LyoTips
Top Ten Recommendations before Buying an R&D Freeze-Dryer
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.
Consider the space and involve your Facilities Supervisor early
Freeze-Dryers require a temperature-controlled environment with approx. 2 ft of clearance.
Data collection capability will pay for itself
Freeze-drying cycles are almost always >8 hours. If a cycle is unsuccessful, data collection is critical to speedy problem solving.
Vacuum control is essential
To have consistent results and/or to develop cycles that can be transferred, the pressure must be controlled.
A Capacitance Manometer should be the controlling vacuum gauge
Unlike Pirani gauges which read high when water vapor is present, capacitance manometers read the true pressure in the system.
Buy at least one method of primary determination endpoint determination that will work for your application
The most common method, using product thermocouples, cannot be used with very small volumes or with products like bone.
Stoppering capability (shelves that can be raised, lowered, adjusted) will greatly facilitate cleanability and the flexibility for changing applications
If your product will be in vials, ask about stoppering pressure, type of stoppering mechanism.
If non-aqueous solvents will be processed, inform the supplier
Provide solvent names, volumes and % of total solvent.
Request loaded performance data
If you know your cycle parameters, share them with the manufacturer. Unloaded performance data will be different.
Discuss computer back-up and networking requirements
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.
Ensure there is a training plan for new users
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.