SCHOTT TopLyo®

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From  €551.95 /Tray
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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)
Chemical Resistance
  • SCHOTT TopLyo® vials have a Si-O-C-H hydrophobic density coating of ~40 nm.
  • The stability of this layer during storage has been proven by accelerated aging at 40 0C and room temperature after three years. 
  • For production control, the standard Hydrolytic Resistance test is a release criteria, involving 0.5h autoclaving at 121 °C with H2O.
Dimensions & Cosmetics
  • Tight geometric tolerances thanks to 100% camera inspection of dimensional and cosmetic parameters along the process line.
  • Strict AQLs, with cosmetic defects a key part of the product specification. Any containers with critical defects are not allowed in the lot. 
Possible Applications
  • Improved lyo cake

Reduced climbing at vial edges results in less disruption and production losses of the lyo cake.

  • Optimized yield

Residual volume after reconstitution minimized by reduced adsorption at the inner glass surface. 

  • No dimensional changes required

Very thin coating layer of ~40 nm means no dimensional changes needed. 

  • Fogging

Reduction of vial fogging caused by Marangoni flow 

Advantages
  • Chemically uniform hydrophobic coating decreases fogging during lyophilization. 
  • Reduced residual drug volumes and higher dosing accuracy after reconstitution. 
  • SCHOTT TopLyo® vials are manufactured according to all relevant international guidelines and standards. 
  • SCHOTT TopLyo® vials are registered with the US FDA and China NMPA regulatory authorities, as well as being available for pharmaceutical registration applications. 

SCHOTT Pharma Online Shop.

Our Online Shop provides an easy and fast access to small volume and high quality pharmaceutical packaging solutions. With standardized and pre-tested products we ensure fast delivery times. Our customer care helps you in case you need a product recommendation to safely package your drug.

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Want to know more? Let's talk.

Whether you need more information, samples, a quote, or advice for a project, we would be delighted to talk to you.

Want to know more? Let's talk.

Whether you need more information, samples, a quote, or advice for a project, we would be delighted to talk to you.