Pre-freezing temperature control: The temperature of the freeze-drying box should be lowered to about -50℃ in advance, and the pre-freezing temperature should be 10℃~20℃ below the eutectic point of the drug in general.
The pre-freezing temperature should generally be 10℃~20℃ below the common melting point of the drug. Incomplete pre-freezing may lead to the phenomenon of boiling and spraying during the decompression process, making the surface of the product uneven.
Incomplete pre-freezing may lead to the phenomenon of boiling and spraying during decompression, making the surface of the products uneven.
Sublimation temperature control: the temperature control of the sublimation stage is crucial, the temperature of the freezing part should be lower than the temperature of the eutectic point of the product; the temperature of the drying part of the product should be lower than its disintegration temperature or the maximum temperature allowed (without burning or sex change).The temperature of the sublimation phase should not be raised too quickly, so that the product does not receive more energy from the shelf than it needs to sublimate, resulting in melting at the bottom and consequent lyophilisation failure.The temperature uniformity: each shelf should have a uniform temperature.
Temperature uniformity: Each shelf should have 5 measurement points, one in each corner and one in the centre, to ensure the uniformity of the shelf temperature.Measurements should be taken on all shelves. Measurements should be carried out on all shelves in order to measure the actual conditions and to fully assess the safety margins of the complete load.
Success Case
Temperature control is the core link in the freeze-drying process, which needs to be precisely controlled according to the product characteristics and process requirements to ensure product quality and freeze-drying efficiency.
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