药品稳定性试验箱

产品用途Usage
 

·本产品适用于制药业，包括长期试验、中间试验及加速试验，符合GMP原则要求，模拟温度、湿度、光照环境。可满足2010版化学药物稳定性研究技术指导原则中药品强光照射试验；美国 FDA、EN、 ICH（Q1A、Q1B）；按照标准要求以科学的方法模拟对药品失效期评测所需要的长时间稳定的工作温度、湿度、光照环境，是制药企业通过GMP认证的设备之一，可提供3Q档（IQ/PQ/OQ）,并可提供多种校正服务，
 

The product can be applied in pharmaceutical industry, including long-run, pilot-plant and short-time test, which complies with the data acquisition system required by GMP. It can also meet the demａnd of drug illumination test in The guiding principles of chemical drug stability research 2010 as well as FDA, EN, ICH (Q1A, Q1B). Based on the standard norm and scientific foundation, the product can simulate an environment of long-period stable working humidity, temperature and sunlight for drug expiration time, which is one of the indispensable equipment for pharmaceutical company to pass GMP certificate.3Qs documents (IQ/PQ/OQ) and calibration service are available. The product has passed EU CE certificate.
 

·箱体的外壳采用冷轧钢板静电喷塑，内胆采用优质SUS304B不锈钢板，   

·箱门具备大视角保温真空钢化玻璃，便于用户视察样品试验过程，

·密封材料：密封条采用发泡硅胶条制作，可耐温300℃不变形，
·测试引线孔：在工作室左侧，使用时可打开孔盖用双层密封形式，加强密封效果。 
 

Warm-keeping vacuum tempered glass in the chamber door keeps the test process monitored.

Sealing material: seal strip is made from silicone foam, 300℃ temperature resistance without deformation

Test lead hole: located in the left of workroom; opening the hole lid when using; duplex sealed

 

   

                            
加热系统Heat system

·加热器热呼应快、控温精度高，综合热效率高,

Heating system employs NiCr electric heater

Even temperature on the exit; accurate temperature control; widely used with great adaptability

加湿系统Humidifying system

·除湿系统采用蒸发器盘管露点温度层流接触式加湿器，·供水系统采用自动控制，

Humidification system: all-stainless steel surface evaporation humidifier

Water supply system is automatically controlled.

·真彩液晶宽屏，带RS232和RS485计算机界面实行人机对话、连线资料传输及远端控制功能，

·执行时间和剩余时间,预约时间日期，·中英文手动切换操作界面，

Imported true color LCD widescreen with RS232 & RS485 computer interface to realize man-machine conversation, online data transmission and remote control ，Automatic temperature and humidity calculation to set proper frequency with control accuracy of 0.1℃ and 0.1% respectively

Chinese-English manual operation interface switching]
 

实时打印温湿度数据或曲线，并带年月日、设备批号功能，打印间断时间可根据需求设置；

USB储存功能具有5年以上的数据记录，含驱动软件界面进行读数浏览保持数据库；