|Pharmaceutical Stability Test Chambers|
»The Pharma Series Test Chambers are designed for Stability Tests on Pharmaceutical products according to ICH Q1A and FDA Guidelines.
To meet the quality criteria of the stability tests, the chemical, microbiological, and physical characteristics of pharmaceutical substances are tested after exposure to temperature and humidity over a defined period.
To that end, the following climate conditions were established for long-term testing, accelerated testing, and testing at intermediate conditions according to the ICH* Guideline Q1A.
Testing at intermediate conditions is carried out in case there are deviations between the first two forms of testing.
• Long-term testing at +25˚C / 60% RH or +30˚C / 65% RH
• Accelerated testing at +40˚C / 75% RH
• Intermediate testing at +30˚C / 65% RH
The following test conditions were stipulated for substances or pharmaceuticals in semi-permeable packaging:
• Long-term testing at +25˚C / 40% RH
• Accelerated testing at +40˚C / <25% RH
During the entire test, the deviation in temperature is limted to ±2˚C and the deviation in relative humidity is limited to ±5% RH
»Quality Environmental Simulation Ensures Confidence
According to the ICH* Guideline Q1A, stability tests have to be performed under defined climatic conditions in order to provide evidence of the stability of active substances and pharmaceuticals.
In cooperation with the pharmaceutical industry, we have developed a specific range of test cabinets and test chambers to meet these requirements.
Stability tests are an important step in the development of new drugs and pharmaceutical substances and an indispensable element in the licensing process defined by federal regulating authorities. However, these tests are just as important for safeguarding the quality of the product within the framework of quality assurance.
Together with committees from the pharmaceutical industry, experts from the licensing authorities (such as the FDA) have developed the ICH* Guidelines for the harmonization of stability tests. These guidelines define standardized storage and batch evaluation as well as the time sequence of the required analytic tests.
The ICH* Guidelines are valid in the EU, Japan and the USA. For other regions, climate zones have also been established. However, depending on the respective country, the execution of such tests may not be mandatory.
* International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.
»Solutions for the Laboratory
The test systems Pharma600, Pharma1300 and Pharma2000 were specially developed for use in laboratories and supplement the spacious walk-in chambers that are used in production areas.
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