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消毒剂的选择与确认,你真的会了吗?

今天主要和大家聊聊如何选择消毒剂以及如何确认消毒剂的相关内容:


微生物的抗性


不同微生物对消毒剂的抗性也各不相同。它们的顺序从大到小的排列如下:


Type of microorganisms

微生物种类

examples

实例

Bacterial spores

细菌芽孢

Bacillus subtilis and clostridium  sporogenes

枯草杆菌,产孢梭菌

Mycobacteria

分枝杆菌

Mycobacterium tuberculosis

结核分枝杆菌

Nonlipid-coated viruses

亲脂病毒

Poliovirus and rhinovirus

脊髓灰质病毒,鼻病毒

Fungal spores and vegetative molds and  yeast

真菌孢子,生长态的霉菌与酵母菌

Trichophyton, cryptococcus, and Candida spp

发藓菌,隐球菌属,念珠菌属等

Vegetative bacteria

生长态的细菌

Pseudomonas aeruginosa, Staphylococcus  Aureus, and salmonella spp

绿脓杆菌,金色葡萄球菌,和沙门氏菌等等

Lipid-coated viruses

亲水病毒

herpes simplex virus, hepatitis B virus,  and human immunodeficiency virus

单纯性疱疹病毒,乙肝病毒,人体免疫缺陷病毒


消毒剂的分类



化学消毒剂按他们的化学型分类。其中包括醛,醇,卤素,过氧化物,季胺类化合物,和酚类化合物。


Chemical entity

化学体

Classification

分类

Example

例证

Aldehydes醛

sporicidal agent

杀孢子剂

2% glutaldehyde

Alcohols醇

General purpose disinfectant, antiseptic,  Antiviral agent,

一般用途的消毒剂,抗菌剂和抗病毒试剂

70% isopropyl alcohol, 70% alcohol,

70%的异丙醇,70%的乙醇

Chlorine and Sodium Hypochlorite

氯和次氯酸钠

sporicidal agent

杀孢子剂

0.5% sodium hypochlorite

0.5%次氯酸钠

Phenolics

酚类化合物

general purpose Disinfectant

一般用途的消毒剂

50μg per g chlorocresol, 500μg per g  chloroxylenol

50μg/g 氯甲酚,500μg/g对氯间二甲酚

Ozone

臭氧

sporicidal agent

杀孢子剂

8%gas by weight

8%的气体(重量百分比)

Hydrogen Peroxide

过氧化氢

vapor phase sterilant, liquid Sporicidal  Agent, antiseptic

蒸汽的杀菌剂,液体杀孢子剂,抗菌剂

4μg per g H2O2 vapor,  10%-25% solution, 3% solution

4μg/g 双氧水蒸汽,10%-25%溶液,3%溶液

Substituted diguanides取代的二甲双胍

antiseptic agent

抗菌剂

0.5% chlorhexidine gluconate

0.5%葡萄糖酸洗必太

Peracetic acid

过氧乙酸

liquid sterilant, Vapor phase Sterilant

液体杀菌剂,蒸汽的杀菌剂

0.2%peracetic acid, 1 μg per g peracetic  acid

0.2%peracetic酸,1 μg/g过氧乙酸

Ethylene oxide

环氧乙烷

vapor-phase Sterilant

蒸汽的杀菌剂

600 μg per g ethylene oxide

600μg/g 环氧乙烷

Quaternary Ammonium Compounds

季氨盐化合物

general purpose disinfectant, antiseptic

一般用途的消毒杀菌剂,抗菌剂

200 μg per g

benzalkonium chloride

200 μg/g洁尔灭氯化物

β-propiolactone

β-丙内酯

sporicidal agent杀孢子剂

100μg per g

β-propiolactone

β-丙内酯


抗微生物化学试剂可分为三类:杀菌剂,消毒剂和杀孢子剂。这里列出的是通常与每个类别相关联的试剂类型。



杀菌剂



由于蒸发快、残留低的特点,消毒已被带入APA的物品时应使用醇类(即异丙醇和乙醇)化学试剂。除非与材料存在相容性问题,应使用70%异丙醇(IPA)代替70%乙醇( EtOH),因为异丙醇的杀菌作用被认为比乙醇稍大。虽然醇类对活细胞具有相对较好的杀菌活性,但醇类的快速挥发显著降低了其效力。醇类杀菌剂对孢子无效。


消毒剂



酚类和季铵化合物对活细胞具有广谱杀菌活性。这些化学物质典型特征会带来表面残留。紧随它们的使用应清除该部分残留,例如通过异丙醇擦拭清除。


杀孢子剂



次氯酸钠(漂白剂)和过氧化氢/过氧乙酸化合物是广泛使用的杀孢子剂。过氧化氢也可用于(通常在6%浓度)提供对霉菌和一些孢子形式微生物提供抗菌活性。过氧化物比醇类抗菌活性更高,分解后形成水和氧气,不产生留残。当消毒程序要求清除孢子类微生物时应采用化学杀孢子剂。不幸的是,除过氧化氢外这些化学品均有一定残留。


消毒剂的作用机理



以下列出了一些具有代表性的消毒剂的活性的作用位置和作用方式:


Target

目标

Disinfectant

消毒剂

Cell wall

细胞壁

Formaldehyde, hypochlorite, and mercurials

甲醛,次氯酸盐,汞制剂

Cytoplasmic membrane, action on membrane potential

细胞膜,膜电位作用

Anilides and hexachlorophene

苯氨,六氯酚

Membrane enzymes, action on electrontransport chain

糖皮质激素酶,电子转移作用

Hexachlorophene

六氯酚

Action on ATP

三磷酸腺苷作用

Chlorhexidine and ethylene oxide

氯己定和环氧乙烷

Action on enzymes with –SH groups

巯基酶作用

Ethylene oxide, glutaraldehyde, hydrogen peroxide, hypochlorite,  iodine, and mercurials

环氧乙烷,戊二醛,过氧化氢,次氯酸盐,碘,汞制剂

Action on general membrane permeability

一般膜渗透性作用

Alcohols, chlorhexidine, and quaternary ammonium compounds

乙醇,氯己定,季胺类化合物

Cell contents, general coagulation

细胞内含物,一般凝固

Chlorhexidine, aldehydes, hexachlorophene, and quaternary ammonium  compounds

氯己定,醛,六氯酚,季胺类化合物

Ribosomes

核糖体

Hydrogen peroxide and mercurials

过氧化氢和汞制剂

Nucleic acids

核酸

Hypochlorites

次氯酸盐

Thiol groups

巯基

Ethylene oxide, glutaraldehyde, hydrogen peroxide, hypochlorite,  mercurials

环氧乙烷,戊二醛,过氧化氢,次氯酸盐,汞制剂

Amino groups

氨基

Ethylene oxide, glutaraldehyde, and hypochlorite

环氧乙烷,戊二醛,次氯酸盐

General oxidation

一般氧化

Ethylene oxide, glutaraldehyde, and hypochlorite

环氧乙烷,戊二醛,次氯酸盐


供应商确认

New suppliers and new antimicrobial chemical agents for use in the disinfection program should be qualified prior to use following established procedures. A satisfactory audit, qualification testing, and a clearly defined
Certificate of Analysis (CoA) are important aspects to be considered as part of the qualification. If changes occur in the agent\'s formulation, packaging, or manufacturing site, an evaluation should be performed to determine if requalification is required.

用于消毒程序的新的供应商和新的杀菌化学试剂应在使用前根据建立的程序进行确认。令人满意的审计、确认测试和清楚定义的检验报告( COA)被认为是确认中的重要部分。如果试剂的配方、包装或生产场所有所变更,则应进行评估以确定是否需要重新确认。


When choosing a new antimicrobial chemical agent from a supplier, evaluate the supplier\'s:
在从一个供应商处选择一个新的杀菌化学试剂时,要评估供应商的:


  • Product literature/technical data
    产品文字/技术数据

  • Material safety information
    物料安全信息

  • Material compatibility
    物料相容性

  • Compatibility information
    相容性信息

  • Storage conditions
    存贮条件

  • Packaging presentations
    包装

  • Expiring dating
    有效期

  • Disposal requirements
    处理要求

  • Efficacy data
    有效性数据

  • Sterility and sterilization information (if the product is provided sterile)
    无菌和灭菌信息(如果产品是作为无菌产品)


In evaluating supplier information related to the efficacy of an antimicrobial chemical agent, it is important to understand the testing methodology and standards used. These often vary depending on where the agent was registered and the claims made regarding its use. 
在评估关于杀菌化学试剂有效性的供应商信息时,了解所用的测试方法和标准非常重要。这些通常根据试剂注册地不同,以及关于其用途的声明而有差异。


Depending on the specific use of the antimicrobial chemical agent and experience with the specific supplier, an audit may need to be performed. Extra attention should be given to the following during an audit:

根据杀菌化学试剂的特定用途和特定供应商的经验,可能需要进行审计。在审计中需要注意以下方面:


Environmental control and cleaning of the manufacturing or packaging area and equipment used to manufacture the antimicrobial chemical agent.
用于生产杀菌化学试剂的生产或包装区域和设备的环境控制和清洁


Control and disinfection or sterilization of the antimicrobial chemical agent packaging containers.
杀菌化学试剂包装容器的控制和消毒或灭菌


  • Documentation and review of antimicrobial chemical agent production processing activities.
    杀菌化学试剂生产处理活动的文件记录和审核

  • For aseptically filled agents, the environmental monitoring (EM) program data, including alert and action levels, trending, corrective actions taken, and the use of neutralizing agents for the EM media used.
    对于无菌灌装试剂,环境监测( EM)程序数据,包括警戒限和行动限、趋势、所采取的纠正措施以及所用EM培养基的中和剂使用

  • For agents labeled as sterile, sterility testing data and qualification of the sterilization process.
    对于标识为无菌的试剂,无菌测试数据和无菌工艺确认

  • Water systems and the quality of water used in the manufacturing process.
    水系统和工艺用水的质量

  • Package or container integrity studies.
    包装或容器完整性研究

  • For double- and triple-bagged containers, disinfection of filled container and overwrapping integrity.
    对于双层或三层袋装容器,灌装容器消毒和外包装完整性

  • For double- and triple-bagged containers where a claim of sterility is made for inner bags, qualification of the sterilization process used.
    对于双层和三层袋装容器,如果内袋有无菌声明,所用的灭菌过程的确认

  • Handling and storage of finished product containers or work in progress.
    成品容器或中间产品的处理和存贮

  • Study results to support label claim of agent.
    支持试剂标签声明的研究结果

  • Documentation related to regulatory approval of agent.
    与试剂法规批准有关的文件记录

  • Change control: customer notification of ingredient changes or process changes that would affect the finished product—for example, wrapping, irradiation, and sterilization.
    变更控制:会影响成品,例如,包装、辐射和灭菌,的成分变更或工艺变更时对客户的通知


消毒剂的确认


Qualification testing of a new antimicrobial chemical agent should include both laboratory and insitu testing. Chemical analysis of the actives and microbial efficacy testing should be performed.
对一个新的抗菌化学试剂的确认测试应包括化验室和现场测试。要进行活性化学分析以及微生物有效性测试。


Chemical analysis of the actives may be provided by the vendor or, alternatively, performed in-house or by a qualified contract laboratory using the vendor\'s method. Microbial efficacy testing, whether in suspension or in
carrier studies, should be performed in-house or by a qualified contract testing laboratory.
活性化学分析可以由供应商提供,或者内部测试,或由一个经过确认的合同化验室使用供应商的方法进行测试。微生物有效性试验,如果是在混悬液中或在载体研究中,应内部进行测试,或由经过确认的第三方化验室进行测试。


The antimicrobials chemical agents used for testing should be close to or beyond their stated in-use expiration date (this should take into account a ready to use and/or a use dilution prepared from a concentrate expiry). Testing should be done in replicate on multiple lots of the antimicrobial chemical agent where applicable. It should be noted that significant registration testing on multiple lots of the agent is performed by the company registering the product to ensure product consistency between lots and stability throughout the stated shelf life.
用于测试的抗菌化学试剂应邻近或超出其使用有效期(这里要考虑直接使用和/或稀释使用时浓缩液的有效期)。如果可以的话,应对多个批次进行平行测试。要注意的是对多批试剂的重要的注册测试是由注册公司来进行的,以确保产品不同批次之间的一致性,以及其所声明的整个货架期的稳定性。


Additional qualification may be performed if changes in product formulation or packaging or site investigations deem it necessary. Information supporting the qualification includes the following seven areas:
如果生产配方或包装进行了变更,或现场调查认为必要时,可能需要进行再次确认。支持确认的信息包括以下七个方面:


  • Description of packaging, label, and container type
    包装、标签和容器类型描述

  • Description of ingredients and concentrations
    成分和浓度描述

  • Lot or batch number
    批号

  • Efficacy testing results
    有效性测试结果

  • Irradiation or other sterilization verification certification
    辐射或其它灭菌确认认证

  • Safety data sheet information

    安全数据信息表

  • Disposal information
    处理信息


Efficacy Testing 

有效性测试


The demonstration of antimicrobial chemical agents to provide their respective kills is a function of the concentration of microorganisms present, the type of microorganisms, the choice of agent, the concentration of the agent, the porosity or texture of the surface to be cleaned, the method of application, and the contact time.Routinely, the agent used should be effective against the normal microbial vegetative flora recovered from the facility. Many efficacy testing guidelines, such as the Association of Official Analytical Chemist (AOAC), suggest high microorganism inoculum levels requiring longer contact times to destroy the population of cells . As the normal clean room bioburden level is very low, the inoculum levels for testing would ideally depict levels seen in the controlled area. As this would not be practical in a test environment ahigher inoculum level should be used and should not exceed 105. The antimicrobial chemical agent used within the industry can be broken into three general areas: sanitizers, disinfectants, and sporicides.
抗菌化学试剂杀灭效果是被杀灭微生物浓度、微生物类型、试剂选择、试剂浓度、要清洁的表面的孔隙度或质地、所使用的方法以及接触时长的函数。一般来说,所用的试剂应对从设施中回收到的常规微生物植物群落有效。许多有效性测试指南,例如美国分析化学家协会( AOAC),建议高浓度微生物接种需要更长的接触时长以摧毁细胞群。由于常规洁净间生物负载水平非常之低,测试的接种水平理想地描述了受控区域所见水平。由于这种情况在测试环境中不现实,需要使用更高的接种水平,应超出105。行业内所用的抗菌化学试剂可以分为三个常规区域:灭菌剂、消毒剂和杀孢子剂。


Sanitizers 

灭菌剂


Sanitizers provide minimal reduction in thirty seconds to ten minutes and are often used for low levels of vegetative microorganisms. The type of sanitizer will dictate the appropriate contact time required. Alcohol is an example of a commonly used sanitizer.
杀菌剂提供在30秒到10分钟最小减少量,通常用于低水平的植物性微生物。灭菌剂的类型决定了所需适当的接触时长。乙醇是常用的灭菌剂的例子。


Disinfectants

 消毒剂


Disinfectants exhibit a higher level of efficacy than sanitizers, and their kill is dependent on the inoculums and the contact time. Disinfectants will typically kill vegetative microorganisms with the exception of spore-forming microorganisms. Examples include quaternary ammonium compounds and phenolics.
消毒剂比灭菌剂具有更高的有效性,其杀灭性与接种水平和接触时长无关。消毒剂一般会杀灭植物性微生物,孢子形态除外。消毒剂例子包括季胺盐和酚醛物。


Sporicides 

杀孢子剂


Sporicides provide up to a total kill depending on the inoculums and the wet contact time and will kill bacterial spore formers as well as mold. Products commonly used today include bleach, hydrogen peroxide, and a mixture of hydrogen peroxide and peracetic acid.
杀孢子剂提供全面杀灭性,其杀灭能力与接种水平、湿润接触时长有关,能杀灭细菌孢子形态以及霉菌。现今常用产品包括漂白剂、过氧化氢、过氧化氢和过氧乙酸混合物。


In general, contact or dry times in qualification studies should not exceed 120 seconds for alcohols (70% isopropanol and 70% denatured ethanol) and 10 minutes for disinfectants and sporicides. Longer contact times may be required based on the specific chemical agents used.
一般来说,在确认研究中接触时长或干燥时长,乙醇( 70%异丙醇,和70%变性乙醇)应超过120秒钟,消毒剂和杀孢子剂应超过10分钟。如果所用的是特定的化学试剂,可能需要更长的接触时长。


Methods to demonstrate efficacy include in-suspension and surface carrier (coupon) studies. In general, a total of three antimicrobial chemical agents (sanitizer, disinfectant, or sporicide) are all that would be qualified within the typical biopharmaceutical or pharmaceutical facility. While historically it was thought that a wide array of disinfectants were required to minimize the buildup of facilityresistant microorganisms, this is no longer a widely
held belief.
证明有效性的方法包括悬浮液和表面载体(样本)研究。一般来说,三种抗菌化学试剂(杀菌剂、消毒剂或杀孢子剂)的总合都要在典型的生物药品或药品设施里进行确认。历史上曾经有过想法需要宽范围的消毒剂来最大程度减少设施耐药菌的累积,但现在这种想法已不再广泛流行了。

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