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 virus 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Pudomonas aeruginosa, Staphylococcus Aureus, and salmonella s
pp 绿脓杆菌，⾦⾊葡萄球菌，和沙门⽒菌等等
Lipid-coated virus 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 purpo disinfectant, antiptic,
Antiviral agent，
⼀般⽤途的消毒剂，抗菌剂和抗病毒试剂
肆无忌惮的意思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 purpo 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 pha sterilant, liquid Sporicidal
Agent, antiptic
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antiptic 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 pha Sterilant
液体杀菌剂，蒸汽的杀菌剂
0.2%peracetic acid, 1 µg per g peracetic
沁园春霾
acid
0.2％peracetic酸，1 µg/g过氧⼄酸
Ethylene oxide 环氧⼄烷vapor-pha 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 purpo disinfectant, antiptic
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。
书法字体有哪些
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 Alcohols, chlorhexidine, and quaternary ammonium compounds
⼀般膜渗透性作⽤⼄醇，氯⼰定，季胺类化合物
古代著名诗人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
调解协议书New suppliers and new antimicrobial chemical agents for u in the disinfection program should be qualified prior to u 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：
单摆周期公式推导
•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 prentations 包装
•Expiring dating 有效期
•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 ud. The often vary depending on where the agent was registered and the claims made regarding its u.
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 u 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 ud 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 aptically filled agents, the environmental monitoring (EM) program data, including alert and action levels, trending, corrective actions taken, and the u of neutralizing agents for the EM media ud. 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 ud 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
从狗的行为看房子风水
•For double- and triple-bagged containers where a claim of sterility is made for inner bags, qualification of the sterilization process ud. 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。
芊泽花Chemical analysis of the actives may be provided by the vendor or, alternatively, performed in-hou 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-hou or by a qualified contract testing laboratory.
