解决方案

你所在的位置:网站首页>解决方案
VHP传递窗如何进行灭菌?
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。
当然如果将过氧化氢发生器的装置安装于单门页箱体,非双门页的传递箱体,它的运用范围会更广泛,我们也称之为过氧化氢灭菌舱,像头套熏蒸舱就是运用的一种。

生物安全传递窗+VHP发生器=VHP传递窗

biosafegy pass box + hydrogen peroxide vapor generator = VHP pass box

(因为VHP发生器固定在传递窗内部,所以不能作为移动发生器来使用)

 

技术方式 

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。
 

灭菌流程

腔体保压

PART 01
在每次灭菌前期,对腔体进行充压操作,并在充压后进行保压过程,直到保压确认无误后才能执行下一步操作。这一步骤是为了确保过氧化氢灭菌传递窗的气密性,防止过氧化氢泄漏,保证现场操作人员的安全和环境不会出现破坏。

腔体自净

PART 02
在保压确认后,使用进风风机和排风风机对腔体进行约2min的气体置换操作,将腔体内部的空气完全排出,达到自净的作用,为下一步的升温除湿做好准备。

腔体升温除湿

PART 03
在自净完成后,使用转轮除湿机对腔体进行升温除湿操作。这一步骤是为了提高腔体内部的温度和降低腔体内部的湿度,为过氧化氢的灭菌提供******的环境条件。空气湿度过高或者环境温度过低都会降低消毒灭菌效果,因此在进行消毒灭菌工作前,必须对消毒灭菌的空间进行清洁干燥,通过控制转轮除湿机,能有效地控制在升温除湿过程中的一切监测数值并进行程序的逻辑判断。

灭菌提升

PART 04
在升温除湿完成后,使用过氧化氢发生器对腔体内部进行过氧化氢气体注入操作,短时间内加速腔体内部过氧化氢的浓度,使得腔体迅速达到灭菌下限浓度值≥300ppm。

灭菌维持

PART 05
在达到灭菌下限浓度值后,保持腔体温湿度在可控范围的情况下,维持浓度≥300ppm一定的时间。这个过程采用内循环的方式,通过除湿机,进风风机和排风风机的循环工作,过氧化氢气体在腔体内部进行置换。这一步骤是为了确保过氧化氢能够充分地接触和杀灭腔体内部的所有微生物。

降解排残

PART 06
灭菌完成后,通过排残风机将腔体内部的过氧化氢气体进行置换操作,迅速将腔体内部的过氧化氢浓度排残至1ppm以内,保证操作人员打开传递窗时不会受到过氧化氢的伤害。设备内部集成催化过滤装置,确保排放夹层也能对夹层操作施工和环境不产生风险和破坏。
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。
过氧化氢作为一种重要的环境友好型消毒剂近年来得到了广泛的应用。特别是汽化过氧化氢自动化灭菌技术过氧化氢等离子灭菌器的开发上市,使得过氧化氢消毒获得了爆发性增长。
汽化过氧化氢可以用于空间消毒,如生物安全实验室、GMP车间、医院病房、实验动物中心等以及各种生物安全设备(如隔离器、孵化器、传递窗、生物安全柜、高效过滤单元及各类通风管道等)的消毒,是一种可靠的消毒灭菌方法,具有广阔的发展前景。随着自动化控制技术与传统的消毒方法的进一步结合,更加标准化、更加安全的过氧化氢消毒技术,将在各行业消毒领域的使用,并发挥重要的社会和经济效益。
过氧化氢等离子灭菌需对腔体进行抽真空,空间相对受限,更适用于不耐湿、不耐高温的医疗器械、器具和物品灭菌,价格也相对贵很多。
图片

注意事项

图片
过氧化氢属于强氧化剂,高浓度对皮肤黏膜有腐蚀性,一旦溅上,应立即用水冲洗5min以上,然后就医。皮肤消毒浓度3%的过氧化氢相对较安全,属实际无毒级。
汽化过氧化氢传递窗目前还没有相关的国家标准,以上也仅为本公司对产品的理解,如有错误的地方,也欢迎指正。因成本和技术的受限,无论资料还是功能与STERIS的差距依然存在,但生物安全设备的国产化已刻不容缓,势在必行,让我们一起为制药行业和生物安全实验室的发展创造企业的社会价值。

参考文献:
GB 15982 2012《医院消毒卫生标准》
GB27955-2020 过氧化氢气体等离子体低温灭菌器卫生要求
GB38498-2020 消毒剂金属腐蚀


关于过氧化氢空间灭菌的资料前文有具体的描述,如果需要了解,可阅读前期文章  汽化过氧化氢VHP灭菌技术的应用 (点击查看)

Vaporized hydrogen peroxide, also known as vaporized hydrogen peroxide, abbreviated as VHP, is a technology that utilizes the advantage of hydrogen peroxide having a stronger ability to kill bacterial spores in a gaseous state than in a liquid state at room temperature, achieving complete sterilization requirements. The VHP transfer window we usually refer to is the vaporized hydrogen peroxide transfer window, which is an integrated transfer window that directly installs the device for vaporized hydrogen peroxide generator inside the transfer window.

By high-temperature flash evaporation, hydrogen peroxide liquid is vaporized into hydrogen peroxide gas, which is then sprayed into the sterilization space through high-speed airflow. When the high-temperature saturated hydrogen peroxide vapor comes into contact with the colder surface of the disinfected item, it forms invisible micro condensation, which attacks pathogenic microorganisms (destroying cell membranes, lipids, proteins, and DNA) through the release of strong oxidative free radicals (hydroxyl groups). Free radicals can achieve a rapid killing effect of log6 on microorganisms. After sterilization, the vaporized hydrogen peroxide sterilization equipment will automatically decompose hydrogen peroxide molecules in the environment into water vapor and oxygen. When the concentration of hydrogen peroxide in the space drops below 1ppm, sterilization is complete. The VHP transfer window adopts dry sterilization technology, which kills bacteria by reducing the humidity of the space and increasing the concentration of hydrogen peroxide. The entire operation process requires dehumidification of the sterilization space, and the humidity is generally required to be controlled below 30%.

Sterilization process
Cavity pressure maintenance
PART 01
In the early stage of each sterilization, the chamber is pressurized and then subjected to a pressure holding process until the pressure holding is confirmed to be correct before proceeding to the next step. This step is to ensure the airtightness of the hydrogen peroxide sterilization transfer window, prevent hydrogen peroxide leakage, ensure the safety of on-site operators, and prevent environmental damage.
Self purification of cavity
PART 02
After pressure confirmation, use the inlet fan and exhaust fan to perform a gas replacement operation on the chamber for about 2 minutes, completely exhausting the air inside the chamber to achieve self purification and prepare for the next step of heating and dehumidification.
Chamber heating and dehumidification
PART 03
After self-cleaning is completed, use a rotary dehumidifier to heat up and dehumidify the chamber. This step is to increase the temperature inside the chamber and reduce the humidity inside the chamber, providing ****** environmental conditions for the sterilization of hydrogen peroxide. Excessive air humidity or low ambient temperature can reduce the effectiveness of disinfection and sterilization. Therefore, before carrying out disinfection and sterilization work, it is necessary to clean and dry the disinfection and sterilization space. By controlling the rotary dehumidifier, all monitoring values during the heating and dehumidification process can be effectively controlled and the program logic judgment can be made.
Sterilization enhancement
PART 04
After the heating and dehumidification are completed, use a hydrogen peroxide generator to inject hydrogen peroxide gas into the interior of the chamber, accelerate the concentration of hydrogen peroxide in the chamber in a short period of time, and quickly reach the sterilization lower limit concentration value of ≥ 300ppm.
Sterilization maintenance
PART 05
After reaching the sterilization lower limit concentration value, maintain the temperature and humidity of the chamber within a controllable range and keep the concentration ≥ 300ppm for a certain period of time. This process adopts an internal circulation method, where the hydrogen peroxide gas is replaced inside the chamber through the circulation of the dehumidifier, inlet fan, and exhaust fan. This step is to ensure that hydrogen peroxide can fully contact and kill all microorganisms inside the chamber.
Degradation and removal of residues
PART 06
After sterilization is completed, the hydrogen peroxide gas inside the chamber is replaced by a residual exhaust fan to quickly exhaust the concentration of hydrogen peroxide inside the chamber to within 1ppm, ensuring that the operator will not be harmed by hydrogen peroxide when opening the transfer window. The equipment is equipped with an integrated catalytic filtration device to ensure that the discharge interlayer can also operate without causing risks and damage to the interlayer construction and environment.
The hydrogen peroxide sterilization transfer window mainly includes: door sealing system, high-efficiency filtration system, peristaltic pump system, inflation and pressure holding system, temperature and humidity control system, loading mode, etc.
The hydrogen peroxide sterilization transfer window uses a 35% high concentration hydrogen peroxide solution to flash evaporate into gas and transport it to the interior of the transfer window chamber for sterilization. The entire process is monitored in real-time, and through process development and PID process adjustment (such as injection volume, temperature and humidity control, air volume, etc.), the surface sterilization of the transferred material is effectively ensured, while no hydrogen peroxide condensate remains on the surface of the material, making its sterilization surface always dry. It comes with an efficient filter for self-cleaning function, a dual door design, and uses JHAO's inflatable sealing technology certified by a third party to seal and isolate the chamber, and achieve double door interlocking to prevent cross infection.
Hydrogen peroxide, as an important environmentally friendly disinfectant, has been widely used in recent years. Especially with the development and launch of automated sterilization technology using vaporized hydrogen peroxide and hydrogen peroxide plasma sterilizers, hydrogen peroxide disinfection has experienced explosive growth.
Vaporized hydrogen peroxide can be used for space disinfection, such as in biosafety laboratories, GMP workshops, hospital wards, experimental animal centers, and various biosafety equipment (such as isolators, incubators, transfer windows, biosafety cabinets, high-efficiency filtration units, and various ventilation ducts). It is a reliable disinfection and sterilization method with broad development prospects. With the further integration of automation control technology and traditional disinfection methods, more standardized and safer hydrogen peroxide disinfection technology will be used in various disinfection fields and play important social and economic benefits.
Hydrogen peroxide plasma sterilization requires vacuuming of the chamber, which is relatively limited in space and more suitable for sterilization of medical devices, instruments, and items that are not resistant to moisture and high temperatures. The price is also relatively expensive.




图片

END

图片
关于上海杰昊

上海杰昊生物技术有限公司位于上海市奉贤区,专注生物安全设备的研发和生产十余载,在洁净行业深耕20余年,为客户提供高等级生物安全实验室整体气密性解决方案。公司产品主要有:生物安全气密门,生物安全传递窗,生物安全渡槽,化学淋浴,强制淋浴,雾淋室,VHP传递窗,过氧化氢空间灭菌设备,不锈钢密闭房,称量罩等产品。





电话
消息
二维码
分享