產品說明
SFS系列藥品穩定性試驗箱（Y）、藥品強光穩定性試驗箱（G）、綜合藥品穩定性試驗箱（Z）
SFS SeriesDrug StabilityTest Chamber（Y）, Drug Strong-light Stability Test Chamber（G）and Comprehensive Drug Stability Test Chamber (Z)
本系列產品滿足2000版藥典藥物穩定性試驗指導原則和GB10586-89有關條款制造。
This series of products are manufactured in accordance withChinese Pharmacopoeia2000 EditionGuidance for Industry: Stability Testing of Drug Substance and DrugProductsand the standard of GB10586-89.
適用范圍：Applicable range
藥品試驗箱是以科學的方法創造瞭對藥品失效評測所需長時間穩定的溫度、濕度環境，適用於制藥企業對藥品及新藥的長期試驗，高溫試驗和強光照射試驗，是制藥企業進行藥品穩定性試驗的最佳選擇。
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..
產品特點：Features
※采用微電腦智能液晶顯示控制溫度、濕度、控制穩定、準確、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;
※獨特風道循環系統，確保工作室內部風力分佈均勻。
Unique air circulating system ensures the uniform distribution of air in the working chamber;
※冷凍機采用進口原裝，全封閉壓縮機自動轉切換，保證試驗設備長時間連續運行，具有穩定、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，可連接記錄機或計算機，可長期記錄溫度、濕度參數標準（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.
※箱體左側可配直徑ф25mm測試孔（選配）。
A testing hole (optional) of diameterф25mmis available on the left of chamber body.
★穩定性試驗條件：Conditions for stability test
在ICH指南中，在功能性、性能和文件方麵，GMP和FDA定義瞭要求。歐洲、日本和美國同意制定一個共用的穩定性試驗，這些試驗的目標是集合信息，作為制定一個關於原料或藥品穩定性的推薦，最終目標是在規定周期中，證明藥品暴露在溫度、濕度、光照或綜合環境中的有效性。
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
強光照射條件光照度Brightness under high-light irradiation condition：4500±5000LX
技術參數Technical parameters：
型號Model 技術參數 Tech. parameters | SFS-100 | SFS-160 | SFS-250 | SFS-500 |
容積Volume | 100L | 160L | 300L | 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 | |||
光照強度/誤差 Intensity of illumination/error | 0-6000LX可調/±500LX 0-6000LX adjustable /±500LX | |||
定時范圍 Timing range | 1-9999min | |||
調溫調濕方式 Temperature and humidity control mode | 平衡調溫調濕方式Balanced temperature and humidity control mode | |||
制冷系統/制冷方式 Refrigeration system/mode | 二套獨立原裝進口全封閉壓縮機，自動輪流切換 Two sets of independent original imported full-enclosed compressor, automatic transfer in turn. | |||
控制器Controller | 微機控制Microcomputer control | |||
濕度傳感器Humidity sensor | 電熔式傳感器Capacitive sensor | |||
工作環境溫度Operating environment temp. | RT+5<, ST1, TCSC="0" NumberType="1" Negative="True" HasSpace="False" Sourcevalue="35" UnitName="℃" :chmetcnv w:st,="on">-35℃ | |||
電源Power supply | ～220V 50Hz | |||
內膽尺寸Dim. of internal bladder | 450×380×600 | 600×400×670 | 650×500×800 | 720×600×1200 |
載物托架（塊）Shelves | 2 | 3 | 4 | 4 |
備註Remark | 型號中帶“Y”為藥品穩定性試驗箱、“G”為藥品強光穩定性試驗箱、“z”為綜合藥品穩定性試驗箱 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. | |||
批發市場僅提供代購諮詢服務，商品內容為廠商自行維護，若有發現不實、不合適或不正確內容，再請告知我們，查實即會請廠商修改或立即下架，謝謝。
.jpg)
