Abbott Analytical
Abbott Analytical Consulting Scientists to the Disinfectant Industry
Certificate of Analysis Product name: Batch or ref no:
Concentrated Antibac Room and Washroom Cleaner Code 41014
Manufacturer or supplier:
Gompels Healthcare Ltd. 1 Swift Way, Bowerhill Industrial Estate, Melksham, SN12 6GX
Sample ref:
14K/188
Date received:
17 October 2014
Date tested:
17 October 2014
Certificate date:
20 October 2014 *
Certificate no:
14K.188IB2.BSC
Page:
1 of 4
Analysis required:
EN 1276:2009, 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 – Test method and requirements (phase 2, step 1)
Storage conditions:
Room temperature
Appearance of product (solution):
Clear blue liquid
Active substance(s) and their concentration(s):
Not declared
* Re-issued 21 October 2014 with amended brand name
Notes: The test results in this report relate only to the sample(s) tested. This test report may not be reproduced except in full, without written approval from Abbott Analytical.
D C Watson BSc,CBiol,MSB,MIFST,ACIEHO Unit 2, Hickmans Road, Birkenhead, CH41 1JH, United Kingdom
Tel: +44 (0)151 324 1276 email: [email protected] www.abbottanalytical.co.uk
Abbott Analytical Consulting Scientists to the Disinfectant Industry Certificate no: 14K.188IB2.BSC
Date: 20 October 2014
Page: 2 of 4
Experimental conditions: Concentration(s) of product tested:
1:20 v/v
Product diluent:
Sterile hard water (300mg/l CaCO3)
Test organism(s):
Pseudomonas aeruginosa (NCTC 13359) Escherichia coli (NCTC 10418) Staphylococcus aureus (NCTC 10788) Enterococcus hirae (NCTC 13383)
Contact time(s):
1 minute & 5 minutes
Test temperature:
20°C ± 0.5°C
Test conditions:
Dirty
Interfering substance:
3.0g/l bovine albumin
Neutralising solution:
30g/l Polysorbate 80 + 3g/l Lecithin + 1g/l L-histidine + 1g/l L-cysteine
Incubation temperature:
37°C ± 1°C
Conclusion: When tested at a concentration of 1:20, this sample of Cleaner & Sanitiser passes the requirements of EN 1276:2009 for bactericidal activity in 1 minute (and in 5 minutes) at 20°C under dirty conditions against Pseudomonas aeruginosa (NCTC 13359), Escherichia coli (NCTC 10418), Staphylococcus aureus (NCTC 10788) and Enterococcus hirae (NCTC 13383).
D C Watson BSc,CBiol,MSB,MIFST,ACIEHO Unit 2, Hickmans Road, Birkenhead, CH41 1JH, United Kingdom
Tel: +44 (0)151 324 1276 email: [email protected] www.abbottanalytical.co.uk
Abbott Analytical Consulting Scientists to the Disinfectant Industry Certificate no: 14K.188IB2.BSC
Date: 20 October 2014
Page: 3 of 4
Results: Pseudomonas aeruginosa (NCTC 13359) Validation and controls: Validation suspension (Nvₒ) Vc1 93 ϰ = Vc2 127 110 30 ≤ ϰ (Nvₒ) ≤ 160 ? ☒ yes ☐ no
Test suspension: (N and Nₒ) 1 244 1 40
Test: 14 14
21 14
Experimental conditions control (A) Vc1 110 ϰ = Vc2 116 113 ϰ (A) ≥ 0.5 x ϰ (Nvₒ)? ☒ yes ☐ no
Neutralizer or filtration control (B) Vc1 97 ϰ = Vc2 112 104.5 ϰ (B) ≥ 0.5 x ϰ (Nvₒ)? ☒ yes ☐ no
N
Vc1 Vc2 244 252 10 40 47 10 -7 1 252 Control of weighted 1 47 mean counts -6
Product Contact test conc. time 1:20 1 min 1:20 5 mins
Vc1
Vc2
10 0
21 0
Method validation (C) Vc1 102 ϰ = Vc2 119 110.5 ϰ (C) ≥ 0.5 x ϰ (Nvₒ)? ☒ yes ☐ no
; lg N = 8.42 ϰ wm = 2.65 x10 8 Nₒ = N/10 ; lg Nₒ = 7.42 7.17 ≤ lg Nₒ ≤ 7.70 ? ☒ yes ☐ no Quotient = 5.70 Between 5 and 15 ? ☒ yes ☐ no
Na = ϰ x10 lg Na < 175 < 140
lg R Status (lg Nₒ = 7.42) PASS > 5.18 PASS > 5.27
< 2.24 < 2.15
Results: Escherichia coli (NCTC 10418) Validation and controls: Validation suspension (Nvₒ) Vc1 89 ϰ = Vc2 95 92 30 ≤ ϰ (Nvₒ) ≤ 160 ? ☒ yes ☐ no
Test suspension: (N and Nₒ) 1 212 1 33
Test: 14 14
14 14
Experimental conditions control (A) Vc1 70 ϰ = Vc2 74 72 ϰ (A) ≥ 0.5 x ϰ (Nvₒ)? ☒ yes ☐ no
Vc1 Vc2 -6 212 238 10 33 42 10 -7 1 238 Control of weighted 1 42 mean counts
Product Contact test conc. time 1:20 1 min 1:20 5 mins
N
Neutralizer or filtration control (B) Vc1 77 ϰ = Vc2 82 79.5 ϰ (B) ≥ 0.5 x ϰ (Nvₒ)? ☒ yes ☐ no
Vc1
Vc2
0 0
0 0
Method validation (C) Vc1 65 ϰ = Vc2 75 70 ϰ (C) ≥ 0.5 x ϰ (Nvₒ)? ☒ yes ☐ no
; lg N = 8.38 ϰ wm = 2.39 x10 8 Nₒ = N/10 ; lg Nₒ = 7.38 7.17 ≤ lg Nₒ ≤ 7.70 ? ☒ yes ☐ no Quotient = 6.00 Between 5 and 15 ? ☒ yes ☐ no
Na = ϰ x10 lg Na < 140 < 140
< 2.15 < 2.15
lg R Status (lg Nₒ = 7.38) PASS > 5.23 PASS > 5.23
D C Watson BSc,CBiol,MSB,MIFST,ACIEHO Unit 2, Hickmans Road, Birkenhead, CH41 1JH, United Kingdom
Tel: +44 (0)151 324 1276 email: [email protected] www.abbottanalytical.co.uk
Abbott Analytical Consulting Scientists to the Disinfectant Industry Certificate no: 14K.188IB2.BSC
Date: 20 October 2014
Page: 4 of 4
Results: Staphylococcus aureus (NCTC 10788) Validation and controls: Validation suspension (Nvₒ) Vc1 113 ϰ = Vc2 140 126.5 30 ≤ ϰ (Nvₒ) ≤ 160 ? ☒ yes ☐ no
Test suspension: (N and Nₒ) 1 216 1 32
Test: 14 14
14 14
Experimental conditions control (A) Vc1 118 ϰ = Vc2 131 124.5 ϰ (A) ≥ 0.5 x ϰ (Nvₒ)? ☒ yes ☐ no
Neutralizer or filtration control (B) Vc1 126 ϰ = Vc2 129 127.5 ϰ (B) ≥ 0.5 x ϰ (Nvₒ)? ☒ yes ☐ no
N
Vc1 Vc2 216 240 10 32 38 10 -7 1 240 Control of weighted 1 38 mean counts -6
Product Contact test conc. time 1:20 1 min 1:20 5 mins
Vc1
Vc2
0 0
0 0
Method validation (C) Vc1 98 ϰ = Vc2 122 110 ϰ (C) ≥ 0.5 x ϰ (Nvₒ)? ☒ yes ☐ no
; lg N = 8.38 ϰ wm = 2.39 x10 8 Nₒ = N/10 ; lg Nₒ = 7.38 7.17 ≤ lg Nₒ ≤ 7.70 ? ☒ yes ☐ no Quotient = 6.51 Between 5 and 15 ? ☒ yes ☐ no
Na = ϰ x10 lg Na < 140 < 140
lg R Status (lg Nₒ = 7.38) PASS > 5.23 PASS > 5.23
< 2.15 < 2.15
Results: Enterococcus hirae (NCTC 13383) Validation and controls: Validation suspension (Nvₒ) Vc1 133 ϰ = Vc2 156 144.5 30 ≤ ϰ (Nvₒ) ≤ 160 ? ☒ yes ☐ no
Test suspension: (N and Nₒ) 1 274 1 50
Test: 14 14
14 14
Experimental conditions control (A) Vc1 120 ϰ = Vc2 125 122.5 ϰ (A) ≥ 0.5 x ϰ (Nvₒ)? ☒ yes ☐ no
Vc1 Vc2 -6 274 280 10 -7 50 57 10 1 280 Control of weighted 1 57 mean counts
Product Contact test conc. time 1:20 1 min 1:20 5 mins
N
Neutralizer or filtration control (B) Vc1 114 ϰ = Vc2 134 124 ϰ (B) ≥ 0.5 x ϰ (Nvₒ)? ☒ yes ☐ no
Vc1
Vc2
0 0
0 0
Method validation (C) Vc1 122 ϰ = Vc2 126 124 ϰ (C) ≥ 0.5 x ϰ (Nvₒ)? ☒ yes ☐ no
8 ; lg N = 8.48 ϰ wm = 3.00 x10 Nₒ = N/10 ; lg Nₒ = 7.48 7.17 ≤ lg Nₒ ≤ 7.70 ? ☒ yes ☐ no Quotient = 5.18 Between 5 and 15 ? ☒ yes ☐ no
Na = ϰ x10 lg Na < 140 < 140
< 2.15 < 2.15
lg R Status (lg Nₒ = 7.48) PASS > 5.33 PASS > 5.33
D C Watson BSc,CBiol,MSB,MIFST,ACIEHO Unit 2, Hickmans Road, Birkenhead, CH41 1JH, United Kingdom
Tel: +44 (0)151 324 1276 email: [email protected] www.abbottanalytical.co.uk
Certificate of Analysis Product name: Batch or ref no:
Concentrated Antibac Room and Washroom Cleaner Code 41014
Manufacturer or supplier:
Gompels Healthcare Ltd. 1 Swift Way, Bowerhill Industrial Estate, Melksham, SN12 6GX
Sample ref:
14K/188
Date received:
17 October 2014
Date tested:
17 October 2014
Certificate date:
20 October 2014 *
Certificate no:
14K.188IB2.BSC
Page:
1 of 4
Analysis required:
EN 1276:2009, 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 – Test method and requirements (phase 2, step 1)
Storage conditions:
Room temperature
Appearance of product (solution):
Clear blue liquid
Active substance(s) and their concentration(s):
Not declared
* Re-issued 21 October 2014 with amended brand name
Notes: The test results in this report relate only to the sample(s) tested. This test report may not be reproduced except in full, without written approval from Abbott Analytical.
D C Watson BSc,CBiol,MSB,MIFST,ACIEHO Unit 2, Hickmans Road, Birkenhead, CH41 1JH, United Kingdom
Tel: +44 (0)151 324 1276 email: [email protected] www.abbottanalytical.co.uk
Abbott Analytical Consulting Scientists to the Disinfectant Industry Certificate no: 14K.188IB2.BSC
Date: 20 October 2014
Page: 2 of 4
Experimental conditions: Concentration(s) of product tested:
1:20 v/v
Product diluent:
Sterile hard water (300mg/l CaCO3)
Test organism(s):
Pseudomonas aeruginosa (NCTC 13359) Escherichia coli (NCTC 10418) Staphylococcus aureus (NCTC 10788) Enterococcus hirae (NCTC 13383)
Contact time(s):
1 minute & 5 minutes
Test temperature:
20°C ± 0.5°C
Test conditions:
Dirty
Interfering substance:
3.0g/l bovine albumin
Neutralising solution:
30g/l Polysorbate 80 + 3g/l Lecithin + 1g/l L-histidine + 1g/l L-cysteine
Incubation temperature:
37°C ± 1°C
Conclusion: When tested at a concentration of 1:20, this sample of Cleaner & Sanitiser passes the requirements of EN 1276:2009 for bactericidal activity in 1 minute (and in 5 minutes) at 20°C under dirty conditions against Pseudomonas aeruginosa (NCTC 13359), Escherichia coli (NCTC 10418), Staphylococcus aureus (NCTC 10788) and Enterococcus hirae (NCTC 13383).
D C Watson BSc,CBiol,MSB,MIFST,ACIEHO Unit 2, Hickmans Road, Birkenhead, CH41 1JH, United Kingdom
Tel: +44 (0)151 324 1276 email: [email protected] www.abbottanalytical.co.uk
Abbott Analytical Consulting Scientists to the Disinfectant Industry Certificate no: 14K.188IB2.BSC
Date: 20 October 2014
Page: 3 of 4
Results: Pseudomonas aeruginosa (NCTC 13359) Validation and controls: Validation suspension (Nvₒ) Vc1 93 ϰ = Vc2 127 110 30 ≤ ϰ (Nvₒ) ≤ 160 ? ☒ yes ☐ no
Test suspension: (N and Nₒ) 1 244 1 40
Test: 14 14
21 14
Experimental conditions control (A) Vc1 110 ϰ = Vc2 116 113 ϰ (A) ≥ 0.5 x ϰ (Nvₒ)? ☒ yes ☐ no
Neutralizer or filtration control (B) Vc1 97 ϰ = Vc2 112 104.5 ϰ (B) ≥ 0.5 x ϰ (Nvₒ)? ☒ yes ☐ no
N
Vc1 Vc2 244 252 10 40 47 10 -7 1 252 Control of weighted 1 47 mean counts -6
Product Contact test conc. time 1:20 1 min 1:20 5 mins
Vc1
Vc2
10 0
21 0
Method validation (C) Vc1 102 ϰ = Vc2 119 110.5 ϰ (C) ≥ 0.5 x ϰ (Nvₒ)? ☒ yes ☐ no
; lg N = 8.42 ϰ wm = 2.65 x10 8 Nₒ = N/10 ; lg Nₒ = 7.42 7.17 ≤ lg Nₒ ≤ 7.70 ? ☒ yes ☐ no Quotient = 5.70 Between 5 and 15 ? ☒ yes ☐ no
Na = ϰ x10 lg Na < 175 < 140
lg R Status (lg Nₒ = 7.42) PASS > 5.18 PASS > 5.27
< 2.24 < 2.15
Results: Escherichia coli (NCTC 10418) Validation and controls: Validation suspension (Nvₒ) Vc1 89 ϰ = Vc2 95 92 30 ≤ ϰ (Nvₒ) ≤ 160 ? ☒ yes ☐ no
Test suspension: (N and Nₒ) 1 212 1 33
Test: 14 14
14 14
Experimental conditions control (A) Vc1 70 ϰ = Vc2 74 72 ϰ (A) ≥ 0.5 x ϰ (Nvₒ)? ☒ yes ☐ no
Vc1 Vc2 -6 212 238 10 33 42 10 -7 1 238 Control of weighted 1 42 mean counts
Product Contact test conc. time 1:20 1 min 1:20 5 mins
N
Neutralizer or filtration control (B) Vc1 77 ϰ = Vc2 82 79.5 ϰ (B) ≥ 0.5 x ϰ (Nvₒ)? ☒ yes ☐ no
Vc1
Vc2
0 0
0 0
Method validation (C) Vc1 65 ϰ = Vc2 75 70 ϰ (C) ≥ 0.5 x ϰ (Nvₒ)? ☒ yes ☐ no
; lg N = 8.38 ϰ wm = 2.39 x10 8 Nₒ = N/10 ; lg Nₒ = 7.38 7.17 ≤ lg Nₒ ≤ 7.70 ? ☒ yes ☐ no Quotient = 6.00 Between 5 and 15 ? ☒ yes ☐ no
Na = ϰ x10 lg Na < 140 < 140
< 2.15 < 2.15
lg R Status (lg Nₒ = 7.38) PASS > 5.23 PASS > 5.23
D C Watson BSc,CBiol,MSB,MIFST,ACIEHO Unit 2, Hickmans Road, Birkenhead, CH41 1JH, United Kingdom
Tel: +44 (0)151 324 1276 email: [email protected] www.abbottanalytical.co.uk
Abbott Analytical Consulting Scientists to the Disinfectant Industry Certificate no: 14K.188IB2.BSC
Date: 20 October 2014
Page: 4 of 4
Results: Staphylococcus aureus (NCTC 10788) Validation and controls: Validation suspension (Nvₒ) Vc1 113 ϰ = Vc2 140 126.5 30 ≤ ϰ (Nvₒ) ≤ 160 ? ☒ yes ☐ no
Test suspension: (N and Nₒ) 1 216 1 32
Test: 14 14
14 14
Experimental conditions control (A) Vc1 118 ϰ = Vc2 131 124.5 ϰ (A) ≥ 0.5 x ϰ (Nvₒ)? ☒ yes ☐ no
Neutralizer or filtration control (B) Vc1 126 ϰ = Vc2 129 127.5 ϰ (B) ≥ 0.5 x ϰ (Nvₒ)? ☒ yes ☐ no
N
Vc1 Vc2 216 240 10 32 38 10 -7 1 240 Control of weighted 1 38 mean counts -6
Product Contact test conc. time 1:20 1 min 1:20 5 mins
Vc1
Vc2
0 0
0 0
Method validation (C) Vc1 98 ϰ = Vc2 122 110 ϰ (C) ≥ 0.5 x ϰ (Nvₒ)? ☒ yes ☐ no
; lg N = 8.38 ϰ wm = 2.39 x10 8 Nₒ = N/10 ; lg Nₒ = 7.38 7.17 ≤ lg Nₒ ≤ 7.70 ? ☒ yes ☐ no Quotient = 6.51 Between 5 and 15 ? ☒ yes ☐ no
Na = ϰ x10 lg Na < 140 < 140
lg R Status (lg Nₒ = 7.38) PASS > 5.23 PASS > 5.23
< 2.15 < 2.15
Results: Enterococcus hirae (NCTC 13383) Validation and controls: Validation suspension (Nvₒ) Vc1 133 ϰ = Vc2 156 144.5 30 ≤ ϰ (Nvₒ) ≤ 160 ? ☒ yes ☐ no
Test suspension: (N and Nₒ) 1 274 1 50
Test: 14 14
14 14
Experimental conditions control (A) Vc1 120 ϰ = Vc2 125 122.5 ϰ (A) ≥ 0.5 x ϰ (Nvₒ)? ☒ yes ☐ no
Vc1 Vc2 -6 274 280 10 -7 50 57 10 1 280 Control of weighted 1 57 mean counts
Product Contact test conc. time 1:20 1 min 1:20 5 mins
N
Neutralizer or filtration control (B) Vc1 114 ϰ = Vc2 134 124 ϰ (B) ≥ 0.5 x ϰ (Nvₒ)? ☒ yes ☐ no
Vc1
Vc2
0 0
0 0
Method validation (C) Vc1 122 ϰ = Vc2 126 124 ϰ (C) ≥ 0.5 x ϰ (Nvₒ)? ☒ yes ☐ no
8 ; lg N = 8.48 ϰ wm = 3.00 x10 Nₒ = N/10 ; lg Nₒ = 7.48 7.17 ≤ lg Nₒ ≤ 7.70 ? ☒ yes ☐ no Quotient = 5.18 Between 5 and 15 ? ☒ yes ☐ no
Na = ϰ x10 lg Na < 140 < 140
< 2.15 < 2.15
lg R Status (lg Nₒ = 7.48) PASS > 5.33 PASS > 5.33
D C Watson BSc,CBiol,MSB,MIFST,ACIEHO Unit 2, Hickmans Road, Birkenhead, CH41 1JH, United Kingdom
Tel: +44 (0)151 324 1276 email: [email protected] www.abbottanalytical.co.uk
