EVERIC® pure
Increased drug stability and delamination control
Conventional vials often encounter increased leachable levels, as well as a greater risk of pH shift and delamination. This is caused by a change in the inner surface of the near-bottom region of the vial due to the standard converting process.
The answer to these challenges is EVERIC® pure. Manufactured using glass tubing with a tightened specification for hydrolytic resistance and patented manufacturing technology, these unique glass vials undergo a dedicated release test that monitors leachable levels throughout production. This ensures a homogenous inner surface of the drug container while keeping delamination under control.
The ideal container for drug development
Made of pure Type I borosilicate glass (excluding post-treatments), EVERIC® pure vials are ideal for the development of high-value drugs, such as biologics. An optimized inner surface ensures that formulations will be more stable, enabling a broader choice and reducing the risk of time-consuming reformulations.
Thanks to their low leachable levels and ability to reduce pH shift, EVERIC® pure vials offer high stability for terminally sterilized formulations – for example, diluents such as water for injection (WFI) or sodium chloride (NaCl). According to USP <1660>, terminal sterilization is one of the key risk factors for delamination, along with certain buffers. EVERIC® pure vials are the ideal container to keep applications in phosphate buffers or diluents stable.
The safe option from the start
EVERIC® pure is the gold standard for Type I borosilicate glass vials, offering:
- Delamination under full control
- Low leachables level, which is especially relevant for low-fill volumes
- Reduced pH shift and conductivity
- No re-registration thanks to unchanged glass composition.
Reduced leachable level
Controlled delamination ensures drug integrity is not compromised
Lower pH shift results in stabilization of the most sensitive drug formulations
Unchanged glass composition means no re-registration is required
EVERIC® pure vials – consistent high quality, from materials and manufacturing to process control
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FIOLAX® CHR glass tubing with a tightened leachable specification is used for all EVERIC® pure vials.
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We offer a wide format range (2-50R) to provide the ideal solution for all types of drug.
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EVERIC® pure vials are available in bulk tray packaging or adaptiQ® ready-to-use standardized packaging.
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EVERIC® pure vials have a TopLine quality level for accurate dimensions and minimal cosmetic defects, as well as a dedicated statistical in-production release test (“Quicktest”), designed to control leachable levels in the heel zone.
Ready-to-use EVERIC® pure
Using the highly standardized secondary packaging adaptiQ®, EVERIC® pure vials are available in a pre-washed and pre-sterilized ready-to-use (RTU) configuration.
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.
adaptiQ® 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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