Dear colleagues, we are currently working on increasing of the throughput of freeze-drying step. One of the identified approaches is the co-loading. The basic idea is to do it with the same product of different strengths (same lyo cycle). Could anyone in the community share her/his experience with co-loading? Any thoughts of critical (common) issues related?
Depending on the concentration and the nature of what yoi will load, the increasing cake resistance as product dries may become a problem. This can cause microcollapse or partial collapse of the product as the resistnce increase, then the pressure in the vial can rise, causing melting of the product. The solution to that would be to program a slow and conservative cycle, but that will not help you speed up the process.
Suggested tools to help you investigate this are available at https://www.sp-lineofsight.com/ and include things like controlled nucleation to induce large ice crystals - this helps faster dryign, and LyoFlux TDLAS which then can monitor the drying performance in real time so that you do not process for longer than required. LyoFlux can also help you very efficiently map the design space for a formulation without needing to perform lots of gravometric Kv determinations.
Kind regards
Rob
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