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VHP傳遞窗如何進行滅菌?
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)更具殺滅細菌芽孢能力的優(yōu)點,達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。
當然如果將過氧化氫發(fā)生器的裝置安裝于單門頁箱體,非雙門頁的傳遞箱體,它的運用范圍會更廣泛,我們也稱之為過氧化氫滅菌艙,像頭套熏蒸艙就是運用的一種。

生物安全傳遞窗+VHP發(fā)生器=VHP傳遞窗

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

(因為VHP發(fā)生器固定在傳遞窗內(nèi)部,所以不能作為移動發(fā)生器來使用)

 

技術(shù)方式 

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,當高溫飽和過氧化氫蒸汽接觸到較冷的被消毒物品表面時,會形成不可見的微冷凝,通過釋放的強氧化自由基(羥基)來攻擊病原微生物(破壞細胞膜、脂類、蛋白質(zhì)和DNA),自由基可對微生物達到log6的快速殺滅效果。滅菌完成后,汽化過氧化氫滅菌設備會自動將環(huán)境中的過氧化氫分子分解為水蒸氣和氧氣,當空間內(nèi)過氧化氫濃度降至1ppm以下時,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菌,整個運行過程需要對滅菌空間進行除濕,濕度一般要求控制在30%以下。

 

 

應用領(lǐng)域 

隨著新版GMP的實施和推廣,我國對藥品的生產(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)公司都會選擇干法過氧化氫滅菌,其對生物指示劑———嗜熱脂肪芽孢桿菌的殺滅率能夠達到log6,成為抗體、CAR T、干細胞等生物領(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告,其主要特點是干燥、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、動物籠交換站、隔離器和醫(yī)療器械等表面的滅菌消毒。
 

滅菌流程

腔體保壓

PART 01
在每次滅菌前期,對腔體進行充壓操作,并在充壓后進行保壓過程,直到保壓確認無誤后才能執(zhí)行下一步操作。這一步驟是為了確保過氧化氫滅菌傳遞窗的氣密性,防止過氧化氫泄漏,保證現(xiàn)場操作人員的安全和環(huán)境不會出現(xiàn)破壞。

腔體自凈

PART 02
在保壓確認后,使用進風風機和排風風機對腔體進行約2min的氣體置換操作,將腔體內(nèi)部的空氣完全排出,達到自凈的作用,為下一步的升溫除濕做好準備。

腔體升溫除濕

PART 03
在自凈完成后,使用轉(zhuǎn)輪除濕機對腔體進行升溫除濕操作。這一步驟是為了提高腔體內(nèi)部的溫度和降低腔體內(nèi)部的濕度,為過氧化氫的滅菌提供******的環(huán)境條件。空氣濕度過高或者環(huán)境溫度過低都會降低消毒滅菌效果,因此在進行消毒滅菌工作前,必須對消毒滅菌的空間進行清潔干燥,通過控制轉(zhuǎn)輪除濕機,能有效地控制在升溫除濕過程中的一切監(jiān)測數(shù)值并進行程序的邏輯判斷。

滅菌提升

PART 04
在升溫除濕完成后,使用過氧化氫發(fā)生器對腔體內(nèi)部進行過氧化氫氣體注入操作,短時間內(nèi)加速腔體內(nèi)部過氧化氫的濃度,使得腔體迅速達到滅菌下限濃度值≥300ppm。

滅菌維持

PART 05
在達到滅菌下限濃度值后,保持腔體溫濕度在可控范圍的情況下,維持濃度≥300ppm一定的時間。這個過程采用內(nèi)循環(huán)的方式,通過除濕機,進風風機和排風風機的循環(huán)工作,過氧化氫氣體在腔體內(nèi)部進行置換。這一步驟是為了確保過氧化氫能夠充分地接觸和殺滅腔體內(nèi)部的所有微生物。

降解排殘

PART 06
滅菌完成后,通過排殘風機將腔體內(nèi)部的過氧化氫氣體進行置換操作,迅速將腔體內(nèi)部的過氧化氫濃度排殘至1ppm以內(nèi),保證操作人員打開傳遞窗時不會受到過氧化氫的傷害。設備內(nèi)部集成催化過濾裝置,確保排放夾層也能對夾層操作施工和環(huán)境不產(chǎn)生風險和破壞。
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)部進行滅菌,這整個過程是被實時監(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,風量等),有效的保證了傳遞物料的表面滅菌,同時不產(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,實現(xiàn)自凈功能,雙扉門設計,由通過第三方認證的JHAO的充氣密封技術(shù),對腔體進行密閉隔離,并實現(xiàn)雙門互鎖,防止交叉感染。
過氧化氫作為一種重要的環(huán)境友好型消毒劑近年來得到了廣泛的應用。特別是汽化過氧化氫自動化滅菌技術(shù)過氧化氫等離子滅菌器的開發(fā)上市,使得過氧化氫消毒獲得了爆發(fā)性增長。
汽化過氧化氫可以用于空間消毒,如生物安全實驗室、GMP車間、醫(yī)院病房、實驗動物中心等以及各種生物安全設備(如隔離器、孵化器、傳遞窗、生物安全柜、高效過濾單元及各類通風管道等)的消毒,是一種可靠的消毒滅菌方法,具有廣闊的發(fā)展前景。隨著自動化控制技術(shù)與傳統(tǒng)的消毒方法的進一步結(jié)合,更加標準化、更加安全的過氧化氫消毒技術(shù),將在各行業(yè)消毒領(lǐng)域的使用,并發(fā)揮重要的社會和經(jīng)濟效益。
過氧化氫等離子滅菌需對腔體進行抽真空,空間相對受限,更適用于不耐濕、不耐高溫的醫(yī)療器械、器具和物品滅菌,價格也相對貴很多。
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注意事項

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過氧化氫屬于強氧化劑,高濃度對皮膚黏膜有腐蝕性,一旦濺上,應立即用水沖洗5min以上,然后就醫(yī)。皮膚消毒濃度3%的過氧化氫相對較安全,屬實際無毒級。
汽化過氧化氫傳遞窗目前還沒有相關(guān)的國家標準,以上也僅為本公司對產(chǎn)品的理解,如有錯誤的地方,也歡迎指正。因成本和技術(shù)的受限,無論資料還是功能與STERIS的差距依然存在,但生物安全設備的國產(chǎn)化已刻不容緩,勢在必行,讓我們一起為制藥行業(yè)和生物安全實驗室的發(fā)展創(chuàng)造企業(yè)的社會價值。

參考文獻:
GB 15982 2012《醫(yī)院消毒衛(wèi)生標準》
GB27955-2020 過氧化氫氣體等離子體低溫滅菌器衛(wèi)生要求
GB38498-2020 消毒劑金屬腐蝕


關(guān)于過氧化氫空間滅菌的資料前文有具體的描述,如果需要了解,可閱讀前期文章  汽化過氧化氫VHP滅菌技術(shù)的應用 (點擊查看)

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.




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關(guān)于上海杰昊

上海杰昊生物技術(shù)有限公司位于上海市奉賢區(qū),專注生物安全設備的研發(fā)和生產(chǎn)十余載,在潔凈行業(yè)深耕20余年,為客戶提供高等級生物安全實驗室整體氣密性解決方案。公司產(chǎn)品主要有:生物安全氣密門,生物安全傳遞窗,生物安全渡槽,化學淋浴,強制淋浴,霧淋室,VHP傳遞窗,過氧化氫空間滅菌設備,不銹鋼密閉房,稱量罩等產(chǎn)品。





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