Stability tests are necessary to determine the shelf life of a medicine. An approval for your product can only be granted after it has passed a quality test in the laboratory. The procedure involves checking whether the defined physical, chemical and microbiological properties correspond to the required specifications over a previously defined period of time. The exact performance of a stability test is precisely specified by the guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and has international validity.
If you want to carry out stability tests, a climatic cabinet is indispensable, because during the test the medicines have to be stored in certain climatic conditions, depending on the consumer region. A climatic cabinet from tritec® makes it possible to simulate different climatic zones with varying humidity. The selection of the test cabinet must therefore be thoroughly thought through, as it must fulfil the guidelines mentioned.
The test procedure in detail
Stability tests are used to test the effectiveness, shelf life and storability of a product. Since many global consumers are accompanied by different living environments, different climatic conditions must be simulated. The ICH guideline defines two test conditions under which finished medicinal products are tested in the final packaging: 25 °C and 60 percent relative humidity or 30 °C and 65 percent relative humidity. The test conditions defined first are summarised in ICH Guideline Q1A, which is applicable to the USA, Europe and Japan. Some storage conditions require a lower humidity. The maximum test duration is five years. However, in some cases, an accelerated quality test in the laboratory is necessary to investigate a preliminary determination of stability. In this case, the medicines are stored in a climatic cabinet for stability testing at 40 °C and 75 percent relative humidity.
Stability tests for biotechnologically manufactured products
For products containing proteins, monoclonal antibodies, and polypeptides, the ICH guideline Q5C applies. Usually, these are biopharmaceuticals. In its basic features, the Q5C guideline corresponds to Q1A, but in addition to the physical and chemical methods of the Q1A guideline, special analytical techniques are required for these stability tests. In your laboratory’s climatic cabinet, storage conditions at temperatures from 8 °C to -60 °C or lower must be investigated for this purpose in order to verify the stability. By continuously checking the specifications, you ensure that all requirements are met over a period of time. Here, the climatic cabinet used must also be able to ensure the conditions for the quality test in the laboratory over the same period of time.