产品品牌：

上海三发

产品型号：

SFS-100Y

功率：

500W

重量：

70KG

温度范围：

0-50 ℃

外形尺寸：

450×380×580

使用电源：

220V 50HZ

外形尺寸：

450×380×580

重量：

70KG

SFS系列药品稳定性试验箱（Y）、药品强光稳定性试验箱（G）、综合药品稳定性试验箱（Z）  SFS Series Drug Stability Test Chamber（Y）, Drug Strong-light Stability Test Chamber （G）and Comprehensive Drug Stability Test Chamber (Z)    本系列产品满足2000版药典药物稳定性试验指导原则和GB10586-89有关条款制造。 This series of products are manufactured in accordance with Chinese Pharmacopoeia 2000 Edition Guidance for Industry: Stability Testing of Drug Substance and Drug Products and the standard of GB10586-89. 适用范围：Applicable range 药品试验箱是以科学的方法创造了对药品失效评测所需长时间稳定的温度、湿度环境，适用于制药企业对药品及新药的长期试验，高温试验和强光照射试验，是制药企业进行药品稳定性试验的选择。 The drug test chamber, with the scientific approaches, creates a good environment for the test of drug invalidity that needs long-term stability of temperature and humidity, it is the best selection for pharmaceutical enterprises to conduct drug stability test, applicable for drug long-term test, high-temperature test and high-light irradiation test, etc..    产品特点：Features ※采用微电脑智有液晶显示控制温度、湿度、控制稳定、准确、可靠。 The microcomputer controller and intelligent LCD are used to control and display the temperature and humidity respectively, with the stability, accuracy and reliability; ※独特风道循环系统，确保工作室内部风力分布均匀。 Unique air circulating system ensures the uniform distribution of air in the working chamber; ※冷冻机采用进口原装，全封闭压缩机自动转切换，保证试验设备长时间连续运行，具有稳定、安全、可靠的特点。 The freezing machine adopts the imported original, full-enclosed compressor can switch automatically, to ensure long-term continuous operation of test equipment, with the features of stability, security and reliability; ※采用不锈钢内胆，四角半圆弧易清洁。The internal bladder is made of stainless steel and four semi-circular corners take convenience for easily cleaning; ※可配RS-485接口，可连接记录仪或计算机，可长期记录温度、湿度参数标准（选配）。 RS-485 interface (optional) is available, which enables the incubator to be connected to the recorder or computer, to record the temperature and humidity for a long term. ※箱体左侧可配直径ф25mm测试孔（选配）。 A testing hole (optional) of diameter ф25mm is available on the left of chamber body.    ★稳定性试验条件：Conditions for stability test 在ICH指南中，在功能性、性能和文件方面，GMP和FDA定义了要求。欧洲、日本和美国同意制定一个共用的稳定性试验，这些试验的目标是集合信息，作为制定一个关于原料或药品稳定性的推荐，终目标是在规定周期中，证明药品暴露在温度、湿度、光照或综合环境中的有效性。 In the respects of functionality, performance and documents in Guidance of ICH, GMP and FDA defined the requirements. Meanwhile, Europe, Japan and USA had reached an agreement about a common stability test, this test is to collect the information, which is used for recommendation of raw material and drug stability, then to prove the drug validity under being exposed in some temperature, humidity, illumination or comprehensive environment.  ★    长期留样的稳定性试验的储藏条件： Storage conditions for the stability test of long-reserved sample 温度Temperature：+25℃±2℃ 湿度Humidity：60±5%RH 时间Time：12个月 12months ★    加速稳定性试验的储藏条件 Storage conditions for accelerating stability test 温度Temperature：+40℃±2℃ 湿度Humidity：75±5%RH 时间Time：6个月 6months 强光照射条件光照度Brightness under high-light irradiation condition：4500±5000LX   技术参数Technical parameters：

型号Model 技术参数 Tech. parameters	SFS-100	SFS-160	SFS-250	SFS-500
容积 Volume	100L	160L	250L	500L
控温范围 Temp. range	无光照0-65℃   有光照5-65℃ No illumination 0-65℃   Illumination 5-65℃
温度分辨率 Temp. resolution	0.1℃
温度波动度 Temp. fluctuation	±0.5℃
温度均匀度 Temp. homogeneity	±2℃
控湿范围Humidity range	40-95%RH
湿度波动Humidity fluctuation	±3%RH
光照强度/误差 Intensity of illumination/error	0-6000LX可调/±500LX  0-6000LX adjustable /±500LX
定时范围 Timing range	1-9999min
调温调湿方式 Temperature and humidity control mode	平衡调温调湿方式Balanced temperature and humidity control mode
制冷系统/制冷方式 Refrigeration system/mode	二套独立原装进口全封闭压缩机，自动轮流切换 Two sets of independent original imported full-enclosed compressor, automatic transfer in turn.
控制器Controller	微机控制Microcomputer control
湿度传感器Humidity sensor	电熔式传感器Capacitive sensor
工作环境温度Operating environment temp.	RT+5-35℃
电源Power supply	～220V 50Hz
内胆尺寸Dim. of internal bladder	450×380×580	600×405×620	680×605×730	750×650×1000
载物托架（块）Shelves	2	3	4	4
备注Remark	型号中带“Y”为药品稳定性试验箱、“G”为药品强光稳定性试验箱、“z”为综合药品稳定性试验箱 In a model, Y represents the drug stability test chamber, G represents the drug high-light stability test chamber, and Z represents the comprehensive drug stability test chamber.

 

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