简介：

无菌无尘热风干燥灭菌柜的设计要点是依据强制对流原理将热空气经快速循环，通过高效空气过滤器达到等级100以内的高洁净度。此热空气达到170℃~260℃时，将置于灭菌室内的瓶子、器具、铝盖、胶塞（低温时）等完全灭菌以符合GMP标准。每台灭菌柜在出厂前皆做完整测试，其报告结果将列于提供给客户IQ及OQ资料中，同时各种仪表及温度传感器，皆提供原始标准文件记录，以符合GMP标准。

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.

适用：

无菌无尘热风干燥灭菌柜适用于制药厂，生物科技，电子工业，化工业及食品过程等。主要应用于玻璃及金属杀菌的去热源反应，如瓶类、注射液瓶、及各种药液瓶、铝塞、胶塞等。

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：

品质可靠，产品符合GMP标准。 采用高温过滤器，DOP测试达99.97%，耐高温398.9℃，确保室内洁净度在100等级之内。内部热风经高效率过滤网过滤后，进入灭菌室，将瓶内热源及细菌完全灭菌，细菌残留量低于6LOG（10-6）下。 进气及排气口可依据需要选择99.97%绝对过滤装置。 设有DOP验证口，使QA人员能测量箱内风压及洁净度。 设有温度验证口，使QA人员能测室内空载热分布及满载热渗透FH/FP，可选择附RS232界面与电脑连线监控。 灭菌柜于空载灭菌时间内，室内各点温度分布情形确保在±5℃之内。 每个过滤器上设有一个差压计检测二侧压力情形及过滤器寿命。 在进排气口有一挡板门，在不同的循环阶段提供启闭的完全控制。

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.

结构：

机器结构全部采用不锈钢304、316L材质制造，完全符合GMP标准。 密封门使用环硅橡胶材料包装,确保热空气无渗漏。 可调整进排气挡板。 全机结构采用氩弧焊接，箱内可用水清洗。 单门式或双门贯通式设计，皆可供应。 自动控制上设有二道超温保护，以确保使用上安全， 以双门关门的模式作为洗瓶室与无菌室的区隔。 洗净瓶子由洗涤室置入后，灭菌完成后由无菌室取出。 门设有互锁装置，以避免不同等级空气造成污染。 灭菌台车采用不锈钢制造，灭菌盘子可配合充填机使用。

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.

控制系统：

高温干燥灭菌柜系列，采用最先进智慧型人机界面及PLC程序自动控制，机器上附有LCD彩色触摸屏，可设定及显示各种不同资料，并可依触摸屏指示操作机器，调整及设定简单容易。 使用SCR动力控制，并配合温度自动控制器采用P.I.D自动演算，将使温度分布曲线值均匀稳定。 六点式温度记录器装置，可完整记录灭菌中各点温度分布情形，可依体积大小另选购12点式温度记录器。 全自动灭菌循环包括加温→干燥→灭菌→冷却→完成五个阶段。 冷却未达到设定低温点，门无法打开，防止高温烫伤及瓶子破裂。 可选购压力检测装置，确认灭菌柜内部压力运转中必须在正压状态，并可在记录器显示压力值。

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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