Due to a need to accelerate time-to-market cycles and increase shelf life stability of biopharmaceuticals, a keen interest in robust and cost-efficient lyophilization has leapt into the limelight. A streamlined lyo cake is crucial for better-automated inspectability – and indeed fundamentally vital to the chief priority ensuring patient safety. For cristalline formulations, any lensing effect of the vial-bottom during freezing must be avoided.
Thanks to their hydrophobic coating and optimized geometry, SCHOTT TopLyo® vials demonstrate higher mechanical stability during – and less disruption of the lyo cake after – the lyophilization process, in addition to reduced residual volumes and higher dosing accuracy after reconstitution.
Chemically uniform (Si-O-C-H hydrophobic coating)
Layer thickness: ~40 nm
Non-porous, covalent bond between glass matrix and coating layer
Processability equal to non-coated type I glass vials
Cost reduction due to decreased overfilling – given lower residual volume
Reduced glass breakage through refined geometry
Prevention of lyo cake disruption and sidewall fogging for improved automated inspection
Lyo cake stability during transportation
Reduced protein aggregation compared to siliconized vials
2R, 6R and 10R ISO formats and lyo bottoms. Customization available on request.