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Penetration tests according to the ISO 11140


Josephus P.C.M van Doornmalen Gomez Hoyos
Croatia, March 27, 2009
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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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The task of the BDT


The task of the BDT is to check pre-vacuum sterilisers
independently from their own gauges etc. for:
Air removal
Steam penetration
Routine (Daily) test
for (steam) sterilizer

Steam

?
Air

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The History of the Bowie and Dick Test


First mentioned in 1961:
"Recent Developments in the Sterilization of Surgical
Materials";
Report of a symposium organised by the Pharmaceutical
Society of Great Britain
Description of the Test in 1963:
"THE BOWIE AND DICK
AUTOCLAVE TAPE TEST"
THE LANCET, March 16, 1963
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The original Bowie and Dick Test Pack


29 "Huckaback-Towels"
Each 36 x 24 inch in size (91 x 61 cm)
Washed prior to the test
Unfolded and aired prior to a test for at least one hour
Folded 3 times to give 8 layers
Stack 11 inch high (28 cm)

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The original Bowie and Dick Test Pack


2 lengths of 12 inch (30 cm)
autoclave tape, "type 1222"
(Minnesota Mining and Manufacturing Company)

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 original "Huckaback Towel Pack" as set up by


Dr. J. H. Bowie and Mr. J. Dick

THE BOWIE AND DICK AUTOCLAVE TAPE TEST, The Lancet, (1963), S.586
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Reasons for BDT failure


Bad vacuum
Leak
Non-condensable
gases

250 ml
residual air
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Process: Vacuum assisted sterilisers

Phase 3:
Drying and
pressure equilibration

Pressure

Phase 1:
Conditioning

Phase 2:
Sterilization

Time

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Bowie and Dick: CEN Towel Pack


EN 285 (26.1)
Plain, bleached cotton
sheets
Size: 90 x 120 cm
Threads: warp 30 +/- 6
weft 27 +/- 5
Stack size: 22 x 30 x 25 cm
Wrapped in similar fabric
Weight: 7 kg +/- 10%
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CEN Towel Pack

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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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Bowie and Dick package simplified

25 cm
22 cm
30 cm
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Steam sterilization process


Start of sterilization phase
Steam sterilization condition

Pressure

Steam injection

Time
Suction
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Pressure

Air (gas mix) removal

Time

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Pressure

Steam injection

Time

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Steam penetration and condensation

Condensation front

Gases sucked out, textile stays wet

Good penetration
Time

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Insufficient deep vacuum


 Condense front will not disappear

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Effect NCGs
Steam Injection
(Steam with NCGs)

O2 ,

N2,

CO2,

H2O

Steam injection, pressure increasing


Condensation of water
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None condensable gases in steam


 Water vapour condenses on surfaces colder than the
vapour
 Gases that will not condense in similar conditions are called
None Condensable Gases
 Oxygen (O2), Nitrogen (N2), Carbon dioxide (CO2)

 Possibilities of introduced in the steam:


 Feed water
 Too small dimension of steam boiler
 Leak in pipe work, vessel
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Non-condensable gases
steam
steam

steam

steam

NCGs do not change their volume


during condensation.
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The temperature depression


Example
Temperature
depression
Temperature:

5K

130C
Temperature:
135C
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Drain

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The Air Pocket

Animation

The air pockets form is not a perfect ball,


but egg shaped.

At 10 cm height
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at 4,5 cm height

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Slow warming up
Phase 3:
Drying and
pressure equilibration

Pressure

Phase 1:
Conditioning

Phase 2:
Sterilization

Time

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When to perform a penetration test


 EN 554
 6.3.4 Process control and monitoring: "If the sterilization
process includes air removal from the product, a steam
penetration test shall be carried out at the commencement
of each day the sterilizer is to be used."
 A.4.3 Routine monitoring and testing:
"e) a steam penetration test (when specified).
Note. A suitable penetration test for a saturated steam
process is being prepared by CEN/TC 102.
 CEN/TC102 WG7 prepared EN 867-4
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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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What the norms say


 Towel pack according to EN 285 with:
an Indicator test sheet in compliance with EN ISO 11140-3
or
alternative indicators according to EN ISO 11140-4

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Examples hollow instruments

Lumen

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Helix

Examples

Helix schematically

Tube

Receptacle

Lumen

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Lumen as representative for lumen

Lumen
 Dimension of the tube:
 Length of the tube

Material of lumen

 Radius of the tube

 Multi layers of different


materials

 Thickness of the tube

 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

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Configuration of instruments

Relatively difficult to penetrate

Relatively easy to penetrate

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Swirl

Swirl

 Well known and described phenomena


Axial dispersion and flow phenomena in helically coiled tubular reactors for flow analysis and
chromatography, R. Tijssen, Analytica Chimica Acta, 114, 1980, 71-89:

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Wall thickness

Wall thickness
More heat capacity
(e.g., more condensation)
Heat transfer

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Research ongoing

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Dimensions of tube
Radius

Length

Research ongoing
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EN ISO 11140-4 and EN 867-5


 The helix or hollow A is postulated in the EN867-5 and is to
be used in small sterilizers (type B and S processes
according to EN13060)
 Steam penetration test for large sterilizers (EN285) should
be a Bowie & Dick test or an alternative, as described in the
EN ISO 11140-4
 So far, no scientific proof has been found in literature (1).
(1)

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Publications in a scientific journal with an impact factor

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Proving for alternative tests


 Show that the alternative test is reacting as the original
Bowie and Dick test.
 Experimental data Bowie and Dick test
 Experimental data for alternative
 Comparison between data Bowie and Dick test and alternative
test
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Hollow A and helix


 Is the hollow A of Helix a good representation of your
instruments with narrow lumen?
 Is a postulated test
 Postulates for small sterilizers type B and S

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Current situation
 At this moment there only:
 B&D test or alternative big sterilizers
 Postulated test for small sterilizers

 ISO working group is started to write ISO 11140 part 6


 This standards is meant to address Process Challenge
Devices
 Research concerning penetration in lumen is on going

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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

 Research and data are needed

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