Coated glass vial for lyophilized injectable drugs
Lyophilization is an essential process in the biopharmaceutical industry, accelerating a drug’s time-to-market cycle and increasing shelf-life stability. But vial lyophilization can cause fogging of the glass container, which can lead to problems in the crucial inspection stage of drug manufacture.
SCHOTT TopLyo® vials feature a chemically uniform hydrophobic coating, which results in a decrease in fogging during the lyophilization process, as well as less disruption of the lyo cake. This improves the efficiency of automated inspection, leading to greater patient safety. In addition, TopLyo® vials offers reduced residual drug volumes and higher dosing accuracy after reconstitution. Please note that TopLyo® vials are not meant for long-term liquid storage. Besides that short interaction with the liquid drug/formulation during the lyophilization process and reconstitution does not affect the functionality of TopLyo®.
- Lower residual volume leads to cost reduction due to decreased overfilling.
- Elimination of lyo cake disruption and sidewall fogging for improved automated inspection.
- Lyo vial cake remains stable during transportation.
- Reduced risks of protein aggregation compared to siliconized vials.
- Product manufactured according to relevant international norms and standards
- Product registered at Regulatory Authorities as e.g. US FDA and China NMPA (and available for Pharmaceutical Registration Applications)