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DE10046427A1 - Bioindicator for determining the effectiveness of a sterilization process, comprises an intermediate layer made of a material which is non-porous to ethylene oxide - Google Patents

Bioindicator for determining the effectiveness of a sterilization process, comprises an intermediate layer made of a material which is non-porous to ethylene oxide

Info

Publication number
DE10046427A1
DE10046427A1 DE2000146427 DE10046427A DE10046427A1 DE 10046427 A1 DE10046427 A1 DE 10046427A1 DE 2000146427 DE2000146427 DE 2000146427 DE 10046427 A DE10046427 A DE 10046427A DE 10046427 A1 DE10046427 A1 DE 10046427A1
Authority
DE
Germany
Prior art keywords
ethylene oxide
bioindicator
effectiveness
intermediate layer
sterilization process
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
DE2000146427
Other languages
German (de)
Inventor
Klaus Elmer
Edgar Bormann
Peter Ludt
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Rose fur Medizintechnik GmbH
Original Assignee
Rose fur Medizintechnik GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Rose fur Medizintechnik GmbH filed Critical Rose fur Medizintechnik GmbH
Priority to DE2000146427 priority Critical patent/DE10046427A1/en
Publication of DE10046427A1 publication Critical patent/DE10046427A1/en
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/26—Accessories or devices or components used for biocidal treatment
    • A61L2/28—Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour

Landscapes

  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

A bioindicator (6) which is placed on top of an ethylene oxide absorbing surface of a test piece to determine the effectiveness of an ethylene oxide sterilization process, has an intermediate layer placed between it and the test piece. The intermediate layer is non-porous to ethylene oxide.

Description

Die Erfindung betrifft eine Anordnung eines Bioindikators auf einer Ethylenoxid absorbierenden Oberfläche eines Prüflings zum Nachweis der Wirksamkeit eines Ethylenoxid-Sterilisations­ prozesses.The invention relates to an arrangement of a bio-indicator an ethylene oxide absorbing surface of a test piece for Evidence of the effectiveness of an ethylene oxide sterilization process.

Bei der Validierung des Ethylenoxid-Sterilisationsprozesses von Medizinprodukten und Verpackungsmitteln für Arzneimittel muss die Inaktivierung von Mikroorganismen nachgewiesen werden. Hierzu werden in der Regel beimpfte Keimträger in die am schwersten zu sterilisierenden Teile der zu untersuchenden Produkte eingebracht.When validating the ethylene oxide sterilization process from Medical devices and packaging materials for pharmaceuticals must the inactivation of microorganisms can be demonstrated. For this purpose, inoculated germ carriers are usually in the on heaviest parts to be sterilized of the parts to be examined Products introduced.

Insbesondere bei diesen schwierig zugänglichen Stellen liegt oftmals der Indikator dicht auf der Oberfläche der zu prüfenden Produkte auf. Die Erfahrung zeigt, dass sich der D-Wert der Keiminaktivierung beim Andrücken des Bioindikators an eine Ethylenoxid absorbierende Oberfläche gegenüber einem lose im Prüfkörper befindlichen Keimträger verändert. Wird der Bioindikator an eine Ethylenoxid absorbierende. Oberfläche gedrückt, zeigt er eine andere Abtötungskinetik, als ein Keimträger, der sich lose im Prüfkörper befindet. Die während einer Ethylenoxid-Sterilisation erzielten Keimreduzierungen sind im Fälle des Andrückens trotz konstanter Behandlungsparameter, nicht immer reproduzierbar. Especially in these difficult to access places often the indicator is close to the surface of the test item Products on. Experience shows that the D value of the Germ inactivation when pressing the bio-indicator on a Ethylene oxide absorbing surface against a loose one Test specimen located germ carrier changed. Will the Bio-indicator of an ethylene oxide absorbent. surface pressed, it shows a different kinetics of killing than one Germ carrier, which is loosely in the test specimen. The while sterilization achieved by means of ethylene oxide sterilization are constant in the case of pressing despite Treatment parameters, not always reproducible.  

Zur Lösung dieses Problems wird nun vorgeschlagen, dass der Indikator unter Zwischenlage einer für Ethylenoxid undurchlässigen Schicht am Prüfling angebracht wird.To solve this problem, it is now proposed that the Intermediate indicator for ethylene oxide impermeable layer is attached to the test specimen.

Vorzugsweise ist die Ethylenoxid undurchlässige Schicht eine Metallschicht.Preferably, the layer impermeable to ethylene oxide is one Metal layer.

Vorzugsweise besteht die Ethylenoxid undurchlässige Schicht aus PTFE (Polytetrafluorethylen).The ethylene oxide impermeable layer preferably consists of PTFE (polytetrafluoroethylene).

Die Erfindung ist in der Zeichnung beispielhaft dargestellt.The invention is exemplified in the drawing.

Die Zeichnung zeigt den vorderen Teil einer dreiteiligen Spritze 1 mit einem Dichtkolben 2. Der am schwierigsten zu sterilisierende Bereich der Spritze 1 ist der Raum 3 zwischen den Dichtlippen 4 und 5 des Kolbens 2 und der Spritze. Wird der Bioindikator 6 in den Raum 3 eingebracht, so sind die erzielten Keimreduzierungen oftmals nicht befriedigend.The drawing shows the front part of a three-part syringe 1 with a sealing piston 2 . The area of the syringe 1 that is the most difficult to sterilize is the space 3 between the sealing lips 4 and 5 of the plunger 2 and the syringe. If the bioindicator 6 is introduced into the room 3 , the bacterial reductions achieved are often unsatisfactory.

Wird jedoch zusätzlich eine für Ethylenoxid undurchlässige Schicht 7 aus Metall oder aus PTFE (Polytetrofluorethylen) in den Raum 2 eingebracht, so werden eindeutige und reproduzierbare Sterilisationsergebnisse erhalten.However, if a layer 7 made of metal or of PTFE (polytetrofluoroethylene) which is impermeable to ethylene oxide is additionally introduced into the room 2 , clear and reproducible sterilization results are obtained.

Es wird vermutet, dass die zusätzliche für Etylenoxid undurchlässige Schicht 7 das Abwandern des Ethylenoxidgases in den Prüfling, hier in den Kolben 2 verhindert bzw. verlangsamt, sodass eine ausreichende Konzentration zur Sterilisation zur Verfügung steht.It is assumed that the additional layer 7 impermeable to ethylene oxide prevents or slows down the migration of the ethylene oxide gas into the test specimen, here into the flask 2 , so that a sufficient concentration is available for sterilization.

Claims (3)

1. Anordnung eines Bioindikators auf einer Ethylenoxid absorbierenden Oberfläche eines Prüflings zum Nachweis der Wirksamkeit eines Ethylenoxid-Sterilisationsprozesses, dadurch gekennzeichnet, dass der Indikator (6) unter Zwischenlage einer für Ethylenoxid undurchlässigen Schicht (7) am Prüfling angebracht, ist.1. Arrangement of a bioindicator on an ethylene oxide absorbing surface of a test specimen to demonstrate the effectiveness of an ethylene oxide sterilization process, characterized in that the indicator ( 6 ) is attached to the test specimen with the interposition of a layer ( 7 ) impermeable to ethylene oxide. 2. Anordnung nach Anspruch 1, dadurch gekennzeichnet, dass die für Ethylenoxid undurchlässige Schicht (7) eine Metallschicht ist.2. Arrangement according to claim 1, characterized in that the layer impermeable to ethylene oxide ( 7 ) is a metal layer. 3. Anordnung nach Anspruch 1, dadurch gekennzeichnet, dass die für Ethylenoxid undurchlässige Schicht (7) aus PTFE (Polytetrofluorethylen) besteht.3. Arrangement according to claim 1, characterized in that the layer ( 7 ) impermeable to ethylene oxide consists of PTFE (polytetrofluoroethylene).
DE2000146427 2000-09-20 2000-09-20 Bioindicator for determining the effectiveness of a sterilization process, comprises an intermediate layer made of a material which is non-porous to ethylene oxide Withdrawn DE10046427A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
DE2000146427 DE10046427A1 (en) 2000-09-20 2000-09-20 Bioindicator for determining the effectiveness of a sterilization process, comprises an intermediate layer made of a material which is non-porous to ethylene oxide

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE2000146427 DE10046427A1 (en) 2000-09-20 2000-09-20 Bioindicator for determining the effectiveness of a sterilization process, comprises an intermediate layer made of a material which is non-porous to ethylene oxide

Publications (1)

Publication Number Publication Date
DE10046427A1 true DE10046427A1 (en) 2002-04-04

Family

ID=7656850

Family Applications (1)

Application Number Title Priority Date Filing Date
DE2000146427 Withdrawn DE10046427A1 (en) 2000-09-20 2000-09-20 Bioindicator for determining the effectiveness of a sterilization process, comprises an intermediate layer made of a material which is non-porous to ethylene oxide

Country Status (1)

Country Link
DE (1) DE10046427A1 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012092684A1 (en) 2011-01-05 2012-07-12 Skan Ag Bioindicator

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5942408A (en) * 1996-07-29 1999-08-24 Christensen; Dennis E. Process challenge device and method
US5955296A (en) * 1997-01-27 1999-09-21 Steritec Products Inc. Biological test pack for ethylene oxide sterilization

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5942408A (en) * 1996-07-29 1999-08-24 Christensen; Dennis E. Process challenge device and method
US5955296A (en) * 1997-01-27 1999-09-21 Steritec Products Inc. Biological test pack for ethylene oxide sterilization

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012092684A1 (en) 2011-01-05 2012-07-12 Skan Ag Bioindicator
CH704312A1 (en) * 2011-01-05 2012-07-13 Skan Ag Bioindicator.

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OP8 Request for examination as to paragraph 44 patent law
8130 Withdrawal