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Stability test in accordance with ICH

Stability tests in climate chambers run for many months, sometimes even for years. An excellent and uniformly constant temperature and humidity homogeneity prevails in the new Memmert climate chamber ICH, so that results can be reliably compared.

Stability test in accordance with ICH

Stability tests in climate chambers run for many months, sometimes even for years. An excellent and uniformly constant temperature and humidity homogeneity prevails in the new Memmert climate chamber ICH, so that results can be reliably compared.

For stability tests in accordance with ICH Q1A, the climate chamber ICH 260 covers a temperature range from.-10 °C to +60 °C and a relative humidity range from 10 to 80%. In addition, the ICH 260L model can be used to perform photostability tests in compliance with standard ICH Q1B, option 2.

Humidity homogeneity in the chamber of the Memmert ICH 260, calculated from a humidity measurement and the temperatures measured at 27 points (example: temperature 25 °C, 60% rh)

Excellent temperature and humidity homogeneity

In order to meet the strict requirements of guidelines such as ICH, WHO, EMA, ASEAN, GMP, GLP or GCCP constant climate chambers, in particular those, in which pharmaceutical products are tested, must be subject to regular validations. Of vital importance is the adherence to the required temperature and humidity homogeneity in the chamber. For this reason, the climate chamber ICH is equipped with an air jacket temperature control system enclosing the chamber on all four sides that guarantees uniform thermal transfer of heat and cold into the interior. The enclosed system ensures that the humidity remains in the chamber and that the water consumption can be kept to a minimum. It is impossible for condensation to form on technical components such as the condenser or the cooling unit, and thus the samples do not dry out, since they are separated from the chamber by the air jacket.