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环氧乙烷（EtO）灭菌

1940

（图片仅供参考）

一种利用环氧乙烷气体的低温化学灭菌方法。它能有效灭菌对热敏性和湿敏性材料，例如…… 塑料, electronic devices, and optical instruments. The process involves alkylation, where EtO disrupts the DNA and proteins of microorganisms, preventing their replication. It requires careful control of gas concentration, temperature, humidity, and exposure time. Before routine use, the sterilizer and its gas control system go through IQ and OQ validation, so that each cycle can be trusted to reach the required conditions.

Ethylene oxide (C2H4O) is a colorless, flammable, and highly reactive gas. Its effectiveness as a sterilant lies in its ability to act as a potent alkylating agent. The process works at a molecular level. The strained three-membered ring of the ethylene oxide molecule readily opens and reacts with nucleophilic groups in essential cellular components. It primarily targets sulfhydryl (-SH), amino (-NH2), carboxyl (-COOH), and hydroxyl (-OH) groups found in proteins and nucleic acids (DNA and RNA). By adding an alkyl group to these sites, EtO permanently modifies the molecules, blocking reactive sites, causing cross-linking, and ultimately preventing microbial metabolism and replication. This mechanism is effective against all forms of microorganisms, including highly resistant bacterial spores. A typical EtO sterilization cycle is complex and must be carefully controlled. It consists of several phases: preconditioning (adjusting temperature and humidity), gas injection (introducing the EtO), exposure or dwell time (holding the load under specified conditions for several hours), and aeration (removing residual EtO gas). Key parameters are gas concentration (typically 400–1200 mg/L), temperature (usually 37–63 °C), relative humidity (40–80%), and exposure time (1–6 hours). The lower temperature range makes it ideal for materials that would be damaged by the heat of autoclaving, such as polymers, electronics, and medical devices with complex designs. However, EtO is toxic, carcinogenic, and explosive, requiring stringent safety protocols and a lengthy aeration period to ensure residual gas is removed from the sterilized items to safe levels before they can be used.

虽然环氧乙烷最早于 1859 年由 Charles-Adolphe Wurtz 合成，但其强大的生物活性直到很久以后才被充分认识。20 世纪 20 年代，Lloyd L. Schrader 为其杀虫熏蒸剂申请了专利。20 世纪 40 年代，人们率先将其用作医疗用品的灭菌剂，并在 20 世纪 50 年代广泛应用，尤其是随着一次性塑料医疗器械的兴起。据报道，美国军方开发了设备灭菌工艺。这项创新具有革命性，因为它填补了一个关键的空白；在 EtO 出现之前，没有可靠的方法来对越来越多的热敏仪器和用品进行灭菌，而这些仪器和用品对现代医学至关重要。它实现了预包装、无菌、一次性设备的大规模生产和使用，从而显著降低了医疗相关感染的风险。

化学回收, Medical, 医疗器械, 塑料, Process Validation, 质量管理, 安全

UNESCO Nomenclature: 2401

– Microbiology

类型

化学过程

中断

Revolutionary

用法

广泛使用

前体

环氧乙烷的发现
了解化学消毒剂和烷化剂
需要对不兼容热或蒸汽的材料进行灭菌

应用程序

一次性医疗器械（如注射器、导管）的灭菌
processing of spices to reduce 微生物 load
精密手术器械的灭菌
档案和博物馆文物保存

专利：

潜在创新理念

closed-loop eto sterilization systems with integrated catalytic converters to neutralize 100% of the gas emissions
开发高度专用的传感器，用于实时、包装内监测环氧乙烷浓度和残留量
提供相同烷基化效果且毒性和致癌性较低的替代气体混合物
微剂量环氧乙烷系统，用于对微电极等小型精密物品进行灭菌，且气体用量极少
基因工程酶可以快速安全地中和灭菌产品上的残留环氧乙烷，缩短曝气时间
integration of eto sterilization chambers into 3d printers for in-situ sterilization of 医疗植入物 as they are fabricated
开发智能包装，在灭菌周期后主动清除残留的环氧乙烷气体
移动式环氧乙烷灭菌装置，用于灾难响应场景中医疗设备的现场处理
计算流体动力学建模，优化复杂设备负载中的气体循环和渗透
混合灭菌循环将低浓度环氧乙烷与汽化过氧化氢相结合，以提高灭菌效果并缩短循环时间

Related to: ethylene oxide, eto, chemical sterilization, low-temperature, alkylation, medical devices, plastics, toxicity, aeration, heat-sensitive.

历史背景

Laboratory scene of insulin isolation by Banting and Best, 1921, endocrinology research.

胰岛素的发现和分离

1921年，在多伦多大学约翰·麦克劳德的指导下，弗雷德里克·班廷和查尔斯·贝斯特从犬胰腺提取物中分离出胰岛素。生物化学家詹姆斯·科利普随后开发了一种纯化工艺，使提取物能够安全用于人类。这一发现将1型糖尿病从一种致命疾病转变为一种可控疾病，班廷和麦克劳德也因此获得了1923年的诺贝尔奖。

Laboratory scene depicting cutaneous vitamin D synthesis research in biochemistry.

皮肤维生素D合成

阳光，特别是波长在 290-315 纳米之间的紫外线 B (UVB) 辐射，能够触发皮肤中维生素 D 的合成。当 UVB 光子照射到皮肤上时，它们会将 7-脱氢胆固醇光化学转化为维生素 D3 前体，后者随后异构化为维生素 D3（胆钙化醇）。这一过程是人类维生素 D 的主要天然来源。

Researcher examining chromatophores in ectothermic vertebrates for hormonal pigment translocation.

激素对色素转运的调控

在许多变温脊椎动物（如鱼类和两栖动物）中，体色变化是一个缓慢的生理过程，受激素调控。色素细胞内的色素颗粒沿着微管细胞骨架运输。诸如促黑素细胞激素（MSH）之类的激素会导致色素分散（变深），而褪黑素或黑素细胞浓缩激素（MCH）则会触发色素聚集（变浅），从而使动物的体色在几分钟到几小时内适应环境。

环氧乙烷（EtO）灭菌

Laboratory cytotoxicity assay with cell cultures and cytotoxic agents in cell biology research.

细胞毒性

细胞毒性是指物质或细胞对其他细胞具有毒性的特性。细胞毒性药物可通过坏死（细胞膜失去完整性，导致细胞溶解和炎症）或凋亡（一种受控的程序性细胞死亡过程）诱导细胞死亡。这与细胞抑制剂不同，细胞抑制剂仅抑制细胞分裂，而不会直接导致细胞死亡。

3D model of an alpha-helix protein structure in a biochemistry lab.

α螺旋（生物化学）

The alpha-helix ([latex]\alpha[/latex]-helix) is a common secondary structure motif in proteins. It is a right-handed coiled conformation in which every backbone N-H group donates a hydrogen bond to the backbone C=O group of the amino acid located four residues earlier ([latex]i+4 \rightarrow i[/latex] hydrogen bonding). This regular pattern pulls the polypeptide chain into a helical shape.

Molecular biology laboratory with DNA sequencing equipment and a scientist.

分子生物学中心法则

分子生物学中心法则描述了生物系统内遗传信息的流动。它指出，信息从DNA流向RNA，最终合成蛋白质。DNA可以复制以产生更多DNA，DNA可以转录成RNA，RNA随后被翻译成蛋白质。这个过程通常是单向的，为基因表达提供了基本框架。

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Thermal sterilization setup with microbial cultures and temperature monitoring in applied microbiology.

十进制减少时间（D值）

The D-value is the time required at a specific temperature to kill 90% (or one log reduction) of a target microorganism population. It is a critical parameter in thermal sterilization, quantifying a microbe's resistance to heat. For example, if a population of [latex]10^6[/latex] spores has a D-value of 2 minutes, it takes 2 minutes to reduce it to [latex]10^5[/latex].

Chemiluminescence experiment with luminol in analytical chemistry.

鲁米诺

鲁米诺 (C8H7N3O2) 与碱性溶液中的氧化剂混合时，会发出强烈的蓝色化学发光。需要催化剂，通常是铁化合物，例如血红蛋白中的血红素。该反应会氧化鲁米诺，形成一种不稳定的过氧化物，过氧化物会分解成处于电子激发态的 3-氨基邻苯二甲酸酯。该激发态随后衰减，发射出蓝色光子。

Biochemist demonstrating protein denaturation in a laboratory setting.

蛋白质变性

蛋白质变性是指蛋白质失去其天然三维结构的过程。这种二级、三级和四级结构的破坏是由外界压力因素（例如高温、极端pH值、有机溶剂或辐射）引起的。虽然氨基酸的一级序列保持完整，但形状的丧失会导致蛋白质生物功能的丧失。

Biochemist studying redox reactions in cellular respiration in a laboratory.

细胞呼吸中的氧化还原

Cellular respiration is a series of redox reactions where organic molecules, like glucose, are oxidized to release energy. Glucose ([latex]C_6H_{12}O_6[/latex]) is oxidized to [latex]CO_2[/latex], while oxygen ([latex]O_2[/latex]) is reduced to water ([latex]H_2O[/latex]). This process transfers electrons through an electron transport chain, creating a proton gradient that drives the synthesis of ATP, the cell's primary energy currency.

Biophysicist studying electrochemical potential in cell membranes with laboratory equipment.

生物膜中的电化学电位

电化学电位是生命的基础，它驱动着跨细胞膜的细胞过程。离子泵主动产生浓度梯度，而离子通道的选择性通透性则产生电位（膜电位）。由此产生的电化学梯度决定了离子的被动流动，这对于神经信号传导（动作电位）、肌肉收缩以及线粒体中的细胞能量产生（ATP合成）至关重要。

Biochemist studying the Calvin Cycle and RuBisCO enzyme in a laboratory.

卡尔文循环（碳固定）

The Calvin cycle, or light-independent reactions, uses the ATP and NADPH produced during the light-dependent stage to convert inorganic carbon dioxide into organic sugar molecules. This process occurs in the stroma of the chloroplast. The key enzyme, RuBisCO, catalyzes the first step: the fixation of [latex]CO_2[/latex] into an organic molecule, initiating a cycle that produces carbohydrates.

Chloroplasts in a laboratory setting highlighting light-dependent reactions in plant physiology.

光反应（光合磷酸化）

The first stage of photosynthesis, the light-dependent reactions, occurs in the thylakoid membranes of chloroplasts. Light energy is captured by chlorophyll to split water (photolysis), releasing oxygen, protons ([latex]H^+[/latex]), and electrons ([latex]e^-[/latex]). This energy is used to create two energy-carrying molecules: adenosine triphosphate (ATP) and nicotinamide adenine dinucleotide phosphate (NADPH), which power the subsequent Calvin cycle.