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Decon Acid Rinse: Certificate of Analysis

Product
Laboratory Reference Number
Manufacturer

Date of receipt
Storage conditions
Active substance(s)
Decon Acid Rinse
00188084
Decon Laboratories Limited
Conway Street, Hove, East Sussex
06 March 2001
Room temperature
Not known
Test method and its validation
Method
Neutralizer

Dilution-neutralization
30g/l Polysorbate 80, 3.0 g/l Lecithin in phosphate
buffer pH 7.0 ± 0.2, sterilized in the autoclave
Experimantal conditions
Period of analysis
Product test concentrations
Test temperature
Contact time
Temperature of incubation

02 May 2001 - 04 May 2001
2 ml/l, 4 ml/l, 8 ml/l
20°C ± 1°C
60 min
36°C ± 1°C
Test organism Bacterial test
suspension count
Bacterial suspension
count Nv
Neutralizer
Toxicity Control
Dilution
Neutralizer Control
Pseudomonas
aeruginosa
2.5 x 108 1.4 x 103 126 123
Staphylococcus
aureus
1.9 x 108 1.5 x 103 105 89
Acceptance
criteria met
Yes Yes Yes Yes
Acceptance
criteria
1.5 x 108 to 5.0 x 108 6 x 102 to 3 x 103 0.05 Nv 0.05 Nv
The neutralization is validated with the neutralizer tested for the concentration of 8ml/l of product as received and for the two strains tested.
Test organism Mean Viable Counts (cfu/ml) for test mixture at concentrations:
2.0% v/v 4.0% v/v 8.0% v/v
Pseudomonas
aeruginosa
<150 <150 <150
Staphylococcus
aureus
820 <150 <150
Reduction in viability
at test concentration
2.0% v/v 4.0% v/v 8.0% v/v
Pseudomonas
aeruginosa
5.2 5.2 5.2
Staphylococcus
aureus
4.4 5.1 5.1
Conclusion
According to EN 1040: 1997 product Decon Acid Rinse possesses bacterial activity for the referenced strains of Pseudomonas aeruginosa ATCC 15442 at 2%, 4% and 8% and Staphylococcus aureus ATCC 6538 at 4% and 8%. In order to qualify the product as an antiseptic and/or chemical disinfectant for a defined purpose, it will be evaluated using additional standard tests which are appropriate to its intended use.
Decon e decomatic sono marchi depositati della Decon Laboratories Limited, GB,
registrati in GB e all’estero.


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