The stability chamber is an equipment that preserves samples, through studies involving climatic factors, as part of a productive or regulatory process. These studies are combined with variables such as lighting, temperature and humidity to define the conditions of stability and uniformity.
For this, the stability study climate chamber can be divided into constant climate chamber and variable climate chamber, and are used to diagnose the states of the samples at defined levels, and consequently, allows the pharmaceutical industries, expand the evaluations, to guarantee and monitor the state of the products.
Procedure for Stability Studies
For the conduct of stability studies, it should be ensured that the climate remains constant during the test at all times, and even small external predominances can distort the result. Therefore, the quality control measures of a climate chamber are of the utmost importance for different types of stability studies.
In order to calculate the behavior of the samples in the best way, certain forms of stability tests have been established, which are:
- Long-term testing: They are used to observe in real time, the active ingredients of the samples long term.
- Ongoing stability monitoring: through continuous analysis, quality control is assessed to ensure that the product does not suffer after launch.
- Accelerated durability testing: represents real-time aging of drugs, at shortened time intervals.
- Stress tests: these are studies involving extreme methods, with regard to temperature, for example, at 60 °C and 60 % relative humidity, and are carried out in order to be able to decide which testing methods.
Depending on the aforementioned tests, they are applied thanks to the participation of the constant climate chamber, which is used for long-term tests, where temperature and humidity intervene at a defined level. As well as the variable weather chamber, where samples change automatically at defined intervals.
Firstly, for the drugs to be marketed, they must meet stability tests, which serve to define expiration dates. It has a lot to do with the study methods, which correspond to storage, and it is recommended that it be at an average room temperature between 8°C and 25°C; For this, the active substance available in the medicine, must be at least 95%, otherwise, it is necessary to change the expiry date or not authorize the medicine.
In the case of extreme temperature tests, at medium ambient temperature, it does not allow the precise expiry of medicinal products to be determined, as they are also used in areas with extreme climates. Medicines must resist both high and low temperatures. Therefore, it is important to include regular stability tests with extreme tests, which are performed at freezing temperatures, with extreme exposures to ultraviolet rays so that in this way, the storage of medicines in outdoor conditions can be simulated.
Climate Chamber of Stability Study in Kalstein
At Kalstein, we are trained to offer you the best medical equipment, capable of meeting all the demands of our clients. We provide the best technology, such as the stability study climate chamber of the YR model, which provides all the benefits for the preservation of medicines. For this reason, our medical team has attractive features, such as: integrated LCD dot matrix display, Chinese and English subtitles, designed for maximum operational comfort. Display parameters: temperature, humidity, cycle, run time, run time and stop. The adaptive PID controller precisely controls temperature and humidity, prevents temperature from rising, keeps ambient temperature stable and uniform. User password protection, built-in multi-function memory menu, multi-device connection (up to 16 drives), real-time monitoring.
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