During freeze drying process the lyophilized vials started to break (possibly more at bottom) and few of vials shown meltback observation. The water content across the trial (various location) found less than 2%.
10mL vials used for lyophilization process.
What will be the cause of this problem? Need experts suggestion!
Dear Nick,
Yes,you are right but this formulation contains only water. None of the excipients associated (No mannitol) to the formulation.
Dear Senthamil Selvan Thangaraj
I would recommend you a following procedure:
When you put the vial with your sample into the liquid nitrogen tank, you can put it at 45 degrees (or even more flat) and slowly roll it until your sample freezes. In this way, you will obtain a frozen sample spread on the walls of the vial but the center of the vial will be empty. This allows for any expansion/contraction during freezing/lyophilization and does not cause excessive strain on vial walls. The only disadvantage of this approach is that you have to lower the volume of your sample.
Good luck
Rani P Ramachandran
mam,Thanks for the suggestion, lets will work on this .
Dear Tomasz Fraczyk ,
I am trying this experiment in lab scale lyophilizer which has the silicone oil (heating/cooling). No option for LN2 provision.
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