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    消毒劑的選擇與確認,你真的會了嗎?

    放大字體  縮小字體 發布日期:2022-05-09  瀏覽次數:114
    核心提示:今天主要和大家聊聊如何選擇消毒劑以及如何確認消毒劑的相關內容:微生物的抗性不同微生物對消毒劑的抗性也各不相同。它們的順序
     今天主要和大家聊聊如何選擇消毒劑以及如何確認消毒劑的相關內容:


    微生物的抗性


    不同微生物對消毒劑的抗性也各不相同。它們的順序從大到小的排列如下:

     

    Type of microorganisms

    微生物種類

    examples

    實例

    Bacterial spores

    細菌芽孢

    Bacillus subtilis and clostridium  sporogenes

    枯草桿菌,產孢梭菌

    Mycobacteria

    分枝桿菌

    Mycobacterium tuberculosis

    結核分枝桿菌

    Nonlipid-coated viruses

    親脂病毒

    Poliovirus and rhinovirus

    脊髓灰質病毒,鼻病毒

    Fungal spores and vegetative molds and  yeast

    真菌孢子,生長態的霉菌與酵母菌

    Trichophyton, cryptococcus, and Candida spp

    發蘚菌,隱球菌屬,念珠菌屬等

    Vegetative bacteria

    生長態的細菌

    Pseudomonas aeruginosa, Staphylococcus  Aureus, and salmonella spp

    綠膿桿菌,金色葡萄球菌,和沙門氏菌等等

    Lipid-coated viruses

    親水病毒

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

    單純性皰疹病毒,乙肝病毒,人體免疫缺陷病毒

     

    消毒劑的分類

     

    化學消毒劑按他們的化學型分類。其中包括醛,醇,鹵素,過氧化物,季胺類化合物,和酚類化合物。

     

    Chemical entity

    化學體

    Classification

    分類

    Example

    例證

    Aldehydes醛

    sporicidal agent

    殺孢子劑

    2% glutaldehyde

    Alcohols醇

    General purpose disinfectant, antiseptic,  Antiviral agent,

    一般用途的消毒劑,抗菌劑和抗病毒試劑

    70% isopropyl alcohol, 70% alcohol,

    70%的異丙醇,70%的乙醇

    Chlorine and Sodium Hypochlorite

    氯和次氯酸鈉

    sporicidal agent

    殺孢子劑

    0.5% sodium hypochlorite

    0.5%次氯酸鈉

    Phenolics

    酚類化合物

    general purpose Disinfectant

    一般用途的消毒劑

    50μg per g chlorocresol, 500μg per g  chloroxylenol

    50μg/g 氯甲酚,500μg/g對氯間二甲酚

    Ozone

    臭氧

    sporicidal agent

    殺孢子劑

    8%gas by weight

    8%的氣體(重量百分比)

    Hydrogen Peroxide

    過氧化氫

    vapor phase sterilant, liquid Sporicidal  Agent, antiseptic

    蒸汽的殺菌劑,液體殺孢子劑,抗菌劑

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

    4μg/g 雙氧水蒸汽,10%-25%溶液,3%溶液

    Substituted diguanides取代的二甲雙胍

    antiseptic agent

    抗菌劑

    0.5% chlorhexidine gluconate

    0.5%葡萄糖酸洗必太

    Peracetic acid

    過氧乙酸

    liquid sterilant, Vapor phase Sterilant

    液體殺菌劑,蒸汽的殺菌劑

    0.2%peracetic acid, 1 μg per g peracetic  acid

    0.2%peracetic酸,1 μg/g過氧乙酸

    Ethylene oxide

    環氧乙烷

    vapor-phase Sterilant

    蒸汽的殺菌劑

    600 μg per g ethylene oxide

    600μg/g 環氧乙烷

    Quaternary Ammonium Compounds

    季氨鹽化合物

    general purpose disinfectant, antiseptic

    一般用途的消毒殺菌劑,抗菌劑

    200 μg per g

    benzalkonium chloride

    200 μg/g潔爾滅氯化物

    β-propiolactone

    β-丙內酯

    sporicidal agent殺孢子劑

    100μg per g

    β-propiolactone

    β-丙內酯

     

    抗微生物化學試劑可分為三類:殺菌劑,消毒劑和殺孢子劑。這里列出的是通常與每個類別相關聯的試劑類型。

     

    殺菌劑

     

    由于蒸發快、殘留低的特點,消毒已被帶入APA的物品時應使用醇類(即異丙醇和乙醇)化學試劑。除非與材料存在相容性問題,應使用70%異丙醇(IPA)代替70%乙醇( EtOH),因為異丙醇的殺菌作用被認為比乙醇稍大。雖然醇類對活細胞具有相對較好的殺菌活性,但醇類的快速揮發顯著降低了其效力。醇類殺菌劑對孢子無效。

     

    消毒劑

     

    酚類和季銨化合物對活細胞具有廣譜殺菌活性。這些化學物質典型特征會帶來表面殘留。緊隨它們的使用應清除該部分殘留,例如通過異丙醇擦拭清除。

    殺孢子劑

     

    次氯酸鈉(漂白劑)和過氧化氫/過氧乙酸化合物是廣泛使用的殺孢子劑。過氧化氫也可用于(通常在6%濃度)提供對霉菌和一些孢子形式微生物提供抗菌活性。過氧化物比醇類抗菌活性更高,分解后形成水和氧氣,不產生留殘。當消毒程序要求清除孢子類微生物時應采用化學殺孢子劑。不幸的是,除過氧化氫外這些化學品均有一定殘留。

     

    消毒劑的作用機理

     

    以下列出了一些具有代表性的消毒劑的活性的作用位置和作用方式:

     

    Target

    目標

    Disinfectant

    消毒劑

    Cell wall

    細胞壁

    Formaldehyde, hypochlorite, and mercurials

    甲醛,次氯酸鹽,汞制劑

    Cytoplasmic membrane, action on membrane potential

    細胞膜,膜電位作用

    Anilides and hexachlorophene

    苯氨,六氯酚

    Membrane enzymes, action on electrontransport chain

    糖皮質激素酶,電子轉移作用

    Hexachlorophene

    六氯酚

    Action on ATP

    三磷酸腺苷作用

    Chlorhexidine and ethylene oxide

    氯己定和環氧乙烷

    Action on enzymes with –SH groups

    巰基酶作用

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

    環氧乙烷,戊二醛,過氧化氫,次氯酸鹽,碘,汞制劑

    Action on general membrane permeability

    一般膜滲透性作用

    Alcohols, chlorhexidine, and quaternary ammonium compounds

    乙醇,氯己定,季胺類化合物

    Cell contents, general coagulation

    細胞內含物,一般凝固

    Chlorhexidine, aldehydes, hexachlorophene, and quaternary ammonium  compounds

    氯己定,醛,六氯酚,季胺類化合物

    Ribosomes

    核糖體

    Hydrogen peroxide and mercurials

    過氧化氫和汞制劑

    Nucleic acids

    核酸

    Hypochlorites

    次氯酸鹽

    Thiol groups

    巰基

    Ethylene oxide, glutaraldehyde, hydrogen peroxide, hypochlorite,  mercurials

    環氧乙烷,戊二醛,過氧化氫,次氯酸鹽,汞制劑

    Amino groups

    氨基

    Ethylene oxide, glutaraldehyde, and hypochlorite

    環氧乙烷,戊二醛,次氯酸鹽

    General oxidation

    一般氧化

    Ethylene oxide, glutaraldehyde, and hypochlorite

    環氧乙烷,戊二醛,次氯酸鹽

     

    供應商確認

    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應商和新的殺菌化學試劑應在使用前根據建立的程序進行確認。令人滿意的審計、確認測試和清楚定義的檢驗報告( COA)被認為是確認中的重要部分。如果試劑的配方、包裝或生產場所有所變更,則應進行評估以確定是否需要重新確認。


    When choosing a new antimicrobial chemical agent from a supplier, evaluate the supplier\'s:
    在從一個供應商處選擇一個新的殺菌化學試劑時,要評估供應商的:

     

    • Product literature/technical data
      產品文字/技術數據

    • 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
      存貯條件

    • Packaging presentations
      包裝

    • Expiring dating
      有效期

    • Disposal requirements
      處理要求

    • Efficacy data
      有效性數據

    • Sterility and sterilization information (if the product is provided sterile)
      無菌和滅菌信息(如果產品是作為無菌產品)


    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. 
    在評估關于殺菌化學試劑有效性的供應商信息時,了解所用的測試方法和標準非常重要。這些通常根據試劑注冊地不同,以及關于其用途的聲明而有差異。


    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:

    根據殺菌化學試劑的特定用途和特定供應商的經驗,可能需要進行審計。在審計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.
    用于生產殺菌化學試劑的生產或包裝區域和設備的環境控制和清潔


    Control and disinfection or sterilization of the antimicrobial chemical agent packaging containers.
    殺菌化學試劑包裝容器的控制和消毒或滅菌

     

    • Documentation and review of antimicrobial chemical agent production processing activities.
      殺菌化學試劑生產處理活動的文件記錄和審核

    • 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.
      對于無菌灌裝試劑,環境監測( EM)程序數據,包括警戒限和行動限、趨勢、所采取的糾正措施以及所用EM培養基的中和劑使用

    • For agents labeled as sterile, sterility testing data and qualification of the sterilization process.
      對于標識為無菌的試劑,無菌測試數據和無菌工藝確認

    • Water systems and the quality of water used in the manufacturing process.
      水系統和工藝用水的質量

    • Package or container integrity studies.
      包裝或容器完整性研究

    • For double- and triple-bagged containers, disinfection of filled container and overwrapping integrity.
      對于雙層或三層袋裝容器,灌裝容器消毒和外包裝完整性

    • For double- and triple-bagged containers where a claim of sterility is made for inner bags, qualification of the sterilization process used.
      對于雙層和三層袋裝容器,如果內袋有無菌聲明,所用的滅菌過程的確認

    • Handling and storage of finished product containers or work in progress.
      成品容器或中間產品的處理和存貯

    • Study results to support label claim of agent.
      支持試劑標簽聲明的研究結果

    • Documentation related to regulatory approval of agent.
      與試劑法規批準有關的文件記錄

    • Change control: customer notification of ingredient changes or process changes that would affect the finished product—for example, wrapping, irradiation, and sterilization.
      變更控制:會影響成品,例如,包裝、輻射和滅菌,的成分變更或工藝變更時對客戶的通知

     

    消毒劑的確認

     

    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.
    對一個新的抗菌化學試劑的確認測試應包括化驗室和現場測試。要進行活性化學分析以及微生物有效性測試。


    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.
    活性化學分析可以由供應商提供,或者內部測試,或由一個經過確認的合同化驗室使用供應商的方法進行測試。微生物有效性試驗,如果是在混懸液中或在載體研究中,應內部進行測試,或由經過確認的第三方化驗室進行測試。


    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.
    用于測試的抗菌化學試劑應鄰近或超出其使用有效期(這里要考慮直接使用和/或稀釋使用時濃縮液的有效期)。如果可以的話,應對多個批次進行平行測試。要注意的是對多批試劑的重要的注冊測試是由注冊公司來進行的,以確保產品不同批次之間的一致性,以及其所聲明的整個貨架期的穩定性。


    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:
    如果生產配方或包裝進行了變更,或現場調查認為必要時,可能需要進行再次確認。支持確認的信息包括以下七個方面:

     

    • Description of packaging, label, and container type
      包裝、標簽和容器類型描述

    • Description of ingredients and concentrations
      成分和濃度描述

    • Lot or batch number
      批號

    • Efficacy testing results
      有效性測試結果

    • Irradiation or other sterilization verification certification
      輻射或其它滅菌確認認證

    • Safety data sheet information

      安全數據信息表

    • Disposal information
      處理信息

     

    Efficacy Testing 

    有效性測試


    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.
    抗菌化學試劑殺滅效果是被殺滅微生物濃度、微生物類型、試劑選擇、試劑濃度、要清潔的表面的孔隙度或質地、所使用的方法以及接觸時長的函數。一般來說,所用的試劑應對從設施中回收到的常規微生物植物群落有效。許多有效性測試指南,例如美國分析化學家協會( AOAC),建議高濃度微生物接種需要更長的接觸時長以摧毀細胞群。由于常規潔凈間生物負載水平非常之低,測試的接種水平理想地描述了受控區域所見水平。由于這種情況在測試環境中不現實,需要使用更高的接種水平,應超出105。行業內所用的抗菌化學試劑可以分為三個常規區域:滅菌劑、消毒劑和殺孢子劑。


    Sanitizers 

    滅菌劑


    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.
    殺菌劑提供在30秒到10分鐘最小減少量,通常用于低水平的植物性微生物。滅菌劑的類型決定了所需適當的接觸時長。乙醇是常用的滅菌劑的例子。


    Disinfectants

     消毒劑


    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.
    消毒劑比滅菌劑具有更高的有效性,其殺滅性與接種水平和接觸時長無關。消毒劑一般會殺滅植物性微生物,孢子形態除外。消毒劑例子包括季胺鹽和酚醛物。


    Sporicides 

    殺孢子劑


    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.
    殺孢子劑提供全面殺滅性,其殺滅能力與接種水平、濕潤接觸時長有關,能殺滅細菌孢子形態以及霉菌。現今常用產品包括漂白劑、過氧化氫、過氧化氫和過氧乙酸混合物。

     

    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.
    一般來說,在確認研究中接觸時長或干燥時長,乙醇( 70%異丙醇,和70%變性乙醇)應超過120秒鐘,消毒劑和殺孢子劑應超過10分鐘。如果所用的是特定的化學試劑,可能需要更長的接觸時長。


    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.
    證明有效性的方法包括懸浮液和表面載體(樣本)研究。一般來說,三種抗菌化學試劑(殺菌劑、消毒劑或殺孢子劑)的總合都要在典型的生物藥品或藥品設施里進行確認。歷史上曾經有過想法需要寬范圍的消毒劑來最大程度減少設施耐藥菌的累積,但現在這種想法已不再廣泛流行了。

    編輯:songjiajie2010

     
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