Human beings are very dependent on drugs from birth. Poliomyelitis drops, vaccines, wound treatments, eye drops, medications for the elderly. There are different drugs for different life stages. These drugs are produced using chemical analysis, biotechnology, microbial cultures, etc. These medicines are just drops of life. If it is produced incorrectly, it can be devastating for the person who eats it, leading to his death. Different types of stability studies have been carried out for these aspects. Established a medical compliance agency. ICH, USFDA and other institutions were established. These pharmaceutical compliance agencies have established standards for manufacturers to follow. Unless these compliance agencies do not provide them with a license to do so, it can ensure that pharmaceutical manufacturers cannot market or sell their products. Before issuing a license, the pharmaceutical agency will check the QA analysis of the drugs produced. It is necessary to check the chemical composition, check the uniformity of the drug, and check the behavior of the drug under different climatic conditions. Pharmaceutical manufacturers need to check the behavior of their products through different stages of quality analysis. One of the stages is "stability". The stability of the product in different environments. Different environmental conditions, such as humidity, temperature, ultraviolet radiation, etc., are artificially generated in a stable room. Heat, humidity and light are all causes of product degradation. Regulatory committees, such as the Federal Drug and Food Administration (FDA), ensure that appropriate precautions are taken to maintain consumer safety. Establishing product integrity in different climatic zones is critical, because small changes in temperature and humidity will affect the drug.
Carry out stability storage and test studies to simulate climate effects. These studies are based on where the product is sold. Understanding all the ways in which finished products or active pharmaceutical ingredients (APIs) are affected by degradation is critical to the storage of these products. Through these studies, XCH Biomedical can determine the shelf life of the drug, determine the best storage method for the drug, and ultimately help ensure the safety of consumers.
What is a stability test chamber? Most stability test chambers are similar to a large scientific refrigerator. Their function is not to keep things cool, but to replicate changes in temperature, humidity, and light for a long time. For example, this is critical when a pharmaceutical company wants to bring a new product to the market. 1. Humidity test The accuracy and repeatability, reliability and durability of the parameters in continuous operation are the primary tasks of the humidity test chamber. The sturdy stainless steel interior should be corrosion resistant and designed to be easy to clean. The programming must be intuitive, and the documentation must meet the requirements of FDA 21 CFR Part 11. Calibration certificates, data loggers and verification documents should of course also be included. 2. Light In the case of light stability test according to ICH Q1B, light supplement temperature and humidity are used as additional parameters. Specify the light source and lighting level for each time unit. Visible light (VIS is similar to ISO 10977 (1993)) must reach an exposure time of at least 1.2 million lux per hour, and near ultraviolet light must be at least 200 hours/m² (320 nm to 400 nm). As with temperature and humidity, uniform light distribution on each shelf is critical. Here, the basic specifications are the intensity distance, and the type of sensor and reflector used 3. Accelerated research or forced degradation is used to predict the shelf life of products. Scientists accelerate the process and speed of decomposition/degradation by increasing the temperature and/or humidity of environmental conditions in a short period of time. These accelerations indicate that if it is introduced to extreme conditions in a short period of time, it will have an impact on the drug. Overall, this gives a general overview of the different characteristics of degradation, including physical, chemical, and microbiological.
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