過氧化氫滅菌傳遞窗

過氧化氫滅菌傳遞窗主要包括：門密封系統(tǒng)、高效過濾系統(tǒng)、蠕動(dòng)泵系統(tǒng)、充氣及保壓系統(tǒng)、溫濕度控制系統(tǒng)、裝載模式等。過氧化氫滅菌傳遞窗通過將35%的高濃度過氧化氫溶液閃蒸成為氣體輸送至傳遞窗腔體內(nèi)部進(jìn)行滅菌，這整個(gè)過程是被實(shí)時(shí)監(jiān)控的，通過工藝開發(fā)和PID工藝調(diào)節(jié)（如注射量，溫濕度控制，風(fēng)量等），有效的保證了傳遞物料的表面滅菌，同時(shí)不產(chǎn)生過氧化氫冷凝物殘留于物料表面，使其滅菌表面始終干燥。其自帶高效過濾器，實(shí)現(xiàn)自凈功能，雙扉門設(shè)計(jì)，由通過第三方認(rèn)證的JHAO的充氣密封技術(shù)，對(duì)腔體進(jìn)行密閉隔離，并實(shí)現(xiàn)雙門互鎖，防止交叉感染。

技術(shù)核心

汽化雙氧水又稱汽化過氧化氫，即Vaporized Hydrogen Peroxide，簡稱VHP，汽化過氧化氫是利用過氧化氫在常溫下氣體狀態(tài)比液體狀態(tài)更具殺滅細(xì)菌芽孢能力的優(yōu)點(diǎn)，達(dá)到完全滅菌要求的一種技術(shù)。我們通常講的VHP傳遞窗指的是汽化過氧化氫傳遞窗，就是將汽化過氫化氫發(fā)生器的裝置直接安裝在傳遞窗內(nèi)部的一種集成式的傳遞窗。

通過高溫閃蒸將過氧化氫液體汽化成過氧化氫氣體，經(jīng)高速氣流噴射到滅菌空間中，當(dāng)高溫飽和過氧化氫蒸汽接觸到較冷的被消毒物品表面時(shí)，會(huì)形成不可見的微冷凝，通過釋放的強(qiáng)氧化自由基（羥基）來攻擊病原微生物（破壞細(xì)胞膜、脂類、蛋白質(zhì)和DNA），自由基可對(duì)微生物達(dá)到log6的快速殺滅效果。滅菌完成后，汽化過氧化氫滅菌設(shè)備會(huì)自動(dòng)將環(huán)境中的過氧化氫分子分解為水蒸氣和氧氣，當(dāng)空間內(nèi)過氧化氫濃度降至１ppm以下時(shí)，滅菌完畢。VHP傳遞窗采用的是干法滅菌的技術(shù)，通過降低空間的濕度，增加過氧化氫的濃度來殺滅細(xì)菌，整個(gè)運(yùn)行過程需要對(duì)滅菌空間進(jìn)行除濕，濕度一般要求控制在30％以下。

應(yīng)用領(lǐng)域

隨著新版GMP的實(shí)施和推廣，我國對(duì)藥品的生產(chǎn)提出了更高的要求，尤其是隨著生物制劑的快速發(fā)展，一次性使用系統(tǒng)技術(shù)越來越得到廣泛應(yīng)用，滅菌一直是生物制藥生產(chǎn)過程中的關(guān)鍵環(huán)節(jié)，為提高產(chǎn)品質(zhì)量，選擇合適的滅菌方式就顯得非常重要。在多種滅菌方式中，大多數(shù)公司都會(huì)選擇干法過氧化氫滅菌，其對(duì)生物指示劑———嗜熱脂肪芽孢桿菌的殺滅率能夠達(dá)到log6，成為抗體、CAR T、干細(xì)胞等生物領(lǐng)域凈化的新選擇。汽化過氧化氫(VHP)生物滅菌技術(shù)是一種在常溫狀態(tài)下將液態(tài)過氧化氫轉(zhuǎn)換成氣態(tài)過氧化氫的滅菌消毒方法,國內(nèi)外均有不少研究成果報(bào)告，其主要特點(diǎn)是干燥、作用快速、無毒無殘留等優(yōu)越性，該滅菌消毒技術(shù)廣泛用在生物技術(shù)、醫(yī)藥衛(wèi)生、制藥行業(yè)等領(lǐng)域，適用于房間、生物安全柜、傳遞窗、動(dòng)物籠交換站、隔離器和醫(yī)療器械等表面的滅菌消毒。

The Hydrogen Peroxide Sterilization Pass box mainly consists of the following systems:

- Door Sealing System: Ensures a tight seal to prevent the escape of vapors and contaminants.
- High-Efficiency Filtration System: Filters the air to maintain a sterile environment within the chamber.
- Peristaltic Pump System: Controls the flow of the hydrogen peroxide solution.
- Inflation and Pressure Retention System: Maintains the necessary pressure within the chamber for effective sterilization.
- Temperature and Humidity Control System: Regulates the environmental conditions within the chamber to optimize the sterilization process.
- Loading Mode: Facilitates the safe and efficient loading of materials into the chamber.

The sterilization process involves vaporizing a 35% concentrated hydrogen peroxide solution into gas and delivering it into the chamber for sterilization. This process is monitored in real-time and adjusted through process development and PID process control (such as injection volume, temperature and humidity control, airflow, etc.), ensuring the surface sterilization of the transferred materials without leaving any hydrogen peroxide condensate residue, keeping the sterilized surface always dry. The window is equipped with a high-efficiency filter for self-cleaning functions and features a double-door design with JHAO's certified inflatable sealing technology for airtight isolation of the chamber and double-door interlocking to prevent cross-contamination.

Technical Core

Vaporized Hydrogen Peroxide (VHP) is a technology that leverages the advantage of hydrogen peroxide being more effective in its gaseous state at room temperature for killing bacterial spores than in its liquid state, meeting the requirements for complete sterilization. The VHP transfer window typically refers to an integrated pass box with the VHP generator installed directly inside.

The process involves vaporizing liquid hydrogen peroxide into gas through high-temperature flashing, which is then sprayed into the sterilization space by high-speed airflow. When the high-temperature saturated hydrogen peroxide vapor comes into contact with the colder surface of the disinfected items, it forms invisible micro-condensates that release strong oxidative free radicals (hydroxyl groups) to attack pathogenic microorganisms (by destroying cell membranes, lipids, proteins, and DNA), achieving a rapid killing effect of log6 on microorganisms. After sterilization, the VHP sterilization equipment automatically decomposes the hydrogen peroxide molecules in the environment into water vapor and oxygen, and when the concentration of hydrogen peroxide in the space drops below 1ppm, the sterilization is complete. The VHP transfer window uses a dry sterilization technique, which requires dehumidifying the sterilization space, typically keeping the humidity below 30%.

Application Fields

With the implementation and promotion of the new GMP, China has set higher standards for pharmaceutical production, especially with the rapid development of biopharmaceuticals and the increasing application of single-use system technologies. Sterilization has always been a key link in the biopharmaceutical production process. To improve product quality, choosing the right sterilization method is crucial. Among various sterilization methods, most companies opt for dry hydrogen peroxide sterilization, which can achieve a log6 kill rate for the biological indicator Geobacillus stearothermophilus, becoming a new choice for purification in the fields of antibodies, CAR T, and stem cells. Vaporized Hydrogen Peroxide (VHP) bio-sterilization technology is widely used in biotechnology, healthcare, and the pharmaceutical industry for the sterilization and disinfection of surfaces such as rooms, biosafety cabinets, transfer windows, animal cage exchange stations, isolators, and medical devices, characterized by its dryness, rapid action, and non-toxic and residue-free advantages.

TAG:

- 過氧化氫滅菌傳遞窗 (Hydrogen Peroxide Sterilization Transfer Window): A transfer window that uses hydrogen peroxide for disinfection and sterilization to ensure sterile standards when transferring items between different environments or rooms.
- 過氧化氫傳遞窗 (Hydrogen Peroxide Transfer Window): A type of transfer window that may have the capability to disinfect with hydrogen peroxide, but primarily focuses on the transfer of items.
- 過氧化氫氣化傳遞窗 (Vaporized Hydrogen Peroxide Transfer Window): A transfer window that uses the vaporization of hydrogen peroxide liquid into gas for disinfection or sterilization purposes, emphasizing the vaporization process.
- 過氧化氫汽化傳遞窗 (Vaporized Hydrogen Peroxide Transfer Window): Identical to "Vaporized Hydrogen Peroxide Transfer Window," referring to a transfer window that disinfects using vaporized hydrogen peroxide.

These terms are all related to equipment that uses hydrogen peroxide for disinfection or sterilization, but they may have slightly different focuses, such as the sterilization process, item transfer, or the vaporization technology of hydrogen peroxide.