Coated glass vials 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 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® offers reduced residual drug volumes and higher dosing accuracy after reconstitution.
Properties
- Lower residual volume leads to cost reduction due to decreased overfilling.
- Elimination of lyo cake disruption and sidewall fogging for improved automated inspection.
- Lyo 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)
