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簡介：

無菌無塵熱風(fēng)干燥滅菌柜的設(shè)計(jì)要點(diǎn)是依據(jù)強(qiáng)制對流原理將熱空氣經(jīng)快速循環(huán)，通過高效空氣過濾器達(dá)到等級100以內(nèi)的高潔凈度。此熱空氣達(dá)到170℃~260℃時，將置于滅菌室內(nèi)的瓶子、器具、鋁蓋、膠塞（低溫時）等完全滅菌以符合GMP標(biāo)準(zhǔn)。每臺滅菌柜在出廠前皆做完整測試，其報告結(jié)果將列于提供給客戶IQ及OQ資料中，同時各種儀表及溫度傳感器，皆提供原始標(biāo)準(zhǔn)文件記錄，以符合GMP標(biāo)準(zhǔn)。

Application:

Hot air sterilizer machinery is designed according to forced convection principle with fast hot-air transmission circulation, and then through HEPA Fliter ensures the chamber air class within 100. Chamber inside the bottle, appliance, aluminum cover, rubber stoppers completed non germ when hot-air temperature up to 170℃~260℃ then reduce temperature, in accodance with the GMP regulations.Before the machine leaves the factory，it needs to finish whole testing and provide equipment IQ &OQ data manual, and all instruments calibrating report such as sheet document, contain varied kind of gauge and temperature sensor, provide original calibration document, in according with GMP requirment.

適用：

無菌無塵熱風(fēng)干燥滅菌柜適用于制藥廠，生物科技，電子工業(yè)，化工業(yè)及食品過程等。主要應(yīng)用于玻璃及金屬殺菌的去熱源反應(yīng)，如瓶類、注射液瓶、及各種藥液瓶、鋁塞、膠塞等。

Application:

Hot air sterilizer machinery applies to pharmaceutical factory, biotechnology, electronic industry, chemical industry and food producing industry, etc. It mainly applies to heat removal reaction of glass and mental sterilization such as vialL, ampoule and all kinds of bottles, aluminum plug and plastic plug, etc.

特色：

品質(zhì)可靠，產(chǎn)品符合GMP標(biāo)準(zhǔn)。 采用高溫過濾器，DOP測試達(dá)99.97%，耐高溫398.9℃，確保室內(nèi)潔凈度在100等級之內(nèi)。內(nèi)部熱風(fēng)經(jīng)高效率過濾網(wǎng)過濾后，進(jìn)入滅菌室，將瓶內(nèi)熱源及細(xì)菌完全滅菌，細(xì)菌殘留量低于6LOG（10-6）下。 進(jìn)氣及排氣口可依據(jù)需要選擇99.97%絕對過濾裝置。 設(shè)有DOP驗(yàn)證口，使QA人員能測量箱內(nèi)風(fēng)壓及潔凈度。 設(shè)有溫度驗(yàn)證口，使QA人員能測室內(nèi)空載熱分布及滿載熱滲透FH/FP，可選擇附RS232界面與電腦連線監(jiān)控。 滅菌柜于空載滅菌時間內(nèi)，室內(nèi)各點(diǎn)溫度分布情形確保在±5℃之內(nèi)。 每個過濾器上設(shè)有一個差壓計(jì)檢測二側(cè)壓力情形及過濾器壽命。 在進(jìn)排氣口有一擋板門，在不同的循環(huán)階段提供啟閉的完全控制。

Feature:

1. The quality is dependable, in according with GMP regulation.
2. Absolute high temperature and high efficiency HEPA Filter (DOP Test 99.97%), ensure the chamber air class within 100. Use hot air effect HEPA Filter to filter after enter chamber will complete sterilize bacteria, chamber inside bacteria quantity below 6 log (10-6).
3. Intake/ exhaust choice 99.97% filter device to use.
4. Charge DOP, particle counter test hole and validation testing holes are available for inspection.
5. Prepare a validation hole to make quality assurance people test the FP/ FH value of the chamber between the heating distribution and the heating penetration.
6. During sterilization process, the chamber empties every position temperature within ±5℃.
7. Every filter has one pressure guard check two-side the pressure and check filter life.
8. Intake/ exhaust has one stop-door can compete control every cycle open and close.

結(jié)構(gòu)：

機(jī)器結(jié)構(gòu)全部采用不銹鋼304、316L材質(zhì)制造，完全符合GMP標(biāo)準(zhǔn)。 密封門使用環(huán)硅橡膠材料包裝,確保熱空氣無滲漏。 可調(diào)整進(jìn)排氣擋板。 全機(jī)結(jié)構(gòu)采用氬弧焊接，箱內(nèi)可用水清洗。 單門式或雙門貫通式設(shè)計(jì)，皆可供應(yīng)。 自動控制上設(shè)有二道超溫保護(hù)，以確保使用上安全， 以雙門關(guān)門的模式作為洗瓶室與無菌室的區(qū)隔。 洗凈瓶子由洗滌室置入后，滅菌完成后由無菌室取出。 門設(shè)有互鎖裝置，以避免不同等級空氣造成污染。 滅菌臺車采用不銹鋼制造，滅菌盤子可配合充填機(jī)使用。

Structure:

1. This machine is designed and fabricated by high quality technique. All construction materials are made of 316L stainless steel and comply with GMP standard.
2. Sealed door packing use ring silicone rubber material, ensure hot air no leakage.
3. Adjust type inter/ exhaust fender
4. Sealed interior chamber (argon welding) and stainless steel chamber permit washing the chamber
5. Single door or pass through type double door available
6. Auto controller has two over temperature protect to ensure operate safely
7. The sterilizer has two-door design that separates the sterilizer from the washing room and sterilized room
8. Bottles are to be loaded into the washing room and to be sterilized by the sterilizer and loaded out to sterilized room.
9. The door control use interlock device to aviod different air class causing contamination.
10. Sterilizer trolley uses stainless and sterilizer tray can harmonize with filling machine use.

控制系統(tǒng)：

高溫干燥滅菌柜系列，采用最先進(jìn)智慧型人機(jī)界面及PLC程序自動控制，機(jī)器上附有LCD彩色觸摸屏，可設(shè)定及顯示各種不同資料，并可依觸摸屏指示操作機(jī)器，調(diào)整及設(shè)定簡單容易。 使用SCR動力控制，并配合溫度自動控制器采用P.I.D自動演算，將使溫度分布曲線值均勻穩(wěn)定。 六點(diǎn)式溫度記錄器裝置，可完整記錄滅菌中各點(diǎn)溫度分布情形，可依體積大小另選購12點(diǎn)式溫度記錄器。 全自動滅菌循環(huán)包括加溫→干燥→滅菌→冷卻→完成五個階段。 冷卻未達(dá)到設(shè)定低溫點(diǎn)，門無法打開，防止高溫燙傷及瓶子破裂。 可選購壓力檢測裝置，確認(rèn)滅菌柜內(nèi)部壓力運(yùn)轉(zhuǎn)中必須在正壓狀態(tài)，并可在記錄器顯示壓力值。

Control System:

Hot air sterilizer system uses human machine interface touch screen (LCD with color) and PLC sequence controller which are easy to operate and maintain, operation panel can set up several types of display information, according the screen to operate, adjust or install the machine. 1.Control system uses silicone control rectifier (scr) module, and coordinates with auto tunning temperature controller (P.I.D), to get very smooth and stable temperature curve during sterilization 2.By temperature recorder to record continuous curve of the chamber sterilization process, can choose 6 points or 12 points 3.Automatic sterilizer cycle includes heating→ drying→ sterilize→ cooling→ finish five stages 4.Prevent hot temperature and bottle break when cooling cycle not yet finishes and the door can’t be open 5.Purchase equipment to check chamber pressure during turning is under regular condition and recorder displays pressure value.

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