Stepping into the world of the pharmaceutical industry, you will find that drug stability is an extremely complex problem that cannot be neglected. Drugs come in a variety of components, from small molecules that are chemically synthesized to large molecules that are extracted from living organisms or prepared through biotechnology. These components are different in nature and have different adaptations to the surrounding temperature environment.
For example, biological drugs with protein as the main component, their structure is delicate and fragile, the temperature is slightly higher, the spatial structure of the protein will gradually loose, deformation, the special conformation that originally shoulder the mission of healing and saving people no longer exists, and the drug will lose its pharmacological activity. For some liquid preparations, if the temperature is too low, some of the solutes may crystallize slowly like ice crystals in the winter lake, which not only changes the original precise concentration ratio of the drug, but also may block the needle and cause adverse reactions when injected, bringing potential health risks to patients.
There are also those drugs that need to be stored for a long time, and the caprices of temperature are like an invisible "carving knife", constantly eroding the stability of the drug. Even the seemingly insignificant temperature cycle changes in daily life will break the "harmonious state" between drug molecules over a long period of time, resulting in drug degradation, impurities, and greatly reduced efficacy.
It is because we know that temperature has such an inextricable effect on drugs, the appearance of temperature chambers in the pharmaceutical industry is particularly critical.
In the early stages of drug development, there are many uncertainties. At this time, the temperature test chamber is the right-hand man for drug development. Suppose you develop an innovative drug for a difficult disease in which multiple compounds are synthesized, but which will stand the test of time and environment? Samples of these compounds were placed in a temperature test chamber and set to different temperature conditions, from high to low, and even to simulate the temperature cycle of four seasons over the course of a day. By observing how samples behave in these different temperature environments, it is possible to screen out those compounds with stable structures and reliable properties, laying a cornerstone for subsequent research and development.
To the drug production stage, it is still inseparable from the high low temperature test chamber. In the pharmaceutical workshop, each batch of raw material is purchased and inspected by it. Take the gelatin made of capsules, the quality of different batches of gelatin may fluctuate due to factors such as temperature differences during production, and it can be judged whether the raw materials are qualified by testing whether they can maintain good gelling characteristics at conventional and extreme temperatures in the temperature test chamber.
For the drug intermediates and finished products that have been made, they also need to play a role in the temperature test chamber. For example, in the process of producing antibiotics, the temperature control of the fermentation process is slightly wrong, and the quality of the produced drugs may be uneven. By simulating the influence of different fermentation temperatures on the final active ingredients of the drugs in the constant temperature chamber, the production staff can accurately control the process parameters to ensure that every antibiotic capsule and every bottle of antibiotic injection have stable and reliable quality.
For those drugs that have gone to the market and are used by patients, the guard of the temperature test chamber has never stopped. Pharmaceutical companies, in accordance with regulatory requirements, will regularly take drug samples from the market and place them in temperature test chambers to carry out long-term stability tests, which can be as short as several months or as long as several years. In this process, the temperature in the test chamber is strictly controlled under conditions close to the actual storage of the drug, and the staff will regularly test the indicators of the drug to see if there is an increase in impurities and a decrease in active ingredients. Once abnormalities are found, pharmaceutical companies can take timely measures, either to adjust storage conditions, or recall the problem drug, to avoid adverse effects on patients.
In this series of work to ensure the stability of drugs, accelerated stability test and long-term stability test are the main work.
The accelerated stability test is like a "fast-forward movie" of drug stability, by setting the temperature test chamber at a much higher than normal storage temperature, such as the common 40 ° C or higher, combined with the right humidity environment, artificially allowing the drug to "experience" changes in a short period of time that may occur in years of storage. Based on these rapidly changing data, researchers use professional mathematical models to estimate the approximate range of expiration dates of drugs under conventional conditions. For pharmaceutical companies, it can quickly judge the potential of drugs in the early stage of research and development, greatly improving the efficiency of research and development.
Long-term stability tests provide a realistic and detailed record of every change in the drug
over time at temperatures close to the actual storage environment. These data are not only an important basis for pharmaceutical companies to determine the accurate expiration date of drugs and optimize storage conditions, but also a key reference for regulatory authorities to review the quality of drugs, which is related to whether drugs can safely circulate in the market and serve patients.
The LIB temperature test chamber can control the temperature fluctuation within ±0.5℃. Moreover, the temperature uniformity in the chamber is also controlled at ±2 ° C, and the drug samples feel the same temperature conditions, avoiding the test error caused by local temperature differences, and making the detection results more real and reliable. LIB temperature test chamber is also equipped with a complete data recording function, the temperature, humidity and other key parameters in the chamber will be recorded in accordance with the set time interval, not only for the pharmaceutical company's internal research and development, production to provide traceable data support, in the face of the strict review of the drug regulatory authorities, but also the pharmaceutical company to prove their strict quality control strong evidence.
With its precise control of the temperature environment, comprehensive support for drug stability testing and constantly upgraded advanced technology, the temperature test chamber has become a solid barrier to protect the quality of drugs. It ensures the stability of each drug from the laboratory to the production line and then to the hands of patients, so that the drug can consistently play a curative effect and escort people's health.
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