Verify shelf temperature uniformity is the lyophilizer equipment is a very important part of the validation.
The lyophilizer shelf temperature are not even directly affect the product homogeneity in the lyophilization process, if the temperature is not uniform, in the process of freeze is likely to make drug freezing rate, or part of the drug not frozen solid: in a dry stage drying rate, also can cause drug may even make some drug temperature above the eutectic temperature and make freeze-dried failure.
Thus the same shelf temperature uniformity and at various points between the different shelf between each point temperature uniformity is particularly important.
check under the set temperature, electric heating system and refrigeration system can ensure plate layer temperature within the allowed fluctuation change, vacuum freeze drying machine no-load running board layer temperature distribution uniformity conforms to the design requirements, temperature control ability to comply with the design and GMP requirements.
methods: resistance temperature detector temperature measuring hole are verified through the lyophilizer in freeze-dried the casing;
Will be numbered 36 root thermocouple probe were distributed evenly over the lyophilizer 10 plate layer, temperature measuring thermocouple probe for contact with the plate layer fully;
Start the lyophilizer, tested temperature distribution under no-load condition, the temperature test points, respectively
40 ℃ and 0 ℃ and 40 ℃, the temperature is constant when 30 min record test data.
After the results of temperature, temperature keeping process, at the same time the lyophilizer each plate layer on all test point of maximum and minimum temperature difference is less than 2 ℃.
