CN108350396A - 清洁和消毒组合物 - Google Patents
清洁和消毒组合物 Download PDFInfo
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- CN108350396A CN108350396A CN201680065840.3A CN201680065840A CN108350396A CN 108350396 A CN108350396 A CN 108350396A CN 201680065840 A CN201680065840 A CN 201680065840A CN 108350396 A CN108350396 A CN 108350396A
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- JKQOBWVOAYFWKG-UHFFFAOYSA-N molybdenum trioxide Chemical compound O=[Mo](=O)=O JKQOBWVOAYFWKG-UHFFFAOYSA-N 0.000 description 1
- 229910000402 monopotassium phosphate Inorganic materials 0.000 description 1
- 235000019796 monopotassium phosphate Nutrition 0.000 description 1
- 229910000403 monosodium phosphate Inorganic materials 0.000 description 1
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- ZBJVLWIYKOAYQH-UHFFFAOYSA-N naphthalen-2-yl 2-hydroxybenzoate Chemical compound OC1=CC=CC=C1C(=O)OC1=CC=C(C=CC=C2)C2=C1 ZBJVLWIYKOAYQH-UHFFFAOYSA-N 0.000 description 1
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- 239000001103 potassium chloride Substances 0.000 description 1
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- GNSKLFRGEWLPPA-UHFFFAOYSA-M potassium dihydrogen phosphate Chemical compound [K+].OP(O)([O-])=O GNSKLFRGEWLPPA-UHFFFAOYSA-M 0.000 description 1
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- 235000017557 sodium bicarbonate Nutrition 0.000 description 1
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- 239000011780 sodium chloride Substances 0.000 description 1
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 description 1
- GCLGEJMYGQKIIW-UHFFFAOYSA-H sodium hexametaphosphate Chemical compound [Na]OP1(=O)OP(=O)(O[Na])OP(=O)(O[Na])OP(=O)(O[Na])OP(=O)(O[Na])OP(=O)(O[Na])O1 GCLGEJMYGQKIIW-UHFFFAOYSA-H 0.000 description 1
- 239000011684 sodium molybdate Substances 0.000 description 1
- 235000015393 sodium molybdate Nutrition 0.000 description 1
- TVXXNOYZHKPKGW-UHFFFAOYSA-N sodium molybdate (anhydrous) Chemical compound [Na+].[Na+].[O-][Mo]([O-])(=O)=O TVXXNOYZHKPKGW-UHFFFAOYSA-N 0.000 description 1
- DZCAZXAJPZCSCU-UHFFFAOYSA-K sodium nitrilotriacetate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CN(CC([O-])=O)CC([O-])=O DZCAZXAJPZCSCU-UHFFFAOYSA-K 0.000 description 1
- KKCBUQHMOMHUOY-UHFFFAOYSA-N sodium oxide Chemical compound [O-2].[Na+].[Na+] KKCBUQHMOMHUOY-UHFFFAOYSA-N 0.000 description 1
- 229910001948 sodium oxide Inorganic materials 0.000 description 1
- 235000020354 squash Nutrition 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- GYBINGQBXROMRS-UHFFFAOYSA-J tetrasodium;2-(1,2-dicarboxylatoethylamino)butanedioate Chemical compound [Na+].[Na+].[Na+].[Na+].[O-]C(=O)CC(C([O-])=O)NC(C([O-])=O)CC([O-])=O GYBINGQBXROMRS-UHFFFAOYSA-J 0.000 description 1
- 150000003628 tricarboxylic acids Chemical class 0.000 description 1
- 229910000404 tripotassium phosphate Inorganic materials 0.000 description 1
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- 239000002699 waste material Substances 0.000 description 1
Classifications
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- A01N37/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids
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- A01N37/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids
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- A01N59/00—Biocides, pest repellants or attractants, or plant growth regulators containing elements or inorganic compounds
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- A—HUMAN NECESSITIES
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- A61B1/12—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements
- A61B1/121—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements provided with means for cleaning post-use
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- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B08B3/04—Cleaning involving contact with liquid
- B08B3/08—Cleaning involving contact with liquid the liquid having chemical or dissolving effect
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- C—CHEMISTRY; METALLURGY
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- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
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- C11D1/722—Ethers of polyoxyalkylene glycols having mixed oxyalkylene groups; Polyalkoxylated fatty alcohols or polyalkoxylated alkylaryl alcohols with mixed oxyalkylele groups
-
- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
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- C11D1/75—Amino oxides
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- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
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- C11D1/88—Ampholytes; Electroneutral compounds
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- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
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- C—CHEMISTRY; METALLURGY
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- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
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- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
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-
- C—CHEMISTRY; METALLURGY
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- C—CHEMISTRY; METALLURGY
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Abstract
本发明涉及一种用于清洁和消毒基材的两部分液体组合物,包含:(A)包含过乙酸的消毒剂介质;和(B)包含非酶清洁剂、腐蚀抑制剂和螯合剂的补充介质。所述补充介质(B)还包含酶清洁剂、表面活性剂、缓冲剂、pH调节剂或其两种以上的混合物。所述基材可以是医疗设备,例如内窥镜。
Description
技术领域
本发明涉及用于清洁和消毒基材的组合物。更具体地说,本发明涉及用于清洁和消毒诸如医疗设备(例如内窥镜)等基材的两部分液体组合物。
背景技术
暴露于血液和其它体液的内窥镜等医疗设备在每次使用之间都需要清洁和消毒。本领域的问题涉及对清洁和消毒系统的需求,该清洁和消毒系统能够用于清洁和消毒不能承受蒸汽消毒的高温的设备,如内窥镜。本发明为此问题提供了解决方案。
发明内容
本发明涉及一种用于清洁和消毒基材的两部分液体组合物,其包含:(A)包含过乙酸的消毒剂介质;和(B)包含非酶清洁剂、腐蚀抑制剂和螯合剂的补充介质;其中所述非酶清洁剂包含链烷醇胺、醇乙氧基化物、烷基葡糖苷、亚烷基二醇、二丙酸烷基酯(alkyldiproprionate)、烷基二烷基氧化胺或其两种以上的混合物。可以将消毒剂介质(A)称为(A)部分,以及可以将补充介质(B)称为(B)部分。补充介质(B)可以用作清洁剂和助洗剂介质(builders medium),因此可以被称为清洁剂/助洗剂介质。补充介质还可以包含酶清洁剂。补充介质(B)还可以包含表面活性剂、缓冲剂、pH调节剂或其两种以上的混合物。消毒剂介质(A)和补充介质(B)可用水稀释。
本发明涉及使用上述两部分液体组合物清洁和消毒基材的方法。该方法的优点在于其适用于清洁和消毒不能承受蒸汽消毒的高温的基材,如包括内窥镜之内的医疗设备等。
在一个实施方案中,本发明涉及使用上述两部分液体组合物清洁和消毒基材的一步法,所述方法包括:将基材与补充介质(B)和消毒剂介质(A)接触以清洁和消毒基材。该方法可以在约15℃至约60℃、或约18℃至约60℃、或约18℃至约56℃、或约18℃至约50℃、或约18℃至约40℃、或约18℃至约30℃、或约18℃至约24℃范围内的温度下进行。接触时间可以在约0.5分钟至约240分钟,或约2分钟至约60分钟的范围内。
在一个实施方案中,本发明涉及使用上述两部分液体组合物清洁和消毒基材的两步法,所述方法包括以下步骤:(1)使基材与补充介质(B)接触以清洁基材;以及(2)使基材与消毒剂介质(A)接触以消毒基材。在一个实施方案中,两步法包括以下步骤:(1)使基材与补充介质(B)和消毒剂介质(A)接触以清洁基材,以及(2)使基材与消毒剂介质(A)接触以消毒基材。在一个实施方案中,两步法包括以下步骤:(1)使基材与补充介质(B)接触以清洁基材,以及(2)使基材与消毒剂介质(A)和补充介质(B)接触以消毒基材。在一个实施方案中,两步法包括以下步骤:(1)使基材与补充介质(B)和消毒剂(A)接触以清洁基材,以及(2)使基材与消毒剂介质(A)和补充介质(B)接触以消毒基材。该方法可以任选地包括在步骤(1)之后、步骤(2)之前漂洗基材。步骤(1)和(2)中的每一步可以在约15℃至约60℃、或约18℃至约60℃、或约18℃至约56℃、或约18℃至约50℃、或约18℃至约40℃、或约18℃至约30℃、或约18℃至约24℃范围内的温度下进行。步骤(1)和(2)中每一步的接触时间可以在约0.5分钟至约240分钟,或约2分钟至约60分钟的范围内。
在一个实施方案中,上述方法可用于使活的微生物(包括孢子、临床上重要的细菌、致病性病毒等)4或5个对数级的降低(对于高水平消毒剂(HLD)目的)或6个对数级的降低(对于灭菌目的)。在一个实施方案中,该方法可以用于清洁和消毒基材。在一个实施方案中,该方法可以用于清洁基材并使基材灭菌。
在一个实施方案中,上述方法可用于将患者污物(和/或通常被FDA所接受的代表更坏情况生物负荷的模拟污物)的生物负荷降低至小于约6微克每平方厘米的水平。
在一个实施方案中,上述方法可用于提供单独的清洁和消毒步骤,同时使被处理的基材(例如内窥镜)的构造材料的有害影响最小化。
在一个实施方案中,可以在环境条件(约18-24℃)下进行上述方法,因此该方法可用于具有或不具有温度控制的再处理器中。
在一个实施方案中,可以在环境温度至约60℃的温度下使用上述方法,因此该方法能够用于具有从环境温度到约60℃的温度控制范围的再处理器。
在一个实施方案中,上述方法可用于各种现有的“开放”自动内窥镜再处理机器中,该再处理机器具有最小的内窥镜再处理器的适应性。
在一个实施方案中,当在室温(约18-24℃)下使用上述方法时,上述方法可以允许消毒剂介质(A)的浓度在再处理循环的暴露阶段内保持稳定。
在一个实施方案中,当在室温(约18-24℃)下使用上述方法时,上述方法可允许消毒剂介质(A)的浓度在跨越多个再处理循环的时间段内保持稳定。
在一个实施方案中,补充介质(B)可使用漂洗助剂组分以促进被处理基材(例如内窥镜)的漂洗。
在一个实施方案中,补充介质(B)可使用消泡组分以减少起泡。
上述两部分液体组合物可用于各种现有的自动内窥镜再处理器(AER)中。这些再处理器可以包括由许多“开放”系统的制造商制造的AER,以及具有自己的专用化学物质的专用“封闭”系统。
上述方法可用于静态浸泡应用(无机器)。
附图说明
在附图中,相同的参考标记表示相同的部件和特征。
图1示出了根据本发明的用于清洁和消毒方法的设备的示意图。
图2是示出使用图1所示装置的操作步骤和示例性方法条件的流程图。
图3A-3D是示出了过乙酸在单次消毒循环所需的时间内的稳定性的图,该稳定性作为存在或不存在两种不同助洗剂制剂以及本发明的补充介质(B)的函数。
图4A-4D是示出了在不同消毒溶液温度下,过乙酸在单次消毒循环所需的时间内的稳定性的图,该稳定性作为存在或不存在两种不同助洗剂制剂以及本发明的补充介质(B)的函数。
图5A-5D是示出了过乙酸在初始和多次消毒循环所需的时间内的稳定性的图,该稳定性作为存在或不存在两种不同助洗剂以及本发明的补充介质(B)的函数。
具体实施方式
本说明书和权利要求书中公开的所有范围和比例限制可以以任何方式组合。应当理解的是,除非另有明确说明,否则所提到的“一”、“一个”和/或“该”可以包括一个或多于一个,并且以单数形式提及的项目也可以包括复数形式的项目。
短语“和/或”应当理解为意指如此结合的元件的“任一个或两个”,即,在一些情况下连带存在并且在其它情况下分离存在的元件。除了由“和/或”从句明确标识的元件之外,无论与那些明确指出的元件相关还是不相关,除非明确地指示相反,其它元件可以可选地存在。因此,作为非限制性实例,所提到的“X和/或Y”在与诸如“包括”之类的开放式语言结合使用时可以指代:在一个实施方案中,X而不是Y(可选地包括除Y之外的元件);在另一个实施方案中,Y而不是X(可选地包括除X之外的元件);在又一个实施方案中,X和Y(可选地包括其它元件);等。
应当理解词语“或”具有与以上定义的“和/或”相同的含义。例如,当分离列表中的项目时,“或”或“和/或”应被解释为包含性的,即,包含至少一个,但也包括多于一个的元件或元件列表,以及任选地附加的未列出的项目。只有明确表示相反的术语,例如“仅一个”或“恰好一个”,可以指包含一个或多个元件列表中的恰好一个元件。一般而言,当如本文使用的术语“或”在排他性术语之前,如“其中之一”,“之一”,“仅其中之一”或“恰好其中之一”时,其只应被解释为表示排他性替代方案(即“一个或另一个但不是两个”)。
一个或多个元件的列表中提及的短语“至少一个”应该理解为是指从元件列表中的任何一个或多个元件中选择的至少一个元件,但不一定包括元件列表内具体列出的每一个元件中的至少一个,并且不排除元件列表中的元件的任何组合。该定义还允许在短语“至少一个”所指的元件列表内具体指出的元件之外的元件可以任选地存在,,无论该元件与具体指出的那些元件相关还是不相关。因此,作为非限制性实例,“X和Y中的至少一个”(或者等同地,“X或Y中的至少一个”,或者等同地“X和/或Y中的至少一个”)可以指代:在一个实施方案中,至少一个(任选地包括多于一个)X,而不存在Y(并且任选地包括除了Y之外的元件);在另一个实施方案中,至少一个(任选地包括多于一个)Y,而不存在X(并且任选地包括除X之外的元件);在又一个实施方案中,涉及至少一个(任选地包括多于一个)X和至少一个(任选地包括多于一个)Y(并且任选地包括其它元件);等。
诸如“包含”、“包括”、“携带”、“具有”、“含有”、“涉及”、“保持”等过渡词或短语应当被理解为是开放式的,即意味着包括但不限于此。
术语“杀死”(或“杀”)微生物是指使微生物不能恢复营养生长。在一个实施方案中,术语杀死微生物是指使微生物不能繁殖、代谢和/或生长。
术语“对数级的降低”是数学术语,以示出通过使微生物与本发明的组合物接触而杀死的活的微生物的数量。“4个对数级的降低”是指活的微生物的数量减少10,000倍。“5个对数级的降低”是指活的微生物的数量减少100,000倍。“6个对数级的降低”是指活的微生物的数量减少1,000,000倍。
术语“酶清洁剂”是指由生物体产生的清洁剂。酶清洁剂可以是脂肪酶、淀粉酶、糖酶或蛋白酶酶清洁剂。
术语“非酶清洁剂”是指不是酶清洁剂的清洁剂。
本文提供的两部分液体组合物可用于清洁基材并实现基材上不期望的微生物的数量的至少4个对数级的降低、或至少5个对数级的降低、或至少6个对数级的降低,该不希望的微生物能够返回或恢复营养生长或感染,或者在一个实施方案中能够再生、代谢和/或生长。这些微生物可以包括孢子、临床上重要的细菌、致病性病毒,其中两种以上的混合物等。当达到6个对数级的降低时,该方法可以被称为灭菌方法。6个对数级的降低可以被称为6个对数的杀死。当达到4个对数级的降低或5个对数级的降低时,该方法可能被认为不如杀菌方法严格,但对各种消毒应用仍然有用。在本文中,术语“消毒剂”(和“消毒”)可以用于指消毒,例如高水平消毒(HLD)以及灭菌。这些可能包括不期望的活的微生物数量的至少约4个对数级的降低、或至少约5个对数级的降低、或至少约6个对数级的降低。
消毒剂介质(A)和补充介质(B)可以出售,并且可以任选地以浓缩物形式使用。浓缩物可以在使用前或使用期间用水稀释。水可来自任何来源。水可包括去离子水、自来水、经处理的自来水,其混合物等。水可以包含软水。在本文中,术语“软水”用于指硬度水平为0毫克/升至约60毫克/升(以碳酸钙计,mg/L)范围内的水。
消毒剂介质(A)可用于对正在被清洗和消毒的基材提供消毒或灭菌。消毒剂介质(A)可以含有水和过乙酸。消毒剂介质(A)中过乙酸的浓度可以在约5重量%至约60重量%、或约15重量%至约45重量%、或约30重量%至约40重量%的范围内、或为约35.5重量%。消毒剂介质(A)可以任选地进一步包含一种或多种另外的成分,包括乙酸、过氧化氢、硫酸或其两种以上的混合物。消毒剂介质(A)中乙酸的浓度可以在高达约62重量%、或约34重量%至约62重量%、或约40重量%至约55重量%的范围内。消毒剂介质(A)中过氧化氢的浓度可以在高达约60重量%、或约5重量%至约60重量%、或约6.5重量%至约32重量%的范围内。消毒剂介质(A)中硫酸的浓度可以在高达约2重量%、或约0.5重量%至约2重量%、或约0.75重量%至约1.5重量%的范围内。消毒剂介质(A)中水的浓度可以在高达约60重量%、或约5重量%至约60重量%、或约10重量%至约50重量%的范围内。可以用作消毒剂介质(A)的市售过乙酸溶液可以商品名Peracetic Acid 35%从FMC Corporation获得。该溶液含有约35.5重量%的过乙酸、约40重量%的乙酸、约6.5重量%的过氧化氢、约1重量%的硫酸和约17重量%的水。具有所示浓度的这些组合物可用于作为浓缩物销售,并且任选地用于本发明的清洁和消毒方法。浓度可以在使用前或使用期间用水稀释。
补充介质(B)可用于清洁基材。在诸如内窥镜之类的医疗设备的情况下,这可能涉及去除残余的异物或污物,如血液、粪便、呼吸道分泌物等。补充介质(B)可以包含水、非酶清洁剂、腐蚀抑制剂和螯合剂。补充介质(B)还可以包含酶清洁剂。补充剂(B)还可以包含缓冲剂、表面活性剂、pH调节剂或其两种以上的混合物。其它添加剂成分也可以包含在补充介质(B)中。补充介质(B)可以被称为清洁/助洗剂制剂。在本文中,术语“助洗剂”用于指可包含在清洁或消毒组合物中的非活性成分的组合。非活性成分可能被称为是非活性的,因为非活性成分不直接导致清洁或消毒,而是用于其它目的。这些其它目的可以包括pH控制、水软化(螯合)、腐蚀抑制等。
非酶清洁剂可包含具有洗涤或其它清洁性质的表面活性剂。非酶清洁剂可以称为表面活性剂清洁剂。非酶活性剂可用于从被清洁的基材上除去污物(例如血液、体液等)。非酶清洁剂可包含链烷醇胺、醇乙氧基化物、烷基葡糖苷、亚烷基二醇、二丙酸烷基酯、烷基二烷基氧化胺或其两种以上的混合物。链烷醇胺可以包含单乙醇胺、二乙醇胺、三乙醇胺或其两种以上的混合物。可以使用的市售醇乙氧基化物为Berol 508(得自Akzo Nobel的醇乙氧基化物)。烷基葡糖苷可以包含衍生自葡萄糖的任何糖苷。烷基葡糖苷可以包含癸基葡糖苷。烷基葡糖苷可以包含烷基聚葡糖苷。烷基聚葡糖苷可以衍生自一种或多种糖和一种或多种脂肪醇。可以使用的市售烷基葡糖苷为购自Alzo Nobel的商品名AG 6206。亚烷基二醇可以包含分子量为约100至约5,000、或约100至约1,500的聚亚烷基二醇。聚亚烷基二醇可以包含聚乙二醇、聚丙二醇或其混合物。二丙酸烷基酯可以包含二丙酸辛酯。可以使用的市售二丙酸辛酯为购自Solvay-Rhodia的商品名Mackam ODP 45M。烷基二烷基氧化胺可以包含辛基二甲基氧化胺。补充介质(B)中非酶清洁剂的浓度可以在约0.1重量%至约25重量%、或约1重量%至约25重量%、或约5重量%至约15重量%的范围内。这些浓度可能适合作为浓缩物销售,并且任选地用于本发明的清洁和消毒方法。浓缩物可以在使用前或使用期间用水稀释。
腐蚀抑制剂可以包括苯并三唑、苯并三唑的钠盐、甲苯基三唑、甲苯基三唑的钠盐、氨基三亚甲基膦酸、辛基甜菜碱、诸如Irgacro L-190(购自BASF的有机羧酸)之类的羧酸、乙醇胺、膦酰基丁烷三羧酸或其两种以上的混合物。可以使用的市售苯并三唑钠以商品名Cobratec 40S购得,其中Cobratec 40S为40重量%的苯并三唑钠水溶液。补充介质(B)中腐蚀抑制剂的浓度可以在约1重量%至约10重量%、或约1重量%至约5重量%的范围内。这些浓度可能适合作为浓缩物销售,并且任选地用于本发明的清洁和消毒方法。浓度可以在使用前或使用期间用水稀释。
螯合剂可以包括乙二胺四乙酸、羟基亚乙基二膦酸、乙二胺四乙酸和羟基亚乙基二膦酸的钠盐、氨基三亚甲基膦酸、膦酸丁烷三羧酸、六偏磷酸钠、次氮基三乙酸三钠一水合物、聚丙烯酸的钠盐、谷氨酸二乙酸的四钠盐、多元羧酸、亚氨基二琥珀酸四钠盐、羧甲基菊粉、硼酸钠、甲基甘氨酸二乙酸或其两种以上的混合物。乙二胺四乙酸的有用钠盐可以是乙二胺四乙酸四钠盐四水合物。可以使用的市售乙二胺四乙酸四钠盐四水合物为购自AkzoNobel的商品名Dissolvine 220-S。Akzo Nobel将Dissolvine 220-S鉴定为含有83重量%至85重量%的乙二胺四乙酸四钠盐四水合物的螯合剂。螯合剂可以包含二羧酸和/或三羧酸。螯合剂可以包含柠檬酸。补充介质(B)中螯合剂的浓度可以在约0.1重量%至约70重量%、或约0.3重量%至约60重量%、或约0.5重量%至约55重量%的范围内。这些浓度可以适合作为浓缩物销售,并且任选地用于本发明的清洁和消毒方法。浓度可以在使用前或使用期间用水稀释。
酶清洁剂可以包括脂肪酶、淀粉酶、糖酶、蛋白酶或其两种以上的混合物。酶清洁剂可以包含蛋白质水解酶、蛋白质消化酶或其混合物。酶清洁剂可以包含蛋白水解酶。酶清洁剂可以包含枯草溶菌素。可以使用的市售的酶的实例包括的Alcalase Ultra 2.5L和Savinase 16L Type EX(两者均是可购自Novozymes的枯草溶菌素)。酶可以与补充介质(B)的其它成分组合使用以分解被处理的污物(例如血液、体液、废物等),从而便于将污物从基材中除去。补充介质(B)中酶清洁剂的浓度可以在高达约25重量%、或约0.2重量%至约25重量%,或约0.5重量%至约10重量%的范围内。这些浓度可以适合作为浓缩物销售,并且任选地用于本发明的清洁和消毒方法。这些浓度可以在使用前或使用期间用水稀释。
缓冲剂可以包含碱金属磷酸盐、碱金属碳酸盐或其混合物。碱金属可以包含钠或钾。缓冲剂可以包括磷酸一钠、磷酸二钠、磷酸三钠、磷酸一钾、磷酸二钾、磷酸三钾、碳酸钠、碳酸氢钠或其两种以上的混合物中的一种或多种。可以使用磷酸二钠。补充介质(B)中缓冲剂的浓度可以在高达约15重量%、或约1重量%至约15重量%、或约4重量%至约10重量%的范围内。这些浓度可以适合作为浓缩物销售,并且任选地用于本发明的清洁和消毒方法。这些浓度可以在使用前或使用期间用水稀释。
表面活性剂可包含这样的化合物,该化合物降低组合物中的组分之间,或组合物与被该组合物处理的基材之间的表面张力(或界面张力)。表面活性剂可以包含润湿剂、乳化剂、发泡剂和/或分散剂。表面活性剂可以包含含有至少一个疏水基团和至少一个亲水基团的化合物。表面活性剂可以包含水不溶性(或油溶性)组分和水溶性组分。表面活性剂可包含一种或多种离子(例如阴离子、阳离子和/或两性离子)化合物和/或非离子化合物。表面活性剂可包含一种或多种聚乙二醇醚(polythylene glycol ethers)、烷基芳基磺酸盐、氧化胺、聚(氧化烯)化合物、包含氧化烯重复单元的嵌段共聚物、羧基化醇乙氧基化物、乙氧基化烷基酚、乙氧基化胺、乙氧基化酰胺、环氧乙烷、乙氧基化脂肪酸、乙氧基化脂肪酸酯、乙氧基化油、脂肪酸酯、脂肪酸酰胺、甘油酯、乙二醇酯、脱水山梨糖醇酯、咪唑啉和/或其衍生物、卵磷脂和/或其衍生物、木质素和/或其衍生物、甘油酯和/或其衍生物、烯烃磺酸酯、磷酸酯和/或其衍生物、丙氧基化和/或乙氧基化脂肪酸和/或丙氧基化和/或乙氧基化醇、烷基酚、脱水山梨糖醇和/或其衍生物、蔗糖酯和/或其衍生物、脂肪酸酯的硫酸盐和/或醇和/或乙氧基化醇、十二烷基和/或十三烷基苯的磺酸盐、缩合萘、磺基琥珀酸酯和/或其衍生物、十三烷基和/或十二烷基苯磺酸、其两种以上的混合物等。表面活性剂可以包含C9-C11Pareth 8(具有平均8摩尔环氧乙烷的C9-C11脂肪醇的混合物的聚乙二醇醚)、C11-C15Pareth 3(具有平均3摩尔环氧乙烷的C11-C15醇的混合物的聚乙二醇醚)、Meroxapol 252(环氧乙烷)、辛基甜菜碱、聚乙二醇椰油胺或其两种以上的混合物。表面活性剂可包含一种或多种消泡剂(例如氢氧化钾、二丙酸辛酯)、泡沫增强剂、除油剂(例如氢氧化钾、硼酸钠)、流变改性(稀释)剂(例如聚丙烯酸)、渗透剂(例如丙二醇)、漂洗助剂或其两种以上的混合物。补充介质(B)中表面活性剂的浓度可以在高达约25重量%、或约1重量%至约25重量%、或约5重量%至约15重量%的范围内。这些浓度可以适合作为浓缩物销售,并且任选地用于本发明的清洁和消毒方法。这些浓度可以在使用前或使用期间用水稀释。
补充介质(B)还可以包含一种或多种阻垢剂、稳定剂(例如月桂胺氧化物)、防腐剂(例如,购自Lonza的DMDM乙内酰脲、抗微生物甲醛释放剂防腐剂(CAS号6440-58-0))、抗絮凝剂(defloculents)或悬浮剂(例如聚丙烯酸钠盐)、金属钝化剂、增稠剂(例如月桂胺氧化物、羟乙基纤维素、丙二醇或其两种以上的混合物)、张力调节剂(例如氯化钠、氯化钾、葡萄糖)、或其两种以上的混合物。这些中的每一种的浓度可以在高达约25重量%、或约0.1重量%至约10重量%、或约0.1重量%至约5重量%的范围内。这些浓度可以在使用前或使用期间用水稀释。
可在本发明方法的清洁和/或消毒步骤中使用的消毒剂介质(A)与补充介质(B)的体积比可以在约5:1至约1:5、或约4:1至约1:4、或约3:1至约1:3、或约2:1至约1:2、或约1.5:1至约1:1.5的范围内、或为约1:1。
消毒剂介质(A)的pH可以在约1至约8、或约3至约6的范围内。补充介质(B)的pH可以在约6至约14、或约6至约9的范围内。消毒剂介质(A)和/或补充介质(B)的pH可以使用氢氧化钠或氢氧化钾、三乙醇胺、柠檬酸或其两种以上的混合物来调节。
如上所述,当将消毒剂介质(A)和补充介质(B)用于本发明的清洁和消毒方法时,消毒剂介质(A)和补充介质(B)可以以所示的浓缩物浓度使用,或者它们可以用水稀释。消毒剂介质(A)的稀释度可以高达1000体积份的水/1体积份的消毒剂介质(A)(即高达为约1000:1),或约20:1至约1000:1、或约35:1至约500:1;或约50:1至约250:1。类似地,补充介质(B)的稀释度可以高达1000体积份的水/1体积份的补充介质(B),或约20:1至约1000:1、或约35:1至约500:1;或约50:1至约250:1。
由消毒剂介质(A)和补充介质(B)制成的两部分液体清洁和消毒组合物可用于清洁和消毒基材(或物品)的方法,包括清洁和消毒不能承受蒸汽杀菌所需的高温的基材的方法。
该方法可能为清洁和消毒基材的一步法,或清洁和消毒基材的两步法。该方法可以包括手动预清洁步骤。
一步法可包括将基材与补充介质(B)和消毒剂介质(A)接触有效的时间段以清洁和消毒基材。该方法可以在约15℃至约60℃、或约18℃至约60℃、或约18℃至约56℃、或约18℃至约50℃、或约18℃至约40℃、或约18℃至约30℃、或约18℃至约24℃的温度下进行。接触时间可以在约0.5分钟至约240分钟,或约2分钟至约60分钟的范围内。
两步法可以包括:(1)使基材与补充介质(B)接触以清洁基材;以及(2)使基材与消毒剂介质(A)接触以消毒基材。该方法可以包括:(1)使基材与补充介质(B)和消毒剂介质(A)接触以清洁基材,以及(2)使基材与消毒剂介质(A)接触以消毒基材。该方法可以包括:(1)使基材与补充介质(B)接触以清洁基材,以及(2)使基材与消毒剂介质(A)和补充介质(B)接触以消毒基材。该方法可以包括:(1)使基材与补充介质(B)和消毒剂(A)接触以清洁基材,以及(2)使基材与消毒剂介质(A)和补充介质(B)接触以消毒基材。该两步法可以任选地包括在步骤(1)之后、步骤(2)之前漂洗基材。
在步骤(1)和(2)的每一步中使用的温度可以在约15℃至约60℃、或约18℃至约60℃、或约18℃至约56℃、或约18℃至约50℃、或约18℃至约40℃、或约18℃至约30℃、或约18℃至约24℃的范围内。步骤(1)和(2)中的每一步可以在室温下进行。
步骤(1)和(2)的每一步中的接触时间可以持续约0.5分钟至约240分钟、或约0.5分钟至约60分钟、或约0.5分钟至约10分钟、或约2分钟至约8分钟、或约4分钟至约8分钟、或约6分钟。
可被清洁和消毒的基材可包括医疗、牙科、制药、兽医或太平间的仪器和设备。这些基材可包括内窥镜。该基材可以由这样的材料制成,该材料包括黄铜、铜、铝、不锈钢、碳钢、塑料、玻璃、粘合剂或其两种以上的组合。
在医疗实践领域中,使用内窥镜进行许多诊断、治疗或外科手术。根据内窥镜的结构以及内窥镜打算如何使用,内窥镜分为两大类,刚性或柔性。其中刚性内窥镜倾向于由金属部件构成,而柔性内窥镜通常由聚合物材料构成。在许多情况下,使用金属和聚合物材料这二者。在任一种情况下,这些医疗设备还可以包括光学、电子或其它特征,这些特征使得医疗设备在处理上既昂贵又精细;特别是在其预期用途之后,当这些器械正在被清洗和消毒以备后用时。
根据内窥镜的类型以及使用内窥镜的程序的类型,这种处理通常涉及后程序擦拭、水槽中的手动预清洁以及消毒或杀菌的组合。
接触血液的基材,例如内窥镜,通常在其下次使用前进行杀菌。对于其它基材或设备,高水平消毒(HLD)可能就足够了。高水平消毒和灭菌之间的区别通常与所用灭菌介质的效力、其作用方式和暴露持续时间有关。
许多医疗设备的消毒或灭菌介质可以是蒸汽、气态化学物质(例如气态过氧化氢或环氧乙烷)或液体化学物质。然而,对于许多复杂的设备,例如各种内窥镜等,蒸汽不能安全使用,因为这些设备中的许多设备对暴露于高热敏感并且可能被高热破坏。类似地,其它介质可能引入其它禁忌,包括耗时的步骤(例如暴露于环氧乙烷后放气)或劳动密集的准备步骤(在暴露于气态过氧化氢之前进行广泛的清洁和干燥,并且由于没有活跃的气体流动而无法进入长而狭窄的管腔区域)。本发明提供了替代方案,其中可以使用诸如内窥镜之类的热敏设备的低温液体再处理,从而实现清洁和消毒。无论是用于消毒还是灭菌,所使用的介质通常都会形成灭菌剂,这意味着在给定的浓度和时间下,培养基可以杀死该特定培养基中高于6个对数的抗性最强的生物。实现6个对数级的降低是获得灭菌剂名称所需要的。尽管消毒通常使用与杀菌相同的灭菌介质,但消毒可以以较低浓度或较短时间(或较低浓度且较短时间)进行,以达到用于某些设备的预期用途的适当消毒水平。
可以通过手动、后程序擦拭来开始可用于内窥镜的清洁和消毒方法。然后该方法可以扩展到手动预清洁步骤和手动消毒步骤(以该顺序)。这可能代表内窥镜再处理成本最低的替代方案,但通常需要较长的消毒剂暴露时间,并且可能会使用户面临更大的风险,该风险包括接触所使用的化学品或受污染设备本身。该方法代表了清洁和消毒内窥镜最常用但却不断减少的方法。
另一方面,完全自动化的机器(再处理器)可以消除大部分手动步骤。这些自动化系统通常与特定的消毒剂化学物质一起共同开发和共同验证,以提供完全集成的再处理方法。这些全自动机器及其专用的消毒剂化学物质也是最昂贵的替代方案,并且代表正在进行的整个再处理程序的基本上较小部分。
近年来,在市场上引入了一些“开放”再处理器以清洁和消毒内窥镜。尽管这些再处理器可以使许多(如果不是全部的话)与内窥镜的手动再处理有关的步骤自动化,但它们通常不是与特定的消毒剂化学制剂共同开发的,而是旨在与一种或多种预先存在的化学物质一起使用。这些机器的灵活性在于它们可以与各种消毒剂一起使用,该消毒剂包括醛类、过氧化物类和基于过乙酸的化学物质。这些设备可以提供替代方案,其将半自动化处理与更广泛的可用化学品(而不是完全集成的系统所能提供的化学品)相结合。而且,尽管比手动方法稍微更昂贵,但这些开放系统在被执行的进程的数量上是增长的。
尽管全自动系统可能提供比其他方法更受控制的方法,但是开放式系统可以具有更广泛的可供选择的化学物质。这可能是重要的,因为各个内窥镜可能对特定化学物质的反应不同。也就是说,当使用一种化学物质时,特定的内窥镜可能更容易受到损害。通常,决定购买哪种全自动系统是基于购买者使用的特定内窥镜,以及专用于该系统的专用化学物质是否与将被处理的内窥镜兼容使用。
本发明的优点是本发明的两部分液体清洁和消毒组合物可以用于专用系统中,或者其可以适用于手动或开放系统。本发明的两部分液体组合物可用于在同一系统中支持和进行高水平消毒或灭菌。本发明的两部分液体组合物可以与内窥镜的广泛组合一起使用,并且能够容易地适应给定内窥镜的特定需要。
本发明的两部分液体组合物允许自动分配并减少了用户与灭菌剂接触的暴露,其中在静态浸泡方法中手动制备混合物或稀释液。
消毒介质(A)和补充介质(B)可以在使用前保存在分开的容器中以提高其稳定性,并防止成分以可能降低其效力或可能引入不需要的副反应产物的方式而彼此相互作用。
在上述的再处理顺序中,在消毒之前进行清洁。该惯例的特点在于,许多再处理器的操作固件将这些操作中的每一个作为由至少一个可选的漂洗周期分隔的单独步骤来解决。
本发明的清洁和消毒方法可以使用任何合适的清洁和消毒装置来进行。在美国专利5,077,008;8,530,184 B2;和8,691,562 B2;以及在美国专利公开US 2012/0230870 A1中公开了上述实例。
使用消毒剂介质(A)和补充介质(B)的两步清洁和消毒方法可以使用图1中示意性示出的装置来进行。参照图1,该装置包括:用于容纳待清洁和消毒的基材(例如内窥镜)的盆10、用于容纳消毒剂介质(A)(如图中所示的部分A)的罐或容器12、用于补充介质(B)(如图中所示的部分B)的单独的罐或容器14、用于将罐或容器12和14与盆10连接的管子或管道、用于向盆10添加水的供水装置16、用于控制从供水装置16到盆10的水流的阀18、用于控制液体从盆10流出至排水口21的流动的阀20、用于控制消毒剂介质(A)向水池10的流动的计量泵22、用于控制补充介质(B)到盆10的流动的计量泵24、以及用于控制阀18和20、加热器(未示出)以及计量泵22和24的控制器26,其可以是微处理器。
在图2中示例了用于操作图1所示的装置的替代服务模式。图2中所示的B/A比是补充介质(B)与消毒剂介质(A)的体积比。图2中使用的术语“软”水和“硬”水是涉及水中的碳酸钙浓度的技术术语。为了本公开的目的,对于什么构成软水和硬水,本文使用由美国地质服务局(U.S.Geological Services)使用的分类。美国地质服务局将含有0-60mg/L碳酸钙的水分类为“软”、61-120mg/L为“中硬”、121-180mg/L为“硬”、以及超过180mg/L是“极硬”。
在下面提供的实施例中,消毒剂介质(A)含有65重量%的水和35重量%的过乙酸(PAA)。补充介质(B)含有3重量%的三乙醇胺、2.2重量%的乙醇胺、2重量%的聚亚烷基二醇、3重量%的辛基二甲基氧化胺、4重量%的Alcalase Ultra 2.5L、4重量%的Savinase16L Type EX、1重量%的甲苯基三唑、1重量%的腐蚀抑制剂、3重量%的柠檬酸、1.1重量%的环氧乙烷、2重量%的聚乙二醇椰油胺、20重量%的丙二醇、0.005重量%的消泡剂、0.15重量%的氯化钙、0.0125重量%的香料,其余为软水。在下面的实施例中,B/A比是体积比。
实施例1
清洁和消毒的方法通过下述方式进行:在第一次清洁步骤中使用补充介质(B),然后在第二次消毒步骤中使用部分(A)和部分(B)的组合。对于消毒步骤,使用四种不同的选项。清洁和消毒步骤都是在室温下进行的。根据使用的水的硬度来调整(B)与(A)之比。
该实施例表明,通过改变消毒过程中使用的部分(B)的比例,用户可以使用部分(B)的硬度控制成分来调整当地的水硬度。
实施例2
本发明的两部分液体组合物可用于常规自动内窥镜再处理器(AER)的消毒。将部分(B)与水结合产生清洁溶液,以在由AER中的现有固件控制的单独清洁阶段期间使用。这不需要由用户或操作系统软件修改任何操作步骤,并且部分(B)仅由处理器的控制系统“看”作清洁剂。在此步骤之后并允许系统进行其常规的漂洗周期,但在本申请中不需要漂洗周期,部分(A)和部分(B)一起用作消毒溶液。不需要改变现有的程序或编程步骤。部分(B)的使用取代了现有技术中使用的消毒溶液的常规助洗剂,从而降低了成本和复杂性。这种配置还允许用户绕过漂洗阶段(如果软件允许的话),从而节省了时间和效用成本而作为进一步的益处。在该实施例中,使用标准的AER操作、清洁、然后排水、然后消毒。
由于将部分(B)用于消毒步骤,因此不需要漂洗步骤。将清洁溶液排干,然后使用消毒溶液。
实施例3
为了使医疗设备的消毒或杀菌成功,需要医疗设备的有效清洁。可以通过使用部分(B)或部分(B)与部分(A)组合来进行清洁步骤。在需要的清洁步骤(其可以手动进行或借助不同的清洁装置进行)之后,部分(A)和部分(B)可用于已经适应某些内窥镜的温度敏感要求的过程中的高水平消毒或杀菌。尽管本发明的化学物质中的消毒在概念上被描述为以便利的1:1比例(例如部分(B)和部分(A)各80mL)使用,但可以以不同方式来调整相对比例以实现不同的消毒用途的稀释条件。为了说明的目的,对于在50℃下进行的消毒操作中,将1:1比设定为期望使用的。如果特定的内窥镜对常规低温消毒或灭菌程序(例如50℃)的热量异常敏感,则可以调整部分(B)与部分(A)的比例,使得在保持消毒的功效的同时可以使用较低的温度。当无法达到标称的50℃消毒温度时,这也是期望的。在更低的温度(40℃)下可以使用比例为1:1.2的部分(B)与部分(A),以提供更多的灭菌剂来抵消热量降低可能导致的对微生物功效的影响。在30℃下可以1:1.5的比例使用,并且如果期望的操作条件是室温(例如20℃),则例如可以使用1:2的比例。
如果这么多的部分(A)对于承受多次消毒循环的特别敏感的设备引入了过多的腐蚀,则该比例可以调节至2:1.5或2:2.0,从而增加由部分(B)提供的腐蚀控制量以减少腐蚀,同时仍提供用于抵消较低温度的额外消毒量(参见实施例4)。
该实施例表明操作员可选择可使用的温度,同时保持消毒功效和适当的水硬度控制。通过增加使用的部分(A)的比例而不是通过延长暴露,可以选择较低的温度以在较短的时间内实现所期望的杀死。
实施例4
部分(A)和部分(B)可用于处理腐蚀敏感的内窥镜。如果设备对热不是特别敏感,但由高度腐蚀敏感的材料构成,则可以调节部分(B)与部分(A)的比例,使得使用适量的部分(A),但添加更多量的部分(B)(例如,比例为2:1或3:1)。这样提供了更多的部分(B)来抵消腐蚀。
该实施例表明,通过增加使用的部分(B)的比例,可以提供额外的耐腐蚀性,同时保持产生有效杀死所需的部分(A)的水平。这可以应用于上面讨论的实施例3选项或者当指示或期望使用更多的部分(A)时。
实施例5
对于难以消毒的内窥镜,可以以下面示例的比例一起使用部分(A)和部分(B)。如果设备不是特别热敏的但具有抗消毒剂标准水平的历史(例如该设备由特定材料或特别复杂的设计构成,该设计保护污染生物体免于有效暴露于消毒剂),根据对腐蚀的敏感性并在较高的常规温度下进行处理,可以将部分(B)与部分(A)之比调节为1:2或2:2。
该实施例表明,通过增加(加倍)部分(A)的使用量,可以实现这样的可能性:在难以消毒设备开始时产生有效杀死。也可以相应调整部分(B)的使用。
在以下实施例6-8中,部分(A)和部分(B)如以上实施例1-5所述。助洗剂1含有两种磷酸钠、苯并三唑、乙二胺四乙酸四钠、钼酸钠、氢氧化钠、乙氧基化聚氧丙烯、聚丙烯酸酯、磷酸钠和水。助洗剂2含有磷酸钠、苯并三唑钠和乙二胺四乙酸的钠盐。
实施例6
图3A-3D示出了过乙酸在单独使用时(图3A)、或与现有技术的助洗剂1结合使用时(图3B)、或与现有技术的助洗剂2结合使用时(图3C)或与在本发明的补充介质部分(B)中使用时(图3D),在单次消毒循环所需时间内的稳定性(短期稳定性)。斜率可用于理解稳定性的动力学(或相反,PAA降解的性质)。而斜率为0(水平线)表示在所研究的时间范围内完美的稳定性;并且斜率为-1表示立即降解,斜率为-0.00005(图3A)表明PAA溶液在指定的时间范围内本身是稳定的。然而,斜率为-0.0013(图3B)表明由示例性的助洗剂1中的成分引起的PAA稍微相对快速地降解。图3C中斜率为-0.0027表明该组合中的PAA组分与图3B的情况几乎处于相同的水平。本发明的补充介质部分(B)(图3D)的影响示出了斜率为-0.005,这表明该补充介质部分(B)使PAA组分的稳定性恢复到与图3A所示的纯PAA的情况几乎相同的水平。
实施例7
图4A-4D示出了过乙酸在单独使用时(图4A)、或与现有技术的助洗剂1结合使用时(图4B)、或与现有技术的助洗剂2结合使用时(图4C)或与在本发明的补充介质部分(B)中使用时(图4D),在不同的消毒溶液温度下在单次消毒循环所需时间内的稳定性(稳定性)。每条线的趋势可用于理解稳定性的动力学(或相反,PAA降解的速率和量)。图4A中的线的趋势表明在较低温度下具有良好的稳定性,但溶液浓度降低并且在所研究的时间范围内随着温度增加而具有较小的稳定性。PAA溶液单独使用时是相对稳定的(图4A),但是该条件不能提供由助洗剂所提供的缓冲能力、耐腐蚀能力或螯合能力。图4B和4C示出了当使用现有技术助洗剂时,随着溶液温度的升高,初始溶液浓度和随后PAA降解速率均显著变化。图4B表示由助洗剂1中的成分引起的快速降解。在助洗剂1和助洗剂2的存在下,PAA溶液相对不稳定。图4D示出了与图4A所示稳定性相似的PAA溶液稳定性。当使用本发明的助洗剂时,浓度与图4A中的浓度几乎相同水平。本发明的补充介质部分(B)(图4D)的影响表明该溶液的稳定性几乎与图4A所示的纯PAA的情况相同,但是具额外的益处,如由部分(B)提供的缓冲能力、耐腐蚀能力和螯合能力。图4A和4D的初始和终点浓度均较高。
实施例8
图5A-5D示出了过乙酸在单独使用时(图5A)、或与现有技术的助洗剂1结合使用时(图5B)、或与现有技术的助洗剂2结合使用时(图5C)或与本发明的补充介质部分(B)组合使用时(图5D),在初始和多次消毒循环所需时间内的稳定性(稳定性)。在期望的实施方案中,本发明组合物的稳定性将使得其在需要补充之前可以支持多于一个循环。要达到这一点需要足够的稳定性,使得所得的消毒溶液浓度足够高,以高于所进行的每个循环中消毒/杀菌的建议最低浓度。虽然消毒/灭菌的实际暴露时间可能仅为(例如)5-7分钟,但每个循环可能需要30-45分钟才能完成整个过程中的所有其他步骤,因此可以进行的循环数取决于在所有操作期间和在所有操作之间的总时间内每种溶液的整体稳定性。对于此数据,使用一个小时的循环时间来进行计算。在给出图5A的数据的实验中,单独使用过乙酸,高达10个完整的小时的长循环是可能的。然而,助洗剂的益处没有发生。图5B和5C表明只能进行一个循环。给出图5D的数据的实验表明,本发明的补充介质部分(B)匹配或超过纯PAA所见的性能,因此能够在10个小时内进行高达10个循环,并且也实现了使用补充介质(B)的所有益处。应当注意的是,尽管现有技术助洗剂2(图5C)具有与单独PAA(图5A)一样高的初始浓度,但如图5D所示,使用部分(B)的本发明也是如此。
尽管已经使用各种实施方案说明了本发明,但应当理解的是,在阅读说明书之后,其变化对本领域技术人员而言可以变得显而易见。因此,应当理解的是,本文规定的本发明的范围旨在包括可落入所附权利要求的范围内的所有变化。
Claims (59)
1.一种用于清洁和消毒基材的两部分液体组合物,包含:
(A)包含过乙酸的消毒剂介质;和
(B)包含非酶清洁剂、腐蚀抑制剂和螯合剂的补充介质;其中所述非酶清洁剂包含链烷醇胺、醇乙氧基化物、烷基葡糖苷、亚烷基二醇、二丙酸烷基酯、烷基二烷基氧化胺或其两种以上的混合物。
2.根据权利要求1所述的组合物,其中所述消毒剂介质(A)还包含乙酸、过氧化氢、硫酸或其两种以上的混合物。
3.根据权利要求1或2所述的组合物,其中所述消毒剂介质(A)包含约5重量%至约60重量%、或约15重量%至约45重量%、或约30重量%至约40重量%、或约34重量%至约36重量%的过乙酸。
4.根据前述权利要求中任一项所述的组合物,其中所述补充介质(B)还包含表面活性剂、缓冲剂、pH调节剂或其两种以上的混合物。
5.根据前述权利要求中任一项所述的组合物,其中所述补充介质(B)还包含酶清洁剂。
6.根据权利要求1所述的组合物,其中所述链烷醇胺包含单乙醇胺、二乙醇胺、三乙醇胺或其两种以上的混合物。
7.根据权利要求1所述的组合物,其中所述烷基葡糖苷包含癸基葡糖苷。
8.根据权利要求1所述的组合物,其中所述烷基葡糖苷包含烷基聚葡糖苷。
9.根据权利要求1所述的组合物,其中所述亚烷基二醇包含聚乙二醇、聚丙二醇或其混合物。
10.根据权利要求1所述的组合物,其中所述亚烷基二醇包含聚乙二醇。
11.根据权利要求1所述的组合物,其中所述二丙酸烷基酯包含二丙酸辛酯。
12.根据权利要求1所述的组合物,其中所述烷基二烷基氧化胺包含辛基二甲基氧化胺。
13.根据前述权利要求中任一项所述的组合物,其中所述补充介质(B)包含单乙醇胺、三乙醇胺、辛基二甲基氧化胺、聚亚烷基二醇、二丙酸辛酯、醇乙氧基化物、烷基葡糖苷或其两种以上的混合物。
14.根据前述权利要求中任一项所述的组合物,其中所述补充介质(B)包含约0.1重量%至约25重量%、或约1重量%至约25重量%、或约5重量%至约15重量%的所述非酶清洁剂。
15.根据前述权利要求中任一项所述的组合物,其中所述补充介质(B)包含脂肪酶、淀粉酶、糖酶、蛋白酶或其两种以上的混合物。
16.根据前述权利要求中任一项所述的组合物,其中所述补充介质(B)包含蛋白水解酶。
17.根据前述权利要求中任一项所述的组合物,其中所述补充介质(B)包含枯草溶菌素。
18.根据前述权利要求中任一项所述的组合物,其中所述补充介质(B)包含蛋白质水解酶、蛋白质消化酶或其混合物。
19.根据前述权利要求中任一项所述的组合物,其中所述补充介质(B)包含高达约25重量%、或约0.2重量%至约25重量%,或约0.5重量%至约10重量%的酶清洁剂。
20.根据权利要求4所述的组合物,其中所述缓冲剂包含碱金属磷酸盐、碱金属碳酸盐或其混合物。
21.根据权利要求4所述的组合物,其中所述补充物质(B)包含高达约15重量%、或约1重量%至约15重量%、或约1重量%至约10重量%、或约1重量%至约5重量%、或约2重量%至约4重量%的所述缓冲剂。
22.根据前述权利要求中任一项所述的组合物,其中所述腐蚀抑制剂包括苯并三唑、甲苯基三唑、苯并三唑的钠盐、甲苯基三唑的钠盐、氨基三亚甲基膦酸、辛基甜菜碱、羧酸、乙醇胺、膦酰基丁烷三羧酸或其两种以上的混合物。
23.根据前述权利要求中任一项所述的组合物,其中所述补充介质(B)包含约0.1重量%至约10重量%、或约1重量%至约5重量%的所述腐蚀抑制剂。
24.根据前述权利要求中任一项所述的组合物,其中所述螯合剂包括乙二胺四乙酸、羟基亚乙基二膦酸、乙二胺四乙酸的钠盐、羟基亚乙基二膦酸的钠盐、氨基三亚甲基膦酸、多元羧酸、亚氨基二琥珀酸四钠、羧甲基菊粉、硼酸钠、甲基甘氨酸二乙酸或其两种以上的混合物。
25.根据前述权利要求中任一项所述的组合物,其中所述螯合剂包括柠檬酸。
26.根据前述权利要求中任一项所述的组合物,其中所述补充介质(B)包含约0.1重量%至约70重量%、或约0.3重量%至约60重量%、或约0.5重量%至约55重量%的所述螯合剂。
27.根据前述权利要求中任一项所述的组合物,其中所述缓冲剂包含胺、羧酸、磷酸盐、碳酸盐或其两种以上的混合物。
28.根据前述权利要求中任一项所述的组合物,其中所述补充介质(B)包含约1重量%至约15重量%、或约4重量%至约10重量%的所述缓冲剂。
29.根据权利要求4所述的组合物,其中所述表面活性剂包含洗涤剂、润湿剂、乳化剂、发泡剂和/或分散剂。
30.根据权利要求4所述的组合物,其中所述表面活性剂包含含有至少一个疏水基团和至少一个亲水基团的化合物。
31.根据权利要求4所述的组合物,其中所述表面活性剂包含水不溶性组分和水溶性组分。
32.根据权利要求4所述的组合物,其中所述表面活性剂包含阴离子化合物、阳离子化合物、两性离子化合物和/或非离子化合物。
33.根据权利要求4所述的组合物,其中所述表面活性剂包含一种或多种聚亚烷基二醇醚、烷基芳基磺酸盐、氧化胺、聚(氧化烯)化合物、包含氧化烯重复单元的嵌段共聚物、羧基化醇乙氧基化物、乙氧基化烷基酚、乙氧基化胺、乙氧基化酰胺、环氧乙烷、乙氧基化脂肪酸、乙氧基化脂肪酸酯、乙氧基化油、脂肪酸酯、脂肪酸酰胺、甘油酯、乙二醇酯、脱水山梨糖醇酯、咪唑啉和/或其衍生物、卵磷脂和/或其衍生物、木质素和/或其衍生物、甘油酯和/或其衍生物、烯烃磺酸酯、磷酸酯和/或其衍生物、丙氧基化和/或乙氧基化脂肪酸和/或丙氧基化和/或乙氧基化醇、烷基酚、脱水山梨糖醇和/或其衍生物、蔗糖酯和/或其衍生物、脂肪酸酯的硫酸盐和/或醇和/或乙氧基化醇、十二烷基苯和/或十三烷基苯的磺酸盐、缩合萘、磺基琥珀酸酯和/或其衍生物、十三烷基和/或十二烷基的苯磺酸、辛基甜菜碱、或其两种以上的混合物。
34.根据权利要求4所述的组合物,其中所述补充介质(B)中的所述表面活性剂的浓度在高达约25重量%、或约1重量%至约25重量%、或约5重量%至约15重量%的范围内。
35.根据前述权利要求中任一项所述的组合物,其中部分所述补充介质(B)还包含一种或多种阻垢剂、防腐剂、抗絮凝剂、悬浮剂、金属钝化剂、增稠剂、消泡剂、泡沫增强剂、除油剂、螯合剂、流变改性剂、渗透剂、溶解剂、漂洗助剂或其两种以上的混合物。
36.根据前述权利要求中任一项所述的组合物,其中所述消毒剂介质(A)的pH在约1至约8、或约3至约6的范围内。
37.根据前述权利要求中任一项所述的组合物,其中所述补充介质(B)的pH可以在约6至约14、或约6至约9的范围内。
38.根据前述权利要求中任一项所述的组合物,其中(B)与(A)的体积比为约5:1至约1:5、或约4:1至约1:4、或约3:1至约1:3、或约2:1至约1:2、或约1.5:1至约1:1.5、或约1:1。
39.根据前述权利要求中任一项所述的组合物,其中用水稀释所述消毒剂介质(A),水与所述消毒剂介质(A)的体积比为高达约1000:1、或约20:1至约1000:1、或约35:1至约500:1;或约50:1至约250:1。
40.根据前述权利要求中任一项所述的组合物,其中用水稀释所述补充介质(B),水与所述补充介质(B)的体积比为高达约100:1、或约20:1至约1000:1、或约25:1至约500:1;或约50:1至约250:1。
41.一种使用前述权利要求中任一项所述的两部分液体组合物清洁和消毒基材的方法,其包括:使所述基材与所述补充介质(B)和所述消毒剂介质(A)接触以清洁和消毒所述基材。
42.一种使用利要求1至40中任一项所述的两部分液体组合物清洁和消毒基材的方法,其包括:
(1)使所述基材与所述补充介质(B)接触以清洁所述基材,以及
(2)使所述基材与所述消毒剂介质(A)接触以消毒所述基材。
43.一种使用利要求1至40中任一项所述的两部分液体组合物清洁和消毒基材的方法,其包括:
(1)使所述基材与所述补充介质(B)和所述消毒剂介质(A)接触以清洁所述基材,以及
(2)使所述基材与所述消毒剂介质(A)接触以消毒所述基材。
44.一种使用利要求1至40中任一项所述的两部分液体组合物清洁和消毒基材的方法,其包括:
(1)使所述基材与所述补充介质(B)接触以清洁所述基材,以及
(2)使所述基材与所述消毒剂介质(A)和所述补充介质(B)接触以消毒所述基材。
45.一种使用利要求1至40中任一项所述的两部分液体组合物清洁和消毒基材的方法,其包括:
(1)使所述基材与所述补充介质(B)和所述消毒剂(A)接触以清洁所述基材,以及
(2)使所述基材与所述消毒剂介质(A)和所述补充介质(B)接触以消毒所述基材。
46.根据权利要求42至45中任一项所述的方法,其包括在步骤(1)之后、步骤(2)之前漂洗所述基材的步骤。
47.根据权利要求41至45中任一项所述的方法,其中所述基材由这样的材料制成,该材料包括黄铜、铜、铝、不锈钢、碳钢、塑料、玻璃或其两种以上的组合。
48.根据权利要求41至45中任一项所述的方法,其中所述基材包括医疗、牙科、制药、兽医或太平间仪器或设备。
49.根据权利要求41至45中任一项所述的方法,其中所述基材包括内窥镜。
50.根据权利要求49所述的方法,其中所述内窥镜包括刚性内窥镜。
51.根据权利要求49所述的方法,其中所述内窥镜包括柔性内窥镜。
52.根据权利要求41至45中任一项所述的方法,其中所述方法在约15℃至约60℃、或约18℃至约60℃、或约18℃至约56℃、或约18℃至约50℃、或约18℃至约40℃、或约18℃至约30℃、或约18℃至约24℃范围内的温度下进行。
53.根据权利要求41至45中任一项所述的方法,其中所述方法进行约0.5分钟至约240分钟、或约0.5分钟至约60分钟、或约0.5分钟至约10分钟的时间段。
54.根据权利要求42至45中任一项所述的方法,其中步骤(1)在约15℃至约60℃、或约18℃至约60℃、或约18℃至约56℃、或约18℃至约50℃、或约18℃至约40℃、或约18℃至约30℃、或约18℃至约24℃范围内的温度下进行。
55.根据权利要求42至45中任一项所述的方法,其中步骤(1)所需要的时间在约0.5分钟至约240分钟、或约0.5分钟至约60分钟、或约0.5分钟至约10分钟的范围内。
56.根据权利要求42至45中任一项所述的方法,其中步骤(2)在约15℃至约60℃、或约18℃至约60℃、或约18℃至约56℃、或约18℃至约50℃、或约18℃至约40℃、或约18℃至约30℃、或约18℃至约24℃范围内的温度下进行。
57.根据权利要求42至45中任一项所述的方法,其中步骤(2)所需要的时间在约0.5分钟至约240分钟、或约2分钟至约60分钟、或约0.5分钟至约10分钟的范围内。
58.根据权利要求41至57中任一项所述的方法,其中对所述基材进行清洁和消毒。
59.根据权利要求41至57中任一项所述的方法,其中对所述基材进行清洁和灭菌。
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