- 產(chǎn)品品牌:
- 上海三發(fā)
- 產(chǎn)品型號:
- SFS-100Y
- 功率:
- 500W
- 重量:
- 70KG
- 溫度范圍:
- 0-50 ℃
- 外形尺寸:
- 450×380×580
- 使用電源:
- 220V 50HZ
- 外形尺寸:
- 450×380×580
- 重量:
- 70KG
SFS系列藥品穩(wěn)定性試驗箱(Y)、藥品強(qiáng)光穩(wěn)定性試驗箱(G)、綜合藥品穩(wěn)定性試驗箱(Z) SFS Series Drug Stability Test Chamber(Y), Drug Strong-light Stability Test Chamber (G)and Comprehensive Drug Stability Test Chamber (Z) 本系列產(chǎn)品滿足2000版藥典藥物穩(wěn)定性試驗指導(dǎo)原則和GB10586-89有關(guān)條款制造。 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. 適用范圍:Applicable range 藥品試驗箱是以科學(xué)的方法創(chuàng)造了對藥品失效評測所需長時間穩(wěn)定的溫度、濕度環(huán)境,適用于制藥企業(yè)對藥品及新藥的長期試驗,高溫試驗和強(qiáng)光照射試驗,是制藥企業(yè)進(jìn)行藥品穩(wěn)定性試驗的選擇。 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.. 產(chǎn)品特點:Features ※采用微電腦智有液晶顯示控制溫度、濕度、控制穩(wěn)定、準(zhǔn)確、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; ※獨特風(fēng)道循環(huán)系統(tǒng),確保工作室內(nèi)部風(fēng)力分布均勻。 Unique air circulating system ensures the uniform distribution of air in the working chamber; ※冷凍機(jī)采用進(jìn)口原裝,全封閉壓縮機(jī)自動轉(zhuǎn)切換,保證試驗設(shè)備長時間連續(xù)運行,具有穩(wěn)定、安全、可靠的特點。 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; ※采用不銹鋼內(nèi)膽,四角半圓弧易清潔。The internal bladder is made of stainless steel and four semi-circular corners take convenience for easily cleaning; ※可配RS-485接口,可連接記錄儀或計算機(jī),可長期記錄溫度、濕度參數(shù)標(biāo)準(zhǔn)(選配)。 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. ※箱體左側(cè)可配直徑ф25mm測試孔(選配)。 A testing hole (optional) of diameter ф25mm is available on the left of chamber body. ★穩(wěn)定性試驗條件:Conditions for stability test 在ICH指南中,在功能性、性能和文件方面,GMP和FDA定義了要求。歐洲、日本和美國同意制定一個共用的穩(wěn)定性試驗,這些試驗的目標(biāo)是集合信息,作為制定一個關(guān)于原料或藥品穩(wěn)定性的推薦,終目標(biāo)是在規(guī)定周期中,證明藥品暴露在溫度、濕度、光照或綜合環(huán)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. ★ 長期留樣的穩(wěn)定性試驗的儲藏條件: Storage conditions for the stability test of long-reserved sample 溫度Temperature:+25℃±2℃ 濕度Humidity:60±5%RH 時間Time:12個月 12months ★ 加速穩(wěn)定性試驗的儲藏條件 Storage conditions for accelerating stability test 溫度Temperature:+40℃±2℃ 濕度Humidity:75±5%RH 時間Time:6個月 6months 強(qiáng)光照射條件光照度Brightness under high-light irradiation condition:4500±5000LX 技術(shù)參數(shù)Technical parameters:
型號Model 技術(shù)參數(shù) Tech. parameters | SFS-100 | SFS-160 | SFS-250 | SFS-500 |
容積 Volume | 100L | 160L | 250L | 500L |
控溫范圍 Temp. range | 無光照0-65℃ 有光照5-65℃ No illumination 0-65℃ Illumination 5-65℃ | |||
溫度分辨率 Temp. resolution | 0.1℃ | |||
溫度波動度 Temp. fluctuation | ±0.5℃ | |||
溫度均勻度 Temp. homogeneity | ±2℃ | |||
控濕范圍Humidity range | 40-95%RH | |||
濕度波動Humidity fluctuation | ±3%RH | |||
光照強(qiáng)度/誤差 Intensity of illumination/error | 0-6000LX可調(diào)/±500LX 0-6000LX adjustable /±500LX | |||
定時范圍 Timing range | 1-9999min | |||
調(diào)溫調(diào)濕方式 Temperature and humidity control mode | 平衡調(diào)溫調(diào)濕方式Balanced temperature and humidity control mode | |||
制冷系統(tǒng)/制冷方式 Refrigeration system/mode | 二套獨立原裝進(jìn)口全封閉壓縮機(jī),自動輪流切換 Two sets of independent original imported full-enclosed compressor, automatic transfer in turn. | |||
控制器Controller | 微機(jī)控制Microcomputer control | |||
濕度傳感器Humidity sensor | 電熔式傳感器Capacitive sensor | |||
工作環(huán)境溫度Operating environment temp. | RT+5-35℃ | |||
電源Power supply | ~220V 50Hz | |||
內(nèi)膽尺寸Dim. of internal bladder | 450×380×580 | 600×405×620 | 680×605×730 | 750×650×1000 |
載物托架(塊)Shelves | 2 | 3 | 4 | 4 |
備注Remark | 型號中帶“Y”為藥品穩(wěn)定性試驗箱、“G”為藥品強(qiáng)光穩(wěn)定性試驗箱、“z”為綜合藥品穩(wěn)定性試驗箱 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. |
本公司供應(yīng)上海三發(fā)SFS-100試驗箱質(zhì)量保證,歡迎咨詢洽談。