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Chongqing Chuangce Technology Co., Ltd

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    1315940635@qq.com

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    13167984542

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    Building 2, Building 35, Liandong U Valley, No. 619 Xiangfu Avenue, Shuangfu New District, Chongqing

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The drug stability test chamber is an instrument used by pharmaceutical companies and drug research institutions to test and detect drugs and new drugs. It is a testing equipment suitable for stability testing of drugs and environmental change detection. Most of the drug stability test chambers on the market are designed and manufactured in accordance with the guidelines for drug stability testing in the Chinese Pharmacopoeia and the relevant provisions of the "Technical Conditions for Damp Heat Test Chambers" (GB/T 10586-2006). They simulate a long-term stable working temperature, humidity, and lighting environment required for drug expiration evaluation using scientific methods. They are equipment certified by pharmaceutical companies through GMP.

1、 The proprietary terms for inspection standards:

① Drug stability test box

A box that provides environmental testing conditions such as temperature, humidity, and light for drug stability research. This box is suitable for pharmaceutical companies to conduct long-term, accelerated, intermediate, and influencing factor tests on drugs.

② Energy efficiency of drug stability testing chamber

The energy consumed to maintain the temperature, relative humidity, and illuminance of the workspace constant per unit volume for 1 hour during the testing process in the test chamber

③ Working space of drug stability testing chamber

The part of the test chamber that can maintain the specified conditions within the specified tolerance range.

④ The temperature of the drug stability test chamber remains constant

The temperature at the geometric center point of the workspace reaches the set temperature value and remains within the given tolerance range.

2、 What aspects of the drug stability test box are mainly tested?

① Measure the workspace of the equipment

Accurately measure the simple geometric shape of measuring equipment, and record the volume, studio size, and external dimensions, etc

② Measurement of Temperature and Humidity at the Geometric Center Point of the Drug Stability Test Chamber

Place the probes of the temperature testing equipment and relative humidity testing equipment at the geometric center of the workspace, and measure them every 1 minute

③ Test the power consumption of the drug stability test chamber

The ambient temperature is 32 ℃. Set the test chamber so that the measured temperature at the geometric center point is 25 ℃ (temperature fluctuation ± 2 ℃) and the relative humidity is 60% (humidity fluctuation ± 5%). Maintain the temperature stable for 4 hours, and record the power consumption for the last 1 hour.

The ambient temperature is 25 ℃, and the test chamber is set to achieve a geometric center point temperature of 40 ℃ (temperature fluctuation ± 2 ℃) and a relative humidity of 75% (humidity fluctuation ± 5%). The temperature is maintained stable for 4 hours, and the power consumption for the last 1 hour is recorded

④ Calculation method for energy efficiency of drug stability test chamber

The energy efficiency of the test chamber is calculated using the ratio of power consumption to volume, and its cooling and heating capabilities are examined separately.

C=E/V

3、 Why conduct energy efficiency testing on drug stability test kits?

① Objective reasons:

The drug stability test chamber is widely used, and the power of each device is mostly above 1500W, with a long usage time of more than 10 days and sometimes more than 1 year of continuous operation, consuming huge amounts of electricity. Due to the lack of energy efficiency testing methods for this type of product, manufacturers and users often only focus on the performance parameters of the product without considering the electricity consumption situation, resulting in huge waste of social energy. Therefore, the national standard "Energy Efficiency Testing Method for Drug Stability Test Chamber" (GB/T 39476-2020) has been formulated

② Subjective reasons:

Check whether the equipment meets the drug testing standards for drug stability test chambers specified in the Chinese Pharmacopoeia

Judging the performance of the stability test box for the produced drugs is a factor that directly affects the quality of the enterprise's equipment

4、 Do you know about the drug stability test box produced by Chongqing Chuangce Technology Institute?

The equipment produced by Chuangce Technology is produced in accordance with the standards specified in the Chinese Pharmacopoeia and meets the standards for drug stability testing set by FDA, ICH, and other relevant organizations. After years of technical accumulation, the drug stability test chamber can achieve stable energy saving, maintain stable temperature and humidity operation for a long time, meet the standard of constant temperature and humidity, and have a temperature fluctuation of ≤± 0.5 ℃.

At present, the drug stability testing chamber of Chuangce Technology has obtained certifications for ISO quality management system, environmental management system, and occupational health system, meeting the requirements for high-quality equipment. It has also obtained multiple new and independently developed water circulation systems, which save more than 40% of water compared to traditional equipment.

Chuangce Technology will continue to produce high-quality drug stability test kits for customers with the concept of "excellence in innovation and precision in testing"!