Abbott Analytical
Abbott Analytical Consulting Scientists to the Disinfectant Industry
Certificate of Analysis
Sample(s):
One sample of Anti Bacterial Cleanser
Date received:
26 November 2012
Date tested:
30 November 2011
Certificate no:
12L.177IB
Certificate date:
4 December 2012
Sample ref:
12L/177
Page:
1 of 2
Analysis required:
EN 1276, 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)
Product stored at:
Room temperature
Active substance:
Not declared
Test conditions:
Dirty
Interfering substance:
3.0g/l bovine albumin
Product test concentration:
Neat as received (80% in test suspension)
Product diluent used during test:
N/A
Appearance of product (dilution):
Clear, colourless liquid
Contact time:
5 minutes
Test temperature:
20°C ± 0.5°C
Neutralising solution:
30g/l Polysorbate 80, 3g/l Lecithin, 1g/l Histidine, 1g/l Cysteine
Incubation temperature:
37°C ± 1°C
Identification of bacterial strain(s) used:
Pseudomonas aeruginosa Escherichia coli Staphylococcus aureus Enterococcus hirae
D C Watson D C Watson BSc, CBiol, MSB, MIFST, ACIEHO PO Box 95, New Ferry, Wirral, CH62 6HA Tel: 0151 637 3331 Mob: 07767 871275 email: [email protected]
NCIMB 10421 NCTC 10418 NCTC 10788 NCIMB 8192
Abbott Analytical Consulting Scientists to the Disinfectant Industry 4 December 2012
Certificate No: 12L.177IB
Page: 2 of 2
Test results: Test Organism
Pseudomonas aeruginosa
Validation Suspension (Nvₒ)
Vc1 166 Vc2 175 Vc1 116 Vc2 138 Vc1 158 Vc2 172 Vc1 142 Vc2 128 = 166 = 175 = 116 = 138 = 158 = 172 = 142 = 128 ẍ = 171 ẍ = 127 ẍ = 165 ẍ = 135
Experimental Control (A)
Vc1 150 Vc2 182 Vc1 125 Vc2 106 Vc1 166 Vc2 140 Vc1 116 Vc2 135 = 150 = 182 = 125 = 106 = 166 = 140 = 116 = 135 ẍ = 166 ≥ 0.5Nvₒ ẍ = 116 ≥ 0.5Nvₒ ẍ = 153 ≥ 0.5Nvₒ ẍ = 126 ≥ 0.5Nvₒ
Neutraliser Control (B)
Vc1 156 Vc2 169 Vc1 104 Vc2 94 Vc1 156 Vc2 162 Vc1 112 Vc2 100 = 156 = 169 = 104 = 94 = 156 = 162 = 112 = 100 ẍ = 163 ≥ 0.5Nvₒ ẍ = 99 ≥ 0.5Nvₒ ẍ = 159 ≥ 0.5Nvₒ ẍ = 106 ≥ 0.5Nvₒ
Method Validation (C)
Vc1 182 Vc2 134 Vc1 124 Vc2 106 Vc1 138 Vc2 174 Vc1 134 Vc2 120 = 182 = 134 = 124 = 106 = 138 = 174 = 134 = 120 ẍ = 158 ≥ 0.5Nvₒ ẍ = 115 ≥ 0.5Nvₒ ẍ = 156 ≥ 0.5Nvₒ ẍ = 127 ≥ 0.5Nvₒ
Test 10 -6 Vc1 323 Suspension TRUE 323 10 -7 Vc1 34 TRUE 34 lg N = (N = ẅ) (Nₒ = 0.1N) lg Nₒ = Results (Na = 10ẍ) (R) Pass: lg R ≥ 5
Escherichia coli
Vc2 TRUE Vc2 TRUE 8.50 7.50
311 Vc1 275 311 TRUE 275 29 Vc1 28 29 TRUE 28 lg N = lg Nₒ =
Vc1 0 Vc2 0 < 14 < 14 lg Na < 2.15 lg R > 5.35 PASS
Vc2 TRUE Vc2 TRUE 8.42 7.42
240 Vc1 298 240 TRUE 298 31 Vc1 27 31 TRUE 27 lg N = lg Nₒ =
Vc1 0 Vc2 0 < 14 < 14 lg Na < 2.15 lg R > 5.27 PASS
Vc = plate count per ml ẍ = average of Vc1 and Vc2
Staphylococcus aureus
Vc2 TRUE Vc2 TRUE 8.50 7.50
Enterococcus hirae
329 Vc1 258 329 TRUE 258 35 Vc1 30 35 TRUE 30 lg N = lg Nₒ =
Vc1 0 Vc2 0 < 14 < 14 lg Na < 2.15 lg R > 5.35 PASS
Vc2 TRUE Vc2 TRUE 8.39 7.39
226 226 23 23
Vc1 0 Vc2 0 < 14 < 14 lg Na < 2.15 lg R > 5.24 PASS
ẅ = weighted mean of ẍ R = reduction (lg R = lg Nₒ – lg Na)
Requirements & Conclusion: This batch of Anti Bacterial Cleanser, when used neat, passes the requirements of EN 1276 for bactericidal activity in 5 minutes at 20°C under dirty conditions against all of the reference organisms detailed.
D C Watson D C Watson BSc, CBiol, MSB, MIFST, ACIEHO PO Box 95, New Ferry, Wirral, CH62 6HA Tel: 0151 637 3331 Mob: 07767 871275 email: [email protected]
cnr
Certificate of Analysis
Sample(s):
One sample of Anti Bacterial Cleanser
Date received:
26 November 2012
Date tested:
30 November 2011
Certificate no:
12L.177IB
Certificate date:
4 December 2012
Sample ref:
12L/177
Page:
1 of 2
Analysis required:
EN 1276, 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)
Product stored at:
Room temperature
Active substance:
Not declared
Test conditions:
Dirty
Interfering substance:
3.0g/l bovine albumin
Product test concentration:
Neat as received (80% in test suspension)
Product diluent used during test:
N/A
Appearance of product (dilution):
Clear, colourless liquid
Contact time:
5 minutes
Test temperature:
20°C ± 0.5°C
Neutralising solution:
30g/l Polysorbate 80, 3g/l Lecithin, 1g/l Histidine, 1g/l Cysteine
Incubation temperature:
37°C ± 1°C
Identification of bacterial strain(s) used:
Pseudomonas aeruginosa Escherichia coli Staphylococcus aureus Enterococcus hirae
D C Watson D C Watson BSc, CBiol, MSB, MIFST, ACIEHO PO Box 95, New Ferry, Wirral, CH62 6HA Tel: 0151 637 3331 Mob: 07767 871275 email: [email protected]
NCIMB 10421 NCTC 10418 NCTC 10788 NCIMB 8192
Abbott Analytical Consulting Scientists to the Disinfectant Industry 4 December 2012
Certificate No: 12L.177IB
Page: 2 of 2
Test results: Test Organism
Pseudomonas aeruginosa
Validation Suspension (Nvₒ)
Vc1 166 Vc2 175 Vc1 116 Vc2 138 Vc1 158 Vc2 172 Vc1 142 Vc2 128 = 166 = 175 = 116 = 138 = 158 = 172 = 142 = 128 ẍ = 171 ẍ = 127 ẍ = 165 ẍ = 135
Experimental Control (A)
Vc1 150 Vc2 182 Vc1 125 Vc2 106 Vc1 166 Vc2 140 Vc1 116 Vc2 135 = 150 = 182 = 125 = 106 = 166 = 140 = 116 = 135 ẍ = 166 ≥ 0.5Nvₒ ẍ = 116 ≥ 0.5Nvₒ ẍ = 153 ≥ 0.5Nvₒ ẍ = 126 ≥ 0.5Nvₒ
Neutraliser Control (B)
Vc1 156 Vc2 169 Vc1 104 Vc2 94 Vc1 156 Vc2 162 Vc1 112 Vc2 100 = 156 = 169 = 104 = 94 = 156 = 162 = 112 = 100 ẍ = 163 ≥ 0.5Nvₒ ẍ = 99 ≥ 0.5Nvₒ ẍ = 159 ≥ 0.5Nvₒ ẍ = 106 ≥ 0.5Nvₒ
Method Validation (C)
Vc1 182 Vc2 134 Vc1 124 Vc2 106 Vc1 138 Vc2 174 Vc1 134 Vc2 120 = 182 = 134 = 124 = 106 = 138 = 174 = 134 = 120 ẍ = 158 ≥ 0.5Nvₒ ẍ = 115 ≥ 0.5Nvₒ ẍ = 156 ≥ 0.5Nvₒ ẍ = 127 ≥ 0.5Nvₒ
Test 10 -6 Vc1 323 Suspension TRUE 323 10 -7 Vc1 34 TRUE 34 lg N = (N = ẅ) (Nₒ = 0.1N) lg Nₒ = Results (Na = 10ẍ) (R) Pass: lg R ≥ 5
Escherichia coli
Vc2 TRUE Vc2 TRUE 8.50 7.50
311 Vc1 275 311 TRUE 275 29 Vc1 28 29 TRUE 28 lg N = lg Nₒ =
Vc1 0 Vc2 0 < 14 < 14 lg Na < 2.15 lg R > 5.35 PASS
Vc2 TRUE Vc2 TRUE 8.42 7.42
240 Vc1 298 240 TRUE 298 31 Vc1 27 31 TRUE 27 lg N = lg Nₒ =
Vc1 0 Vc2 0 < 14 < 14 lg Na < 2.15 lg R > 5.27 PASS
Vc = plate count per ml ẍ = average of Vc1 and Vc2
Staphylococcus aureus
Vc2 TRUE Vc2 TRUE 8.50 7.50
Enterococcus hirae
329 Vc1 258 329 TRUE 258 35 Vc1 30 35 TRUE 30 lg N = lg Nₒ =
Vc1 0 Vc2 0 < 14 < 14 lg Na < 2.15 lg R > 5.35 PASS
Vc2 TRUE Vc2 TRUE 8.39 7.39
226 226 23 23
Vc1 0 Vc2 0 < 14 < 14 lg Na < 2.15 lg R > 5.24 PASS
ẅ = weighted mean of ẍ R = reduction (lg R = lg Nₒ – lg Na)
Requirements & Conclusion: This batch of Anti Bacterial Cleanser, when used neat, passes the requirements of EN 1276 for bactericidal activity in 5 minutes at 20°C under dirty conditions against all of the reference organisms detailed.
D C Watson D C Watson BSc, CBiol, MSB, MIFST, ACIEHO PO Box 95, New Ferry, Wirral, CH62 6HA Tel: 0151 637 3331 Mob: 07767 871275 email: [email protected]
cnr
