Woman doing visual quality checks on pharmaceutical vials

SCHOTT TopLyo®

Pharmaceutical glass vials to avoid fogging for lyophilized drugs
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Prevent fogging and improve residual emptying

Due to the low stability of biologics, more than 50% are lyophilized. However, lyophilization can cause fogging, which results in an increase in rejects, while vials are often overfilled to compensate for losses due to poor residual emptying after reconstitution. A solution to both issues is the unique SCHOTT TopLyo® vial, which combines hydrophobic behavior and the avoidance of free silicone to prevent fogging and improve residual emptying.

Diagram of a SCHOTT TopLyo® vial with close up of the interior and exterior surface
Applications

Improved lyophilization for injectable drugs

Most vaccines are mass produced and may also require transportation to some of the world’s most remote areas, stable storage is vital, along with a seamless fill-and-finish process. SCHOTT TopLyo® vials feature a chemically uniform hydrophobic inner coating, which results in a decrease in fogging during freeze-drying – an increasing problem for antibody drug conjugates (ADCs). This hydrophobicity also provides less disruption of the lyo cake, leading to a reduction of rejects, as well as reduced residual drug volumes and higher dosing accuracy after reconstitution.
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Advantages

A unique combination of hydrophobic behavior and no free silicone

SCHOTT TopLyo® vials feature a chemically uniform hydrophobic coating that leads to less fogging during the lyophilization process, as well as lower disruption of the lyo cake. This results in less cosmetic rejects and reduced production costs.

The application of the coating via PICVD (plasma impulse chemical vapor deposition) forms a covalent bond, avoiding free silicone. SCHOTT TopLyo® is therefore unique in combining hydrophobic behavior and the avoidance of free silicone to avoid fogging and improve residual emptying.

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No fogging Trust SCHOTT’s hydrophobic inner surface

Elegant lyo cake reduce rejects due to improved aesthetics

Improved emptying results in less residual volume with no overfilling required

No free silicone due to PICVD coating

Specifications

Increased lyo process efficiency and patient safety

  • Made using high quality Type I FIOLAX® Borosilicate Glass.

  • Formats range from 2-50 R.

  • Packaging options include bulk tray, as well as pre-washed and pre-sterilized adaptiQ® (tray, cup nest, clip nest)*.

  • TopLine quality level with an additional, dedicated, statistical in-production release test. 

    *50 R not available in clip nest configuration.

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Sterile format

Ready-to-use TopLyo® vials

Small batches of personalized medications and high-value pharmaceuticals often present challenges for fill-and-finish operations. Not only do they require higher quality containers, but they also require more flexibility, with frequent switching between different medications to avoid costly waste.

SCHOTT TopLyo® vials are available in a pre-washed and pre-sterilized ready-to-use (RTU) configuration, and can be processed on a variety of new and existing fill-and-finish lines, keeping vials nested throughout the process (including freeze-drying).

 

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Four elements of the SCHOTT adaptiQ® system for glass vials

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Diana Löber

Diana Löber

Global Product Manager Vials

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