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 during lyophilization fogging can occur, which leads to problems in the crucial final inspection of the filled vial as well as the acceptance by the end user.
SCHOTT TopLyo® vials feature a chemically uniform hydrophobic inner 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, SCHOTT TopLyo® vials offer reduced residual drug volumes and therefore a higher dosing accuracy after reconstitution. Over-filling of the vial can be avoided.
Please note that SCHOTT TopLyo® vials are not meant for long-term liquid storage.
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 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).
Datasheets SCHOTT TopLyo
