稳定性室的类型

药物的稳定性参数那食物， 和cosmetics在早期的文章中涵盖。这些构成预测产品保质期的主要部分，但这些研究延伸到其他材料，如建筑材料，电子元件，包装材料等。这种材料的测试需要对液氮等温度的极端环境条件temperature (-185°C) to above 200°C and relative humidity’s ranging from 20 – 98% for extended periods of time. It is not practical for you to move to different climatic regions every time for the purpose of study with your samples. Stability chambers offer the required conditions to conduct such studies in your laboratory wherever you may be located.

Stability Chambers

稳定性测试室是专门用于对不同产品进行稳定性和保质期研究的设计。根据申请广泛讲，他们被归类为

• Environmental chambers
• 温度湿度室
• 加速测试腔室
• Photostability chambers

The chambers conform to international standard guidelines and have internal mirror finish corrosion resistant stainless steel body with insulated exterior MS sheet having white powder coating. The door has a magnetic gasket with key coded door lock. High quality stainless steel trays are provided for storage of samples. Cooling is affected by hermetically sealed compressor. Controlled airflow inside ensures even distribution of humidity and temperature.

到达室

Reach- in chambers are small in size and are convenient to use when the number of samples is less and conditions are likely to be changed

步入室

步入室are larger in size and suitable when large number of samples are to be stored and when storage conditions are to be maintained over extended time periods

将单独的室保持用于每个所需的储存条件。根据国际协调委员会（ICH），药品稳定性研究的规定温度和湿度条件是

长期研究：25°C +/- 2°C，60 +/- 5％RH

Intermediate studies:30°C + / - 2°C，65％+/- 5％RH

加速稳定性研究：40°C +/- 2°C，75％+/- 5％RH

稳定性数据才有效，仅当环境条件在产品曝光期间一致时才有效。对于该条件，必须以规则的时间间隔执行自动数据记录，并且预防性维护例程在稳定性室上定期执行，以确保在延长的曝光期间不进行故障操作。

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