綜合藥品穩(wěn)定性試驗箱適用范圍：Applicable range

綜合藥品穩(wěn)定性試驗箱是以科學(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*試驗，高溫試驗和強光照射試驗，是制藥企業(yè)進行藥品穩(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

※采用微電腦智能液晶顯示控制溫度、濕度、控制穩(wěn)定、準(zhǔn)確、可靠。

The microcomputer controller and inligent LCD are used to control and display the temperature and humidity respectively, with the stability, accuracy and reliability;

※*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;

※冷凍機采用進口原裝，全封閉壓縮機自動轉(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，可*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*，zui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.

★    *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

強光照射條件光照度Brightness under high-light irradiation condition：4500±5000LX

技術(shù)參數(shù)Technical parameters：