What is a microclimate and product stability testing methods.by Nguyen Nghe nvn1998
Microclimate cabinets or Humidity Cabinet (tủ vi khí hậu) are also known as environmental simulators (humidifying cabinets) to create the necessary conditions to test the stability of different materials. A microclimate can be used to simulate different temperature and humidity conditions. In addition, lighting simulation is also important for some tests. There are two types of microclimate cabinets: cabinets with constant temperature - humidity and cabinets with continuously changing temperature - humidity. Constant climate cabinets are commonly used for long-term stability testing and can be used to maintain temperature and humidity at defined levels. On the other hand, variable temperature and humidity cabinets can be used to run specific test programs in which temperature and humidity are automatically modified at certain times.
2. Humidifier and other important elements in the microclimate
Microclimate cabinets create stable temperature, humidity and lighting conditions. There are many Models and options can be changed according to testing requirements. To ensure that the tests are good results, too a decimal and write your data in the ENTIRE process is essential.
The system climate and cooler are conventionally perfected to achieve optimum levels in the cabinet - even in the refrigerator location as well as when filling samples in the cabinet. Gas meter condition for all tests, regardless of sample size and number is very important, especially for long term conformance tests with GLP and GMP standards. A compressed air cooling system is often used to ensure that tests are carried out under favorable conditions, while an independent temperature safety device monitors data by direct and audible alarms.
Humidity set is connected to humidity sensor (not floating). This is anbred time safe fast recovery, accurate measurement, short recovery time after opening the door. FDA compliant test results thanks to microprocessor-tested dehumidification and dehumidification systems. The wet is connected to an easy-to-use (plug and play) water supply system and offers options such as connecting to an existing water line or a built-in water tank to easily move the cabinet anywhere. sedge.
3. Stability testing and stress-testing in a microclimate
To use the results of a stability test, the microclimate must ensure uniform conditions throughout the test. Even the smallest external influences can distort the results, which is why the quality assurance measures provided by the Microclimate are so important for the tests. different stability tests.
There are 4 main types of stability tests:
To most effectively analyze sample variability, specific types of stability tests have been developed as follows:
>> Long-term tests: This test method is used to observe the variation of products (pharmaceuticals) under real conditions. Samples are tested at specific temperatures, relative humidity depending on the climate zone. During this time, the active ingredients in the pharmaceuticals are regularly analyzed while they are still in the microclimate. Depending on the properties of the particular sample, a Long-term trial can last up to several years.
>> On-going stability testing: This method is used to check whether the quality of a product can maintain even after its expiration date. The GMP standard requires continuous analysis of products already on the market to ensure that the quality of pharmaceutical products will not deteriorate after they are on the market.
>> Accelerated shelf-life testing: these simulate real-time aging of a drug at shorter times. In accelerated aging tests, samples will tend to be exposed to higher temperatures. For example, using this method a state can be achieved within 6 weeks, which under normal conditions can take from 1 to several years.
>> Stress tests: Stability tests under extreme conditions, e.g. at 60oC and 60% RH, are usually conducted in the early stages of research to decide which test method is most suitable for the performance. the active part is mentioned. Stress testing is well defined in the ICH Q1A guidelines.
Only a few Microclimate Manufacturers are capable of performing these test methods. In particular, BINDER microclimate cabinets (tủ vi khí hậu binder) have the world's leading quality.
Created on Aug 23rd 2021 12:33. Viewed 150 times.
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