What is the difference between a comprehensive drug stability test chamber and a drug stability test chamber?

I.
Definition: Comprehensive drug stability test chamber: The comprehensive drug stability test chamber is based on the 2020 edition of the pharmacopoeia chemical drug stability test and ICH Q1B guidelines (pharmacopoeia chemical drug stability test guidelines stipulate: drug production and development must be specified temperature, humidity and strong light irradiation test), the temperature and humidity in the test chamber can reach the required temperature and humidity value, and maintain long-term stability, suitable for pharmaceutical companies to drug stability verification and testing
.

The comprehensive drug stability test chamber is manufactured
with reference to the "GB10586-2006 wet heat box technical conditions".

It is a set of temperature, humidity, light test conditions, etc.
as one of the equipment, suitable for pharmaceutical companies and new drugs stability investigation, strong light irradiation test, etc.
, to meet the new version of GMP, FDA, ICH principles specified in the accelerated test, long-term test and low humidity test and other technical conditions, but also to meet the chemical drug stability technical guidelines: strong light irradiation test 4500±500LX, to meet ICH: Q1B total illumination ≥ 1.
2×106LuX.
hr, The test requirements of the near-ultraviolet energy ≥200W.
hr/m2 are comprehensive test equipment
that can fully simulate the stability of drugs under environmental conditions (temperature, humidity, light, ultraviolet irradiation).

Among them, temperature, humidity, light and ultraviolet are the key
to the comprehensive drug stability test.

Drug stability test chamber: The drug stability test chamber is manufactured
with reference to "GB10586-2006 wet heat box technical conditions".

It is suitable for the stability investigation test of drugs and new drugs in pharmaceutical enterprises, and meets the technical conditions
of accelerated test, long-term test and high and low temperature damp and heat test stipulated in the new version of GMP, FDA, ICH principles.

It also meets the 40 °C, 20% R.
H low humidity test
of special drugs such as large infusions.

Second, the difference 1, the scope of application is different: (1) the comprehensive drug stability test chamber is the need to meet the acceleration, long-term, low temperature and other drug tests on the basis of simulated environmental conditions for drug stability tests, environmental simulation includes (temperature, humidity, light and ultraviolet radiation) in one, with a strong test type, can meet the needs of different customer test conditions (2) and drug stability test chamber only needs to meet the temperature and humidity changes, on the basis of which the drug acceleration, long-term, And low humidity test, for the general drug stability test is more applicable, but can not meet the special class of environmental simulation experiments
.

2, the technical conditions are different: (1) The comprehensive drug stability test box has a variety of technologies in one, including temperature and humidity changes, light intensity, ultraviolet radiation and other technologies, which are more accurate in environmental simulation and time control, and can meet the impact of different environmental conditions on drugs and investigate
the stability of drugs.

(2) The drug stability test box does not have light and ultraviolet simulation, and only the stability of a single drug is investigated, and the technical conditions are lower
than the comprehensive drug stability test box.

The experimental effects produced are also different
.

3.
The structure of the box is different: (1) The drug stability test box only has a single box structure (divided into single door and double door opening), which only changes in capacity and volume, and can only simulate a single environmental change
.

(2) The comprehensive drug stability test box can be divided into single, double and multiple boxes according to customer needs, each box can exist independently, meet the environmental simulation under different conditions, and can more accurately and conveniently investigate the changes of drugs under different environmental conditions
.

Third, the comprehensive drug stability test chamber of Chuangxue Technology 1.
Main features: (1) imported temperature and humidity sensor
.

It can ensure the accuracy of environmental testing, improve the quality assurance and service life of products
.

(2) Temperature + humidity + light + ultraviolet radiation in one, and with high-definition color touch screen integrated display, more intuitive, convenient reflection of the experimental situation, the parameters of the experiment in a timely manner to understand and adjust
.

(3) It can effectively maintain long-term stability
.

After more than ten years of technical accumulation, the comprehensive drug stability test chamber produced by Chuangshi Technology can ensure the accuracy of the test chamber for drug stability investigation experiments, the temperature fluctuation degree is small, and the long-term stability
of the drug simulation environment is maintained.

2.
Related parameters: