博客

蒸发过氧化氢（H2O2）VS。汽化的氧化乙烷（ETO）

皮里塔·莫努（Piritta Maunu）

生命科学Regulatory Compliance and Industry Expert

发布： Jan 21, 2019

Industrial Measurements

生命科学

The Future of Bio-decontamination & Sterilization

What does Vaisala do?

Vaisala开发了用于监视和控制关键环境的解决方案。我们的传感器和系统用于制造药品和生物技术产品，以及其他与生命科学相关的活动，包括：医疗设备的制造或专业实验室和环境测量医院世界各地。Vaisala的传感器测量参数温度,Humidity,Dew Point,CO₂and vaporized过氧化氢。

该博客于2019年2月18日进行了编辑 - 感谢Steris Corporation.

Learning from our Customers

During customer site visits we have learned a lot aboutbio-decontamination和灭菌。例如，我们的客户和原始设备制造商（OEM) around the world anticipate an increase in the use of vaporized hydrogen peroxide over ethylene oxide. To understand this trend, it is useful to compare vaporized hydrogen peroxide to ethylene oxide to define applications that are best served by each.

灭菌类型

灭菌是通过方法或技术“纯化”生产产品以去除微生物或产品中的产品以确保产品安全性和功效的过程。从微生物学的角度来看，灭菌的目的是达到预定的不育保证水平（SAL）为10-6或更高。（即灭菌过程后单个可行微生物存在的理论概率等于小于1 x 10-6；一百万分之一。）
灭菌是通过以下技术进行的：

1.干热灭菌通常在称为Deprogogenator的设备中，使用非常热的空气。

2. Moist heat sterilization in autoclaves (typically at 121.5°C).

3. Sterilization by ionizing radiation (gamma irradiation from a radioactive source or beta radiation, which means high energy electron irradiation from an accelerator).

4. Sterilization with ethylene oxide (EtO).

5. Filtration of medicinal products that cannot be sterilized in their final container (aseptic filling processes; through a membrane with 0.2 µm or smaller pore size).

Vaporized hydrogen peroxide is used in bio-decontamination of various rooms and enclosures, isolators, filling lines, biosafety cabinets, and in material transfer chambers and airlocks. In addition, vaporized hydrogen peroxide is widely used for medical devices that have been used in a health care setting and that are being presented for re-sterilization, as well as for terminal surface sterilization in industrial pharmaceutical manufacturing applications, per ISO14937 requirements. Vaporized hydrogen peroxide is also defined as vapor phase sterilizing agent per USP 1229.11.

Vaporized Hydrogen Peroxide Bio-decontamination

Vaporized hydrogen peroxide is an easy-to-use, safe, low-temperature bio-decontamination agent in equipment and facilities used within the life science industry and healthcare facilities. It is widely used to decontaminate isolators and cleanrooms in which aseptic filling processes are typically performed, or hospital rooms to get rid of infectious microorganisms such as Clostridium difficile. It is also used in sterilization equipment, for example in the AMSCO V-PRO maX manufactured by Steris Corporation.

产品that are effectively sterilized with vaporized hydrogen peroxide include medical devices e.g. outer surfaces of pre-filled vaccine syringes, contact lenses, forceps, scissors or endoscopes. Using vaporized H₂O₂is an ecological method of performing bio-decontaminations and sterilizations because it leaves no residues, only water and oxygen.

当在密封区域中施用低温蒸发过氧化氢时，它可以有效地针对广泛的生物生物（包括病毒，孢子，细菌和真菌），可实现超过6-log Bioburden还原。蒸发过氧化氢也与多种材料兼容。

In reference to Eudralex Volume 4, Annex 1 and expressed in "Expectations of the MHRA on Decontamination with Hydrogen Peroxide.”...

"it is not an acceptable method to substitute component pre-sterilization with vaporized hydrogen peroxide introduced in an isolator manufacturing setting."

Ethylene Oxide Sterilization

Vaporized Ethylene Oxide is typically used in low-temperature sterilization chambers on materials like electronics, optical equipment, paper, rubber, plastics, and especially medical devices, which are sensitive to temperature, moisture, or other chemicals. Ethylene oxide is a colorless flammable gas that leaves no residue when allowing for adequate aeration time after exposure.

EtO destroys microorganisms in a process called alkylation, which destroys cell membranes and the DNA of affected microorganisms. One of the main benefits of EtO is its wide range of material compatibility. Ethylene Oxide is accepted for sterilization of healthcare products. However, this method should only be used for sterilization activities when no other method is practicable. There are downsides to EtO, elaborated briefly below. More information can be found inISO 11135：2014并在Eudralex Volume 4 Annex 1.

Comparison of Vaporized H₂O₂vs. EtO

EtO has greater efficacy than vaporized hydrogen peroxide in penetrating hard-to-reach areas, such as lumens and different kinds of tubing. It’s also an accepted method for sterilization processes in healthcare facilities. Nevertheless experts and OEMs around the world see serious problems in using EtO, which are listed below:

EtO is poisonous and carcinogenic, with serious risks for the environment as well as personnel and patients. Its toxicity has been tested and proved in animal studies.
EtO is a flammable and explosive gas that can only be used in Atex classified areas.
用ETO灭菌的材料需要大量的充气才能清除危险残差。没有有效的充气，吸收ETO是一种严重的健康风险。
Regulatory authorities have different acceptance limits (including residual ppms and EtO decay analysis) in different countries; these limits are often based on time. This can make following the regulatory requirements difficult, complex and time-consuming.
衰减分析包括三个独立的分子，即：氧化乙烷，乙二醇和乙烯氯氢蛋白。（在该过程中可以将ETO降解为乙二醇和乙烯氯氢化蛋白）。

用H代替ETO₂O₂

Because of these issues many experts and OEMs that currently use EtO see its use decreasing in the future. Many companies foresee that vaporized hydrogen peroxide might be a good alternative for effective bio-decontamination and sterilization. The use of hydrogen peroxide has been increasing steadily as the tolerance for unsustainable, possibly dangerous processes decreases. Some OEMs already manufacture several different types of devices made to be sterilized with vaporized H₂O₂, while others still rely on vaporized EtO.

To serve this trend, Vaisala has developed theHPP270 vaporized hydrogen peroxide probes,可以与Indigo200 Transmitters. The Indigo transmitters are also used with Vaisala's smart probes for Humidity, CO₂和h₂O₂sensors.

The new HPP270-series probe usesVaisala’s PEROXCAP® sensordesigned for demanding hydrogen peroxide bio-decontamination. The probe is ideal wherever repeatable, stable, and accurate measurement is essential. The HPP270 probes are used in isolators, material transfer hatches, and room bio-decontamination applications.

There are two probe options: the basic HPP271 probe measures only H₂O₂蒸气浓度。高级HPP272探针提供了您在生物污染过程中测量所需的所有参数，包括过氧化氢蒸气，温度和湿度；相对饱和和相对湿度。最近，还将露点和蒸气压在HPP272测量中。

The HPP270 probes can be used with Indigo transmitters as described above, or as standalone sensors to be connected to available systems such as programmable logic controllers. For easy calibration and adjustment the probe can be connected toVaisala’s Insight PC software.