DE102004035881A1 - Composition, useful for machine cleaning and disinfecting medical instrument of composite materials (e.g. flexible endoscope), comprises active substance combination of alkyldimethylammonium and protease, surfactant, water and additives - Google Patents

Abstract

Composition (A), for machine cleaning and disinfecting medical instrument of composite material, comprises: an active substance combination of di-7-10C-n-alkyldimethylammonium, mono-n-8-14C alkyldimethylbenzylammonium compound and/or guanidine and enzyme (lipase, protease and/or amylase); surfactant (alkyl 10-18C-fattyalcoholalkoxylate with alkoxylation degree of 4-20 (preferably 6-20)); water and optionally additives. Independent claims are also included for: (1) an agent, for machine cleaning and disinfecting medical instruments of composite materials (preferably endoscopes), comprising 0.25-5 wt. % of (A) in water; and (2) a method for machine cleaning and disinfecting medical instrument of composite materials comprising adding (A) in a concentration of 0.5-2 % in diluted form at 40-70 [deg]C and terminating the cleaning/disinfecting procedure after 5-20 minutes.

Description

object the registration

The The invention relates to a composition for material-saving comprehensive mechanical simultaneous cleaning and disinfection of medical Composite instruments, which is a special combination from short-chain quaternary Ammonium compounds, and / or guanidines and one or more Enzymes, selected from lipases, proteases, amylases, together with one or more medium-chain fatty alcohol alkoxylates, and water contains. Preferably can one or more solubilizers to be available.

The The invention also relates to a method for machine cleaning and disinfecting and the use of such a composition, in particular for comprehensive microbicidal cleaning and disinfection in particular flexible endoscopes with elimination of bacteria including Mycobacteria, fungi and viruses.

background the invention

at the cleaning of medical Composite instruments, in particular endoscopes on the one hand a comprehensive disinfection and on the other hand residue-free Removal of dirt done.

Comprehensive Disinfection means in the sense of the present invention the elimination of both the practice-relevant pathogens E. coli, P. aeruginosa, Pr. Vulgaris, S. aureus as well as the elimination of mycobacteria, fungi, incl. Candida albicans, Aspergillus niger as well as covered and unencumbered viruses such as HBV, vaccinia viruses, SV40 and analogues or polioviruses.

Furthermore exist in such instruments both due to the material mix made of different plastics such as e.g. PVC, silicone, polyurethane, NBR (acrylonitrile butadiene rubber), metals such as aluminum, stainless steel, Copper, brass, glass, adhesives and special construction These instruments, which include narrow canals and hoses, present significant problems usable substances as well as their efficient application also regarding. reaching all parts of these instruments. Another Problem in the machine cleaning is the demand for low foaming power as well the tolerance of the individual substances with each other.

In the DE 198 14 829.1 will describe an agent for disinfecting and cleaning endoscopes, which is aldehyde-free and has as active ingredient one or more alpha hydroxy acids, and as surfactant one or more C6-C12 alkyl sulfonates in addition to nitrogen or phosphate-containing complexing agents. This agent should be used for machine cleaning. Alkyl sulfonates are very good detergents, but because of their anionic character, they must be used in the slightly acidic pH range in order to achieve a disinfecting effect, which at worst can lead to material problems.

The European Patent EP B 0 774 504 relates in particular to powdery compositions for cleaning medical devices such as endoscopes, which z. B. quaternary Ammonium compounds (Quats) and / or other antimicrobial agents as well as encapsulated enzymes of at least two families as well as EDTA contain. A machine cleaning at elevated temperatures is here not mentioned.

In the DE 199 07 120 there is described an instrument disinfectant comprising an invert soap having a branched alkyl chain such as nonyl, dodecyl, tridecyl, the former being particularly preferred. This should be a particularly advantageous, ie reduced foaming power can be achieved.

After DE 199 09 303 describe disinfectants which, in addition to known biocidal compounds such as quaternary ammonium salts as active ingredients nor a mixture of primary amines. This should be achieved good efficacy against mycobacteria, which would not be possible only with the known drugs. A machine cleaning is not described.

In the DE 43 21 566 C2 Surface and instrument disinfectants are described, soft as well as cationic compounds such as quaternary ammonium salts, in particular benzalkonium chloride, a mixture of secondary and tertiary amines as active ingredients for improving the biocidal activity as explained above.

The WO 01/76647 discloses a method for cleaning contaminated medical devices, in particular Endoscopes by the device manually into a solution is dipped, which is an enzyme and a Hospital Grade A Disinfectant having. Hospital Grade A disinfectants are quaternary C8 to C22 alkyl ammonium compounds and especially C16-C22 alkylbenzyldimethylammonium chloride. In addition to this can selected different enzymes be like Proteases, esterases, lipases, carbohydrases, cellulases, Peroxidases, catalases, invertases and mixtures thereof. Due to the Variety of enzymes and their sensitivity are therefore mandatory so-called activity protectors required, which is a cross reaction of enzyme and disinfectant should prevent. This includes Enzyme stabilizers such as borates, in particular combinations thereof with ether - alcohols (DPM-mono / di-polyalcohols). Furthermore, this should be used as further amplifiers Formates, calcium, citrates, sulfates, EDTA, phosphates, di-triethanolamine, polyfunctional amino acids. A synergistic effect is seen for the combination of borates and DPM = di (propylene glycol) methyl ether (the latter in an amount of 5 and 10%, respectively). Optionally, also surfactants of different Art be included. With a composition containing tetraborate with C16-C22 alkylbenzyldimethylammonium chloride and a nonylbenzyl ethoxylate as Addition can in a manual purification especially Escherichia coli, Pseudomonas aeruginosa, Proteus vulgaris, Staphylococcus aureus effectively removed become. A machine cleaning at higher temperatures is here not mentioned and not provided: rather, here is the goal, a means to provide, with which cleaned by hand medical instruments be and then preventing cross infection even with the staff can be.

The WO 02/07789 describes a method for the purification of medical devices like endoscopes. In particular "biofilms" should be removed, for this purpose Used agents containing at least one surfactant (selected from anionic, cationic, amphoteric and nonionic surfactants) at least a solvent, at least one co-surfactant, at least one amine-based co-solvent such as Acetamide, ethanolamine and an N-containing biocide and one in particular having organic chelating agent. As a chelating agent are called organolithium compounds (lithium lactate, lithium lauryl sulfate, TriLiEDTA). In the experiments described here is the distance a biofilm caused by E. coli, P. aeruginosa. A Machine cleaning is not mentioned here.

Object of the present invention

task The present invention is to provide a means with which overcome the above-mentioned disadvantages can be. In particular, this should be done at the same time a cleaning and disinfection. This is not just to remove the above mentioned Hospital Grade A Disinfectant Lead germs, but also to the residue-free Removal of mycobacteria, viruses and fungi. The agent should while safe in the application and without a variety of different Be drug classes. Furthermore, it should be a machine work at elevated Temperatures and short exposure times not only in the acidic range enable.

Solution of the task

These The object is achieved by a composition wherein both in terms of biocidal substances as well as the surfactants and mandatory other active substances a targeted selection takes place. In particular, the composition of the invention characterized in that they act as a combination of agents of N-containing substances selected from one or more short-chain - n-alkyldimethylammonium compounds, short chain mono-n-alkyl-dimethylbenzylammonium compounds, and Guanidines or mixtures thereof, with one or more enzymes selected from Lipases, proteases, amylases, and also one or more surfactants, selected from medium chain alkyl fatty alcohol alkoxylates with degrees of alkoxylation from 4 to 20, and water and optionally conventional additives.

The composition may contain 0-45% solubilizer as described below. Preferably, one or more solubilizers selected from monohydric and dihydric aliphatic alcohols or mixtures thereof are additionally present, e.g. B. 1 to 45%, especially 5-45 wt.%. In contrast to the known agents thus anionic surfactants are not included, and may also be preferred EDTA or their lithium analogs, lithium organics, and alkylamines are dispensed with as active ingredients. Boron compounds as used in the above-described prior art are also not required and are also preferably not used. In addition, as enzymes only very specific ones are selected as described, which moreover do not have to be encapsulated and therefore are preferably not.

With Such a composition or diluted forms thereof is more surprising Way possible, that medical Composite instruments, in particular endoscopes all flexible endoscopes, by machine in one go Temperatures from 40 to 70 ° C, in particular 45 to 60 ° C and especially at about 55 ° C over a short period such as 5 to 20, preferably 5 to 15 minutes be cleaned and disinfected. As follows from the examples explains can thus effectively substantially avoiding material problems in an extended pH range both the above Hospital Grade A germs as well as beyond mycobacteria, fungi as well as covered and unsheated Viruses such as HBV or polioviruses are eliminated. This was special therefore surprising because from the known state of the art on the one hand substances as essential which are not used here and beyond no indication was given, especially the invention described Combination to choose for a comprehensive machine cleaning and disinfection to arrive without any stability and / or activity or foaming problems to occur with the composition.

Further description of the invention

• a) eine Wirkstoffkombination, ausgewählt aus jeweils wenigstens einem oder mehreren Vertretern aus: i) einem oder mehreren Di-C7 bis C10 – n-Alkyldimethylammonium-Verbindungen, Mono-n-C8-C14alkyl-dimethylbenzylammonium-Verbindungen, Guanidinen oder Mischungen hiervon; und ii) einem oder mehreren Enzymen, ausgewählt aus Lipasen, Proteasen, Amylasen oder Mischungen hiervon; sowie weiterhin
• b) ein oder mehrere Tenside, ausgewählt aus AlkylC10-C18-Fettalkoholalkoxylaten mit Alkoxylierungsgraden von 4 bis 20, insbesondere 6 bis 20; und
• c) weiterhin Wasser und ggf. Zusatzstoffe enthält.

The present invention therefore relates to a composition for the comprehensive mechanical cleaning and disinfection of medical instruments made of composite materials, which is characterized in that it

• a) an active ingredient combination selected from in each case at least one or more representatives of: i) one or more di-C7 to C10-n-alkyldimethylammonium compounds, mono-n-C8-C14alkyl-dimethylbenzylammonium compounds, guanidines or mixtures thereof; and ii) one or more enzymes selected from lipases, proteases, amylases or mixtures thereof; and continue
• b) one or more surfactants selected from alkyl C 10 -C 18 fatty alcohol alkoxylates having degrees of alkoxylation of 4 to 20, in particular 6 to 20; and
• c) further contains water and optionally additives.

The Active substances of group a) i) have in particular no branches on. The surfactants according to b) are non-ionic.

The Enzymes of group a) ii) are preferably not encapsulated.

Prefers is in addition to the composition one or more solubilizers contained in amounts as indicated, selected from monovalent and divalent aliphatic alcohols or mixtures thereof.

In a preferred embodiment is the amount of active ingredients 2 to 25 wt.%, In particular 2 to 15 % By weight, and especially 2 to 12% by weight.

All Quantities are by weight, unless otherwise stated specified.

It is further preferred if the amount of surfactant 1 to 15 wt. %, in particular 1 to 10 wt.% Is.

Of the or the solubilizers are especially in an amount of 5 to 45 wt.%, In particular 7 to 40%, preferably 10 to 30% by weight and in particular 15 to 25 Wt.%, Included.

The Composition contains Continue to use water or water / solubilizer as described.

In a further preferred embodiment the composition comprises additives, preferably 0.1 to 25 wt. %. These are chosen in particular from corrosion inhibitors, foam regulators, pH regulators, Perfumes, or mixtures thereof.

Especially preferred compositions comprise from 2 to 25% by weight of one or several active substances of group a) i), 0.1 to 2.5 wt.% (the percentage refers here to the dry residue of the commercial Enzyme) of one or more enzymes of group a) ii), 1 to 15 wt. % of one or more surfactants, and 0.1 to 20% by weight of one or more several additives and water (as a remainder). Especially preferred these compositions contain additionally 5 to 45 wt or more solubilizers.

In a further preferred embodiment the composition comprises 2 to 10% by weight of one or more active substances of group a) i), 0.1 to 1 wt% of enzymes (reference as above) of the group a) ii); 5 to 25 wt.% Of one or more solubilizers, 1 to 10 wt. % of one or more surfactants, and 0.1 to 10% by weight of one or more several additives and water as the remainder.

When Active ingredients are used in particular for the quaternaries Ammonium compounds a) i) the chlorides used. Alternatively they are also bromides, propionates or sulfates possible. Especially preferred here are dioctyldimethylammonium chloride and di-decyldimethylammonium chloride, the former being most preferred.

When Guanidines are particularly suitable polyhexamethylene biguanide, octinidine hydrochloride, Polyhexanides. Particular preference is given in the compositions according to the invention Polyhexamethylene.

Become Mixtures of quaternary Ammonium compounds and guanidines chosen so are particularly suitable for this purpose Di-octyldimethylammonium chloride together with polyhexamethylene biguanide.

When Enzymes are one or more proteases, one or more lipases, one or more amylases or mixtures of representatives of one, two or all of these groups used. The enzymes are in particular as a solution before, or will be for sale in the form of solutions received, z. In propylene glycol or polyglycols.

Especially preference is given to propylene glycolic solutions of proteases and amylases, each for yourself or in combination.

When Surfactants are in an advantageous embodiment of the invention Alkyl fatty alcohol ethoxylates, wherein the alkyl chain is greater than 9 and especially C10-C18, preferably C12-C18, and the number of degrees of alkoxylation 4 to 20, in particular 6 to 20. These include ethoxylates (EO), propoxylates (PO) and butoxylates (BuO), each individually or as mixtures z. B. mixtures in a surfactant or in different Surfactants. Especially preferred are mixed ethoxylates, e.g. as PO, EO, BuO, wherein a degree of alkoxylation 6 to 20 for EO / PO mixtures or such for EO / PO in a mixture with BuO with a degree of alkoxylation of less than 8.

All especially advantageous are, in particular, C 12 -C 18 -alkyl (polyethylene) polybutylene (6-20) (less than 8 BuO) ether or C12-C18 alkyl (polyethylene) (smaller 8) polypropylene glycol (less than 8 PO) ether, polyglycol ethers, or mixtures thereof or chosen by two of these 3 representatives.

When solubilizers are monovalent C2-5 n- or branched-chain alkanols such as: Ethanol, propanols, butanol, isobutanol, amyl alcohol or isoamyl alcohol, or C2-6 n-chain dihydric and trihydric alcohols, e.g. Ethylene glycol, propylene glycol, butyl diglycol, dipropylene diglycol methyl ether or glycerin used. It can also selected mixtures thereof become. Preference is given to propylene glycol, polyglycols and 2-propanol or mixtures thereof. Particularly preferred is propylene glycol and 2% propanol.

• a) Korrosionsinhibitoren wie Benzotriazol; 2-Butin-1,4-diol oder Triethanolamin;
• b) Schaumbeeinflussern wie Silikonschaumbeeinflusser wie Organopolysiloxane; Ester der Phosphorsäure wie z.B.: Tributylphosphat oder Triisobutylphosphat; C6-C12-Alkylcarbonsäuren; Terpene; langkettige C8-C26 Alkohole wie z.B: 2-Ethylhexanol oder Cetyalkohol;
• c) pH-Wert Regulatoren wie Säuren, Basen, z. B. organische anorganische Säuren, Basen, z. B. Phosphate; Citrate; Carboxylate; oder 2-Amino-(hydroxymethyl)propan-1,3-diol (Tris-Puffer); Phosphonsäuren und/oder Aminosäurederivate oder Mischungen hiervon;
• d) Parfümstoffen der hierfür geeigneten Art.

The additives are chosen in particular from:

• a) corrosion inhibitors such as benzotriazole; 2-butyne-1,4-diol or triethanolamine;
• b) Schaumbeeinflussern such as silicone foam influencing agents such as organopolysiloxanes; Esters of phosphoric acid such as: tributyl phosphate or triisobutyl phosphate; C6-C12 alkyl carboxylic acids; terpenes; long chain C8-C26 alcohols such as: 2-ethylhexanol or cetyl alcohol;
• c) pH regulators such as acids, bases, z. As organic inorganic acids, bases, z. For example phosphates; Citrate; carboxylates; or 2-amino- (hydroxymethyl) propane-1,3-diol (Tris buffer); Phosphonic acids and / or amino acid derivatives or mixtures thereof;
• d) perfumes of the kind suitable for this purpose.

Particularly preferred additives are corrosion inhibitors, Schaumbeeinflusser, pH Re gulatoren and perfumes and mixtures thereof, in particular from the first three mentioned.

The Amount of additives corresponds to the usual and on the mentioned Area known quantities.

All particular preference is given to compositions in which solubilizers as described and additives selected from corrosion inhibitors, Schaumbeeinflussern and pH value regulators and mixtures thereof possibly also in combination with perfumes.

In a preferred embodiment, the composition as active ingredients) the group a) i) one or more C7 to C10 dialkyldimethylammonium chloride (s); as enzymes) of group a) ii) protease and amylase, as surfactant (s) Alkyl C 10 -C 18 fatty alcohol alkoxylates with degrees of alkoxylation of 4 to 20, and as a solubilizer Glycols and monohydric alcohols and additives and the remainder Water on.

Especially suitable in such a composition are as additives Foaming agents, corrosion inhibitors and pH regulators.

In Another particularly advantageous embodiment are as active ingredients) the group a) i) di-n-octyldimethylammonium chloride in an amount from 4-15%, especially 5-10%; % By weight, as well as from group a) ii) Proteases or proteases and amylases in an amount of 0.5-1%; as surfactants) fatty alcohol ethoxylates in an amount of 1 to 10%, in particular 2 to 5 wt.%, as a solubilizer propylene glycol in in an amount of from 5 to 25% by weight, and as additives, Schaumbeeinflusser, Corrosion inhibitors and pH regulators in a total amount from 1 to 10%, preferably 2 to 8% by weight selected.

In In another embodiment of the present invention, the active ingredients a) i + ii) and the one or more surfactants in a ratio of 8: 1 to 2: 1 to each other used.

such Compositions can be formulated as a concentrate and thus remain stable. to Application for The described machine cleaning will expediently with water to 400: 1 to 50: 1 (400 or 50 parts of water to a Diluted concentrate), so that a concentration of 0.25 to 5%, in particular 1%, is present.

there can the pH of the solution 4-10, in particular 5.5 to 9. It may also be particularly worked in the neutral to mild alkaline range pH 7 to 11 become.

So is the composition of the invention irrespective of the material, Especially with flexible endoscopes a wide variety of material groups and from this a variety of individual substances, depending on the purpose combined which are different requirements z. B. to the pH of cleaning baths put.

The In particular, composition as described or in diluted form for the mechanical cleaning and disinfection of medical instruments Composite materials, in particular endoscopes, especially flexible Endoscopes, at temperatures as indicated, e.g. B. from 40 to 70 ° C, especially 55 ° C, z. B. in a concentration of 0.5 to 2%, over a period of about Used for 5 to 20 minutes.

Possibly it may be advantageous if, before application of the composition according to the invention a pre-cleaning in a conventional manner with suitable on the pollution matched cleaning agents z. B. manually or is preferably made by machine.

Production and application

The Compositions of the invention be considered fluid Concentrate prepared by adding the described components in water or in the water-solubilizer mixture be solved in a known manner. The dilution done with water.

With Such a composition is surprisingly possible with the described short exposure time and temperatures a comprehensive cleaning and disinfection of medical instruments made of composite materials to achieve, even stubborn Stains such. As blood, mucus, stool are eliminated.

The Product has a comprehensive microbicidal action against both the practical Hospitalismuserregern as described as well as against mycobacteria as well as continue opposite Mushrooms, including Candida albicans, Aspergillus niger and also over-enveloped and non-enveloped Viruses like HBV, polio and analogues. It is gentle on materials also opposite the most diverse materials of composite tools and has a very low foaming power on.

in the With regard to the described prior art, wherein similar Products were described, this was particularly surprising, therefore, because of the selection of certain active substances, namely the short-chain quats with the enzymes mentioned together with medium-chain ones Surfactants waived the essential substances described therein can be.

embodiments and examples

The The invention will be explained in more detail with reference to the following examples.

1. Production examples

example 1 Dioctydimethylammoniumchlorid 8th % 1,2-propylene glycol 15% Fatty alcohol ethoxylate: alkyl (C12C18) -polyethylene glycol (<8EO) -polypropylene glycol (<8 PO) -ether 3% Protease (based on dry matter) 2% Amylase (on dry matter) 0.5% 2Ethyl-hexanoic 1.0% benzotriazole 0.1% VE water 71%

Example 2. dioctyl 5% polyhexanides 8th % diglycol 20% Fatty alcohol ethoxylate: alkyl (C12C18) -polyethylene glycol (<8EO) -polypropylene glycol (<8 PO) -ether 5% Protease (based on dry matter) 1.2% Amylase (on dry matter) 0.3% 2Ethyl-hexanoic 0.4% ethylhexanol 2.5% benzotriazole 0.1% VE water 55.5%

Application examples: Microbial investigations

Example 3

In the following Example 3, a composition of the invention, prepared as described in Example 1, with respect to their germ reduction ability against various relevant germs including mycobacteria in the quantitative suspension test according to DIN EN 13727 (2004); Water control according to DHGM (2001), Tables 3A to 3C and DIN EN 13624 (2004); Water control according to DHGM (2001), Tables 3D, 3E and in the quantitative suspension test according to prEN 14348 (2002); Table 3F, examined. In the following tables 3A to 3K showing the results:
MW = average; RF = reduction factor; nd = not performed; E = self-inhibition; RF ₁ and RF ₂ = control MW - logx; x = average; nz = not countable; n. n = not necessary; N = test suspension:

Table 3 A

• Test germ: S. aureus;
• Load: 0.3% albumin + 0.3 sheep erythrocytes;
• Incubation temperature: 36 ± 1 ° C;
• Incubation time: 48 h
• Method: dilution neutralization method, Surface method;
• Starting bacterial count: 4.90 × 10 ⁸ cfu / ml (8.69 lg)
• Test temperature: 55 ± 1 ° C
• Response time: as indicated

Table 3A

Table 3B

• Test germ: E. hirae;
• Load: 0.3% albumin + 0.3 sheep erythrocytes;
• Incubation temperature: 36 ± 1 ° C;
• Incubation time: 48 h
• Method: dilution neutralization method, Surface method;
• Starting bacterial count: 2.40 × 10 ⁸ cfu / ml (8.38 lg)
• Test temperature: 55 ± 1 ° C
• Response time: as indicated

Table 3B

Table 3C:

• Test germ: P. aeruginosa
• Load: 0.3% albumin + 0.3 sheep erythrocytes;
• Incubation temperature: 36 ± 1 ° C;
• Incubation time: 48 h
• Method: Dilution Neutralization process, surface process;
• Starting bacterial count: 4.45 x 10 ⁸ cfu / ml (8.65 lg)
• Test temperature: 55 ± 1 ° C
• Response time: as indicated

Table 3C

Table 3D:

• Test germ: C. albicans
• Load: 0.3% albumin + 0.3 sheep erythrocytes;
• Incubation temperature: 30 ± 1 ° C;
• Incubation time: 48 h
• Method: dilution neutralization method, Surface method;
• Starting bacterial count: 3.14 x 10 ⁷ cfu / ml (7.50 lg)
• Test temperature: 55 ± 1 ° C
• Response time: as indicated

Table 3D

Table 3E

• Test germ: A. niger
• Load: 0.3% albumin + 0.3 sheep erythrocytes;
• Incubation temperature: 30 ± 1 ° C;
• Incubation time: 72 h
• Method: dilution neutralization method, Surface method;
• Starting bacterial count: 3.75 x 10 ⁷ cfu / ml (7.57 lg)
• Test temperature: 55 ± 1 ° C
• Response time: as indicated

Table 3E

Table 3F

• Test germ: M. terrae
• Load: 0.3% albumin + 0.3 sheep erythrocytes;
• Incubation temperature: 36 ± 1 ° C;
• Incubation period: 21d
• Method: Dilution Neutralization process, surface process;
• Starting bacterial count N: 7.90 × 10 ⁸ cfu / ml (8.90 lg)
• Starting bacterial count N ₀ : 7.90 × 10 ⁷ cfu / ml (7.90 lg)
• Test temperature: 40 ± 1 ° C
• Response time: as indicated

Table 3F

Example 4

n. d.: nicht durchgeführt Verdünnungsmittel-Kontrolle: 184,0 Untere Nachweisbarkeitsgrenze des HbsAg I 254,1 in den einzelnen Ansätzen (cut off) II 220,5 Effectiveness of the composition according to the invention against HB viruses in the HbsAG test The instrument disinfectant according to Example 1 was tested as a 1% solution in the antigen test for its hepatitis B-inactivating properties in terms of volume ratios and protein load in accordance with the guidelines of the Federal Health Office (BGA, now Robert Koch Institute) and the German Association for the Control of Virus Diseases e. V. (DW) for testing chemical disinfectants for effectiveness against viruses. In the antigen test, the measure of HBV efficacy is the destruction of the immunological reactivity of the hepatitis B surface antigen (HBsAg). Complete destruction was always assumed in the experiments described here when, after exposure to the disinfectant, the radioactivity was below 2.1 times the value of the disinfectant controls. The results are summarized in Table 4 below: Table 4

nd: not performed Diluent Control: 184.0 Lower detectability limit of HbsAg I 254.1 in the individual approaches (cut off) II 220.5

As From this it can be seen that viruses with the application according to the means effectively inhibited. In view of the fact that the hepatitis B virus how to transmit the HIV virus is more stable than HIV (see Deutsches Ärzteblatt, 84, No. 18, page B 874, 1987), are measures against transfer of hepatitis B, so its inactivation, so far against HIV preventive.

Claims (15)

Composition for comprehensive mechanical cleaning and disinfection of medical instruments made of composite materials, characterized in that it comprises a) an active ingredient combination selected from in each case at least one or more representatives selected from: i) one or more di-C7 to C10-n-alkyldimethylammonium compounds , Mono-n-C8-C14alkyl-dimethylbenzylammonium compounds, guanidines or mixtures thereof; and ii) one or more enzymes selected from lipases, proteases, amylases or mixtures thereof; and furthermore b) one or more surfactants selected from alkyl C 10 -C 18 fatty alcohol alkoxylates having degrees of alkoxylation of from 4 to 20, in particular from 6 to 20; and c) water and optionally additives. Composition according to Claim 1, characterized that in addition one or more solubilizers, selected of mono- and dihydric aliphatic alcohols or mixtures are included. A composition according to claim 1 or 2, characterized characterized in that it contains 0.1 to 25% additives selected from Corrosion inhibitors, Schaumbeeinflussern, pH regulators, perfumes, or mixtures thereof. A composition according to any one of claims 1 to 3, characterized in that as alkoxylates b) ethoxylates, propoxylates, Butoxylates with EO / PO / BuO degrees of 4 to 20, preferably 6 to 20, each in individual surfactants or as multiple surfactants are. A composition according to any one of claims 1 to 4, characterized in that it is present as a concentrate and 2 to 25% by weight of one or more active substances of group a) i) and 0.1 to 2.5% by weight of one or more enzymes of group a) ii); 1 to 15% by weight of one or more surfactants, and 0.1 to 20% by weight one or more additives and water. Composition according to Claim 5, characterized that in addition 5 to 45 wt.% Of one or more solubilizers. A composition according to claim 5 or 6, characterized in that they contain 2 to 10% by weight of one or more active substances of group a) i) and 0.1 to 1% by weight of enzymes of group a) ii), 5 to 25% by weight of one or more solubilizers, 1 to 10% by weight % of one or more surfactants, and 0.1 to 10% by weight of one or more has several additives and water. A composition according to any one of claims 1 to 7, characterized in that as active ingredients) of group a) i) one or more C7 to C10 dialkyldimethyl ammonium chloride (s); as enzymes) of the group a) ii) protease and amylase, as surfactant (e) alkyl C 10 -C 18 fatty alcohol alkoxylates with degrees of alkoxylation from 4 to 20, and as a solubilizer Glycols and monohydric alcohols and additives, and water are included. Composition according to Claim 8, characterized that as additive (s) Schaumbeeinflusser, corrosion inhibitors and pH regulators are included. A composition according to any one of claims 1 to 9, characterized in that the ratio of active ingredients a) i + ii) to surfactants) is 8: 1 to 2: 1. A composition according to any one of claims 1 to 10, characterized in that they as active ingredients) of the group a) i) di-n-octyldimethylammonium chloride in an amount of 4-15%, in particular 5-10%; Gew%, as well as from the group a) ii) proteases or Proteases and amylases in an amount of 0.5-1%; as surfactant (s) Fatty alcohol ethoxylates in an amount of 1 to 10%, in particular 2 to 5% by weight, as a solubilizer Propylene glycol in an amount of 5 to 25% by weight, and as additives Foaming agents, corrosion inhibitors and pH regulators in a total amount of 1 to 10%, preferably 2 to 8% by weight, having. Means for automated cleaning and disinfection from medical Instruments made of composite materials, in particular endoscopes, thereby characterized in that it contains from 0.25 to 5% by weight of a composition according to a the claims 1 to 11 in water. Process for automated cleaning and disinfection from medical Composite instruments, characterized in that a composition according to one the claims 1 to 11 in diluted Mold or according to claim 12 at temperatures of 40 to 70 ° C, in a concentration of 0.5-2% and the cleaning / disinfection process ended after 5 to 20 minutes. Method according to claim 13, characterized in that in particular flexible endoscopes be cleaned and disinfected. Use of a composition according to one the claims 1 to 12 for mechanical cleaning and disinfection of medical Composite instruments, in particular endoscopes.