综合药品稳定性试验箱

综合药品稳定性试验箱适用范围：Applicable range

综合药品稳定性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，综合药品稳定性试验箱是制药企业进行药品稳定性试验的***佳选择。

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..  

综合药品稳定性试验箱产品特点：Features

※采用微电脑智能液晶显示控制温度、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

企业名片