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?
2026-02-04 17:30 守护     
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There is no "hard" number (like 24 hours) in the regulations, the industry standard for a "shortened" hold time usually falls between 8 to 24 hours.

To justify your specific duration, you must prove you have simulated the following "Worst-Case" elements:

  • Vacuum Hold Time: A minimum of several hours (often 8+ hours) to allow for potential "breathing" or microscopic leaks in the chamber door gaskets or pipework to manifest.

  • Aseptic Interventions: Any planned or unplanned interventions (e.g., clearing a fallen vial, sensor adjustments) must be performed during this window.

  • Staff Shifts: If your commercial process spans multiple shifts, the APS should ideally incorporate shift changes to simulate the personnel flow and fatigue factors.

If you do not simulate the full commercial cycle, the duration should be based on a Risk Assessment that identifies the most critical points of potential contamination.

2026-02-05 10:17 EllenZ     
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