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藥品穩定性試驗箱

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藥品穩定性試驗箱

產品用途UsageThis product is mainly applied in pharmaceutical industry, medicine, biotechnology and other industries

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產品用途
Usage

 

This product is mainly applied in pharmaceutical industry, medicine, biotechnology and other industries related to life sciences. Through tests, whether the function of products is qualified or not can be known, facilitating product design, improvement, test and QC.
 

·本產品適用于制藥業,包括長期試驗、中間試驗及加速試驗,符合GMP原則要求,模擬溫度、濕度、光照環境。可滿足2010版化學藥物穩定性研究技術指導原則中藥品強光照射試驗;美國 FDA、EN、 ICH(Q1A、Q1B);按照標準要求以科學的方法模擬對藥品失效期評測所需要的長時間穩定的工作溫度、濕度、光照環境,是制藥企業通過GMP認證的必備設備之一,可提供3Q檔(IQ/PQ/OQ),并可提供多種校正服務,
 

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.
 

·箱體的外殼采用冷軋鋼板靜電噴塑,內膽采用優質SUS304B不銹鋼板,   

·箱門具備大視角保溫真空鋼化玻璃,便于用戶視察樣品試驗過程,

·密封材料:密封條采用發泡硅膠條制作,可耐溫300℃不變形,
·測試引線孔:在工作室左側,使用時可打開孔蓋用雙層密封形式,加強密封效果。 

 

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

 

   images/91/2019/05/IWDS2uLZZwdmdD8d2366rrjd8SMs3g.png

                            

加熱系統Heat system

·加熱器熱呼應快、控溫精度高,綜合熱效率高,

 

Heating system employs NiCr electric heater

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

加濕系統Humidifying system

 

·除濕系統采用蒸發器盤管露點溫度層流接觸式加濕器,·供水系統采用自動控制,

Humidification system: all-stainless steel surface evaporation humidifier

Water supply system is automatically controlled.

 

·原裝進口真彩液晶寬屏,帶RS232和RS485計算機界面實行人機對話、連線資料傳輸及遠端控制功能,

·執行時間和剩余時間,預約時間日期,·中英文手動切換操作界面,

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]
 

 images/91/2019/05/ut7iQ0za8Up0qq8Z7Tad7PiQrQqp1Q.png

 

實時打印溫濕度數據或曲線,并帶年月日、設備批號功能,打印間斷時間可根據需求設置;

USB儲存功能具有5年以上的數據記錄,含驅動軟件界面進行讀數瀏覽保持數據庫;

 images/91/2019/05/ZlczgZeWrh5qwvr3QZ90qV4eWWB5V4.png

  

備案號:蘇ICP備17025541號-5    版權所有:江蘇富奇恒溫設備有限公司    技術支持:智程網絡

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