We’ve witnessed thousands of freeze-dryer installations and have seen plenty of mistakes made along the way. Here are some lessons learned to help you avoid common pitfalls.
Freeze-Dryers require a temperature-controlled environment with approx. 2 ft of clearance.
Freeze-drying cycles are almost always >8 hours. If a cycle is unsuccessful, data collection is critical to speedy problem solving.
To have consistent results and/or to develop cycles that can be transferred, the pressure must be controlled.
Unlike Pirani gauges which read high when water vapor is present, capacitance manometers read the true pressure in the system.
The most common method, using product thermocouples, cannot be used with very small volumes or with products like bone.
If your product will be in vials, ask about stoppering pressure, type of stoppering mechanism.
Provide solvent names, volumes and % of total solvent.
If you know your cycle parameters, share them with the manufacturer. Unloaded performance data will be different.
Explore this topic thoroughly before ordering. Involve your IT. Put a disaster recovery plan in place at time of start-up. The freeze-dryer cannot run without a working computer.
No doubt you know your product/formulation well. A thorough understanding of lyophilization science and of the freeze-dryer software and mechanicals are also needed for successful outcomes.