The drug stability test chamber industry is developing rapidly, and the bottleneck of technical "stuck neck" has yet to be broken

【Pharma Network Technical Article】In the pharmaceutical industry, the GMP principle requires 25°C/60%RH humidity long-term stability test conditions
.
In the accelerated test 40°C/75%RH humidity test 6 months standard, is the pharmaceutical industry stability test system field, mainly simulating the environmental climate in temperature, humidity, light test
.
Drug stability test chamber is an instrument for measuring the long-term stable temperature, humidity environment and light environment required for drug failure, suitable for pharmaceutical enterprises to accelerate the test, high temperature test and strong light irradiation test of drugs and new drugs, is the pharmaceutical enterprise drug stability test option program, mainly used in the pharmaceutical industry, medicine, biotechnology industry and all related industrial fields
including life sciences 。 From the technical principle, in terms of control principle, the temperature and humidity sensor will transmit the current temperature and humidity value to the controller, the controller according to the current operating state, the temperature value and humidity value are compared with the set value, PID calculation, determine the heating and humidification output power size, through the control of the solid state relay, control the heating and humidification connection time, that is, the controller in the time of the turn-on percentage
.
By continuously adjusting the heating and humidification output, the temperature and humidity are relatively stable
.
In terms of refrigeration and dehumidification principle, the compressor compresses the refrigerant (R134a) into a high temperature and high pressure gas, condenses into a room temperature and high pressure liquid through the condenser, sprays into the evaporator through the throttling device for gasification, and the refrigerant gasifies a large amount of heat absorbing, so that the temperature of the evaporator is reduced, and the evaporator absorbs the air heat flowing through the evaporator and liquefies the water vapor in the air, so that the air temperature drops and the humidity decreases
.
The low-temperature, low-pressure gas is sucked back into the compressor and so on
.
In recent years, with the promotion of new pharmaceutical policies such as the acceleration of new drug review and approval, the normalization of centralized procurement, the domestic pharmaceutical industry, including the innovative drug industry, has developed rapidly, and more and more pharmaceutical companies have increased their enthusiasm
for drug innovation and research and development 。 In order to provide a basis and reference for the energy efficiency test methods of drug stability test chambers, on August 20, 2021, the national standard "GB/T 40326-2021 Laboratory Equipment Energy Efficiency Grade Drug Stability Test Chamber" was approved and released, and will be implemented from March 1, 2022, which will further promote the development and progress
of industry technology.
At present, the drug stability test chamber industry in the domestic market is developing rapidly, and the number of manufacturers is also large
.
However, on the whole, the independent innovation ability of domestic drug stability test chamber manufacturers is relatively low, and there are some defects in performance, such as long-term continuous operation; And some parts and technologies have "stuck necks", mainly relying on imported manufacturers
.
With the continuous efforts of domestic enterprises, some powerful enterprises have successively developed reliable domestic products
through hard study and increased research and development efforts.
For example, there is a new generation of drug stability test chamber created by manufacturers, which integrates the company's many years of design and production experience, introduces and digests German technology, breaks through the existing domestic drug test chamber can not run continuously for a long time, and becomes a GMP certified equipment
for pharmaceutical factories.
At present, the domestic pharmaceutical industry is accelerating innovation and development, and the future market prospects of drug stability test chambers are considerable, but domestic enterprises still need to keep pace with the times, maintain innovation, continuously increase investment in research and development, and create equipment that meets the requirements of domestic pharmaceutical companies and has hard core and independent property rights, in order to occupy more market cakes
in the market.
From the perspective of development trend, the drug stability test chamber industry will be upgraded
in the direction of high efficiency, low energy consumption, stable long-term operation and safety.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice
to anyone.