Penetration Tests According To The ISO 11140

Medical Market Laboratory EMEA
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Penetration tests according to the ISO 11140

Josephus P.C.M van Doornmalen Gomez Hoyos
Croatia, March 27, 2009
3M 2008. All Rights Reserved.
Medical Markets Laboratory (Europe)
Outline
Purpose penetration tests
Original Bowie and Dick test
Alternatives for original Bowie and Dick test
Norms
Conclusions
2
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
3
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
4
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
5
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)
6
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
7
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
8
Reasons for BDT failure

Bad vacuum
Leak
Non-condensable
gases
250 ml
residual air
9
Process: Vacuum assisted sterilisers
Phase 3:
Drying and
pressure equilibration
Pressure
Phase 1:
Conditioning
Phase 2:
Sterilization
Time
10
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%
11
CEN Towel Pack
EN 285:2006+A1:2008 (E)
Bowie and Dick package
and test defined
Dimensions
Material
Way of folding
Conditioning
12
Bowie and Dick package simplified
25 cm
22 cm
30 cm
13
Steam sterilization process

Start of sterilization phase
Steam sterilization condition
Pressure
Steam injection
Time
Suction
14
Pressure
Air (gas mix) removal
Time
15
Pressure
Steam injection
Time
16
Steam penetration and condensation
Condensation front
Gases sucked out, textile stays wet
Good penetration
Time
17
Insufficient deep vacuum

Condense front will not disappear
18
Effect NCGs
Steam Injection
(Steam with NCGs)
O2 ,
N2,
CO2,
H2O
Steam injection, pressure increasing

Condensation of water
19
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
20
Non-condensable gases
steam
steam
steam
steam
NCGs do not change their volume

during condensation.
21
The temperature depression

Example
Temperature
depression
Temperature:
5K
130C
Temperature:
135C
22
Drain
The Air Pocket
Animation
The air pockets form is not a perfect ball,

but egg shaped.
At 10 cm height
23
at 4,5 cm height
Slow warming up
Phase 3:
Drying and
pressure equilibration
Pressure
Phase 1:
Conditioning
Phase 2:
Sterilization
Time
24
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
25
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.
26
Alternative Products
Alternative Bowie & Dick
Test products
Increased reproducibility
Constant test conditions
Performance requirements
are covered by a
dedicated standard
(EN ISO 11140 - 4)
27
31300
Disposable Test
Pack
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
28
Examples hollow instruments
Lumen
29
Helix
Examples
Helix schematically
Tube
Receptacle
Lumen
30
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)
31
Pressure
Penetration in lumen
Time
Length = L
Length = L
32
Closed end
Configuration of instruments
Relatively difficult to penetrate
Relatively easy to penetrate
33
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:
34
Wall thickness
Wall thickness
More heat capacity
(e.g., more condensation)
Heat transfer
35
Research ongoing
Dimensions of tube
Radius
Length
Research ongoing
36
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)
37
Publications in a scientific journal with an impact factor
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
11
12
35
38
13
14
15
16
17 18 19
22
21 20
24 25 26
27 28 29 30 31
32 33 34
36
38 37
39 40 41
42
43
44
45
46
47
23
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
39
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
40
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
41

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Penetration Tests According To The ISO 11140

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Medical Market Laboratory EMEA

Space for 3M Montage

Penetration tests according to the ISO 11140

Medical Markets Laboratory (Europe)

Medical Markets Laboratory (Europe)

Medical Markets Laboratory (Europe)

The task of the BDT

Medical Markets Laboratory (Europe)

The History of the Bowie and Dick Test

Medical Markets Laboratory (Europe)

The original Bowie and Dick Test Pack

Medical Markets Laboratory (Europe)

The original Bowie and Dick Test Pack

Medical Markets Laboratory (Europe)

The original "Huckaback Towel Pack" as set up by

Medical Markets Laboratory (Europe)

Reasons for BDT failure

Medical Markets Laboratory (Europe)

Process: Vacuum assisted sterilisers

Medical Markets Laboratory (Europe)

Bowie and Dick: CEN Towel Pack

CEN Towel Pack

Medical Markets Laboratory (Europe)

Medical Markets Laboratory (Europe)

Bowie and Dick package simplified

Medical Markets Laboratory (Europe)

Steam sterilization process

Medical Markets Laboratory (Europe)

Air (gas mix) removal

Medical Markets Laboratory (Europe)

Medical Markets Laboratory (Europe)

Steam penetration and condensation

Gases sucked out, textile stays wet

Medical Markets Laboratory (Europe)

Insufficient deep vacuum

Medical Markets Laboratory (Europe)

Steam injection, pressure increasing

Medical Markets Laboratory (Europe)

None condensable gases in steam

Possibilities of introduced in the steam:

Medical Markets Laboratory (Europe)

NCGs do not change their volume

Medical Markets Laboratory (Europe)

The temperature depression

Medical Markets Laboratory (Europe)

The Air Pocket

The air pockets form is not a perfect ball,

Medical Markets Laboratory (Europe)

Medical Markets Laboratory (Europe)

When to perform a penetration test

Medical Markets Laboratory (Europe)

Medical Markets Laboratory (Europe)

Medical Markets Laboratory (Europe)

What the norms say

Medical Markets Laboratory (Europe)

Examples hollow instruments

Medical Markets Laboratory (Europe)

Medical Markets Laboratory (Europe)

Lumen as representative for lumen

Radius of the tube

Multi layers of different

Thickness of the tube

Medical Markets Laboratory (Europe)