Campden Technology Limited
Station Road
Campden
BRI
food and drink innovation
Chipping Campden
Gloucestershire
GL55 6LD, UK
Tel:+44 (0)1386 842000
Fax: +44 (0) 1386 842100
www.campden. co.uk
Investigation into the effectiveness of Termisan when tested in accordance with
BS EN 1650:2008 - 'Chemical disinfectants and antiseptics - Quantitative suspension
test for the evaluation Of fungicidal or yeasticidai activity of chemical disinfectants and
antiseptics used in food, industrial, domestic, and institutional areas'
(MA-FH-006)
Dr. Karen E. Middleton, Edyta Margas, Urszula Gawrylak & Daria Lecznar
3rd November 2009
Approved Signatories:
Dr. J.T. Holah Dr.
K.E. Middleton
Head of Food Hygiene Department
Principal Research Officer
Report No.: FH/REP/117506/3
Page 1 of 6
WPRef.:hygiene/2009/Contract/ldeal Manufacturing Ltd/EN1650 Termisan
Campden Technology Limited, Registered no. 3836922. Incorporated in England & Wales Registered Office: Station Road, Chipping
Campden, Gloucestershire. GL55 6LD Part of Campden BRI Group Information emanating from Campden BRI is given after the exercise
of all reasonable care and skill in its compilation, preparation and issue, but is provided without liability in its application and use.
SUMMARY
When tested in accordance with BS EN 1650:2008, Termisan (FH/117506/1)
tested at 1% possesses yeasticidal activity in 15 minutes at 20°C under clean
(0.03% bovine albumen final concentration in the test) and dirty (0.3% bovine
albumen final concentration in the test) conditions against Candida albicans
When tested in accordance with BS EN 1650:2008, Termisan (FH/117506/1)
tested at 0.1% possesses yeasticidal activity in 15 minutes at 20°C under clean
(0.03% bovine albumen final concentration in the test) and dirty (0.3% bovine
albumen final concentration in the test) conditions against the additional test
organism Saccharomyces cerevisiae.
When tested in accordance with BS EN 1650:2008, Termisan (FH/117506/1)
tested at 5%, possesses fungicidal activity in 15 minutes at 20°C under clean
(0.03% bovine albumen final concentration in the test) and dirty (0.3% bovine
albumen final concentration in the test) conditions against Aspergillus niger.
INTRODUCTION
Ideal Manufacturing Ltd requested the Food Hygiene Department of Campden
Technology Limited (Campden BRI) to assess the efficacy of Termisan for
yeasticidal and fungicidal activity in accordance with BS EN 1650:2008 'Chemical disinfectants and antiseptics - Quantitative suspension test for the
evaluation of fungicidal or yeasticidal activity of chemical disinfectants and
antiseptics used in food, industrial, domestic, and institutional areas' (MA-FH006).
METHOD
For the fungicidal and yeasticidal tests, BS EN 1650:2008 - 'Chemical
disinfectants and antiseptics - Quantitative suspension test for the evaluation of
fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used
in food, industrial, domestic, and institutional areas' (MA-FH-006) was followed.
Report No.: FH/REP/117506/3
Page 2 of 6
Manufacturing Ltd/EN1650 Termisan
WPRef.:hygiene/2009/Contract/ldeal
Fungicidal activity in general use conditions
a)
IDENTIFICATION OF THE TEST LABORATORY
Food Hygiene Department, Campden BRI
b)
c)
IDENTIFICATION OF CLIENT
IDENTIFICATION OF THE SAMPLE
Ideal Manufacturing Ltd
FH/117506/1 Termisan
Name of the product
Batch number and if available expiry date
Manufacturer or if not known supplier
Condition on receipt
Date of delivery
Storage conditions
Appearance of product e.g. liquid, clear
Product diluent recommended by the
manufacturer for use e.g. potable water
Active substance(s) and its (their)
concentrations(optional)
d)
OPERATING PROCEDURE
Methods used
Neutraliser method
Neutralised rinse media
e)
Ideal Manufacturing Ltd
OK
11/08/09
Food Hygiene Sample Store, Dark, Ambient
Liquid, clear, colourless
N/A
N/A
Fungicidal Test- BS EN 1650:2008
(MA-FH-006)
Dilution Neutralisation & Membrane filtration
European Standard default neutraliserlecitin
3 g/l; polysorbate 80 30g/l; sodium
thiosulphate 5g/l; L-histidine 1 g/l; saponin
30g/l; 0.2g/l phosphate buffer 10ml, deionised
water 1000ml Diluent BS
EXPERIMENTAL CONDITIONS
Period of analysis
Product diluent used for product test
solutions (WSH or SOW) Product test
concentrations Appearance of product
dilutions Contact time Test temperature
Interfering substance
Stability & appearance of the mixture
during the procedure (interfering
substance & product diluted in hard
water)
Temperature of incubation
August-October 2009
Water of Standard Hardness (WSH)
0.1%, 1%,5%(v/v)
Clear, produced foam
Yeasticidal & Fungicidal Tests -15 minutes
Yeasticidal & Fungicidal Tests - 20°C
Bovine Serum Albumin @ 0.03% ("CLEAN")
and 0.30% ("DIRTY") in Sterile Distilled Water
(SDW)
Stable
Yeasticidal &Fungicidal Tests - 30°C ± 1°C
Report No.: FH/REP/117506/3 Page 3 of 6
WPRef.:hygiene/2009/Contract/ldea Manufacturing
Ltd/EN1650 Termisai
Identification of fungicidal strains used
f)
g)
h)
Standard yeasticidal test strain:
Candida albicans
Ca FH/154/a
Additional test strain:
Saccharomyces cerevisiae
Sc FH/70/c
Standard fungicidal test strain:
Aspergillus niger
An FH/128/a
TEST RESULTS
Controls and validation
Number of replicates per test organism
Evaluation of fungicidal activity
See attached table
See attached table
See attached table
DEVIATIONS FROM METHODS
MA-FH-006
CONCLUSION
According to BS EN 1650:2008 the supplied
Termisan (FH/117506/1) tested at 1% (v/v),
possesses yeasticidal activity in 15 minutes at
20°C under clean and dirty conditions for the
referenced test strain: Candida albicans
According to BS EN 1650:2008 the supplied
Termisan (FH/117506/1) tested at 0.1% (v/v),
possesses yeasticidal activity in 15 minutes at
20°C under clean and dirty conditions for the
additional test strain: Saccharomyces cerevisiae
According to BS EN 1650:2008 the supplied
Termisan (FH/117506/1) tested at 5% (v/v),
possesses fungicidal activity in 15 minutes at
20°C under clean and dirty conditions for the
referenced strain: Aspergillus niger
N.B. KEY TO CODES ON RESULT SHEET...
Vc:
R:
Na:
Nv:
viable count
reduction in viability
the number of cfu/ml in the test mixture
the number of cfu/ml of the yeast suspension for validation controls
NVQ:
the number of cfu/ml of the yeast suspension for validation controls at the beginning of
the contact time
N:
the number of cfu/ml of the yeast test suspension
N0:
the number of cfu/ml of the yeast test suspension at the beginning of the contact time
A:
the number of cfu/ml of the experimental conditions validation
B:
the number of cfu/ml of the neutraliser toxicity validation or of the filtration validation
C:
the number of cfu/ml of the dilution neutralisation test validation, or of the membrane
filtration test validation
Report No.: FH/REP/117506/3
Page 4 of 6
WPRef.:hygiene/2009/Contract/ldeal
Manufacturing Ltd/EN1650 Termisan
TABLE 1
RESULTS AND VALIDATIONS (Dilution Neutralisation)
Test procedure at concentration % (v/v)
Test
criteria
T*ocf
Validation Test
suspension
Candida
albicans
Vc: 155, 150
Nv: 1.5 x103
Vc: 133, 143
Vc: 138, 134
Vc: 135,138
Vc:>330>330
-6:42,40
FH/154/a
Clean
Nvo 1.5 xIO2
A: 1.4 xlO2
B 1 .4x l O 2
C: 1.4X102
Candida
albicans
Vc: 155, 150
Nv: 1.5 x103
Vc: 133, 143
Vc: 138, 134
Vc: 140, 139
Vc: >330,>330
-6:42,40
FH/154/a
Dirty
Nvo 1.5 xIO2
A: 1.4x102
B:1.4x102
C: 1.4 x102
N:4.1x10 7
Saccharomyces
cfu/ml in
test pot
N 0:4.1x10 b
Log NO' 6 61
Pass/Fail/
Invalid
Vc: 0, 0
Na:<1.4x102
Pass at 1%
N:4.1x10 7
Log Na: > 3.52
LogNa:<2.15
Log Na:< 2.15
Valid
Log N: 7.61
Log R: < 3.09
Log R: > 4.35
Log R: > 4.35
Vc: >330, >330
Na:>3.3x103
Vc: 0, 0
Na: <1.4x102
Vc: 0, 0
Na:<1.4x102
Pass at 1%
Log Na: > 3.52
LogNa:<2.15
Log Na:< 2.15
Valid
Log R: < 3.09
Log R: > 4.35
Log R: > 4.35
Vc: 5, 1
Na:<1.4x10 2
Vc: 0, 0
Vc: 0, 0
N a ^l ^x l O 2
LogNa:<2.15
Log R:> 4.18
Vc: 0, 0
Na: < 1.4x102
LogNa: <2.15
Log R:> 4.18
Na: < 1 A x *\<?
N0:4. 1 x 10b
Loo No' 6 61
Vc: 209, 212
-6:20,21
b
Nv0: 8.3 x 101
A:8.6x101
B:8.3x101
C:8.4x101
N: 2.1 x 10
Log N: 7.32
Saccharomyces
cerevisiae
Vc: 88, 78
Nv:8.3x102
Vc: 73, 87
Vc:81,85
Vc: 80, 84
Vc: 209, 212
-6: 20, 21
FH/70/c
Dirty
Nv0:8.3x101
A:8.0x101
B:8.3x101
C:8.2x101
N:2.1 x107
LogNa:<2.15
Log N: 7.32
Log R:> 4.18
Report No.: FH/REP/117506/3
5%
Vc: 0, 0
Na: <1.4x102
Vc: 86, 86
Quotient Ca: 8.0
Vc: 83, 84
%
Vc: >330, >330
Na:>3.3x103
Log N: 7.61
Vc: 81 , 85
0.1%
Vc: 88, 78
Nv 8.3 xIO2
cerevisiae
FH/70/c
Clean
Result
No: 2.1 x 10
Log No: 6.32
LogNa:<2.15
Log R: > 4.18
N0:2.1x10°
Log No 6.32
Vc: 12, 11
Na: < 1.4x102
Pass at
0.1%
LogNa:<2.15
Log R:> 4.18
Valid
Vc: 0, 0
Na:< 1.4 x102
Pass at
01%
Valid
Log Na:< 2.15
Log R:> 4.18
Quotient Sc:1O.3
Page 5 of 6
WPRef.:hygiene/2009/Contract/ldeal Manufacturing Ltd/
EN1650Termisan
TABLE 2
RESULTS AND VALIDATIONS (Membrane filtration)
Test
criteria
Aspergillus
niger
FH 128/a
Clean
Aspergillus
niger FH
128/a Dirty
Vc: 47, 38
Nv:4.2x10 2
Nv0:4.2x101
Vc: 47, 38
NV14.2X102
Nv0:4.2x101
Test procedure at concentration % (v/v)
Test
suspension
Validation Test
Vc: 59, 45
Vc: 46, 55
Vc: 49, 52
A:5.2x10 1
B:5.0x10 1
C:5.0x10 1
Vc: 43, 39
Vc: 46, 55
Vc: 48, 49
A: 4.1 x101
B:5.0x10 1
C:4.8x10 1
Vc: 188,176 6: 30,29 N:
1.9x10 7
Log N: 7.28
Vc: 188,176
-6: 30, 29 N:
1.9x10 7 ' Log
N: 7.28
cfu/ml in
test pot
N0: 1.9x10b
Log N0: 6.28
N0: 1.9x10b
Log N0: 6.28
0.1%
1%
Result
5%
Vc: >55, >55
Na:>5.5x 10 2
Log Na: > 2.7
Log R: < 3.6
Vc: >55, >55
Na:>5.5x10 2
Log Na: > 2.7
Log R: < 3.6
Vc: 1 1 , 8
Na:<1.4x10 2
Log Na: < 2.1
Log R: > 4.2
Vc: >55, >55
Na:>5.5x10 2
Log Na: > 2.7
Log R: < 3.6
Vc: >55, >55
Na:>5.5x 102
Log Na: > 2.7
Log R: < 3.6
Vc: 4, 2
Na:<1.4x10 2
Log Na: < 2.1
Log R: > 4.2
Pass/Fail
/Invalid
Pass at 5%
Valid
Pass at 5%
Valid
Quotient An: 6.2
Report No.: FH/REP/117506/3
Page 6 of 6
WPRef.:hygiene/2009/Contract/ldeal Manufacturing Ltd/
EN1650Termisan
Campden Technology Limited
Station Road
Chipping Campden
Campden BRI
Gloucestershire
GL55 6LD, UK
f o o d a n d d ri n k i n n o va t io n
Tel:+44 (0)1386 842000
Fax:+44 (0)1386 842100
www.campden.co.uk
Investigation into the effectiveness of Termisan when tested in accordance with
BS EN 1276:1997 - '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'
(MA-FH-004)
Dr. Karen E. Middleton & Daria Lecznar
24th August 2009
Report
Approv
ed By
:
Name
Approved Signatories:
Report
Check
ed By
Dr. J.T. Holah
Dr. K.E. Middleton
Head of Food Hygiene Department
Principal Research Officer
.
Report No.: FH/REP/117506/1
Page 1 of 9
Campden Technology Limited, Registered no. 3836922, Incorporated in England & Wales
Registered Office: Station Road, Chipping Campden, Gloucestershire. GL55 6LD Part of
Campden BRI Group
Information emanating from Campden BRI is given after the exercise of
all reasonable care and skill in its compilation, preparation and issue, but is
provided without liability in its application and use.
WPRef.:hygiene/2009/Contract/ldeal
Manufacturing/ EN1276 Termisan
SUMMARY
When tested in accordance with the method of BS EN 1276:1997, Termisan
(FH/117506/1) tested at 1%, possesses bactericidal activity in 5 minutes at
10°C under clean (0.03% bovine albumen final concentration in the test) and
dirty (0.3% bovine albumen final concentration in the test) conditions against:
Eschehchia coll, Enterococcus hirae, Staphylococcus aureus and
Pseudomonas aeruginosa.
When tested in accordance with the method of BS EN 1276:1997, Termisan
(FH/117506/1) tested at 1%, possesses bactericidal activity in 5 minutes at
10°C under clean (0.03% bovine albumen final concentration in the test) and
dirty (0.3% bovine albumen final concentration in the test) conditions against
the additional test organisms Salmonella Typhimurium, Listeria
monocytogenes, Yersinia enterocolitica and E. coli O157:H7 (non toxigenic).
INTRODUCTION
Ideal Manufacturing Ltd requested the Food Hygiene Department of Campden
Technology Limited (Campden BRI) to assess the efficacy of Termisan for
bactericidal activity in accordance with BS EN 1276:1997 - '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' (MA-FH-004).
METHOD
For the bactericidal tests, BS EN 1276:1997 - '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' (MA-FH-004) was followed.
NOTES
Termisan could not be neutralised sufficiently using dilution neutralisation
against Staphylococcus aureus and Listeria monocytogenes and was
subsequently
re-tested
using
membrane
filtration.
Deviations from methods
Tested at 10°C only.
Neutralisation method
Dilution Neutralisation & Membrane
Filtration
Neutralised rinse media
European Standard default neutraliser:
lecithin 3 g/l; polysorbate 80 30g/l; sodium
thiosulphate 5g/l; L-histidine 1 g/l; saponin
30g/l; 0.25M phosphate buffer 10ml, deionised
water 1000ml BS Diluent
e)
TEST RESULTS
See attached tables
f)
CONCLUSION
When tested according to the method of
BS EN 1276:1997, the supplied Termisan
(FH/117506/1), tested at 1%, possesses
bactericidal activity in 5 minutes at 10°C
under clean and dirty conditions for the
referenced strains: Escherichia coli
Enterococcus hirae Staphylococcus aureus
Pseudomonas aeruginosa
And for the additional strains:
Salmonella Typhimurium Listeria
monocytogenes Yersinia
enterocolitica E. coli O157:H7 (non
toxigenic)
N.B. KEY TO CODES ON RESULT SHEET...
Vc:
viable count
R:
reduction in viability
Na:
the number of cfu/ml in the test mixture
Nv:
the number of cfu/ml of the bacterial suspension for validation controls
N:
the number of cfu/ml of the bacterial test suspension
A:
the number of cfu/ml of the experimental conditions control
B:
the number of cfu/ml of the neutraliser toxicity validation or of the filtration validation
C:
the number of cfu/ml of the dilution neutralisation test validation, or of the membrane
filtration test validation
Report No.: FH/REP/117506/1
Page 5 of 9
WPRef.:hygiene/2009/Contract/ld Manufacturing/EN1276 Termisan
TABLE 1 – RESULTS AND VALIDATIONS (Dilution Neutralisation)
Test procedure at concentration % (v/v)
Test
criteria
Escherichia
coli FH 64/f
Clean
Escherichia
coli FH 64/f
Dirty
Staphylococcus
aureus FH 73/e
Clean
Staphylococcus
aureus FH 73/e
Dirty
Enterococcus
hirae FH 65/f
Clean
Enterococcus
hirae FH 65/f
Dirty
Pseudomonas
aeruginosa
FH72/h Clean
Pseudomonas
aeruginosa FH
72/h Dirty
Validation Test
Vc: 132,139
-2: 12, 13
Nv: 1.4x103
Vc: 150, 148
A:1.5x10 2
Vc: 132,139 2: 12,13 Nv: Vc: 159, 155
1.4x103
A:1.6x10 3
Vc: 132,148
Vc: 166, 163
-2: 14, 15
Nv. 1.4 x103
A: 1.6 x102
Vc: 132, 148
Vc: 175, 173
-2: 14, 15
Nv: 1.4x103
A: 1.7x102
Vc: 105,103
Vc:120, 118
-2: 10,9
Nv:1.0x103
A:1.2x10 2
Vc: 105, 103
Vc: 122. 120
-2: 10, 9
Nv:1.0x103
A:1.2x10 2
Vc: 98, 98
-2: 9, 8
Nv9.8xIO 2
Vc: 98, 98
-2: 9, 8
Nv.9.8xIO 2
Test
suspension
Vc: 162, 156
Vc: 151, 147
B: 1.6x102
C:1.5x10 2
Vc: 162, 156
Vc: 160, 153
B: 1.6x102
C:1.6x10 2
Vc: 166, 161
Vc: 0, 0
B: 1.6x102
C: 0
Vc: 166, 161
B: 1.6x102
C:0
'Vc: 123, 121
Vc:125, 119
B: 1.2x102
C: 1.2x102
'Vc: 123, 121
Vc: 120, 123
B: 1.2 x102
C: 1.2x102
Vc: 112,110
Vc: 99, 104
A: 1.0x102
B: 1.1 x102
C: 1.0X102
Vc: 108, 98
Vc: 112,110
Vc: 99, 108
A: 1.0x102
B: 1.1 x102
C: 1.0 x102
0.1%
1%
S%
Pass/Fail/
Invalid
Vc: 257, 253
-7: 26,27
N:2.6x108
2.6x107
Vc : 13, 8
Na:<1.5x102
R:>105
Vc: 0, 0
Na:<1.5x102
R:>105
Vc : : 0. O
N A =:< 1.5x10 2
R: >1O6
Vc: 257, 253
-7: 26,27
N:2.6x108
2.6x107
Vc: 132, 120
Na: 1.3x103
R: <105
Vc: 3, 2
Na:<1.5x102
R:>106
Vc:=:0,0
NA < 1.5x10 2
R:-< >1 05
Vc: 272, 279
-7: 27,28 N:
2.8 x108
2.8x107
Vc: 2, 2
Na:<1.5x10 2
R: >105
Vc: 0, 0
Na:<1.5x10 2
R: >105
Vc:=:0. 0
NA:< 1.5x102
R: >1 05
Passat 0.1%
Vc: 272, 279
2.8 x10 7
Vc: 12, 18
Na:<1.5x10 2
R: >105
Vc: 0, 0 Na:<
1.5 x102
R: >105
Vc=:0. 0
NA-:< 1.5x10 2
R:< >1 O5
Pass at 0.1%
2.0x107
Vc: 0, 0
Na:<1.5102
R: >105
Vc: 0, 0 Na:<
1.5 102
R:>106
V<0:~:0, 0
NA:<: 1.510 2
R : >1 O5
Vc: 204, 200
-7: 22,20
N:2.0x108
2.0x107
Vc: 5, 6
Na:<1.5x10 2
R: >105
Vc: 0, 0 Na:<
1.5 X102
R: >105
Vc=:0, 0
NA:< 1.5x10 2
R: >1O 5
Vc: >300,>300
-7: 36,31
N: 3.4 x 108
3.4 x107
Vc: >300,>300
-7: 36, 31
N: 3.4x108
3.4 x107
Vc: 0, 0
Vc: 101, 101
Report No.: FH/REP/117506/1
cfu/ml in
test pot
Result
-7: 27, 28
N:2.8x108
Vc: 204, 200
-7: 22,20
N: 2.0x108
Passat 0.1%
Valid
Pass at 1%
Valid
Invalid C
Invalid C
Pass at 0.1%
Valid
Pass at 0.1%
Valid
Page 6 of 9
Vc: 10, 9
Na:<1.5x102
R: >105
Vc: 0, 0 Na:<
1.5 x102
R: >105
Vc:=:0, 0
NA:< 1.5x102
R >1O5
Vc: 169, 170
Na:1.7x103
R:<105
Vc: 13, 14 Na:<
1.5 x102
R:>105
V c: 0 , 0
NA : 1.5 x 102
R >1 Os
Pass at 0.1%
Valid
Pass at 1%
Valid
WPRef.:hygiene/20t8CZ)9/ContracMdeal Manufacturing/
EN1276Termisan
TABLE 2 - RESULTS AND VALIDATIONS (Membrane Filtration)
Test
criteria
Staphylococcus
aureus FH 73/e
Clean
Staphylococcus
aureus
FH 73/e Dirty
Validation Test
Vc: 131,131
-2: 13, 12
Nv: 1.3x103
Vc: 131,131
-2: 13, 12
Nv: 1.3x103
Vc: 110, 100 Vc:113, 111
A: 1.0x103
B:1.1 x103
Vc: 115, 113 Vc: 113, 111
A: 1.1 x103
Report No.: FH/REP/117506/1
B: 1.1 x103
Test
suspension
Result
Test procedure at concentration % (v/v)
cfu/mi in
test pot
Vc: 226, 221
Vc: 107, 114 -7: 24, 22
N: 2.2 x 108
C:1.1x10 3
2.2 x107
Vc: 226, 221
Vc: 110, 114 -7: 24, 22
N: 2.2 x108
C: 1.1 x103
2.2 x 107
Page 7 of 9
0.1%
1%
5%
Vc:10, 10
Na:<1.5x102
R: >105
Vc: 0, 0
Na:<1.5x10 2
R:>105
Vc: 0, 0
Na:<1.5 x 102
R: >105
Vc: 90, 1 1 1
Na:1.0x103
R: <105
Vc: 0, 0
N a ^L S x I O 2
R: >105
Vc: 0, 0
Na: <1.5x102
R:>105
Pass/Fail/
Invalid
Pass at 0.1%
Valid
Pass at 1%
Valid
WPRef.:hygiene/2009/Contract/ Ideal Manufacturing/
EN1276Termisan
TABLE 3 - RESULTS AND VALIDATIONS FOR ADDITIONAL ORGANISMS (Dilution Neutralisation)
Test
criteria
Test
suspension
Validation Test
Test procedure at concentration % (v/v)
cfu/ml in
test pot
Listeria
monocytogenes
Lm FH 66/c Clean
Vc: 153, 150
-2: 15, 15
Nv:1.5x103
Listeria
monocytogenes
Lm FH 66/c Dirty
Vc: 153, 150 2:15,15 Nv: Vc: 169, 169 Vc: 173, 174 Vc: 0, 0
1.5x103
A:1.7x10 2
B:1.7x10 2
C:0
Salmonella
Typhimurium
FH 68/c Clean
Vc: 195, 199
-2: 19,20
Nv. 2.0x1 03
Salmonella
Typhimurium
FH 68/c Dirty
Vc: 195, 199
-2: 19,20
Nv: 2.0 x 103
Yersinia
enterocolitica
Ye FH 67/b
Clean
Yersinia
enterocolitica
Ye FH67/b'
Dirty
E. co// O157:H7
FH 45/a Clean
E. co// 0157:H7
FH45/a Dirty
Vc: 180, 177
-2: 18, 17
Nv: 1.8x103
Vc: 180, 177
-2: 18, 17
Nv: 1.8 x103
Vc: 137,130
-2: 13, 13
Nv: 1.3x1 03
Vc: 137, 130
-2: 13,13
Nv:1.3x103
Vc: 161, 163 Vc: 173, 174 Vc: 0, 0
A: 1.6 x102
B:1.7x10 2
C:0
Vc: 214, 216 Vc: 217, 218 Vc: 199, 200
A:2.2x10 2
B:2.2x102
C: 2.0x1 02
Vc: 221, 21 9 Vc: 217, 218 Vc: 219, 215
A:2.2x10 2
B:2.2x102
C: 2.2x1 02
Vc: 180, 179 Vc: 181, 180 Vc: 134, 133
A:1.8x10 2
B:1.8x10 2
Vc: 182, 183 Vc:
A:1.8x10 2
C:1.3x10 2
181,180 Vc:138, 135
B: 1.8x102
C:1.4x10 2
Vc: 142, 144 Vc: 148, 140 Vc: 139, 139
A:1.4x10 2
B: 1.4x102
C:1.4x10 2
Vc: 146, 150 Vc: 148, 140 Vc: 150, 148
A:1.5x10 2
Reoort No.: FH/REP/117506/1
B: 1.4x102
C:1.5x10 2
0.1%
1%
Result
5%
Vc: 278, 279
-7: 27, 26
N:2.8x10 8
2.8x10 7
Vc: 278, 279
-7: 27,26
N: 2.8 x 108
2.8x10 7
Vc: >300, >300
-7: 41,40
N:4.0x10 8
4.0x10 7
Vc :>300,>300 Vc: 1 , 0
Na:>3.0x10 3 Na:<1.5x102
R: <105
R: >105
Vc: 0, 0 Na:
<1.5x102
R: >10S
Vc: >300, >300
-7:41,40
N:4.0x10 8
4.0x10 7
Vc:>300>300
Na:>3.0x10 3
R: <105
Vc: 0, 0 Na:
<1.5x102
R:>106
Vc: 298, 286
-7: 28,29
N: 2.9 x108
2.9x10 7
Vc: 298, 286
-7: 28,29
N: 2.9 x108
2.9 x
107
Vc: 238, 238
-7: 22,23
N: 2.4x1 08
2.4x10 7
Vc: 0, 1
Na:<1,5x102
R: >105
Vc: 238, 238
-7: 22,23
N:2.4x10 8
2.4x10 7
Vc: >300,>300 Vc: 0, 0
Na: > 3.0x1 03 Na:<1.5x10 2
R: < 105
R: >105
Vc: 0, 0
Na:<1.5102
R: >105
Vc: 0, 0 Na:
<1.5102
R: >105
Vc: 0, 0 Na:
<1.5102
R: >106
Vc: 1,0 Na:
<1.5x102
R:>105
Vc: 0, 0
Na:<1.5x102
R: >105
Vc: 0, 0
Na^LSxIO2
R: >105
Pass/Fail/
Invalid
Pass at 0.1%
Invalid C
Pass at 0.1%
Invalid C
Pass at 1%
Valid
Vc: 0, 0
Na:<1.5x102
R: >105
Pass at 1%
Valid
Vc: 2. 2
Vc: 0, 0 Na:
Na:< 1.5 x102 <1.5x102
R: >105
R: >105
Vc: 0, 0
Na:<1.5x102
R: >105
Pass at 0.1%
Valid
Vc: >300,>300 Vc: 0, 0 Na:
Na:>3.0x10 3 <1.5x102
R: <105
R: >105
Vc: 0, 0
Na:<1.5x10 2
R: >105
Pass at 1%
Valid
Vc: 0, 0 Na:
<1.5x102
R: >105
Vc: 0, 0
Na:<1.5x10 2
R: >106
Pass at 0.1%
Valid
Page 8 of 9
Vc: 0, 0
Na:<1.5x10 2
R: >105
Pass at 1%
Valid
WPRef.:hygiene/2009/Contract/ldeal Manufacturing/
EN1276Termisan
TABLE 4 - RESULTS AND VALIDATIONS FOR ADDITIONAL ORGANISMS (Membrane Filtration)
Test
criteria
Test
suspension
Validation Test
Listeria
monocytogenes
FH 66/c Clean
Vc: 170, 170
-2: 16, 17
Nv:1.7x103
Listeria
monocytogenes
FH 66/c Dirty
Vc: 170, 170
-2: 16, 17
Nv:1.7x103
Vc: 125, 120 Vc: 135, 130 Vc: 120, 121
A: 1.2x103
Vc:
C: 1.2x103
134,130 Vc: 135, 130 Vc: 128, 128
A: 1.3x103
Report No.: FH/REP/117506/1
B:1.3x10 3
B: 1.3x103
C: 1.3x103
Test procedure at concentration % (v/v)
cfu/ml in
test pot
0.1%
1%
Result
5%
Vc: >300 >300 - 3.4x10 7
7: 32,35
N:3.4x10 8
Vc : 5, 4
Na:<1.5x102
R: >105
Vc: 0, 0
Na:<1.5x 102
R: >105
Vc: 0, 0 Na:<
1.5 x102
R: >105
Vc: >300,>300 - 3.4x10 7
7: 32,35
N:3.4x10 8
Vc: 13,14
Na^LSxIO 2
R:>105
Vc: 0, 0
Na:<1.5x102
R:>105
Vc: 0, 0
Na:<1.5x102 R:
>105
Page 9 of 9
Pass/Fail/
Invalid
Pass at 0.1%
Valid
Pass at 0.1%
Valid
WPRef.:hygiene/2009/Contract/ Ideal Manufacturing/
EN1276Termisan