过氧化氢灭菌传递窗
过氧化氢灭菌传递窗主要包括：门密封系统、高效过滤系统、蠕动泵系统、充气及保压系统、温湿度控制系统、装载模式等。过氧化氢灭菌传递窗通过将35%的高浓度过氧化氢溶液闪蒸成为气体输送至传递窗腔体内部进行灭菌，这整个过程是被实时监控的，通过工艺开发和PID工艺调节（如注射量，温湿度控制，风量等），有效的保证了传递物料的表面灭菌，同时不产生过氧化氢冷凝物残留于物料表面，使其灭菌表面始终干燥。其自带高效过滤器，实现自净功能，双扉门设计，由通过第三方认证的JHAO的充气密封技术，对腔体进行密闭隔离，并实现双门互锁，防止交叉感染。
技术核心
汽化双氧水又称汽化过氧化氢，即Vaporized Hydrogen Peroxide，简称VHP，汽化过氧化氢是利用过氧化氢在常温下气体状态比液体状态更具杀灭细菌芽孢能力的优点，达到完全灭菌要求的一种技术。我们通常讲的VHP传递窗指的是汽化过氧化氢传递窗，就是将汽化过氢化氢发生器的装置直接安装在传递窗内部的一种集成式的传递窗。
通过高温闪蒸将过氧化氢液体汽化成过氧化氢气体，经高速气流喷射到灭菌空间中，当高温饱和过氧化氢蒸汽接触到较冷的被消毒物品表面时，会形成不可见的微冷凝，通过释放的强氧化自由基（羟基）来攻击病原微生物（破坏细胞膜、脂类、蛋白质和DNA），自由基可对微生物达到log6的快速杀灭效果。灭菌完成后，汽化过氧化氢灭菌设备会自动将环境中的过氧化氢分子分解为水蒸气和氧气，当空间内过氧化氢浓度降至１ppm以下时，灭菌完毕。VHP传递窗采用的是干法灭菌的技术，通过降低空间的湿度，增加过氧化氢的浓度来杀灭细菌，整个运行过程需要对灭菌空间进行除湿，湿度一般要求控制在30％以下。
应用领域
随着新版GMP的实施和推广，我国对药品的生产提出了更高的要求，尤其是随着生物制剂的快速发展，一次性使用系统技术越来越得到广泛应用，灭菌一直是生物制药生产过程中的关键环节，为提高产品质量，选择合适的灭菌方式就显得非常重要。在多种灭菌方式中，大多数公司都会选择干法过氧化氢灭菌，其对生物指示剂———嗜热脂肪芽孢杆菌的杀灭率能够达到log6，成为抗体、CAR T、干细胞等生物领域净化的新选择。汽化过氧化氢(VHP)生物灭菌技术是一种在常温状态下将液态过氧化氢转换成气态过氧化氢的灭菌消毒方法,国内外均有不少研究成果报告，其主要特点是干燥、作用快速、无毒无残留等优越性，该灭菌消毒技术广泛用在生物技术、医药卫生、制药行业等领域，适用于房间、生物安全柜、传递窗、动物笼交换站、隔离器和医疗器械等表面的灭菌消毒。
Hydrogen Peroxide Sterilization Pass Box
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:
- 过氧化氢灭菌传递窗 (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.
- 过氧化氢传递窗 (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.
- 过氧化氢气化传递窗 (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.
- 过氧化氢汽化传递窗 (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.
