How to simulate the duration time of lyophilization in APS?
无菌验证与消毒效力
According to the guideline of PDA TR22, it says that it is not nessary to silulate the full time of the lyophilization process, Could you please advise that if not simulating the full time of lyophilization process, what specific duration of simulation would be reasonable? Or what is the minimum acceptable duration for simulation?
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