Premier-WFI Klercide 60/40 Sterile IPA Advantages

Premier-WFI Klercide 60/40 Sterile IPA
Sterile spore free 60/40 v/v IPA blended with highest grade (EP) Water for Injection.
Advantages
•
High quality product
The product is blended with the highest grade (EP) Water for
Injection, with guaranteed endotoxin levels below 0.25 EU/ml.
They are double bagged for easy transfer into Grade A and B
cleanrooms and gamma irradiated to ensure a sterile, spore free
product.
•
Guaranteed sterility during use
The SteriShield Delivery System on the trigger spray format has
been validated to give an in-use shelf life of three months, so
there is no need to discard unused product.
•
Reduction in atmospheric alcohol
By having a concentration of 60% instead of the traditional 70% concentration, results in a
reduction of the atmospheric alcohol available if the same quantity of product is used.
Description
Premier-WFI Klercide 60/40 IPA is a blend of 60% isopropyl alcohol with Water for Injection.
Endotoxin levels for this product are guaranteed to be below 0.25 EU/ml.
The alcohol blend is 0.2 micron filtered, filled and double bagged under Grade A (ISO Class 5)
laminar air flow in a Grade C (ISO Class 7) cleanroom, before irradiation using a validated
process at no less than 25 kGy.
All trigger spray bottles incorporate the patented SteriShield Delivery System and an adjustable
trigger spray. The unique way in which the SteriShield Delivery System works as a closed system
ensures that the sterility of the contents is preserved throughout use.
Use biocides safely. Always read the label and product information before use.
Technical Specification
Product Composition
Premier-WFI Klercide 60/40 Sterile IPA consists of a v/v
formulation of 60% IPA blended with 40% Water for
Injection
Colour
Colourless
Odour
Characteristic of IPA
Clarity
Clear
Specific Gravity
0.898 – 0.908
Refractive Index
22 – 24
Production
Premier-WFI Klercide 60/40 IPA is filtered to 0.2 micron
and bottled in a Grade C cleanroom
Packaging
All products are cleanroom packed and double bagged
All sprays are manufactured utilising the SteriShield
Delivery System.
Sterility
Premier-WFI Klercide 60/40 IPA is sterilised by gamma
irradiation at not less than 25kGy
The efficacy of Isopropyl Alcohol (IPA)
Efficacy testing of all alcohol products manufactured by Shield Medicare Ltd is performed to
the following standards:A.
British Standard 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.
B.
British Standard BS EN 1650: 1998
Chemical Disinfectants and Antiseptics - Quantitative suspension test for the evaluation of
fungicidal activity of chemical disinfectants and antiseptics used in food, industrial,
domestic and institutional areas.
C.
British Standard BS EN 13697:2001
Chemical Disinfectants and Antiseptics - Quantitative non-porous surface test for the
evaluation of bactericidal and/or fungicidal activity of chemical disinfectants used in food,
industrial, domestic and institutional areas.
Test: BS EN 1276:1997
BS EN 1276:1997 employs the following standard organisms.
Organism
Pseudomonas aeruginosa
Escherichia coli
Staphylococcus aureus
Enterococcus hirae
ATCC
ATCC
ATCC
ATCC
Strain
15442
10536
6538
10541
Test Method
1. A Test suspension of bacteria in a solution of interfering substances is added to a
prepared sample of the product under test diluted in hard water. The mixture is
maintained at 20°C ±1°C for 5 minutes ±10s
2. At this contact time an aliquot is taken; the bactericidal and or the bacteriostatic action
in this portion is immediately neutralised or suppressed by a validated method. The
method of choice is dilution neutralisation. If a suitable neutraliser cannot be found,
membrane filtration is used.
3. The number of surviving bacteria in each sample is determined and the reduction in
viable counts is calculated.
Test: BS EN 1650:1998
BS EN 1650:1998 employs the following standard organisms
Organism
Strain
Candida albicans
ATCC 102311
Aspergillus niger
ATCC 16404
Test Method
1. A test suspension of yeast cells or mould spores in a solution of interfering substances
is added to a prepared sample of the product under test diluted in hard water.
2. The mixture is maintained at 20°C ±1°C for 15 mins ±10s (required test conditions).
3. After this contact time an aliquot is taken: the fungicidal action of this portion is
immediately neutralised or suppressed by a validated method. The method of choice is
dilution neutralisation. If a suitable neutraliser cannot be found membrane filtration is
used.
4. The number of surviving yeast or mould cells in each sample is determined and the
reduction in viable counts is calculated.
Test: BS EN 13697:2001
BS EN 13697:2001 employs the following standard organisms.
Organism
Pseudomonas aeruginosa
Escherichia coli
Staphylococcus aureus
Enterococcus hirae
Candida albicans
Aspergillus niger
ATCC
ATCC
ATCC
ATCC
ATCC
ATCC
Strain
15442
10536
6538
10541
102311
16404
Test Method
1. A test suspension of bacteria or fungi in a solution of interfering substances is
inoculated onto a test stainless steel surface and dried. A prepared sample of the
product under test is applied in a manner which covers the dried film. The surface is
maintained at between 18°C ±1°C and 25°C ±1°C for 5 minutes for bacteria and 15
minutes for fungi.
2. The surface is transferred to a previously validated neutralisation medium so that the
action of the disinfectant is immediately neutralised.
3. The number of surviving organisms that can be recovered from the surface is
determined quantitatively. The number of bacteria on a surface treated with hard water
in place of the disinfectant is also determined and the reduction in viable counts
attributed to the product is calculated by the difference.
Results of efficacy testing on IPA products
Table 1: BS EN 1276:1997
Organism
Pass
Criteria
Test Results
Log Reduction
Clean
Pass/Fail
Validation
Method Used
P.aeruginosa
Log 5
Reduction
>5.50
PASS
PASS
Dilution
Neutralisation
E.coli
Log 5
Reduction
>5.46
PASS
PASS
Dilution
Neutralisation
E.hirae
Log 5
Reduction
>5.37
PASS
PASS
Dilution
Neutralisation
S.aureus
Log 5
Reduction
>5.51
PASS
PASS
Dilution
Neutralisation
Validation
Method Used
Table 2: BS EN 1650:1998
Organism
Pass
Criteria
Test Results
Log Reduction
Clean
Pass/Fail
A.niger
Log 4
Reduction
1.02
FAIL
PASS
Dilution
Neutralisation
C.albicans
Log 4
Reduction
>4.42
PASS
PASS
Dilution
Neutralisation
Table 3: BS EN 13697:2001
Organism
Pass
Criteria
Test
Conditions
Result
Log Reduction
Validation
Method Used
Stainless Steel
P.aeruginosa
Log 4
Reduction
Clean
>6.30
PASS
PASS
Pour plate
E.coli
Log 4
Reduction
Clean
>6.25
PASS
PASS
Pour plate
E.hirae
Log 4
Reduction
Clean
>6.29
PASS
PASS
Pour plate
S.aureus
Log 4
Reduction
Clean
>6.24
PASS
PASS
Pour plate
C.albicans
Log 3
Reduction
Clean
>4.74
PASS
PASS
Pour plate
A.niger
Log 3
Reduction
Clean
0.54
FAIL
PASS
Pour plate
Mode of action of Alcohols
Alcohols like isopropyl alcohol and ethanol are optimally bactericidal in aqueous solution at
concentrations of 50% to 80%, and have very little bactericidal effect outside this range, e.g.
when 'absolute' or diluted too much.
Alcohols represent the group of substances, which most rapidly and efficiently reduces the
number of micro-organisms on the skin. They are microbiocidal against bacteria including
mycobacteria, fungi and especially lipid containing virus. They are not active against spores
and non-lipid containing viruses.
The mode of action of alcohols revolves around their ability to denature proteins, and affect the
cell membranes of bacteria.
Denaturation of protein by Alcohols
Proteins are essential to the function and growth of all living organisms and are involved in all
of the necessary functions for life.
Alcohols act to change the configuration of these proteins and as such prevent them from
performing their specific functions. For example, enzymes which work on the specific
configuration mechanism by the interaction of substrate, product and enzyme become non
functional as exposure to 50% to 80% alcohols at the binding site by which the substrate and
enzyme interact is altered in such a way that that binding is not possible.
This was demonstrated by work performed by Dudley et al (1950) that showed an increase in
the lag phase of Enterobacter aerogenes when in the presence of 0.41M concentrations of
Ethanol, however this effect was decreased in the presence of amino acids.
This showed that the alcohol inhibited the action of the enzymes and thus interfered with the
metabolism of the bacteria.
Cell membrane disruption
Alcohols have the capacity to dissolve lipids and therefore have a lytic effect on the membrane
of cells. All bacteria employ a bi lipid phosphoglycerol based membrane structure within cell
walls.
When the cell membrane comes into contact with 50 – 80% alcohol solutions the surface
tension of the membrane is lowered which allows extracellular water present in the surrounding
environment to pass via osmosis through the membrane resulting in bacterial lysis.
This was demonstrated by work performed by Pulverstaft and Lumb (1948) that showed the
lysis of micro-organisms. Lysis was most marked with staphylococci, pneumococci, Bacillus
subtilis and Escherichia coli.
KC020E-3
Shield Medicare Limited
Cheyenne House West Street Farnham GU9 7EQ UK
Telephone +44 (0)1252 717616 Facsimile +44 (0)1252 715269
[email protected] www.shieldmedicare.com