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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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Medical Markets Laboratory (Europe)

Outline 
Purpose penetration tests 
Original Bowie and Dick test 
Alternatives for original Bowie and Dick test 
Norms 
Conclusions

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Medical Markets Laboratory (Europe)

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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Medical Markets Laboratory (Europe)

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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All Rights Reserved. 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. 1963 5 © 3M 2008. .Medical Markets Laboratory (Europe) The History of the Bowie and Dick Test • First mentioned in 1961: "Recent Developments in the Sterilization of Surgical Materials". March 16.

All Rights Reserved. .Medical Markets Laboratory (Europe) 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 © 3M 2008.

. All Rights Reserved.Medical Markets Laboratory (Europe) 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. Andrew’s cross on a sheet of unglazed paper • In the middle of the stack 7 © 3M 2008.

S. J.586 8 © 3M 2008. The Lancet. Bowie and Mr.Medical Markets Laboratory (Europe) The original "Huckaback Towel Pack" as set up by Dr. (1963). All Rights Reserved. Dick THE BOWIE AND DICK AUTOCLAVE TAPE TEST. . J. H.

Medical Markets Laboratory (Europe) Reasons for BDT failure • Bad vacuum • Leak • Non-condensable gases 250 ml residual air 9 © 3M 2008. . All Rights Reserved.

.Medical Markets Laboratory (Europe) Process: Vacuum assisted sterilisers Phase 3: Drying and pressure equilibration Pressure Phase 1: Conditioning Phase 2: Sterilization Time 10 © 3M 2008. All Rights Reserved.

bleached cotton sheets • Size: 90 x 120 cm • Threads: warp 30 +/.5 • Stack size: 22 x 30 x 25 cm • Wrapped in similar fabric • Weight: 7 kg +/.6 weft 27 +/.10% 11 © 3M 2008. All Rights Reserved.1) • Plain. CEN Towel Pack .Medical Markets Laboratory (Europe) Bowie and Dick: CEN Towel Pack • EN 285 (26.

Medical Markets Laboratory (Europe) EN 285:2006+A1:2008 (E)  Bowie and Dick package and test defined  Dimensions  Material  Way of folding  Conditioning 12 © 3M 2008. All Rights Reserved. .

All Rights Reserved. .Medical Markets Laboratory (Europe) Bowie and Dick package simplified 25 cm 22 cm 30 cm 13 © 3M 2008.

Medical Markets Laboratory (Europe) Steam sterilization process Start of sterilization phase Steam sterilization condition Pressure Steam injection Time Suction 14 © 3M 2008. All Rights Reserved. .

All Rights Reserved. .Medical Markets Laboratory (Europe) Pressure Air (gas mix) removal Time 15 © 3M 2008.

Medical Markets Laboratory (Europe) Pressure Steam injection Time 16 © 3M 2008. All Rights Reserved. .

Medical Markets Laboratory (Europe) Steam penetration and condensation Condensation front Gases sucked out. All Rights Reserved. . textile stays wet Good penetration Time 17 © 3M 2008.

Medical Markets Laboratory (Europe) Insufficient deep vacuum  Condense front will not disappear 18 © 3M 2008. . All Rights Reserved.

H2O Steam injection. CO2. All Rights Reserved. N2. pressure increasing Condensation of water 19 © 3M 2008.Medical Markets Laboratory (Europe) Effect NCG’s Steam Injection (Steam with NCG’s) O2 . .

vessel 20 © 3M 2008. Nitrogen (N2). Carbon dioxide (CO2)  Possibilities of introduced in the steam:  Feed water  Too small dimension of steam boiler  Leak in pipe work.Medical Markets Laboratory (Europe) 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). . All Rights Reserved.

All Rights Reserved. . 21 © 3M 2008.Medical Markets Laboratory (Europe) Non-condensable gases steam steam steam steam NCG’s do not change their volume during condensation.

Medical Markets Laboratory (Europe) The temperature depression Example Temperature depression Temperature: 5K 130°C Temperature: 135°C 22 © 3M 2008. Drain . All Rights Reserved.

but egg shaped. All Rights Reserved.5 cm height . at 4. At 10 cm height 23 © 3M 2008.Medical Markets Laboratory (Europe) The Air Pocket Animation The air pocket’s form is not a perfect ball.

.Medical Markets Laboratory (Europe) Slow warming up Phase 3: Drying and pressure equilibration Pressure Phase 1: Conditioning Phase 2: Sterilization Time 24 © 3M 2008. All Rights Reserved.

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.3.4.3 Routine monitoring and testing: "e) a steam penetration test (when specified). Note. .  CEN/TC102 WG7 prepared EN 867-4 25 © 3M 2008. All Rights Reserved. A suitable penetration test for a saturated steam process is being prepared by CEN/TC 102."  A.Medical Markets Laboratory (Europe) When to perform a penetration test  EN 554  6.

."  A. 26 © 3M 2008. All Rights Reserved.3.”  Statements to the same effect can be found in EN 554 which will be replaced by EN ISO 17665.6.2 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.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.1.Medical Markets Laboratory (Europe) EN ISO 17665  12. a steam penetration test shall be carried out each day before the sterilizer is used.

4) 27 © 3M 2008. 31300 Disposable Test Pack .Medical Markets Laboratory (Europe) Alternative Products • Alternative Bowie & Dick Test products • Increased reproducibility • Constant test conditions • Performance requirements are covered by a dedicated standard (EN ISO 11140 . All Rights Reserved.

.Medical Markets Laboratory (Europe) 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 © 3M 2008. All Rights Reserved.

Medical Markets Laboratory (Europe) Examples hollow instruments Lumen 29 © 3M 2008. . All Rights Reserved.

All Rights Reserved. .Medical Markets Laboratory (Europe) Helix Examples Helix schematically Tube Receptacle Lumen 30 © 3M 2008.

radius tube) 31 © 3M 2008.Medical Markets Laboratory (Europe) 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. All Rights Reserved. .

Medical Markets Laboratory (Europe) Pressure Penetration in lumen Time Length = L Length = L 32 © 3M 2008. All Rights Reserved. Closed end .

. All Rights Reserved.Medical Markets Laboratory (Europe) Configuration of instruments Relatively difficult to penetrate Relatively easy to penetrate 33 © 3M 2008.

All Rights Reserved. 114. 1980.Medical Markets Laboratory (Europe) Swirl Swirl  Well known and described phenomena Axial dispersion and flow phenomena in helically coiled tubular reactors for flow analysis and chromatography. R. Tijssen. . 71-89: 34 © 3M 2008. Analytica Chimica Acta.

All Rights Reserved.Medical Markets Laboratory (Europe) Wall thickness Wall thickness More heat capacity (e.. more condensation) Heat transfer 35 © 3M 2008. Research ongoing .g.

All Rights Reserved. r .Medical Markets Laboratory (Europe) Dimensions of tube Radius Length Research ongoing 36 © 3M 2008.

as described in the EN ISO 11140-4  So far. Publications in a scientific journal with an impact factor . no scientific proof has been found in literature (1). (1) 37 © 3M 2008. All Rights Reserved.Medical Markets Laboratory (Europe) 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.

All Rights Reserved. 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 .Medical Markets Laboratory (Europe) 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 © 3M 2008.

All Rights Reserved.Medical Markets Laboratory (Europe) 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 © 3M 2008. .

. All Rights Reserved.Medical Markets Laboratory (Europe) 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 © 3M 2008.

All Rights Reserved. .Medical Markets Laboratory (Europe) 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 © 3M 2008.