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EP1126013B1 - Cleaning composition for medical devices - Google Patents

Cleaning composition for medical devices Download PDF

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Publication number
EP1126013B1
EP1126013B1 EP01100242A EP01100242A EP1126013B1 EP 1126013 B1 EP1126013 B1 EP 1126013B1 EP 01100242 A EP01100242 A EP 01100242A EP 01100242 A EP01100242 A EP 01100242A EP 1126013 B1 EP1126013 B1 EP 1126013B1
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EP
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Prior art keywords
cleaning composition
composition according
weight
cleaning
alkyl group
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.)
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EP01100242A
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German (de)
French (fr)
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EP1126013B2 (en
EP1126013A1 (en
Inventor
Harald Albrecht
Richard Dr. Bloss
Thomas Fehling
Roland Dr. Knieler
Monika Link
Hanns Dr. Pietsch
Dagmar Schulte-Schrepping
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Bode Chemie GmbH and Co KG
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Bode Chemie GmbH and Co KG
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Classifications

    • CCHEMISTRY; METALLURGY
    • C11ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11DDETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D3/00Other compounding ingredients of detergent compositions covered in group C11D1/00
    • C11D3/48Medical, disinfecting agents, disinfecting, antibacterial, germicidal or antimicrobial compositions
    • CCHEMISTRY; METALLURGY
    • C11ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11DDETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D1/00Detergent compositions based essentially on surface-active compounds; Use of these compounds as a detergent
    • C11D1/66Non-ionic compounds
    • C11D1/72Ethers of polyoxyalkylene glycols
    • CCHEMISTRY; METALLURGY
    • C11ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11DDETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D3/00Other compounding ingredients of detergent compositions covered in group C11D1/00
    • C11D3/16Organic compounds
    • C11D3/26Organic compounds containing nitrogen
    • C11D3/33Amino carboxylic acids

Definitions

  • the present invention relates to liquid detergents containing Surfactants, corrosion inhibitors and other additives that enhance the cleaning and their use for cleaning medical instruments, in particular for cleaning flexible endoscopes.
  • Endoscopes are tubular or tubular instruments used for examination used by body cavities and hollow organs. You are with one optical system consisting of lens and eyepiece, a lighting device and mostly rinsing and suction devices and channels for introducing special Equipped instruments.
  • Flexible endoscopes (which are also called fiber endoscopes be designated) are equipped with a glass fiber optic cable, which consists of a densely packed bundles of hair-fine and therefore highly flexible individual fibers. Due to the flexibility of the glass fibers, light and picture can be over virtually any Angled be transmitted.
  • In addition to the fiber bundles and the Bowden cables for the movement of the top are channels for water flushing and air as well as one in the Usually housed larger biopsy and simultaneously suction channel.
  • the endoscopy can be alone, for example, for taking tissue samples, but also in combination with other methods, such.
  • B. the ultrasound diagnostics (Endosonography) or X-ray diagnostics.
  • Endosonography X-ray diagnostics
  • ERP endoscopic retrograde cholangiography
  • ERCP endoscopic retrograde Cholangiopancreatography
  • X-ray contrast agents are means of improving X-ray Presentation of body spaces, hollow organs and vessels. They absorb X-rays either weaker (negative X-ray contrast agent) or stronger (positive X-ray contrast agents) as the surrounding body tissue.
  • the radiopaque (i.e., radiopaque) positive X-ray contrast agents contain predominantly Elements of high atomic numbers (such as iodine and barium), since their absorption capacity larger for X-rays.
  • For cholangiography are usually organic iodine derivatives derived from pyridines or aromatic carboxylic acids derive, used.
  • iodoxamic acid [3,3 '- (4,7,10,13-tetraoxahexadecanedioyldiamino) -bis (2,4,6-triiodobenzoic acid)] and lotroxic acid [3,3 '- (3,6,9-trioxaundecanedioyldiamino) bis (2,4,6-tri-benzoic acid)].
  • Endoscopies mostly take place in microbially colonized areas of the body.
  • infections with a long incubation period are very difficult and in the Practice mostly impossible to detect.
  • patients whose condition is mute or unrecognized are in contact with endoscopes come.
  • infections with Micro-organisms that are transmitted through the blood and mucous membranes, such as Tuberculosis, hepatitis, HIV infections, salmonellosis, Yersinia infections, Dysentery and the like more.
  • liquid cleaning agents of the prior art are in the removal of Blood and secretion tests as well as the separation of fat and others hydrocarbon compounds relatively well effective. However, they are suitable not to completely remove residues of X-ray contrast agents.
  • the object of the invention was therefore to develop a liquid detergent, the does not have the disadvantages of the prior art, which is therefore a good Cleaning performance with high material compatibility shows and also for Removal of X-ray contrast agents, such.
  • the cleaning agent of the invention can be with the cleaning agent of the invention also dried poorly soluble aromatic halogen compounds, such as. B. X-ray contrast agent residues, completely detach from the surfaces. Because of the engagement The cleaning agents according to the invention are flexible endoscopes even after months constant use in practice microbiologically still flawless. Thereby the safety of the patients is substantially increased and the lifespan of these extended quality medical equipment.
  • the invention Detergents especially for duoendoscopes, via the X-ray contrast agent preferably administered, one compared to the cleaners of the prior Technology have much better cleaning performance. This allowed the microbiological status of duoendoscopes (after subsequent disinfection) strong be improved.
  • the one or more nonionic surfactants are selected from the Group of alkyl ethoxylates whose alkyl group is a saturated or unsaturated, straight or branched-chain alkyl group having 10 to 18, preferably 12 to 14 Carbon atoms, preferably 2 to 15, in particular 5 to 9, especially containing 7 ethylene oxide units.
  • the Group of alkyl ethoxylates whose alkyl group is a saturated or unsaturated, straight or branched-chain alkyl group having 10 to 18, preferably 12 to 14 Carbon atoms, preferably 2 to 15, in particular 5 to 9, especially containing 7 ethylene oxide units.
  • Isotridecanol ethoxylate and / or fatty alcohol polyglycol ether are particularly preferred.
  • the total amount of nonionic surfactants in the range of 1.0 to 20.0 wt .-%, preferably from 10.0 to Selected 15.0 wt .-%, each based on the total weight of the preparations.
  • the pyrrolidonecarboxylic acid (pyroglutamic acid), which is characterized by the following structural formula: used.
  • the total amount of the amino acid from the range of 0.1 to 10.0% by weight, preferably from 0.5 to 2.0% by weight chosen, in each case based on the total weight of the preparations.
  • the cleaning agents according to the invention may further contain amphoteric surfactants.
  • Amphoteric surfactants are surfactants that possess both acidic and basic hydrophilic groups and thus behave acidic or basic depending on the condition.
  • amphoteric surfactants based on aliphatic polyamines having carboxy, sulfo or phosphono side chains, such as, for example, R-NH- (CH 2 ) n -COOH are advantageous.
  • amphoteric surfactants whose alkyl group is a saturated or unsaturated, straight or branched chain alkyl group of 10 to 18, preferably 12 to 14 carbon atoms.
  • amphoteric surfactants from the group of amphopropionates such as. Cocobetainamido amphopropionate, which is characterized by the following structure:
  • the total amount of amphoteric surfactants in the range of 1.0 to 10.0 wt .-%, preferably from 2.0 to 5.0 wt .-%, each based on the total weight of the preparations.
  • the cleaning agents according to the invention can be in the form of liquid concentrates be present and packed for example in dosing, so that a Use solution can be freshly prepared. It is particularly advantageous when the pH of the concentrate is between 5 and 9.
  • the liquid concentrates are preferably diluted with water to a use solution.
  • Use solutions containing 0.5 to 5 wt .-% of detergent according to the invention contain.
  • the use solution preferably has a pH of between 6 and 8 to achieve optimal protection of the sensitive material.
  • the cleaning agents according to the invention may also advantageously additionally conventional Corrosion inhibitors, such as benzotriazole, in particular if they when used with metallic surfaces, especially non-refined Steels or materials made of non-ferrous alloys, may come into contact. It is preferred, the content of one or more corrosion inhibitors between 0.1 and 5% by weight, based on the total weight of the formulation.
  • Corrosion inhibitors such as benzotriazole
  • the cleaning agents according to the invention can furthermore advantageously additionally Complexing agents and / or pH regulators contain the negative influence to reduce fluctuating water hardness or to ensure that the pH of the cleaning agent is in an area that does not contain the sensitive material damaged.
  • the inventive Detergents for such preparations usual preservatives, dyes, Contain fragrances and / or other conventional adjuvants. These carry in the majority The cases do not contribute to the cleaning effect, but serve the storability as well aesthetic purposes. However, it is also possible to use such components the one (preservative, nourishing effect and at the same time for provide a specific color and / or a pleasant fragrance.

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  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Wood Science & Technology (AREA)
  • Organic Chemistry (AREA)
  • Detergent Compositions (AREA)

Abstract

A liquid cleaning agent for surgical instruments contains a non-ionic tenside and an amino-acid and/or an amino-acid derivative. The non-ionic tenside is selected from the group of alkylethoxylates whose alkyl groups have a saturated or unsaturated, straight or branched chained alkyl group with 10 to 18 pref. 12 to 14 carbon atoms. The fluid system contains amino-acid carboxylic acid and/or glutaminic acid. The non-ionic tenside contains isotri-decanolethoxylate and/or lipid alcohol polyglycol-ether.

Description

Die vorliegende Erfindung betrifft flüssige Reinigungsmittel mit einem Gehalt an Tensiden, Korrosionsschutzmitteln und weiteren Zusätzen, die die Reinigung verstärken sowie deren Verwendung zur Reinigung von medizinischen Instrumenten, insbesondere zur Reinigung von flexiblen Endoskopen.The present invention relates to liquid detergents containing Surfactants, corrosion inhibitors and other additives that enhance the cleaning and their use for cleaning medical instruments, in particular for cleaning flexible endoscopes.

Endoskope sind röhren- oder schlauchförmige Instrumente, welche zur Untersuchung von Körperhohlräumen und Hohlorganen verwendet werden. Sie sind mit einem optischen System, bestehend aus Objektiv und Okular, einer Beleuchtungseinrichtung und meist Spül- und Absaugvorrichtungen sowie Kanälen zum Einführen spezieller Instrumente ausgestattet. Flexible Endoskope (welche auch als Fiberendoskope bezeichnet werden) sind mit einem Glasfaserlichtleiter ausgerüstet, welcher aus einem dicht gepackten Bündel aus haarfeinen und deshalb hochflexiblen Einzelfasern besteht. Durch die Flexibilität der Glasfasern können Licht und Bild über praktisch jede beliebige Abwinklung übertragen werden. Zusätzlich zu den Faserbündeln und den Bowdenzügen für die Bewegung der Spitze sind Kanäle für Wasserspülung und Luft sowie ein in der Regel größerer Biopsie- und gleichzeitig Absaugkanal untergebracht.Endoscopes are tubular or tubular instruments used for examination used by body cavities and hollow organs. You are with one optical system consisting of lens and eyepiece, a lighting device and mostly rinsing and suction devices and channels for introducing special Equipped instruments. Flexible endoscopes (which are also called fiber endoscopes be designated) are equipped with a glass fiber optic cable, which consists of a densely packed bundles of hair-fine and therefore highly flexible individual fibers. Due to the flexibility of the glass fibers, light and picture can be over virtually any Angled be transmitted. In addition to the fiber bundles and the Bowden cables for the movement of the top are channels for water flushing and air as well as one in the Usually housed larger biopsy and simultaneously suction channel.

Die Endoskopie kann allein, beispielsweise zur Entnahme von Gewebeproben, aber auch in Kombination mit weiteren Methoden, wie z. B. der Ultraschalldiagnostik (Endosonographie) oder der Röntgendiagnostik durchgeführt werden. Gebräuchlich sind beispielsweise Röntgenkontrastdarstellungen der Gallenblase und der Gallengänge sowie des Pankreasgangsystems. Hierbei wird - z. B. im Rahmen einer endoskopischen retrograden Cholangiographie (ERC) bzw. einer endoskopischen retrograden Cholangiopankreatikographie (ERCP) - ein Röntgenkontrastmittel unter Röntgenkontrolle in das zu untersuchende Gangsystem eingebracht.The endoscopy can be alone, for example, for taking tissue samples, but also in combination with other methods, such. B. the ultrasound diagnostics (Endosonography) or X-ray diagnostics. In use For example, X-ray contrast images of the gallbladder and bile ducts as well as the pancreatic duct system. This is -. B. in the context of an endoscopic retrograde cholangiography (ERC) or endoscopic retrograde Cholangiopancreatography (ERCP) - an X-ray contrast medium X-ray control introduced into the duct system to be examined.

Röntgenköntrastmittel sind Mittel zur Verbesserung der röntgenographischen Darstellung von Körperräumen, Hohlorganen und Gefäßen. Sie absorbieren Röntgenstrahlung entweder schwächer (negative Röntgenkontrastmittel) oder stärker (positive Röntgenkontrastmittel) als das umgebende Körpergewebe. Die radioopaken (d. h. strahlungsundurchlässigen) positiven Röntgenkontrastmittel enthalten vorwiegend Elemente hoher Ordnungszahlen (wie lod und Barium), da deren Absorptionsvermögen für Röntgenstrahlen größer ist. Für die Cholangiographie werden in der Regel organische lod-Derivate, die sich von Pyridinen oder aromatischen Carbonsäuren ableiten, verwendet. Beispiele hierfür sind lodoxaminsäure [3,3'-(4,7,10,13-Tetraoxahexadecandioyldiamino)-bis(2,4,6-triiodbenzoesäure)] und lotroxinsäure [3,3'-(3,6,9-Trioxaundecandioyldiamino)bis(2,4,6-trüodbenzoesäure)].X-ray contrast agents are means of improving X-ray Presentation of body spaces, hollow organs and vessels. They absorb X-rays either weaker (negative X-ray contrast agent) or stronger (positive X-ray contrast agents) as the surrounding body tissue. The radiopaque (i.e., radiopaque) positive X-ray contrast agents contain predominantly Elements of high atomic numbers (such as iodine and barium), since their absorption capacity larger for X-rays. For cholangiography are usually organic iodine derivatives derived from pyridines or aromatic carboxylic acids derive, used. Examples of these are iodoxamic acid [3,3 '- (4,7,10,13-tetraoxahexadecanedioyldiamino) -bis (2,4,6-triiodobenzoic acid)] and lotroxic acid [3,3 '- (3,6,9-trioxaundecanedioyldiamino) bis (2,4,6-tri-benzoic acid)].

Endoskopien finden zum Großteil in mikrobiell besiedelten Körperbereichen statt. Die Anzahl endoskopischer Untersuchungen des oberen und unteren Gastrointestinaltraktes und des Tracheobronchialsystems, häufig verbunden mit invasiven Eingriffen, ist sehr hoch. Eine Übertragung von Krankheitserregern durch kontaminierte Endoskopien selbst und durch endoskopisches Zubehör konnte vielfach belegt werden.Endoscopies mostly take place in microbially colonized areas of the body. The Number of endoscopic examinations of the upper and lower gastrointestinal tract and the tracheobronchial system, often associated with invasive surgery, is very high. Transmission of pathogens through contaminated endoscopy itself and endoscopic accessories could be documented many times.

Insbesondere Infektionen mit langer Inkubationszeit sind nur sehr schwer und in der Praxis meist gar nicht zu erfassen. Ferner muß damit gerechnet werden, daß auch Patienten, deren Erkrankung stumm oder unerkannt ist, mit Endoskopen in Berührung kommen. Besonderes Gewicht haben in diesem Zusammenhang Infektionen mit Mikroorganismen, deren Übertragung durch das Blut und über die Schleimhäute erfolgt, wie z. B. Tuberkulose, Hepatitis, HIV-Infektionen, Salmonellose, Yersinien-Infektionen, Ruhr und dergleichen mehr.In particular, infections with a long incubation period are very difficult and in the Practice mostly impossible to detect. Furthermore, it must be expected that also Patients whose condition is mute or unrecognized are in contact with endoscopes come. Of particular importance in this context are infections with Micro-organisms that are transmitted through the blood and mucous membranes, such as Tuberculosis, hepatitis, HIV infections, salmonellosis, Yersinia infections, Dysentery and the like more.

Eine Anforderung an die Endoskopie sollte daher die uneingeschränkte Einhaltung aller erforderlichen Schutzmaßnahmen zur Infektionsverhütung sein. Allerdings war die Reinigung und Desinfektion der Fiberendoskope lange Zeit ein Stiefkind der technologischen Entwicklung. So gibt es beispielsweise Probleme mit Restwasser und entsprechender bakterieller Fehlbesiedlung, darüberhinaus lassen sich Endoskope nur schwer trocknen. A requirement for endoscopy should therefore be full compliance with all necessary preventive measures for infection prevention. However, the cleaning was and disinfecting the fiber endoscopes long time a stepchild of the technological Development. For example, there are problems with residual water and the like Bacterial incorrect colonization, moreover, endoscopes are difficult to dry.

Daher muß im Vorfeld einer endoskopischen Untersuchung nicht nur die Übertragung von Mikroorganismen, die von Patienten stammen, verhindert werden, sondern es sollte ferner ein besonderes Augenmerk auf Krankheitserreger aus Spülwasser oder stagnierendem Wasser gerichtet werden.Therefore, in the run-up to an endoscopic examination, not only the transmission of microorganisms that come from patients, but it should be prevented Furthermore, special attention to pathogens from rinsing water or be stagnant water.

Der Stand der Technik kennt flüssige Reinigungsmittel zur Reinigung von flexiblen Endoskopen, welche neben Tensiden im wesentlichen organische Lösemittel, Säuren oder Laugen sowie teilweise auch Enzyme enthalten. Allerdings weisen die genannten Verbindungen einige Nachteile auf:The prior art knows liquid detergents for cleaning flexible Endoscopes, which in addition to surfactants, essentially organic solvents, acids or lyes and sometimes contain enzymes. However, the mentioned Compounds have some disadvantages:

Lösemittel, Säuren und Laugen sind zwar von ihrer Wirksamkeit her zur Reinigung prinzipiell geeignet, haben aber den Nachteil, daß sie für das empfindliche Material zu aggressiv sind und die Endoskope dementsprechend beschädigen können.Although solvents, acids and alkalis are effective in their purification in principle suitable, but have the disadvantage that they are for the sensitive material too are aggressive and can damage the endoscopes accordingly.

Der Umgang mit enzymhaltigen Reinigern ist aus Arbeitssicherheitsgründen problematisch, da diese als sensibilisierende Stoffe und dementsprechend gesundheitsschädlich eingestuft werden, weshalb z. B. Berührungen mit der Haut vermieden werden sollten.The handling of enzyme-containing cleaners is for reasons of occupational safety problematic, as these are sensitizing substances and accordingly be classified as harmful, which is why, for. B. Skin contact should be avoided.

Die flüssigen Reinigungsmittel des Standes der Technik sind bei der Entfernung von Blut- und Sekretresten sowie bei der Ablösung von Fett und anderen kohlenwasserstoffhaltigen Verbindungen relativ gut wirksam. Allerdings eignen sie sich nicht, um Reste von Röntgenkontrastmitteln vollständig zu entfernen.The liquid cleaning agents of the prior art are in the removal of Blood and secretion tests as well as the separation of fat and others hydrocarbon compounds relatively well effective. However, they are suitable not to completely remove residues of X-ray contrast agents.

Bereits geringste Mengen zurückgebliebenes Röntgenkontrastmittel schließen Bakterien in den Endoskopkanälen ein, die mit den üblichen Desinfektionsmitteln dann nicht mehr vollständig beseitigt werden können. Bei regelmäßigem Einsatz flexibler Endoskope in der Praxis baut sich so im Laufe der Zeit auf der Innenseite der Kanäle ein zunehmender Film des Röntgenkontrastmittels und weiterer Rückstände auf, was zur Folge haben kann, daß das mikrobiologische Ergebnis selbst nach der an die Reinigung anschließenden Desinfektion nicht mehr befriedigend ist. Even the smallest amounts of remaining X-ray contrast media close bacteria in the endoscope channels, which then no longer with the usual disinfectants can be completely eliminated. With regular use of flexible endoscopes in practice builds up over time on the inside of the channels increasing film of the X-ray contrast agent and other residues on what the May have the consequence that the microbiological result even after the cleaning Subsequent disinfection is no longer satisfactory.

Für die Patienten bedeutet dies ein erhöhtes Infektionsrisiko und stellt dementsprechend eine erhebliche Gefährdung dar. Zum Schutz vor Infektionen bleibt dann nur noch die Möglichkeit einer Reparatur, was zum einen aufwendig und zum anderen teuer ist.For the patients, this means an increased risk of infection and presents accordingly a considerable danger. To protect against infections then only the Possibility of a repair, which is both expensive and expensive.

Aufgabe der Erfindung war es daher, ein flüssiges Reinigungsmittel zu entwickeln, das die Nachteile des Standes der Technik nicht aufweist, welches also eine gute Reinigungsleistung bei zugleich hoher Materialverträglichkeit zeigt und sich auch zur Entfernung von Röntgenkontrastmitteln, wie z. B. organischen, aromatischen lod-Derivaten, insbesondere aus flexiblen Endoskopen eignet.The object of the invention was therefore to develop a liquid detergent, the does not have the disadvantages of the prior art, which is therefore a good Cleaning performance with high material compatibility shows and also for Removal of X-ray contrast agents, such. B. organic, aromatic iodine derivatives, especially suitable for flexible endoscopes.

Es wurde nun überraschend gefunden, daß alle diese Aufgaben gelöst werden durch flüssige Reinigungsmittel für medizinische Instrumente, dadurch gekennzeichnet, daß sie

  • mindestens ein nichtionisches Tensid und
  • Pyrrolidoncarbonsäure
enthalten.It has now surprisingly been found that all these objects are achieved by liquid detergents for medical instruments, characterized in that they
  • at least one nonionic surfactant and
  • pyrrolidone
contain.

Es war insbesondere überraschend, daß die erfindungsgemäßen Reinigungsmittel besser und schonender reinigen als die Zubereitungen des Standes der Technik und daß durch diese verbesserte Reinigung bei den überprüften flexiblen Endoskopen das mikrobiologische Problem des Standes der Technik wesentlich verringert werden konnte.It was particularly surprising that the inventive detergents Clean better and gentler than the preparations of the prior art and that by this improved cleaning in the examined flexible endoscopes the microbiological problem of the prior art are significantly reduced could.

Erstaunlicherweise lassen sich mit dem erfindungsgemäßen Reinigungsmittel auch angetrocknete schwerlösliche aromatische Halogenverbindungen, wie z. B. Röntgenkontrastmittelrückstände, vollständig von den Oberflächen ablösen. Durch den Einsatz der erfindungsgemäßen Reinigungsmittel sind flexible Endoskope auch nach Monaten ständigen Einsatzes in der Praxis mikrobiologisch immer noch einwandfrei. Dadurch wird die Sicherheit der Patienten wesentlich erhöht und die Lebensdauer dieser hochwertigen medizinischen Geräte verlängert.Surprisingly, can be with the cleaning agent of the invention also dried poorly soluble aromatic halogen compounds, such as. B. X-ray contrast agent residues, completely detach from the surfaces. Because of the engagement The cleaning agents according to the invention are flexible endoscopes even after months constant use in practice microbiologically still flawless. Thereby the safety of the patients is substantially increased and the lifespan of these extended quality medical equipment.

So konnte beispielsweise nachgewiesen werden, daß die erfindungsgemäßen Reinigungsmittel besonders bei Duoendoskopen, über die Röntgenkontrastmittel bevorzugt verabreicht werden, eine im Vergleich zu den Reinigern des Standes der Technik wesentlich bessere Reinigungsleistung haben. Hierdurch konnte der mikrobiologische Status der Duoendoskope (nach anschließender Desinfektion) stark verbessert werden.For example, it has been demonstrated that the invention Detergents especially for duoendoscopes, via the X-ray contrast agent preferably administered, one compared to the cleaners of the prior Technology have much better cleaning performance. This allowed the microbiological status of duoendoscopes (after subsequent disinfection) strong be improved.

Gegenstand der Erfindung ist demensprechend auch die Verwendung von flüssigen Reinigungsmitteln, welche

  • mindestens ein nichtionisches Tensid und
  • Pyrrolidoncarbonsäure
enthalten, zur Reinigung empfindlicher medizinischer Instrumente, flexibler Endoskope und empfindlicher medizinischer Oberflächen.The subject matter of the invention is also the use of liquid cleaning agents which
  • at least one nonionic surfactant and
  • pyrrolidone
For cleaning delicate medical instruments, flexible endoscopes and delicate medical surfaces.

Erfindungsgemäß vorteilhaft werden das oder die nichtionische Tenside gewählt aus der Gruppe der Alkylethoxylate, deren Alkylgruppe eine gesättigte oder ungesättigte, geradoder verzweigtkettige Alkylgruppe mit 10 bis 18, vorzugsweise 12 bis 14 Kohlenstoffatomen ist, wobei sie vorzugsweise pro Molekül 2 bis 15, insbesondere 5 bis 9, speziell 7 Ethylenoxideinheiten enthalten. Ganz besonders bevorzugt sind Isotridecanolethoxylat und/oder Fettalkoholpolyglykolether.According to the invention, the one or more nonionic surfactants are selected from the Group of alkyl ethoxylates whose alkyl group is a saturated or unsaturated, straight or branched-chain alkyl group having 10 to 18, preferably 12 to 14 Carbon atoms, preferably 2 to 15, in particular 5 to 9, especially containing 7 ethylene oxide units. Very particularly preferred are Isotridecanol ethoxylate and / or fatty alcohol polyglycol ether.

Vorteilhaft wird die Gesamtmenge an nichtionischen Tensiden (eine oder mehrere Verbindungen) aus dem Bereich von 1,0 bis 20,0 Gew.-%, vorzugsweise von 10,0 bis 15,0 Gew.-% gewählt, jeweils bezogen auf das Gesamtgewicht der Zubereitungen.Advantageously, the total amount of nonionic surfactants (one or more Compounds) in the range of 1.0 to 20.0 wt .-%, preferably from 10.0 to Selected 15.0 wt .-%, each based on the total weight of the preparations.

Erfindungsgemäß wird die Pyrrolidoncarbonsäure (Pyroglutaminsäure), welche sich durch die folgende Strukturformel auszeichnet:

Figure 00050001
eingesetzt. According to the invention, the pyrrolidonecarboxylic acid (pyroglutamic acid), which is characterized by the following structural formula:
Figure 00050001
used.

Vorteilhaft wird die Gesamtmenge der Aminosäure aus dem Bereich von 0,1 bis 10,0 Gew.-%, vorzugsweise von 0,5 bis 2,0 Gew.-% gewählt, jeweils bezogen auf das Gesamtgewicht der Zubereitungen.Advantageously, the total amount of the amino acid from the range of 0.1 to 10.0% by weight, preferably from 0.5 to 2.0% by weight chosen, in each case based on the total weight of the preparations.

In einer besonders vorteilhaften Ausführungsform können die erfindungsgemäßen Reinigungsmittel ferner Amphotenside enthalten. Amphotenside sind Tenside, die sowohl saure als auch basische hydrophile Gruppen besitzen und sich also je nach Bedingung sauer oder basisch verhalten. Vorteilhaft im Sinne der vorliegenden Erfindung sind beispielsweise Amphotenside auf der Basis von aliphatischen Polyaminen mit Carboxy-, Sulfo- oder Phosphono-Seitenketten, wie beispielsweise R-NH-(CH2)n-COOH.In a particularly advantageous embodiment, the cleaning agents according to the invention may further contain amphoteric surfactants. Amphoteric surfactants are surfactants that possess both acidic and basic hydrophilic groups and thus behave acidic or basic depending on the condition. For the purposes of the present invention, for example, amphoteric surfactants based on aliphatic polyamines having carboxy, sulfo or phosphono side chains, such as, for example, R-NH- (CH 2 ) n -COOH, are advantageous.

Erfindungsgemäß bevorzugt sind z. B. Amphotenside, deren Alkylgruppe eine gesättigte oder ungesättigte, gerad- oder verzweigtkettige Alkylgruppe mit 10 bis 18, vorzugsweise 12 bis 14 Kohlenstoffatomen ist.According to the invention are preferred z. As amphoteric surfactants whose alkyl group is a saturated or unsaturated, straight or branched chain alkyl group of 10 to 18, preferably 12 to 14 carbon atoms.

Insbesondere vorteilhaft sind ferner Amphotenside aus der Gruppe der Amphopropionate, wie z. B. das Cocobetainamido Amphopropionat, welches sich durch die folgende Struktur auszeichnet:

Figure 00060001
Also particularly advantageous are amphoteric surfactants from the group of amphopropionates, such as. Cocobetainamido amphopropionate, which is characterized by the following structure:
Figure 00060001

Vorteilhaft wird die Gesamtmenge an Amphotensiden (eine oder mehrere Verbindungen) aus dem Bereich von 1,0 bis 10,0 Gew.-%, vorzugsweise von 2,0 bis 5,0 Gew.-% gewählt, jeweils bezogen auf das Gesamtgewicht der Zubereitungen.Advantageously, the total amount of amphoteric surfactants (one or more Compounds) in the range of 1.0 to 10.0 wt .-%, preferably from 2.0 to 5.0 wt .-%, each based on the total weight of the preparations.

Die erfindungsgemäßen Reinigungsmittel können in Form von flüssigen Konzentraten vorliegen und beispielsweise in Dosierbeutel abgepackt werden, so daß eine Gebrauchslösung jeweils frisch angesetzt werden kann. Es ist insbesondere vorteilhaft, wenn der pH-Wert des Konzentrates zwischen 5 und 9 liegt. Die flüssigen Konzentrate werden vorzugsweise mit Wasser zu einer Gebrauchslösung verdünnt. Bevorzugt sind Gebrauchslösungen, die 0,5 bis 5 Gew.-% an erfindungsgemäßen Reinigungsmittel enthalten. Die Gebrauchslösung hat vorzugsweise einen pH-Wert zwischen 6 und 8, um eine optimale Schonung des empfindlichen Materials zu erreichen.The cleaning agents according to the invention can be in the form of liquid concentrates be present and packed for example in dosing, so that a Use solution can be freshly prepared. It is particularly advantageous when the pH of the concentrate is between 5 and 9. The liquid concentrates are preferably diluted with water to a use solution. Preferred are Use solutions containing 0.5 to 5 wt .-% of detergent according to the invention contain. The use solution preferably has a pH of between 6 and 8 to achieve optimal protection of the sensitive material.

Vorteilhaft ist es, die Verdünnung so durchzuführen, daß der Gehalt der einzelnen Substanzen in der Gebrauchslösung wie folgt ist:

  • nichtionische Tenside: zwischen 0,005 und 1 Gew.-%
  • Aminosäure: zwischen 0,0005 und 0,5 Gew.-%
  • Amphotenside: zwischen 0,005 und 0,5 Gew.-%
It is advantageous to carry out the dilution in such a way that the content of the individual substances in the working solution is as follows:
  • nonionic surfactants: between 0.005 and 1% by weight
  • Amino acid: between 0.0005 and 0.5 wt .-%
  • Amphoteric surfactants: between 0.005 and 0.5% by weight

Die erfindungsgemäßen Reinigungsmittel können ferner vorteilhaft zusätzlich übliche Korrosionsinhibitoren, wie beispielsweise Benzotriazol, enthalten, insbesondere falls sie bei ihrer Anwendung mit metallischen Oberflächen, insbesondere mit nicht veredelten Stählen oder Werkstoffen aus Buntmetallegierungen, in Berührung kommen können. Es wird bevorzugt, den Gehalt an einem oder mehreren Korrosionsinhibitoren zwischen 0,1 und 5 Gew.-%, bezogen auf das Gesamtgewicht der Formulierung, zu wählen.The cleaning agents according to the invention may also advantageously additionally conventional Corrosion inhibitors, such as benzotriazole, in particular if they when used with metallic surfaces, especially non-refined Steels or materials made of non-ferrous alloys, may come into contact. It is preferred, the content of one or more corrosion inhibitors between 0.1 and 5% by weight, based on the total weight of the formulation.

Die erfindungsgemäßen Reinigungsmittel können darüberhinaus vorteilhaft zusätzlich Komplexbildner und/oder pH-Regulatoren enthalten, um den negativen Einfluß schwankender Wasserhärte zu reduzieren bzw. um zu gewährleisten, daß der pH-Wert des Reinigungsmittels in einem Bereich liegt, der das empfindliche Material nicht schädigt.The cleaning agents according to the invention can furthermore advantageously additionally Complexing agents and / or pH regulators contain the negative influence to reduce fluctuating water hardness or to ensure that the pH of the cleaning agent is in an area that does not contain the sensitive material damaged.

Zusätzlich zu den vorstehend genannten Komponenten können die erfindungsgemäßen Reinigungsmittel für derartige Zubereitungen übliche Konservierungsstoffe, Farbstoffe, Duftstoffe und/oder andere übliche Hilfsstoffe enthalten. Diese tragen in der Mehrzahl der Fälle nicht zur reinigenden Wirkung bei, sondern dienen der Lagerbarkeit sowie ästhetischen Zwecken. Es ist jedoch auch möglich, solche Komponenten zu verwenden, die eine (konservierende, pflegende Wirkung entfalten und dabei gleichzeitig für eine bestimmte Farbe und/oder einen angenehmen Duft sorgen. In addition to the above components, the inventive Detergents for such preparations usual preservatives, dyes, Contain fragrances and / or other conventional adjuvants. These carry in the majority The cases do not contribute to the cleaning effect, but serve the storability as well aesthetic purposes. However, it is also possible to use such components the one (preservative, nourishing effect and at the same time for provide a specific color and / or a pleasant fragrance.

Die jeweils einzusetzenden Mengen an derartigen Trägerstoffen und Parfüm können in Abhängigkeit von der Art des jeweiligen Produktes vom Fachmann durch einfaches Ausprobieren leicht ermittelt werden.The amounts of such carriers and perfume to be used in each case can be found in Dependence on the nature of the respective product by the skilled person by simple Try it out easily.

Die folgenden Beispiele dienen dazu, die Erfindung zu beschreiben, selbstverständlich ohne daß beabsichtigt ist, die Erfindung auf diese Beispiele zu beschränken. Alle Mengenangaben, Anteile und Prozentanteile sind, soweit nicht anders angegeben, auf das Gewicht und die Gesamtmenge bzw. auf das Gesamtgewicht der Zubereitungen bezogen. The following examples serve to describe the invention, of course without intending to limit the invention to these examples. All quantities, Shares and percentages are, unless otherwise stated, to the Weight and the total amount or the total weight of the preparations based.

Beispiele:Examples: Beispiel 1:Example 1:

5 %5% Pyrrolidoncarbonsäurepyrrolidone 5 %5% Isotridecanolethoxylatisotridecanol 5 %5% FettalkoholpolyglykoletherFettalkoholpolyglykolether 3 %3% Cocobetainamido AmphopropionatCocobetainamido amphopropionate 1 %1 % Korrosionsschutzcorrosion protection 10 %10% Glykolglycol 1 %1 % pH-RegulatorpH regulator Restrest Wasserwater

Es wird ein pH-Wert von 8 eingestellt.It is set to a pH of 8.

Beispiel 2:Example 2:

7,5 %7.5% Pyrrolidoncarbonsäurepyrrolidone 5 %5% Isotridecanolethoxylatisotridecanol 5 %5% FettalkoholpolyglykoletherFettalkoholpolyglykolether 1 %1 % Korrosionsschutzcorrosion protection 10 %10% Alkoholealcohols 1 %1 % pH-RegulatorpH regulator 3 %3% Komplexbildnercomplexing Restrest Wasserwater

Es wird ein pH-Wert von 8 eingestellt. It is set to a pH of 8.

Beispiel 3:Example 3:

1 %1 % Pyrrolidoncarbonsäurepyrrolidone 6 %6% Isotridecanolethoxylatisotridecanol 6 %6% FettalkoholpolyglykoletherFettalkoholpolyglykolether 2,25 %2.25% Cocobetainamido AmphopropionatCocobetainamido amphopropionate 1 %1 % Korrosionsschutzcorrosion protection 10 %10% Glykolglycol 2 %2% pH-RegulatorpH regulator 3 %3% Komplexbildnercomplexing Restrest Wasserwater

Es wird ein pH-Wert von 8 eingestellt.It is set to a pH of 8.

Mit einem flüssigen Reinigungsmittel gemäß Beispielrezeptur 3 wurde ein Anwendungstest durchgeführt. Dazu wurden 129 Duoendoskope mit einem Reinigungsmittel des Standes der Technik (enzymatischer Reiniger) und 97 Duoendoskope mit dem erfindungsgemäßen Reinigungsmittel jeweils gereinigt und anschließend desinfiziert; danach wurde der mikrobiologische Status der Geräte überprüft. Es ergaben sich die folgenden Ergebnisse: eR Beispiel 3 geprüfte Duoendoskope 129 97 mikrobiologisch einwandfrei 94 91 mikrobiologisch nicht einwandfrei 35 6 An application test was carried out with a liquid detergent according to example formulation 3. For this purpose, 129 duoendoscopes were cleaned with a cleaning agent of the prior art (enzymatic cleaner) and 97 duoendoscopes with the cleaning agent according to the invention in each case and then disinfected; Thereafter, the microbiological status of the devices was checked. The results were as follows: he Example 3 tested duoendoscopes 129 97 microbiologically perfect 94 91 microbiologically not perfect 35 6

Claims (12)

  1. Liquid cleaning composition for medical instruments, characterized in that it contains at least one non-ionic surfactant and pyrrolidonecarboxylic acid.
  2. Cleaning composition according to Claim 1, characterized in that the non-ionic surfactant(s) is/are chosen from the group consisting of the alkyl ethoxylates whose alkyl group is a saturated or unsaturated, straight-chain or branched-chain alkyl group having 10 to 18, preferably 12 to 14, carbon atoms.
  3. Cleaning composition according to either of Claims 1 and 2, characterized in that it contains, as the non-ionic surfactant, isotridecanol ethoxylate and/or fatty alcohol polyglycol ether.
  4. Cleaning composition according to one of Claims 1 to 3, characterized in that it contains, as the further constituent(s), at least one amphoteric surfactant.
  5. Cleaning composition according to Claim 4, characterized in that the amphoteric surfactant(s) is/are chosen from the group consisting of the amphoteric surfactants whose alkyl group is a saturated or unsaturated, straight-chain or branched-chain alkyl group having 10 to 18, preferably 12 to 14, carbon atoms.
  6. Cleaning composition according to either of Claims 4 and 5, characterized in that it contains cocobetainamido amphopropionate as the amphoteric surfactant.
  7. Cleaning composition according to one of Claims 4 to 6, characterized in that the amount of amphoteric surfactant (one or more compounds) is chosen from the range from 1.0 to 10.0% by weight, preferably from 2.0 to 5.0% by weight, in each case based on the total weight of the preparations.
  8. Cleaning composition according to one of Claims 1 to 7, characterized in that it contains one or more non-ionic surfactants in an amount from 1.0 to 20.0% by weight, preferably from 10.0 to 15.0% by weight, in each case based on the total weight of the preparations.
  9. Cleaning composition according to one of Claims 1 to 8, characterized in that it contains pyrrolidonecarboxylic acid in an amount from 0.1 to 10.0% by weight, preferably from 0.5 to 2.0% by weight, in each case based on the total weight of the preparations.
  10. Cleaning composition according to one of Claims 1 to 9, characterized in that it has a pH of between 5 and 9.
  11. Cleaning composition according to one of Claims 1 to 10, characterized in that it is present in the form of a concentrate which, before use, is diluted with water to give a working solution.
  12. Use of liquid cleaning compositions which contain at least one non-ionic surfactant and pyrrolidonecarboxylic acid, for the cleaning of medical instruments, flexible endoscopes and medical surfaces.
EP01100242A 2000-02-17 2001-01-03 Cleaning composition for medical devices Expired - Lifetime EP1126013B2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10007323 2000-02-17
DE10007323A DE10007323A1 (en) 2000-02-17 2000-02-17 Detergent for medical instruments

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EP2918663A1 (en) 2014-03-14 2015-09-16 Bode Chemie GmbH Cleaning agent for inanimated surfaces with special efficacy against mucus, secretions, blood and biofilms

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Publication number Priority date Publication date Assignee Title
EP2918663A1 (en) 2014-03-14 2015-09-16 Bode Chemie GmbH Cleaning agent for inanimated surfaces with special efficacy against mucus, secretions, blood and biofilms

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EP1126013B2 (en) 2013-03-27
DE10007323A1 (en) 2001-08-23
ATE287442T1 (en) 2005-02-15
EP1126013A1 (en) 2001-08-22

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