Envirotronics Pharmaceutical Stability Test Chambers

Envirotronics Pharmaceutical Stability Test Chambers

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.

Envirotronics now offers a range of test cabinets and test chambers, developed in cooperation with the pharmaceutical industry to meet these requirements.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. The functionality of the cabinets satisfies the basic requirements of the official guidelines as well as the demands of special applications.

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.

For more info go to our ›Pharma Series page.