Read the cake before you touch the vial. An intact, opaque, evenly distributed puck that sits proud of the vial base is what a good lyophilisation cycle produces. Anything else — collapse, melt-back at the stopper, a glassy film, a cake that has slumped to one side — is evidence about the cycle, the shipping, or both.
Room temperature before drawing is worth the ten minutes. Cold solution is more viscous, draws slower, and is more likely to pull a bubble past the plunger seal.
The relevant detail is that number of stopper piercings matters less than the gauge doing the piercing.
Coring of elastomeric closures is a well-characterised failure mode in the parenteral packaging literature.
The practical summary: fine gauge, gentle swirl, diluent down the wall, room temperature before drawing, and check the syringe scale.
3Does this change at lower concentrations, or does adsorption start to dominate? – tandem_gradient 2 months ago add a comment