Penetration Tests According To The ISO 11140
Penetration Tests According To The ISO 11140
Outline
Purpose penetration tests
Original Bowie and Dick test
Alternatives for original Bowie and Dick test
Norms
Conclusions
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Sterilization conditions
Sterilization conditions:
100 % saturated steam
At the aimed temperature, e.g., 134 C
For the right amount of time, e.g., 134 C for 3 minutes
On all surfaces
Textile fibres
Inside of tubes
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Steam
?
Air
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In the form of a
St. Andrews cross on
a sheet of unglazed paper
In the middle of the stack
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THE BOWIE AND DICK AUTOCLAVE TAPE TEST, The Lancet, (1963), S.586
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250 ml
residual air
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Phase 3:
Drying and
pressure equilibration
Pressure
Phase 1:
Conditioning
Phase 2:
Sterilization
Time
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EN 285:2006+A1:2008 (E)
Bowie and Dick package
and test defined
Dimensions
Material
Way of folding
Conditioning
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25 cm
22 cm
30 cm
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Pressure
Steam injection
Time
Suction
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Pressure
Time
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Pressure
Steam injection
Time
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Condensation front
Good penetration
Time
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Effect NCGs
Steam Injection
(Steam with NCGs)
O2 ,
N2,
CO2,
H2O
Non-condensable gases
steam
steam
steam
steam
5K
130C
Temperature:
135C
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Drain
Animation
At 10 cm height
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at 4,5 cm height
Slow warming up
Phase 3:
Drying and
pressure equilibration
Pressure
Phase 1:
Conditioning
Phase 2:
Sterilization
Time
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EN ISO 17665
12.1.6 Process control and monitoring: "If the sterilization process
relies on the removal of air from the sterilizer chamber in order to
achieve rapid and even penetration of steam into the sterilizer load, a
steam penetration test shall be carried out each day before the
sterilizer is used."
A.6.2 Routine monitoring and testing:
"An alternative test pack may be used providing the challenge to the
sterilization process has been demonstrated to be equal to or greater
than the challenge from the standard test pack described in A.3.
Statements to the same effect can be found in EN 554 which will be replaced
by EN ISO 17665.
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Alternative Products
Alternative Bowie & Dick
Test products
Increased reproducibility
Constant test conditions
Performance requirements
are covered by a
dedicated standard
(EN ISO 11140 - 4)
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31300
Disposable Test
Pack
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Lumen
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Helix
Examples
Helix schematically
Tube
Receptacle
Lumen
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Lumen
Dimension of the tube:
Length of the tube
Material of lumen
Heat transfer
Heat capacity
Dimension (length tube,
radius tube)
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Pressure
Penetration in lumen
Time
Length = L
Length = L
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Closed end
Configuration of instruments
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Swirl
Swirl
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Wall thickness
Wall thickness
More heat capacity
(e.g., more condensation)
Heat transfer
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Research ongoing
Dimensions of tube
Radius
Length
Research ongoing
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Current situation
At this moment there only:
B&D test or alternative big sterilizers
Postulated test for small sterilizers
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Conclusions
Penetration is a daily equipment test
Penetration tests must fulfil ISO 11140 part 3 or part 4
Documented evidence for alternative tests must be
available fore end-users:
Experiments
Data
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