102 6.8x102 2.6x108

<1.5x102 <1.5x102 >3.0x103


8.4x102 7.4x102 5.8x102 4.8x102 2.2x108

<1.5x102 <1.5x102 >3.0x103

Staphylococcus aureus ATCC 6538

6.4x102 5.8x102 4.6x102 3.3x102 2.6x108

<1.5x102 <1.5x102 >3.0x103


9.8x102 8.8x102 7.6x102 4.9x102 2.4x108

<1.5x102 <1.5x102 >3.0x103

Salmonella

butantan

NCTC 7831 1.3x103 1.0x103 9.2x102 7.4x102 2.9x108

<1.5x102 <1.5x102 >3.0x103

Listeria monocytogenes

NCTC 11994 2.8x103 1.1x103 9.5x102 7.4x102 2.6x108

<1.5x102 <1.5x102 >3.0x103

Staphylococcus

aureus MRSA

NCTC 12493 2.6x103 1.1x103 9.8x102 6.4x102 2.8x108

<1.5x102 <1.5x102 >3.0x103

6.0 Validation of Test Conditions

6.0.1 Validation of Selected Experimental Conditions

1ml of Bovine Albumin solution was placed in a test tube with 1ml of bacterial test suspension containing approximately 6.0

x 102 - 3.0 x 103 cfu/ml. This was placed in a water bath at the test temperature of 20oC for 2 minutes. At the end of this time

8 ml of sterile water was added. This mixture was left in the water bath for the test contact time of 5 minutes. 1ml of the

test solution was pipetted in duplicate and poured with 12-15mls of TSA. The plates were incubated at 37oC for 24 and 48

hours.

6.0.2 Neutraliser Toxicity Validation

8ml of Neutraliser and 1ml of water were placed in a test tube. 1ml of bacterial suspension containing approximately 6.0 x

102 - 3.0 x 103 cfu/ml was added. The mixture was placed in the water bath at 20oC for 5 minutes. 1ml was then pipetted

onto duplicate plates and poured with 12-15mls of TSA. The plates were incubated at 37oC for 24 and 48 hours.

6.0.3 Dilution- Neutralisation Validation

1ml of Bovine Albumin solution was placed in a test tube with 1ml of Tryptone Sodium Chloride solution and 8ml of the

product test solution. The test tube was placed in a waterbath at 20oC for 5 minutes. 1ml was then taken and added to 8ml

neutraliser and placed in the waterbath at 20oC for 5 minutes. After this time 1ml of the bacterial suspension was added.

The mixture was left in the waterbath for 30 minutes. 1ml was then plated in duplicate and poured with 12-15mls of TSA.

The plates were incubated at 37oC for 24 and 48 hours.

For each test organism:

Bacterial suspension should be between 6x102 and 3x103

6.0.1 should be equal to or greater than 0.05 times bacterial suspension

6.0.2 should be equal or greater than 0.05 times the bacterial suspension

6.0.3 should be equal to or greater than 0.5 times 6.0.2

Lisa McCormack

Microbiology Production Manager

CERTIFICATE OF ANALYSIS

Nine Group International Freedom House

Par Moor Road St Austell Cornwall PL24 2SQ

SAMPLE: Medi9 Solution

DATE OF ISSUE: 08/09/06

TEST DESCRIPTION: QUANTITATIVE SUSPENSION TEST (EN:1276 )

ORGANISMS:

Pseudomonas aeruginosa ATCC 15442 105 Reduction

Escherichia coli ATCC 10536 105 Reduction

Staphylococcus aureus ATCC 6538 105 Reduction

Enterococcus hirae ATCC 10541 105 Reduction

Staphylococus aureus ATCC 12493 MRSA 105 Reduction

Salmonella butantan NCTC 7831 105 Reduction

Listeria Monocytogenes NCTC 1194 105 Reduction

PASSED ALL CRITERIA

Chemical Disinfectants and Antiseptics


Medi9 Solution Hygienic Hand Rub

BS EN 1500:1997

1.0 Aim

The aim of the test is to evaluate whether a product for hygienic hand rub reduces the release of transient flora according

to the requirements when rubbed onto the artificially contaminated hands of laboratory staff.


• Tryptone soya agar

• Tryptone soya broth


• Sterile water

• Soft soap

• Propan-2-ol 60%

• Incubator 37oC

• Stopwatch

• Vortex mixer



3.0 Test Organisms


The test organism was kept frozen using Pro-lab micro bank beads. Two beads were taken and used to inoculate two 5ml

universals of TSB. The universals were then incubated at 37oC for 24 hours. The two universals were then transferred to two

1litre bottles of TSB and incubated at 37oC for 24hours. The resulting broths were then pooled and diluted to give an

estimated 4.6x108 cfu/ml.

4.0 Test Method

4.0.1 Application of contamination fluid

The hands were prepared by washing them for 1 minute with soft soap solution to remove natural transients. The hands were then dried thoroughly on paper towels. The contamination fluid was poured into a large container and the hands were immersed up to the mid-metacarpals for 5 seconds with the fingers spread apart. After 5 seconds the hands were removed and the surplus liquid allowed to drain back into the container. The hands were then left to air dry for 3 minutes while being held in a horizontal position with the fingers spread out and rotated to avoid the formation of droplets.

4.0.2 Prevalues

Immediately after drying, the fingertips and thumb of the right hand were rubbed in a petri dish containing 10ml of TSB

without neutraliser for 1 minute. This was repeated with a separate petri dish for the left hand. Dilutions of 10 -3 and 10-4

were prepared in TSB and 0.1ml spread over the surface of a TSA plate. The plates were then incubated at 37oC for 24hours.

4.0.2 Reference Hand Rub Procedure (R)

After the prevalue test, 3ml of Propan-2-ol 60% w/v was applied to cupped dry hands and rubbed vigorously for 30 seconds

in accordance with the standard hand rub procedure. This was repeated with a further 3mls for 30 seconds. The reference

procedure was completed by a five second rinse under running tap water and excess water shaken off.

Immediately afterwards, the fingertips and thumb of the right hand were rubbed in a petri dish containing 10ml of TSB with

neutraliser for 1 minute. This was repeated with a separate petri dish for the left hand. 1ml and 0.1ml of the undiluted

sampling fluid was spread over the surface of a TSA plate. The plates were then incubated at 37oC for 24hours.

4.0.3 Product Hand Rub Procedure (P)

After the prevalue test, the product was applied to cupped dry hands and rubbed vigorously for 30 seconds in accordance

with the standard hand rub procedure. This was repeated with a further application for 30 seconds. The product procedure

was completed by a five second rinse under running tap water and excess water shaken off.

Immediately afterwards, the fingertips and thumb of the right hand were rubbed in a petri dish containing 10ml of TSB with

neutraliser for 1 minute. This was repeated with a separate petri dish for the left hand. 1ml and 0.1ml of the undiluted

sampling fluid was spread over the surface of a TSA plate. The plates were then incubated at 37oc for 24hours.

5.0 Test Validation and Evaluation of Product

5.0.1 Validation

The results of the test should be accepted for further evaluation if they conform to the following criteria:

a) All results from at least 12 subjects are available

b) The overall mean of the log pre values for the reference and test procedure shall be at least 5.00

c) In each individual procedure, R and P, not more than three individual log reduction factors fewer than

3.00 shall occur

5.0.2 Evaluation of Product (P)

If all the data complies with 5.0.1 then the following pass criteria should be applied

a) For any product the mean log reduction factor should not be significantly smaller than the results obtained for the

reference hand rub (R)

b) If the mean log reduction factor of the product (P) is smaller than the reference hand rub (R) the difference should

be tested for statistical significance.

c) If the mean log reduction factor is significantly smaller that that obtained with the reference hand rub (R), the test

product does not conform to EN: 1500 standard.

6.0 Significance Testing

For the testing of the mean log RF of P against R, the Wilcoxon matched pairs signed ranks tests were used. The level of

significance applied is set at P= 0.1

The test was used one sided. The discrimination efficiency of the test procedure has been set to detect a difference between

the two mean log reduction factors of approximately 0.6 log at a power of 95%.

7.0 Results Tables

7.0.1 Reference Hand Rub Procedure- Experimental Results

Preparation R (Propan-2-ol 60% V/V)

Date Of Test 15/01/07

Test Organism E. coli NCTC 10538

Suspension 4.6x108

Subject Hand Prevalues Postvalues

10-3 10-4 Neat -1 -2

1 L >300 36 400 20 5

R >300 20 200 15 4

2 L >300 26 90 5 0

R >300 94 60 1 0

3 L >300 37 11 1 0

R >300 21 15 0 0

4 L >300 140 114 4 0

R >300 280 200 15 2

5 L >300 180 114 1 0

R >300 200 98 1 0

6 L >300 39 27 5 0

R >300 24 60 0 0

7 L >300 60 200 15 2

R >300 47 114 11 1

8 L >300 67 19 1 0

R >300 71 376 25 1

9 L >300 300 40 1 0

R >300 240 20 0 0

10 L >300 300 118 10 4

R >300 210 85 1 0

11 L >300 36 200 15 4

R >300 21 241 21 2

12 L >300 76 60 1 0

R >300 60 91 2 0

13 L >300 190 60 0 0

R >300 200 104 2 0

14 L >300 290 400 24 2

R >300 360 200 10 5

15 L >300 36 246 25 1

R >300 21 119 10 1

7.0.2 Nine Group Int Product Hand Rub Procedure- Experimental Results

Preparation P (Nine Group Int – Medi9 Solution)

Date Of Test 15/01/07

Test Organism E. coli NCTC 10538

Suspension 4.6x108

Subject Hand Prevalues Postvalues

10-3 10-4 Neat -1 -2

1 L 40 4 24 2 0

R 33 8 8 1 0

2 L >300 95 18 3 0

R >300 60 50 1 0

3 L >300 170 600 5 0

R >300 160 300 24 3

4 L >300 190 36 2 0

R >300 110 90 6 0

5 L >300 34 1200 60 4

R >300 56 1600 22 5

6 L >300 25 110 20 2

R >300 40 90 5 0

7 L >300 200 600 20 2

R >300 160 400 60 2

8 L >300 25 60 5 0

R >300 60 100 2 0

9 L >300 200 64 5 0

R >300 140 190 6 0

10 L >300 20 160 8 0

R >300 36 200 4 0

11 L >300 200 91 5 0

R >300 140 40 4 0

12 L >300 94 140 0 0

R >300 34 110 4 0

13 L >300 240 110 2 0

R >300 62 64 5 0

14 L >300 164 280 26 5

R >300 48 200 20 5

15 L >300 92 90 2 0

R >300 40 40 2 0

7.0.3 List of Computed Log Values and Log Reduction Factors of experimental Results (Tables 7.0.1 & 7.0.2)

Subject Reference Procedure (R)

Test Product Procedure (P)

Log X Log Y Log Z Log X Log Y Log Z

1 5.44 2.47 2.97 4.56 1.20 3.36

2 5.77 1.87 3.90 5.88 1.53 4.35

3 5.46 1.11 4.35 6.19 2.65 3.54

4 6.32 2.19 4.13 6.18 1.79 4.39

5 6.27 2.02 4.25 6.65 3.14 3.51

6 5.49 1.63 3.86 5.51 2.00 3.51

7 5.72 2.19 3.53 6.25 2.69 3.56

8 5.83 2.29 3.54 5.63 1.90 3.73

9 6.43 1.47 4.96 6.23 2.10 4.13

10 6.40 2.00 4.40 5.43 2.25 3.18

11 5.45 2.34 3.11 6.23 1.81 4.42

12 5.83 1.87 3.96 5.80 2.09 3.71

13 6.29 1.91 4.38 6.18 1.93 4.25

14 6.51 2.47 4.04 6.50 2.38 4.12

15 5.45 2.26 3.19 5.81 1.81 4.00

~

S

N

5.91

0.41

15

2.00

0.38

15

3.90

0.55

15

5.94

0.51

15

2.08

0.48

15

3.85

0.40

15 Log X= log Prevalue ~ = Overall mean of log X Y and Z

Log Y= log Postvalue S = Standard Deviation

Log Z= Log Reduction Factor N = Number of Values (=subjects in each column)

Table 7.0.4 Statistical Comparison Of Values As Obtained With R and P

(Wilcoxon’s Matched Pairs Signed Ranks Test)

Subject Log RF Derived From

Difference R-P Rank Of Difference

R P Without Sign With Sign

1 2.97 3.36 -0.39 8 -8

2 3.90 4.35 -0.45 9 -9

3 4.35 3.54 0.81 12 +12

4 4.13 4.39 -0.26 6 -6

5 4.25 3.51 0.74 10 +10

6 3.86 3.51 0.35 7 +7

7 3.53 3.56 -0.03 1 -1

8 3.54 3.73 -0.19 4 -4

9 4.96 4.13 0.83 13 +13

10 4.40 3.18 1.22 14 +14

11 3.11 4.42 -1.31 15 -15

12 3.96 3.71 0.25 5 +5

13 4.38 4.25 0.13 3 +3

14 4.04 4.12 -0.08 2 -2

15 3.19 4.00 -0.80 11 -11

RF: Reduction factor

Sum of Ranks (+) = 64

Sum of Ranks (-) = 56

Table 7.0.5 Wilcoxon’s Matched-Pairs-Signed-Ranks-Test: Critical levels of the lower of both sums of ranks with (+) and (-)

sign at different significance levels.

N (Number of subjects used)

Level of Significance

0.1 0.05 0.01

12 12 17 9

13 26 21 12

14 31 25 15

15 36 30 19

8.0 Conclusion

The smaller sum of ranks is compared with the tabulated values from the Wilcoxon Table (7.0.5) For N = 15 (Total Number

of Subjects used) at a level of significance of P = 0.1. If the calculated sum of ranks is < or equal to 36, the product must be

rejected as significantly less effective. If > than 36 the product has passed the required criteria for EN: 1500. Therefore the

Test Product (P) gave a result of 56, which is above the required value of 36 and passes the criteria for EN: 1500.

Lisa McCormack


Quantitative Suspension Test for the Evaluation of Fungicidal

Activity of Chemical Disinfectants and Antiseptics Used in Food,

Industrial, Domestic and Institutional Areas

Nine Group International Medi9 Solution

European Standard EN 1650 : 1998

1.0 Aim

The aim of the test is to evaluate the fungicidal activity of the Medi9 solution received from Nine Group International.


• Tryptone sodium chloride solution


• 0.05%w/v polysorbate 80 solution in water

• Sterile water

• Bovine albumin solution

• Incubator 30oc

• Water bath 20oc and 45oc

• Stopwatch

• Vortex mixer



• Malt extract agar (MEA)

3.0 Test Organisms

Candida albicans ATCC 1023

Aspergillus niger ATCC 16404

The test organisms were kept frozen using Pro-lab micro bank beads. One bead was taken and used to inoculate a MEA

slope. The slopes were then incubated at 30oc for 48 hours. This was then repeated to obtain a third subculture.

Candia albicans: Serial dilutions of the organism were then performed using Tryptone Sodium Chloride Solution to give

inoculum levels of approximately 1.5 x107- 5.0 x107.

Aspergillus niger: From the MEA slope, the organism was subcultured into a roux flask of MEA and incubated at 30oc for 7-

9 days. The working culture was then suspended in 10ml of 0.05%w/v Polysorbate 80 solution and examined by microscopy

for the presence on mycelia. The suspension was then centrifuged at 2000g for 20 minutes. This solution was resuspended

in diluent and recentrifuged until the mycelia were no longer present. The number of spores estimated in the solution

was 1.5x107-5.0x107.

4.0 Test Method


Temperature: 20 oc

Contact Time: 1 min, 5min and 15 min


Product concentrations: Neat, 1/25

1ml of interfering substance as added to 1ml of fungal test suspension (Approximately x107) and placed in a waterbath at

20oc for 2 minutes. At the end of this time 8ml of the product test solution was added and placed in the waterbath for a

further 1 minute. After a contact time of 1 minute, 5 minutes and 15 minutes, a 1ml aliquot was pipetted into 8ml

neutraliser and 1ml of water. After a neutralisation time of 5 minutes, 1 ml of this neutralised mixture was then plated in

duplicate into a petri dish and poured with 12-15mls of Malt Extract Agar. This step was repeated using all product

concentrations and test organism strains.

5.0 Conclusion

The results indicate that the Medi9 solution has the required fungicidal effect on the test organisms used under the agreed

test condition, contact times and temperature. The Medi9 solution produces at least a 104 reduction in numbers of viable



Test Organisms Validation Test Results

Bacterial

Test Suspension

Test Procedures at Contact time 1 minute

Bacterial

suspension Experimental Conditions 6.0.1



Neat Test

solution

1/25

Non Active

Candida albicans

ATCC 1023

6.8x102 1.0x103 1.6x103 2.0x103 3.4x107 3.8x105 >3.0x103 >3.0x103

Aspergillus niger

ATCC 16404 1.0x103 2.0x103 2.9x103 3.6x103 5.4x107 >3.0x103 >3.0x103 >3.0x103



Bacterial Test Suspension

Test Procedures at Contact time 5 minutes

Bacterial

suspension




Neat Test

solution

Non Active

Candida albicans

ATCC 1023

6.8x102 1.0x103 1.6x103 2.0x103 3.4x107 <1.0x102 1.0x102 >3.0x103


1.0x103 2.0x103 2.9x103 3.6x103 5.4x107 <1.0x102 90 >3.0x103

Test Organism Inoculum Level Cfu/ml Recovery After 5 minutes

Candida albicans ATCC 1023 3.4x107 1.0x102

Aspergillus niger ATCC 16404 5.4x107 90





minutes

Bacterial




Neat Test

solution Non Active

Candida albicans

ATCC 1023

6.8x102 1.0x103 1.6x103 2.0x103 3.4x107 <1.0x102 <1.0x102 >3.0x103


1.0x103 2.0x103 2.9x103 3.6x103 5.4x107 <1.0x102 <1.0x102 >3.0x103

6.0 Validation of Test Conditions

6.0.1 Validation of Selected Experimental Conditions

1ml of Bovine Albumin solution was placed in a test tube with 1ml of fungal test suspension containing approximately 6.0

x 102- 3.0 x 10 3 cfu/ml. This was placed in a water bath at the test temperature of 20oc for 2 minutes. At the end of this

time 8 ml of sterile water was added. This mixture was left in the water bath for the test contact time of 5 minutes. 1ml

of the test solution was pipetted in duplicate and poured with 12-15mls of MEA. The plated were incubated at 30oc for 48

hours.


8ml of Neutraliser and 1ml of water were placed in a test tube. 1ml of fungal suspension containing approximately 6.0 x

102- 3.0 x 10 3 cfu/ml was added. The mixture was placed in the water bath at 20oc for 5 minutes. 1ml was then pipetted

onto duplicate plates and poured with 12-15mls of MEA. The plated were incubated at 30oc for 48 hours.


1ml of Bovine albumin solution was placed in a test tube with 1ml of Tryptone Sodium Chloride solution and 8ml of the

product test solution. The test tube was placed in a waterbath at 20oc for 5 minutes. 1ml was then taken and added to 8ml

neutraliser and placed in the waterbath at 20oc for 5 minutes. After this time 1ml of the fungal suspension was added. The

mixture was left in the waterbath for 30 minutes. 1ml was then plated in duplicate and poured with 12-15mls of MEA. The

plated were incubated at 30oc for 48 hours.


Fungal suspension should be between 6x10 2 and 3.0x10 3

6.0.1 should be equal to or greater than 0.05 times fungal suspension

6.0.2 should be equal or greater than 0.05 times the fungal suspension


Lisa McCormack




Par Moor Road

St Austell Cornwall PL24 2SQ




ORGANISMS:

Aspergillus niger ATCC16404 104 Reduction

Candida albicans ATCC 10231 104 Reduction

PASS ALL CRITERIA

Passed at neat and 1/25 dilution at a contact time of 5 minutes under dirty conditions.

Quantitative Suspension Test for the Evaluation of Sporocidal

Activity of Chemical Disinfectants and Antiseptics used in Food,



Medi9 Solution


1.0 Aim

The aim of the test is to evaluate the sporocidal activity of the Medi9 solution received from Nine Group International.


Tryptone Sodium Chloride Solution

Neutralising solution

Sterile water

Bovine albumin solution

Incubator 30oC

Water bath 20oC and 45oC

Stopwatch

Vortex mixer

Variable Pipette and sterile tips

90mm Triple vent Petri dishes Anaerobic cabinet

Glucose Yeast Extract Agar (GYEA)

Yeast Extract Agar (YEA)

Tryptone Glucose Broth (TGB)

Tryptone Broth (TB)

Tryptone Agar (TA)

Meat Glucose Yeast Agar (MGYA)

3.0 Test Organisms

Bacillus stearothermophilus NCTC 10339 Clostridium dificile NCTC 11209

Bacillus strain:


TGB. The broths were then incubated at 30oC for 24 hours. 2-3mls of broth was then transferred to a roux flask containing

MYA. This was then incubated at 30oC for 3 days. When sporolation had occurred, the flask was rinsed with water to

produce a suspension. The suspension was then centrifuged at 10,000rpm for 20minutes, the suspension was then re-

flushed and repeated four times. The last suspension was heat treated at 75oC for 10 minutes. The stock suspension should

be maintained at 1.5x106 - 5.0x106.

Clostridium strain:


TB. The broth was then covered with paraffin and incubated at 37oC for 48 hours. 2-3mls of broth was then transferred to

a roux flask containing TA. This was then incubated anaerobically at 37oC for 3 days. When sporolation had occurred, the

flask was rinsed with water to produce a suspension. The suspension was then centrifuged at 10,000rpm for 20minutes,

the suspension was then re-flushed and repeated four times. The last suspension was heat treated at 75oC for 10 minutes.

The stock suspension should be maintained at 1.5x1065.0x106.

4.0 Test Method


Temperature: 20oC

Contact Time: 1 min, 5min, 15 min and 60 min



1ml of interfering substance was added to 1ml of sporocidal test suspension (approximately x106) and placed in a

waterbath at 20oC for 2 minutes. At the end of this time 8ml of the product test solution was added and placed in the

waterbath for a further 1 minute. After a contact time of 1 minute, 5 minutes, 15 minutes and 60 minutes, a 1ml aliquot

was pipetted into 8ml neutraliser and 1ml of water. After a neutralisation time of 5 minutes, 1ml of this neutralised mixture

was then plated in duplicate into a petri dish and poured with 12-15mls of GYA. This step was repeated using all product

concentrations and test organism strains (for Clostridium dificile use MGYA and incubate plates anaerobically at 37oC for

3 days)

Test Organism Inoculum Level Cfu/ml Recovery After 1

minutes

Bacillus stearothermophilus NCTC 10339 1.8x106 <1.5x102

Clostridium dificile NCTC 11209 2.6x106 <1.5x102

5.0 Conclusion

The results indicate that the Medi9 solution has the required sporocidal effect on the test organisms used under the agreed







minute

Bacterial




Neat Test

solution Non Active

Bacillus stearothermophilus NCTC 10339

2.8x103 1.9x103 1.6x103 9.8x102 1.8x106

<1.5x102 <1.5x102 >3.0x103

Clostridium dificile NCTC 11209 1.4x103 9.8x102 9.4x102 6.4x102 2.6x106

<1.5x102 <1.5x102 >3.0x103





minutes

Bacterial




Neat Test

solution Non Active

Bacillus stearothermophilus NCTC10339

2.8x103 1.9x103 1.6x103 9.8x102 1.8x106

<1.5x102 <1.5x102 >3.0x103


<1.5x102 <1.5x102 >3.0x103





minutes

Bacterial




Neat Test

solution Non Active


2.8x103 1.9x103 1.6x103 9.8x102 1.8x106

<1.5x102 <1.5x102 >3.0x103


<1.5x102 <1.5x102 >3.0x103





minutes

Bacterial




Neat Test

solution Non Active


2.8x103 1.9x103 1.6x103 9.8x102 1.8x106

<1.5x102 <1.5x102 >3.0x103


<1.5x102 <1.5x102 >3.0x103

6.0 Validation of test conditions.

6.0.1 Validation of selected Experimental Conditions

1ml of Bovine Albumin solution was placed in a test tube with 1ml of spore test suspension containing approximately

6.0x102 - 3.0x103 cfu/ml. This was placed in a water bath at the test temperature of 20oC for 2 minutes. At the end of this


of the test solution was pipetted in duplicate and poured with 12-15mls of GYA. The plates were incubated at 30oC for 3

days. The above was then repeated for Clostridium dificile using MGYA. The plates were incubated anaerobically at 30oC

for 3 days.


8ml of Neutraliser and 1ml of water were placed in a test tube. 1ml of spore test suspension containing approximately

6.0x102 - 3.0x103 cfu/ml was added. The mixture was placed in the water bath at 20oC for 5 minutes. 1ml was then pipetted

onto duplicate plates and poured with 12-15mls of GYA. The plates were incubated at 30oC for 3 days. The above was then

repeated for Clostridium dificile using MGYA. The plates were incubated anaerobically at 30oC for 3 days.



product test solution. The test tube was placed in a waterbath at 20oC for 5 minutes. 1ml was then taken and added to

8ml neutraliser and placed in the waterbath at 20oC for 5 minutes. After this time 1ml of the spore test suspension was

added. The mixture was left in the waterbath for 30 minutes. 1ml was then plated in duplicate and poured with 12-15mls

of GYA. The plates were incubated at 30oC for 3 days. The above was then repeated for Clostridium dificile using MGYA.

The plates were incubated anaerobically at 30oC for 3 days.


Spore suspension should be between 6x102 and 3.0x103

6.0.1 should be equal to or greater than 0.05 times spore suspension

6.0.2 should be equal or greater than 0.05 times the spore suspension


Lisa McCormack




Par Moor Road

St Austell Cornwall PL24 2SQ




ORGANISMS:

Clostridium difficile NCTC 11209 103 Reduction

Bacillus stearothermophilus NCTC 10339 103 Reduction

PASSED ALL CRITERIA

Appendix to Test Certification EN 13704

From: Julie Hulme

Sent: 21 March 2014 14:30

Subject: European Standard EN 13704 : 2002

Good afternoon, to confirm I have reviewed the data in the report detailed below;

Quantitative suspension test for the evaluation of the sporocidal activity if chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas. Nine Group International – Medi9 Solution

And based upon the stated bacterial test suspension levels and the stated recovery of <150 for all contact times, a greater than 10^5 reduction in viable numbers was demonstrated;

Bacillus stearothermophilus 1,800,000 cfu/ml calculated reduction in numbers based on a recovery of 150 equates to 1,799,850 (6.255Log)

Clostridium difficile 2,600,000 cfu/ml calculated reduction in numbers based on a recovery of 150 equates to 2,99,850 (6.447Log)

Regards

Julie Hulme

Food Microbiology Technical Manager

ALcontrol Laboratories

Yeomanry Road, Battlefield Enterprise Park, Shrewsbury, Shropshire, UK, SY1 3EH Mob: +44 (0) 7951 720 709 Switchboard: +44 (0) 1743 463 322 • Fax: +44 (0) 07143 463 324 E-mail: [email protected] • www.alcontrol.com


http://www.alcontrol.com/

Quantitative Suspension Test for the Evaluation of Sporocidal

Activity of Chemical Disinfectants and Antiseptics used in Food,



Medi9 Solution


1.0 Aim

The aim of the test is to evaluate the sporocidal activity of the Medi9 solution received from Nine Group International.


Tryptone Sodium Chloride Solution

Neutralising solution

Sterile water

Bovine albumin solution

Incubator 30oC

Water bath 20oC and 45oC

Stopwatch

Vortex mixer

Variable Pipette and sterile tips

90mm Triple vent Petri dishes Anaerobic cabinet

Glucose Yeast Extract Agar (GYEA)

Yeast Extract Agar (YEA)

Tryptone Glucose Broth (TGB)

Tryptone Broth (TB)

Tryptone Agar (TA)

Meat Glucose Yeast Agar (MGYA)

3.0 Test Organisms

Bacillus stearothermophilus NCTC 10339 Clostridium dificile NCTC 11209

Bacillus strain:


TGB. The broths were then incubated at 30oC for 24 hours. 2-3mls of broth was then transferred to a roux flask containing

MYA. This was then incubated at 30oC for 3 days. When sporolation had occurred, the flask was rinsed with water to

produce a suspension. The suspension was then centrifuged at 10,000rpm for 20minutes, the suspension was then re-

flushed and repeated four times. The last suspension was heat treated at 75oC for 10 minutes. The stock suspension should

be maintained at 1.5x106 - 5.0x106.

Clostridium strain:


TB. The broth was then covered with paraffin and incubated at 37oC for 48 hours. 2-3mls of broth was then transferred to

a roux flask containing TA. This was then incubated anaerobically at 37oC for 3 days. When sporolation had occurred, the

flask was rinsed with water to produce a suspension. The suspension was then centrifuged at 10,000rpm for 20minutes,

the suspension was then re-flushed and repeated four times. The last suspension was heat treated at 75oC for 10 minutes.

The stock suspension should be maintained at 1.5x1065.0x106.

4.0 Test Method


Temperature: 20oC

Contact Time: 1 min, 5min, 15 min and 60 min



1ml of interfering substance was added to 1ml of sporocidal test suspension (approximately x106) and placed in a

waterbath at 20oC for 2 minutes. At the end of this time 8ml of the product test solution was added and placed in the

waterbath for a further 1 minute. After a contact time of 1 minute, 5 minutes, 15 minutes and 60 minutes, a 1ml aliquot

was pipetted into 8ml neutraliser and 1ml of water. After a neutralisation time of 5 minutes, 1ml of this neutralised mixture

was then plated in duplicate into a petri dish and poured with 12-15mls of GYA. This step was repeated using all product

concentrations and test organism strains (for Clostridium dificile use MGYA and incubate plates anaerobically at 37oC for

3 days)

Test Organism Inoculum Level Cfu/ml Recovery After 1

minutes

Bacillus stearothermophilus NCTC 10339 1.8x106 <1.5x102

Clostridium dificile NCTC 11209 2.6x106 <1.5x102

5.0 Conclusion

The results indicate that the Medi9 solution has the required sporocidal effect on the test organisms used under the agreed







minute

Bacterial




Neat Test

solution Non Active


2.8x103 1.9x103 1.6x103 9.8x102 1.8x106

<1.5x102 <1.5x102 >3.0x103


<1.5x102 <1.5x102 >3.0x103





minutes

Bacterial




Neat Test

solution Non Active

Bacillus stearothermophilus NCTC10339

2.8x103 1.9x103 1.6x103 9.8x102 1.8x106

<1.5x102 <1.5x102 >3.0x103


<1.5x102 <1.5x102 >3.0x103





minutes

Bacterial




Neat Test

solution Non Active


2.8x103 1.9x103 1.6x103 9.8x102 1.8x106

<1.5x102 <1.5x102 >3.0x103


<1.5x102 <1.5x102 >3.0x103





minutes

Bacterial




Neat Test

solution Non Active


2.8x103 1.9x103 1.6x103 9.8x102 1.8x106

<1.5x102 <1.5x102 >3.0x103


<1.5x102 <1.5x102 >3.0x103

6.0 Validation of test conditions.

6.0.1 Validation of selected Experimental Conditions

1ml of Bovine Albumin solution was placed in a test tube with 1ml of spore test suspension containing approximately

6.0x102 - 3.0x103 cfu/ml. This was placed in a water bath at the test temperature of 20oC for 2 minutes. At the end of this


of the test solution was pipetted in duplicate and poured with 12-15mls of GYA. The plates were incubated at 30oC for 3

days. The above was then repeated for Clostridium dificile using MGYA. The plates were incubated anaerobically at 30oC

for 3 days.


8ml of Neutraliser and 1ml of water were placed in a test tube. 1ml of spore test suspension containing approximately

6.0x102 - 3.0x103 cfu/ml was added. The mixture was placed in the water bath at 20oC for 5 minutes. 1ml was then pipetted

onto duplicate plates and poured with 12-15mls of GYA. The plates were incubated at 30oC for 3 days. The above was then

repeated for Clostridium dificile using MGYA. The plates were incubated anaerobically at 30oC for 3 days.



product test solution. The test tube was placed in a waterbath at 20oC for 5 minutes. 1ml was then taken and added to

8ml neutraliser and placed in the waterbath at 20oC for 5 minutes. After this time 1ml of the spore test suspension was

added. The mixture was left in the waterbath for 30 minutes. 1ml was then plated in duplicate and poured with 12-15mls

of GYA. The plates were incubated at 30oC for 3 days. The above was then repeated for Clostridium dificile using MGYA.

The plates were incubated anaerobically at 30oC for 3 days.


Spore suspension should be between 6x102 and 3.0x103

6.0.1 should be equal to or greater than 0.05 times spore suspension

6.0.2 should be equal or greater than 0.05 times the spore suspension


Lisa McCormack




Freedom House

Par Moor Road

St Austell

Cornwall

PL24 2SQ




ORGANISMS:

Clostridium difficile NCTC 11209 103 Reduction

Bacillus stearothermophilus NCTC 10339 103 Reduction

PASSED ALL CRITERIA

Client: Nine Group International Certificate No.: CQI/007/0509

Freedom House Par Moor Road Sample Ref No.: CPF/001/5

St Austell Cornwall Date Received: 08.05.2009 PL24 2SQ Date Reported: 18.05.2009

TEST REPORT

Sample: Lab prep G

Test method: EN1276 Chemical disinfectants and antiseptics. Quantitative

suspension test for the evaluation of bactericidal activity of chemical

disinfectants and antiseptics used in food, industrial, domestic, and

institutional areas.

Sample Test organism Result Test period

Lab prep G E. coli 99.999% Reduction after 10 sec

Lab prep G E. coli 99.999% Reduction after 5 min

Lab prep G MRSA 99.999% Reduction after 10 sec

Lab prep G MRSA 99.999% Reduction after 5 min

Richard Hastings, PhD, Microbiologist

Warwick Microbiology Ltd

Registered Office 46 Kingsbridge Road, Weddington, Nuneaton, Warwickshire, CV10 0BZ

[email protected] Tel: 077 6644 4477

WWWWWWWWaaaaaaaarrrrrrrrwwwwwwwwiiiiiiiicccccccckkkkkkkk MMMMMMMMiiiiiiiiccccccccrrrrrrrroooooooobbbbbbbbiiiiiiiioooooooollllllllooooooooggggggggyyyyyyyy LLLLLLLLttttttttdddddddd MMMMMMMMiiiiiiiiccccccccrrrrrrrroooooooobbbbbbbbiiiiiiiioooooooollllllllooooooooggggggggiiiiiiiiccccccccaaaaaaaallllllll tttttttteeeeeeeessssssssttttttttiiiiiiiinnnnnnnngggggggg –––––––– MMMMMMMMiiiiiiiiccccccccrrrrrrrroooooooobbbbbbbbiiiiiiiiaaaaaaaallllllll rrrrrrrreeeeeeeesssssssseeeeeeeeaaaaaaaarrrrrrrrcccccccchhhhhhhh

School of Life Sciences, Glasgow Caledonian University, Glasgow, G4 0BR, Scotland, UK T: +44 (0) 141 3318245 m: +44 (0) 7989 96 48 11 F: =44 (0) 141 331 3208 E: [email protected] w: www.bluscientific.com Bluscientific Test Date is based in the School of Life Sciences at Glasgow Caledonian University Glasgow Caledonian University is a registered Scottish charity, number SC02 1474

Test Report. EN 14476:2005 Chemical disinfectants and antiseptics - Virucidal quantitative suspension test for chemical disinfectants and antiseptics used in human medicine -Test method and requirements (phase 2/step 1). BOVINE VIRAL DIARRHEA VIRUS (Hepatitis C virus surrogate) Test Laboratory BluScientific Test Data School of Life Sciences Glasgow Caledonian University Glasgow G4 0BA Indentification of sample Name of the product Nine Group – Medi9 Batch Number BN: 231207 Manufacturer Nine Group International Date of Delivery 06 February 2008 Storage conditions Room Temperature Active substances Not Known Test Method and its Validation Method Dilution-neutralization Neutralizer Dulbecco’s modified Eagles medium +5% v/v foetal bovine serum. Experimental Conditions Period 25-30 September 2008 Product diluent used Sterile, hard water Product test concentrations 2.0% v/v; 10% v/v; 80% v/v Appearance product dilutions N/A Contact time t = 5 minutes ± 10s; Test temperature 20ºC ± 1ºC Interfering substance 0.6g/l foetal bovine serum Stability of mixture Precipitate absent throughout the test Temperature of incubation 37ºC ± 1ºC Identification of virus Bovine viral diarrhea virus ATCC VR – 1422/BT-1 cells


http://www.bluscientific.com/


PROTOCOL SUMMARY Exposure times as standard are 60 minutes (obligatory), 30, 15 and 5 minutes (optional), with test conditions as clean (0.3g/l BSA) and/or dirty (3.0g/l BSA + 3% sheep erythrocytes). Three dilutions of disinfectant were used, with at least one out with the expected efficacy range. Disinfectant was diluted in sterile synthetic hard water (shH20). The basic Virucidal Efficacy Test is set up with one test per concentration of disinfectant (3 concentrations as specified by client) /exposure time. Virus is exposed to disinfectant in 24-well plates. The initial dilution and neutralisation step for each test is performed in a 24-well plate at 4ºC, with the subsequent dilution series from 10-2-10-8 made in 96-well deep well blocks. Virus was titred in 96-well tissue culture plates (TCID50). All assay plates are set up in advance. For each virus;- Neutralisation: In a 24-well plate, to each well was added 0.9ml EMEM (+ 2% serum, 1% PSG), and the plates maintained at 4ºC. Dilution series: To each well in a 96-well deep well block is pipetted 0.9ml of EMEM (+2% serum, 1%PSG), and the plates maintained at 4ºC. In a second 96 well block (which can be shared by both test viruses), 2 columns of 6 wells are prepared as follows: into rows 1 and two pipette 0.9ml EMEM + 2% FBS, and into rows 3-6 pipette 0.9ml PBS +2% FBS. In the next 2 columns, to each of 6 wells, pipette 0.9ml PBS+ 2% FBS. TCID50 assay: For an exposure time of 60 minutes only, a total of 8 plates per virus/cell line are prepared in advance, with an additional 2 plates required for each extra exposure time. Into every well of rows A-F was seeded 1x104 cells in 100µl EMEM + 2% FBS. The plates are incubated until required. NB: The cytotoxicity control described below should be performed at least 1 day prior to the Test Exposure to disinfectant was carried out in a 24-well plate, in a single replicate/test.

1. A l00µl volume of shH20 at ambient room temperature (22ºC, ± 2º) is pipetted into the test well. A l00µl volume of virus suspension (minimum 1x109 TCID50/ml) is added and mixed by pipetting. 2. To this add 800µl of disinfectant, and the mixture incubated for the required exposure time, timed by stopwatch. 3. The reaction was neutralised by transferring 100µl to 0.9ml ice cold medium prepared as above, and incubated at 4ºC for 5 minutes 4. After incubation, a ten-fold dilution series from 10-2 – 10-7 was made by serial transfer of 100µl through each of the prepared wells of the 96-well deep block. 5. A 100µl volume of each dilution was transferred to each of 6 adjacent wells in the TCID50 assay 96-well tissue culture plates.




6. All 96-well plates were incubated at 37ºC with 5%CO2 and scored for cytopathic effect (cpe) after 4-5 days.

Controls

1. Cytotoxicity; a 200µl volume of shH2O was added to 800µl of the highest concentration of disinfectant used. The mixture was immediately diluted to 10-7 in culture medium as before, and 100µl transferred to each of six wells per dilution in a TCID50 assay 96-well tissue culture plates. The lowest dilution of disinfectant which showed no cytotoxic effect was determined for use in the following control. 2. Cell sensitivity; established cell cultures in 96-well assay plates were treated with either PBS or the lowest dilution of disinfectant which does not show cytotoxic effect, as established by cytotoxicity test. To each of 6 rows of 10 wells in an assay plate was added 100 µl of disinfectant (Concentration as noted above), and incubated for 1 hour at 37°C. After incubation the supernatant was discarded. Stock virus was diluted from10-1 to 10-10 and titred on the treated cells as per TCID50 SOP. A second 96-well assay plate was mock-treated with PBS as described. 3. Efficiency of disinfectant suppression; the test mixture was prepared as per steps 1 and 2 above. A 1 in 10 dilution was made immediately, in ice cold culture medium, and incubated on ice for 30 minutes. After incubation a tenfold dilution series was performed in ice cold culture medium, and 100µl transferred to each of 6 adjacent wells in a 96-well assay plate. 4. Virus recovery; virus recovery was performed at t=0 and at t=5. VR was performed as in steps 1-6 above, with the exception that in step 2,800µl shH20 was added instead of disinfectant. 5. Reference virus inactivation; (Formaldehyde was initially titrated to find the exact concentration of formaldehyde, then diluted to a concentration of 1.4% (w/v)).

a. Virus inactivation: a 200µl volume of virus suspension was added to 800µl PBS. To this was added 1ml formaldehyde solution. The mixture was incubated as per the test conditions used (60 minutes obligatory). Immediately after incubation, 2x tenfold dilutions were performed in ice cold culture medium. Further dilutions to 10-6 were performed in ice cold PBS +2 % FBS. A 100µl volume of each dilution was transferred to 6 adjacent wells in a 96-well assay plate.

b. Cytotoxicity of formaldehyde: a 1ml volume of formaldehyde (1.4% w/v) was added to 1ml PBS. A dilution series to 10-4 was performed in ice cold PBS + 2% FBS. A 100µl volume of each dilution was transferred to each of 6 adjacent wells in a 96-well assay plate.




RESULTS

Product Interfering substance Concentration Level of cytotoxicity

lg TCIDSO >3 lg

reduction after...min 0min 5min

Medi9 0.3g/l BSA 80% (v/v) 2.50 7.00 <2.50 <5

10% (v/v) 2.50 7.00 6.67 >5

2% (v/v) 2.50 7.00 6.67 >5 Formaldehyde 0.7% (w/v) 5.50 7.00 5.50 n.a.

virus control n.a. n.a. 7.00 7.17 n.a.




Exposure time Virus recovery 0 min

(TCID50/ml) Virus recovery 5 min

(TCID50ml) CytotoKicity {1%)

(TCID50/ml) Disinfectant Suppression

(TCID50/ml) 80% Disinfectant

(TCID50/ml) 10% Disinfectant

{TCID50/ml) 2% Disinfectant

(TCID50/ml)

raw data

TCID50

raw data

TCID50

raw data

TCID50

raw data

TCID50

raw data

TCID50

raw data

TCID50

raw data

TCID50

5 min 5.50 1.00E+07 5.67 1.48E+07 1.00 3.16E+02 5.50 1.00E+07 1.00 3.16E+02 5.17 4.68E+06 5.17 4.68E+06

1.00E+07 1.48E+07 3.16E+02 1.00E+07 3.16E+02 4 68E+06 4.68E+06 log 7.00 7.17 2.50 7.00 2.50 6.67 6.67

log difference 0.17 4.67 0.50 0.50

Stock Virus 6.50 1.00E+08 (TCID50)

Formaldehyde reference Inactivation control

Exposure time Virus recovery 0 min

(TCID50/ml) Virus recovery 60 min

(TCID50/ml) CytotoKicity (1%) 0.7% Formaldehyde

(TCID50/ml)

5 min

log

log difference

raw data

5.50

TCID50

1.00E+07

1.00E+07

7.00

raw data

5.67

TCID50

1.48E+07

1.48E+07

7 17

raw data

4.00

TCID50

3.16E+05

3.16E+05

5.50

raw data

4.00

TCID50

3.16E+05

3.16E+05

5.50

1.67




Conclusion Verification of the methodology A test is only valid if the following criteria are fulfilled: a) test virus suspension (see 6.3) has TCID50 108/ml, or possesses at least a concentration which allows the determination of a 4 lg reduction of the virus titre; THIS WAS ACHIEVED. b) detectable titre reduction is at least 4 lg; THIS WAS ACHIEVED AT A CONCENTRATION OF 80.0% V/V. c) cytotoxicity of the product solution does not affect cell morphology and growth or susceptibility for the test virus in the dilutions of the test mixtures which are necessary to demonstrate a 4 lg reduction of the virus; DILUTIONS OF DISINFECTANT TO SUB-ACUTE LEVELS DID NOT INTERFERE IN THE GENERATION OF VIRAL CYTOPATHIC EFFECT (VIROTOXICITY CONTROL) d) comparative virus titration on cells treated with test mixture dilutions (or without, i.e. only addition of PBS) result in a difference of< 1lg of virus titre. THIS IS CALLED THE DISINFECTANT SUPPRESSION TEST IN THIS PROTOCOL THE DIFFERENCE WAS -0.17 LOGS INDICATING EFFECTIVE NEUTRALIZATION OF THE VIRUCIDAL ACTIVITY OF THE DISINFECTANT BY DILUTION AT A CONCENTRATION OF 80.0% V/V. According to EN 14476: 2005, NINE GROUP – MEDI9 BATCH BN: 231207 Possesses virucidal activity against Bovine viral diarrhea virus ATCC VR - 1422/BT-1 cells at 20ºC following 5 MINUTES CONTACT UNDER CLEAN CONDITIONS at a concentration of 80.0% V/V. This therefore established that this agent possesses virucidal activity and therefore should be effective against Hepatitis C virus. Signed Dr Chris Woodall, Director BluScientific Test Data Glasgow, UK 2 OCTOBER 2008




TEST Report Test Laboratory BLUESCIENTIFIC TEST DATA School of life Sciences Glasgow Caledonian University GLASGOW G4 0BA Identification of sample

Name of the product NINE GROUP SURFACE BIOCIDE Batch Number N/A Manufacturer NINE GROUP INTERNATIONAL INDUSTRIES PLC Date of Delivery 4.2.05 Storage Conditions ROOM TEMPERATURE Product Diluent Hard Water Active substances NOT KNOWN

Test Method and its validation Method Dilution-neutralization Neutralizer Dulbecco’s modified Eagles medium + 5% v/v foetal Bovine serum.

Experimental Conditions Period of analysis 15.1.06 – 21.1.06 Product diluent used Sterile hard water Product test concentrations 2% V/V, 5% V/V, 10% V/V Appearance product dilutions PALE YELLOW, clear product solution Contact time t=5 minutes ± 10s Test temperature 20°C ± 1°C Interfering substance 0.6 g/l foetal bovine serum Stability of mixture Precipitate absent throughout the test Temperature of incubation 37°C ± 1°C Identification of virus Influenza A virus HIN1 (ATCC VR-1465)




Dilution of MEDI9 Disinfectant Solution Contact time. Log10 reduction In virus viability (mean of 4 samples, 6 replicates/sample)

2%V/V 5 minutes 1.0 =FAIL

5%V/V 5 minutes 0.4 =FAIL

10%V/V 5 minutes 3.4 = PASS

Influenza A (HlNl) (TC Adapted) (ATCC- VR-1469). MEDI9 Disinfectant.

Controls CELL CULTURE Cell death was not observed (4 samples, 6 replicates/sample).

CYTOTOXICITY Cytotoxicity was not observed at a greater dilution than 10-2. This restricts the

sensitivity of the assay to <2.5Log10. TCID50 units/ml (4 samples, 6 replicates/sample)

Signed

Dr Chris Woodall

Director, BluScientific Test Data.

4th April 2006. Glasgow, UK.



BluScientific

Test Data

Virucidal Activity Test

Nine Group International Surface Biocide

Test Report Test Laboratory

Identification of sample

BLUSCIENTIFIC TEST DATA

School of Life Sciences Glasgow Caledonian University GLASGOW G4 0BA

Name of the product Nine Group International Surface Biocide Batch number N/A Manufacturer Nine Group International Date of delivery 4.2.05 Storage conditions Room Temperature Product diluent Hard Water Active substances Test

Method and its validation

Not Known

Method Dilution-neutralisation Neutraliser Experimental

Conditions

Dulbecco’s modified Eagles medium + 5% v/v foetal bovine serum.

Period of analysis 1.3.05 – 3.3.05 Product diluent used Sterile hard water Product test concentrations 1%V/V, 10% V/V, 80% V/V Appearance product dilutions PALE YELLOW, clear product solution Contact time t = 5 minutes + 10 s Test temperature 20 oC + 1 oC Interfering substance 0.6 g/l foetal bovine serum Stability of mixture Precipitate absent throughout the test Temperature of incubation 37 oC + 1 oC Identification of virus FELINE CORONAVIRUS

Test Result (See table 1)

Conclusion

NINE GROUP SURFACE BIOCIDE when used at a 1/100 DILUTION, possesses virucidal activity in FIVE minutes at 20°C

under clean conditions (0,6 g/L protein as foetal bovine serum) for FELINE CORONAVIRUS (SARS VIRUS SURROGATE).

Signed Dr Chris Woodall

Director, BluScientific Test Data

16h May 2005 Glasgow, UK

Test Report

Table 1

5 Minute Contact Test

Virus Titre

Virus Recovery

(TCID50/mL)

Cytotoxicity (1%

Disinfectant)

1% V/V Disinfectant (TCID50/mL)

10% V/V Disinfectant (TCID50/mL)

80%V/V Disinfectant (TCID50/mL)

1 8.0 x 107 2.0 x 106 <2.5 x 103 <2.5 x 103 <2.5 x 103 <2.5 x 103

2 2.0 x 107 3.1 x 106 <2.5 x 103 <2.5 x 103 <2.5 x 103 <2.5 x 103

3

3.1 x 106 <2.5 x 103 <2.5 x 103 <2.5 x 103 <2.5 x 103

4

7.9 x 106 <2.5 x 103 <2.5 x 103 <2.5 x 103 <2.5 x 103

Mean 5.0 x 107 4.0 x 106 <2.5 x 103 <2.5 x 103 <2.5 x 103 <2.5 x 103

Log

6.6 <3.4 <3.4 <3.4 <3.4

Log Difference

>3.2 >3.2 >3.2

Feline coronavirus (SARS surrogate) suspension test results for the efficacy NINE GROUP SURFACE BIOCIDE at a 5

minute contact with a soil load of 0.6g/L as foetal bovine serum.

VIRUCIDAL ACTIVITY IS BASED ON A REDUCTION IN VIRUS VIABILITY OF A MINIMUM OF 3 LOG10

Test Report Test Laboratory BLUSCIENTIFIC TEST DATA

School of Life Sciences Glasgow Caledonian University GLASGOW G4 0BA

Identification of sample

Name of the product Nine Group Surface Biocide Batch number N/A Manufacturer Nine Group International Date of delivery 4.2.05 Storage conditions Room Temperature Product diluent Hard Water Active substances Not Known

Test Method and its validation

Method Dilution-neutralisation Neutraliser Dulbecco’s modified Eagles medium + 5% v/v foetal bovine serum. Experimental Conditions Period of analysis 1.3.05 – 3.3.05 Product diluent used Sterile hard water Product test concentrations NEAT Appearance product dilutions PALE YELLOW, clear product solution Contact time t = 5 minutes + 10 s Test temperature 20 oC + 1 oC Interfering substance 0.6 g/l foetal bovine serum Stability of mixture Precipitate absent throughout the test Temperature of incubation 37 oC + 1 oC Identification of virus FELINE CALICIVIRUS Test Result (See table 2) Conclusion

NINE GROUP SURFACE BIOCIDE when USED NEAT, possesses virucidal activity in FIVE minutes at 20°C under clean conditions (0,6 g/L protein as foetal bovine serum) for FELINE CALICIVIRUS (HUMAN NOROVIRUS SURROGATE). Signed Dr Chris Woodall

Director, BluScientific Test Data. 16h May 2005 Glasgow, UK

Test Result

Table 2

5 Min Contact

Test Virus Titre Virus

Recovery (Tcid50/Ml)

Cytotoxicity (1%

Disinfectant)

Neat Disinfectant (Tcid50/Ml)

1 1.3 x 108 2.0 x 107 <2.5 x 103 <2.5 x 103

2 1.0 x 108 2.0 x 107 <2.5 x 103 <2.5 x 103

3

5.0 x 107 <2.5 x 103 <2.5 x 103

4

3.1 x 107 <2.5 x 103 <2.5 x 103

Mean 1.2 x 108 3.0 x 107 <2.5 x 103 <2.5 x 103

Log

7.5 <3.4 <3.4

log difference

>4.1

Feline calicivirus surface test results for the efficacy of NINE GROUP DISINFECTANT SOLUTION at a 5 minute contact with a soil load of 0.6g/L as foetal bovine serum. VIRUCIDAL ACTIVITY IS BASED ON A REDUCTION IN VIRUS VIABILITY OF A MINIMUM OF 4 LOG10

SAFETY DATA SHEET MEDI9 INFECTION CONTROL PRODUCTS

Page: 1

[cont...]

Compilation date: 02/02/2013

Revision No: 2

Section 1: Identification of the substance/mixture and of the company/undertaking

1.1. Product identifier

Product name: MEDI9 INFECTION CONTROL PRODUCTS

Index number: 091

1.2. Relevant identified uses of the substance or mixture and uses advised against

Use of substance / mixture: PC8: Biocidal products (e.g. Disinfectants, pest control).

1.3. Details of the supplier of the safety data sheet

Company name: Nine Group International LLP

Freedom House

Par Moor Road

St Austell

PL24 2SQ

United Kingdom

Tel: 01726 813979

Fax: 0845 2992490

Email: [email protected]

1.4. Emergency telephone number

Emergency tel: 01726 813979

(office hours only)

Section 2: Hazards identification

2.1. Classification of the substance or mixture

Classification under CHIP: This product has no classification under CHIP.

2.2. Label elements


Page: 2

[cont...]

Label elements under CHIP:

Hazard symbols: No significant hazard.

2.3. Other hazards

PBT: This substance is not identified as a PBT substance.

Section 3: Composition/information on ingredients

3.2. Mixtures

Hazardous ingredients:

BRONOPOL (INN)

EINECS CAS CHIP Classification CLP Classification Percent

200-143-0 52-51-7 Xn: R21/22; Xi: R37/38; Xi: R41; N: R50

Acute Tox. 4: H312; Acute Tox. 4: H302;

STOT SE 3: H335; Skin Irrit. 2: H315;

Eye Dam. 1: H318; Aquatic Acute 1: H400

<1%

Section 4: First aid measures

4.1. Description of first aid measures

Skin contact: Not applicable.

Eye contact: Bathe the eye with running water for 15 minutes.

Ingestion: Wash out mouth with water.

Inhalation: Not applicable.

4.2. Most important symptoms and effects, both acute and delayed

Skin contact: No symptoms.

Eye contact: There may be irritation and redness.

Ingestion: There may be irritation of the throat.

Inhalation: No symptoms.

4.3. Indication of any immediate medical attention and special treatment needed


Page: 3

[cont...]

Immediate / special treatment: Not applicable.

Section 5: Fire-fighting measures

5.1. Extinguishing media

Extinguishing media: Suitable extinguishing media for the surrounding fire should be used. Use water spray

to cool containers.

5.2. Special hazards arising from the substance or mixture

Exposure hazards: In combustion emits toxic fumes.

5.3. Advice for fire-fighters

Advice for fire-fighters: Wear self-contained breathing apparatus. Wear protective clothing to prevent contact

with skin and eyes.

Section 6: Accidental release measures

6.1. Personal precautions, protective equipment and emergency procedures

Personal precautions: Refer to section 8 of SDS for personal protection details. Turn leaking containers leak-

side up to prevent the escape of liquid.

6.2. Environmental precautions

Environmental precautions: Contain the spillage using bunding.

6.3. Methods and material for containment and cleaning up

Clean-up procedures: Absorb into dry earth or sand.

6.4. Reference to other sections

Reference to other sections: Refer to section 8 of SDS.

Section 7: Handling and storage

7.1. Precautions for safe handling

7.2. Conditions for safe storage, including any incompatibilities


Page: 4

[cont...]

Storage conditions: Store in cool, well-ventilated area. Keep container tightly closed.

7.3. Specific end use(s)

Specific end use(s): No data available.

Section 8: Exposure controls/personal protection

8.1. Control parameters

Workplace exposure limits: Not applicable.

8.2. Exposure controls

Respiratory protection: Respiratory protection not required.

Hand protection: Not applicable.

Eye protection: Safety glasses. Ensure eye bath is to hand.

Skin protection: Not applicable.

Section 9: Physical and chemical properties

9.1. Information on basic physical and chemical properties

State: Liquid

Colour: Colourless

Odour: Odourless

Solubility in water: Soluble

Viscosity: Non-viscous

Boiling point/range°C: >35 Flash point°C: >93

Relative density: 0.999 pH: Approx. 7

9.2. Other information

Other information: Not applicable.


Page: 5

Section 10: Stability and reactivity

10.1. Reactivity

Reactivity: Stable under recommended transport or storage conditions.

10.2. Chemical stability

Chemical stability: Stable under normal conditions.

10.3. Possibility of hazardous reactions

Hazardous reactions: Hazardous reactions will not occur under normal transport or storage conditions.

Decomposition may occur on exposure to conditions or materials listed below.

10.4. Conditions to avoid

Conditions to avoid: Heat.

10.5. Incompatible materials

Materials to avoid: Strong oxidising agents. Strong acids.

10.6. Hazardous decomposition products

Haz. decomp. products: In combustion emits toxic fumes.

Section 11: Toxicological information

11.1. Information on toxicological effects

Toxicity values: Not applicable.

Symptoms / routes of exposure

Skin contact: No symptoms.

Eye contact: There may be irritation and redness.

Ingestion: There may be irritation of the throat.

Inhalation: No symptoms.

Section 12: Ecological information

12.1. Toxicity

Ecotoxicity values: Not applicable.


Page: 6

12.2. Persistence and degradability

Persistence and degradability: Biodegradable.

12.3. Bioaccumulative potential

Bioaccumulative potential: No bioaccumulation potential.

12.4. Mobility in soil

Mobility: Readily absorbed into soil.

[cont...]

12.5. Results of PBT and vPvB assessment

PBT identification: This substance is not identified as a PBT substance.

12.6. Other adverse effects

Other adverse effects: Negligible ecotoxicity.

Section 13: Disposal considerations

13.1. Waste treatment methods

Disposal operations: Transfer to a suitable container and arrange for collection by specialised disposal

company. Small quantities can be disposed of by use of the waste water system.

Section 14: Transport information

Transport class: This product does not require a classification for transport.

Section 15: Regulatory information

15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture

15.2. Chemical Safety Assessment

Chemical safety assessment: A chemical safety assessment has not been carried out for the substance or the mixture

by the supplier.


Page: 7

Section 16: Other information

Other information

* Clarification - Disposal

It must be noted that the disposal processes outlined in this report under section 6.2 and

6.3 are referring to the disposal of industrial quantities, where facilities such as bunds and

sand in quantity are available for just such incidents. Small quantities referred to in section

13 can be disposed of via the waste system. One should not dispose of medium to large

amounts into the waste system. These amounts should be collected by a specialist

chemical disposal company.

Other information: This safety data sheet is prepared in accordance with Commission Regulation (EU) No

453/2010.

* indicates text in the SDS which has changed since the last revision.

Phrases used in s.2 and 3: H302: Harmful if swallowed.

H312: Harmful in contact with skin.

H315: Causes skin irritation.

H318: Causes serious eye damage.

H335: May cause respiratory irritation.

H400: Very toxic to aquatic life.

R21/22: Harmful in contact with skin and if swallowed.

R37/38: Irritating to respiratory system and skin.

R41: Risk of serious damage to eyes.

R50: Very toxic to aquatic organisms.

Legal disclaimer: The above information is believed to be correct but does not purport to be all inclusive

and shall be used only as a guide. This company shall not be held liable for any damage

resulting from handling or from contact with the above product.

[final page]

10, Portman Road,

Reading, Berkshire

RG30 1EA, UK

Tel: 0118 939 8700

Fax: 0118 939 8701

ASSESSMENT OF SAFETY FOR HUMAN HEALTH

Client: Nine Group International

Freedom House

Par Moor Road

Par

Cornwall

PL24 2SQ

FAO: Karl Glazebrook

Sample: Medi9 FORMULATION- SKIN WIPE

Laboratory No: S0704486/GC Reference No: 27556704

Order No:

Date received:

08/06/2007

I have reviewed the information supplied by Nine Group International, namely the ingredients, their

chemical nature and toxicological profile and intended consumer exposure of the finished product.

Based on the information received, together with the toxicological profile of the ingredients and an

assessment of the final product subject to the provisions indicated within the report being satisfied,

the product put on the market should not cause damage to human health when applied to the body

under normal and reasonably foreseeable conditions of use.

If this product is reported to cause significant adverse reaction amongst consumers (e.g. with an

abnormally high number of complaints) the undersigned must be informed and a new evaluation

made.

Ian Steedman C.Chem, MRSC

Technical Consultant - Chemicals

All comments relate only to the sample(s) received for evaluation.

28th June 2007

Nine Grp International LLP Risk Assessment of Medi9

ISO 14971:2007 1

Revision 1 20/05/2010 Author: S. Preston

DESCRIPTION AND INTENEDED USE

Medi9 is supplied in accordance with customers’ requirements. The disinfectant is intended for infection control and disinfecting other medical devices. Medi9 is supplied into the medical market. RISK ESTIMATION - SEVERITY AND PROBABILITY

SEVERTITY degree PROBABILITY of

occurrence degree RISK TOTAL

1. None 1. Improbable Severity x Probability 2. Negligible 2. Rare 3. Moderate 3. Occasional 4. Critical 4. Probable

5. Catastrophic 5. Frequent CATEGORIES OF RISK INDEX

SEVERITY LIKELYHOOD

1. CATASTROPHIC 2. CRITICAL 3. MODERATE 2. NEGLIGIBLE 1. NONE LOW 1. IMPROBABLE 2. RARE MEDIUM 3. OCCASIONAL 4. PROBABLE


ISO 14971:2007 2


HIGH 5. FREQUENT

HAZARDS TYPE RELATED TO THE USE/MANUFACTURE OF THE

DEVICE A OR

N/A ASSOCIATED RISK

1. Biological

1.1 Bioburden/Contamination N/A 1.2 Bio-incompatibility A Medi9 entering open wound of

operator. 1.3 Incorrect formulation A Poor / inadequate performance in

use. 1.4 Toxicity A Ingress into the body of a toxic

substance causing adverse affects. 1.5 Allergenicity A Skin irritation or dermatitis. 1.6 Re- and/or Cross-Infection N/A 1.7 Inability to maintain hygienic safety N/A 1.8 Degradation A Poor / inadequate performance in

use. 2. Environmental Hazards and Contributory Fact ors

2.1 Incompatibility with other devices with which it is intended to be used

A Adverse reaction with other substrates.

3. Hazards related to the use of the Medical Device and Contributory Factors


ISO 14971:2007 3


3.1 Inadequate instructions for use A Poor / inadequate performance in use.

3.2 Use by unskilled/untrained personnel A Potential misuse on patients or equipment.

4. Hazards Arising from Functional Failure, Maintenance and Ageing and Contributory Factors.

4.1 Lack of, inadequate specification for maintenance including N/A inadequate specification of post-maintenance functional checks

4.2 Inadequate maintenance N/A POTENTIAL HAZARD CONSEQUENC

E PROBABLE OCCURENCE

EFFECT AND/OR RISK REDUCTION FROM

HAZARDS RISK

ESTIMATION

SEV./PROB. HAZARDS

1. BIOLOGICAL

Biocompatibility If used on open wounds

Improbable Product ingredients used for many years with no complaints history. Known safety of components.

Low/

improbable Incorrect Formulation Use of out of

specification product

Improbable Quality control tests, and compliance to ISO 9001 / 13485 Low /

improbable

Toxicity Exposure to disinfectant

Improbable Product not known to be toxic from assessment to human health certificate.

Low /

improbable


ISO 14971:2007 4


Allergic reaction Skin disorder to disinfectant

Improbable Historic ingredients, certified suppliers of components, no history of allergy.

Low /

improbable Degradation Use of product

after use by date Improbable Shelf life statement. Low /

improbable 2. ENVIRONMENTAL HAZARDS

Incompatibility with other

devices with which it is

intended to be used

If used on non- invasive devices.

Rare Known compatibility with other devices, no issues. Low /

improbable

3.HAZARDS RELATED TO THE USE OF THE DEVICE

Inadequate operating

instructions If used by persons without reference instructions.

Rare Adequate instructions provided on the label. Low /

improbable

Use by unskilled/untrained

personnel If used by unskilled persons or patient relation

Improbable Adequate labelling and low risk safe for human health formulation.

Low /

improbable

Summary of Risk Assessment (after action taken) 1. Risk Identification

Medi9 does not constitute any undesirable side effect or injury but the following items are the possible risks to patients and should be re-evaluated using the Risk Management assessment procedure.


ISO 14971:2007 5


TYPE OF HAZARD Expected Consequences Total Risks After Action 1. Biological Low Low 2. Environmental Hazards Low Low 3. Hazards Relating to the Use of the Device Low Low 2. Risk Evaluation & Verification

The identified risks have been evaluated as above demonstrating risk acceptability levels and those risks potentially remaining after actions taken at assessment, manufacture and post market. 3. Comments/Risk Review

No further actions required. No customer complaints or any feedback such as post market surveillance.




Medi9

Trials & Evaluations


July 2014

Trial of alcohol-free hand sanitiser by CFT courier team Leslie Lawson-Kinross, Infection Control/Medical Devices Lead.

1. Introduction Background - Many studies show that use of an alcohol-based hand rub (ABHR) that contains at least 60% alcohol works well to reduce microbes in clinical settings like hospitals, where hands come into contact with germs but generally are not heavily soiled or greasy (CDC,2013). Approximately 3 mL of the alcoholic compound is taken from a dispenser onto dry hands and rubbed in for 30 s or until the alcohol evaporates. Microorganisms are killed by the disinfectant and not physically removed as observed with hand washing. Microorganisms not in direct contact with the alcohol will not be affected. The addition of emollients can even enhance activity by postponing evaporation of the alcohol and increase exposure time (Widmer, 2000). The World Health Organisation (WHO, 2009) recommends that hand hygiene is most effective when performed at the point of patient care, however, all healthcare staff regardless of their job role, should be encouraged to cleanse their hands regularly throughout the working day to reduce the transmission of pathogenic microorganisms. The courier team visit multiple healthcare settings during a shift, having contact with many “high touch” surfaces and may subsequently transfer pathogens to the vehicles they use. From discussions with the courier team, some felt they were at increased risk of infection due to the multiple sites that were visited i.e. increasing exposure to pathogens, problems experienced when handling specimen containers such as contaminated outer packaging and the perceived lack of availability of hand hygiene products. The CFT courier team currently have two ABHR products available to them which contain between 50-75% ethanol. One is a liquid, the other a gel. Use of ABHR varies between members of staff with some stating that they use it every time they enter/exit their vehicles and others only using it prior to meal breaks. A number of factors may contribute to this variance such as availability or acceptability of the current ABHR. The products are not always carried in the courier vehicles. As Absolute ethanol is flammable at room temperature ethanol based products have a relatively low flashpoint, typically between 17.5C and 26.5C. This could potentially pose a hazard in environments such as vehicles where the ambient temperature can easily reach >25C especially during the Summer. Objective – To evaluate the tolerability of an alcohol-free foam hand sanitiser within the courier team.

2. Methodology 10 x 600ml bottles of Medi9 Hand Sanitising Foam were given to the courier team to use for 4 weeks. Total potential sample size was 18 staff /10 vehicles. Feedback was requested anonymously in the form of an analogue scale questionnaire which was based on the WHO Protocol for Evaluation and Comparison of Tolerability and Acceptability of Different Alcohol-based Handrubs: Method 2 (WHO, 2009).

July 2014

Questionnaires were collected by the author at the end of the trial period. Staff also gave additional verbal comments about the product at this time, which were noted. Medi9 Tough Wipes were also distributed for trial, and although favourable, only 1 feedback form was received so this has not been included in the report.

3. Results 3 questionnaires were completed and 2 verbal comments were given at the time of collection. All respondents scored the product either 6 or 7 (on a scale of 1-7) for all elements. The verbal comments were noted – “it’s better than the other stuff, you have to throw half of that away because there’s too much in your hand” and “it’s much nicer on your skin, it doesn’t dry it like the other stuff”. Both comments referred to the liquid ABHR.

4. Discussion While ABHRs are widely used in the clinical setting as a suitable alternative to soap and water for hand washing, other work environments such as vehicles can present certain challenges in regulating ambient temperatures. Alcohol-free hand sanitisers can reduce the risk associated with flammable ethanol-based products. Cost comparison (based on recommended dosage)– BBraun Softalind Pure –£ 2.45 / 167 applications (1.5p per application) Gojo Purell VF – £3.36 / 117 applications (2.9p per application) Medi 9 - £5.99 / 400 applications (1.5p per application) Medi9 Hand Sanitising Foam costs the same per application as the existing ABHR liquid however, an overall cost saving would be achieved due to the reduction in wastage through more appropriate use. Equally, although alcohol-based hand sanitizers can inactivate many types of microbes very effectively when used correctly, staff may not be using a large enough volume of the liquid ABHR or may wipe it off before it has dried thereby decreasing the efficacy of their hand hygiene practice. Medi9 Hand Sanitising Foam was well tolerated by the courier team during the trial period. Studies show that an improved adherence to hand hygiene practice can be achieved with increased availability of hand rubs as well as the introduction of a product that is acceptable to staff (WHO, 2009)

5. Recommendations Medi9 Hand Sanitising Foam is an acceptable alternative to ABHR for the courier team. Further study to include analysis and comparison of consumption, as well as data from the NHS staff survey, may determine whether the product remains acceptable to staff.

July 2014

6. References http://www.cdc.gov/handwashing/show-me-the-science-hand-sanitizer.html Widmer, A.F. (2000) “Replace hand washing with use of a waterless alcohol hand rub?” Clinical Infectious Disease 31 (1) 136 – 143 World Health Organisation (2009) WHO Guidelines on Hand Hygiene in Health Care: First Global Patient Safety Challenge. Clean Care is Safer Care. Available from: http://whqlibdoc.who.int/publications/2009/9789241597906_eng.pdf?ua=1 accessed 4.8.2014 World Health Organisation (2009) Protocol for Evaluation and Comparision of Tolerability and Acceptability of Different Alcohol-based Handrubs: Method 2. Available from: http://www.who.int/gpsc/5may/Protocol_for_Evaluation_of_Handrub_Meth2.doc accessed 4.8.2014

http://www.cdc.gov/handwashing/show-me-the-science-hand-sanitizer.html

http://whqlibdoc.who.int/publications/2009/9789241597906_eng.pdf?ua=1

http://www.who.int/gpsc/5may/Protocol_for_Evaluation_of_Handrub_Meth2.doc%20accessed%204.8.2014

http://www.who.int/gpsc/5may/Protocol_for_Evaluation_of_Handrub_Meth2.doc%20accessed%204.8.2014

July 2014

Evaluation of Tolerability and Acceptability of Medi9 Hand Foam

What is your opinion of the test product for hand hygiene?

1 2 3 4 5 6 7

Colour Unpleasant Pleasant

Smell Unpleasant Pleasant

Texture Very sticky Not sticky at all

Irritation (stinging) Very irritating Not irritating

Drying effect Very much Not at all

Ease of use Very difficult Very easy

Speed of drying Very slow Very fast

Application Very unpleasant Very pleasant

Overall evaluation Dissatisfied Very satisfied

Evaluation of skin condition

Self-assessment of the skin on your hands (after use of the test product):

Appearance (supple, red, blotchy, rash) Abnormal Normal

Intactness (abrasions, fissures) Abnormal Normal

Moisture content (dryness) Abnormal Normal

Sensation (itching, burning, soreness) Abnormal Normal

How would you assess the overall integrity of the skin on your hands?

Very altered Perfect

Medi9 Feedback from Housekeeping Team at Longreach House

Cornwall Partnership NHS Foundation Trust – Mental Health

Colleen Woodley – Housekeeping Team Lead

After trialling Medi9 for three months in conjunction with the fogging machine to date there have

been no outbreaks of winter viruses. Our regime is to use the product throughout the building and

fog after any deep cleans and constant use of the wipes on touch points. We had an environmental

Health Officer visit for his regular check, he was pleasantly surprised that we used a fogging machine

and at what was included in the active ingredients, he was impressed by the independent testing of

the product to EN1276 (BACTERIA) EN13704 (SPORES) EN14476 (VIRUSES) EN1650 (MOULDS)

etc.

The wipes are suitable for use as food probe wipes and sanitiser in the kitchens. He was very pleased

on all aspects and we scored a 5 as all good practices were in place. All GSA staff have been trained

in the use of the product they say using one product is far easier than so many different chemicals

especially on touch points and glass. No one has reported any adverse effects while using Medi9.

The fogger emits a fine mist and with their training they know to walk out of the room working

backwards and let the solution settle in front of them. Medi9 contains no alcohol which is preferred

considering the nature of the environment we work in.

We have found the system to be advantageous in our work and commitment to reduce infection in

the facility, it has helped to save time and increased productivity.

Colleen Woodley

Jan 2015

Trial of Medi 9 hand sanitizer

TRURO STEPs team Oct 2014

Methodology Bottles of Medi9 Hand Sanitising Foam were given to the 3 members of the STEPs team to use for 4 weeks. 1 member of staff who trialled this product has extremely sensitive skin. Feedback was requested in the form of a questionnaire. Questionnaires were collected at the end of the trial period. Staff also gave additional verbal comments about the product at this time. In the office a larger bottle of the sanitizer was used by staff when they came in. Results 3 questionnaires were completed and 3 verbal comments were given at the time of collection. All respondents scored the product either 6 or 7 (on a scale of 1-7) for all elements. The verbal comments were noted – “it’s better than the other sanitiser, you don’t need very much and it doesn’t dry your hands out” and “it’s much nicer on your skin” and “I want to keep it and not go back.” Medi9 Hand Sanitising Foam was well liked by the team during the trial period. Medi9 Hand Sanitising Foam is an acceptable alternative to the hand sanitizer currently used by the STEPs teams Regards

Andrea

Andrea Retallick Area Manager

STEPs Truro Education, Health and Social Care

Cornwall Council

External tel: 01872 324399 Mobile: 07891840198

Fax: 01872 324460 [email protected]

STEPs Team Leader Office Tresillian House

Old County Hall Truro Cornwall

TR1 3AY


Medi9 Technical Data - UD Jan 15

Documents

Transcript of Medi9 Technical Data - UD Jan 15