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Constant climate chamber for pharmaceutical industry Nov 30, 2021
Although drug discovery has received much attention in the pharmaceutical industry, stability also plays an equally important role. Drugs must remain effective and safe for a long time after they leave the production facility. Ensuring this security requires a series of technologies and applications.

Stability and light stability testing of active pharmaceutical ingredients and finished products
Stability and light stability tests are used for research aimed at providing information about how active pharmaceutical ingredients (API) or finished pharmaceuticals (FPP) change over time and are affected by temperature, climate, and light. The follow-up inspection period, expiration date and recommended storage conditions of the active pharmaceutical ingredients are determined based on these data. In conducting these studies, the incubator is the key.

Stability test Phase stability test
The level of stability testing is often divided into three categories: mandatory, accelerated, and real-time stability. In the mandatory stability test, the company exposes the compound to harsh environments, such as high temperature or humidity. The temperature is usually close to the melting temperature of the active pharmaceutical ingredient. This can also include testing under strong light. The results can be used to predict reaction kinetics.

Accelerated stability testing is less demanding. It can include, for example, a temperature of 50 degrees Celsius to predict what might happen to the drug over a long period of time at room temperature.

For real-time stability testing, the pharmaceutical company stores the drug at room temperature, natural light, and the expected humidity level of the drug sales area. These tests usually run for several years. In addition, real-time testing must include potentially destructive scenarios. “It covers whether someone left the medication on the dashboard of the car and then went to the beach that same day, or if the medication shipped around the world was left out on the pallet at the airport,” Ladd said.

Consumers may think that the therapeutic drug product in the home medicine cabinet effectively achieves the effect claimed on its label. Similarly, medical professionals expect prescription products to meet efficacy, safety, and stability requirements. The confidence of both parties is based on the expectation of biopharmaceutical companies to thoroughly test therapeutic products long before they enter the market.

Considering stability, constant climate manufacturers need to know that when the product is placed on the shelf, it will not lose its effectiveness or degrade into dangerous things. For the stability test of the finished product, the product is stored under controlled conditions, and then periodically removed from these conditions and checked to ensure that it meets the standards. Various characteristics are measured to create degradation lines during the product's shelf life. In some cases, a study may span multiple years.

For a substance that is under development but has not yet been approved for clinical use, the company cannot wait for several years due to competitive pressure, market demand, and tight time for patent expiration. In order to speed up the stability testing process, scientists put the substance under pressure conditions such as high humidity and temperature to highlight stability issues more quickly.

If they have standardized technologies, practices, and data to support integrated methods of stability testing and analysis, they can also use virtual models. Virtual testing, also called computer testing, can usually predict stability issues early in the research and discovery phase.

The constant temperature and humidity drug stability chamber is a reliable and high-efficiency environmental test chamber that meets the test requirements. The XCH Biomedical environmental protection box is designed with imported technology and imported high-quality parts and components, with stable and reliable performance. It is a reliability and efficiency environmental test chamber that meets the test requirements.

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