Siliconization

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Content protection and maximized extraction

Surface treatment of pharmaceutical glass packaging is an established method of protection for most parenteral content and certain APIs and excipients that may interact with the glass surface. While the hydrolytic resistance of Type I Borosilicate glass makes it a suitable containment solution for most applications, some liquids when in contact with an untreated glass surface pose a risk of glass delamination, excessive surface adhesion, and fogging.

DWK’s siliconization formulation has been carefully engineered to bond a REACh compliant Dimethicone to the glass surface. Resulting in siliconized vials designed to protect sensitive biologics, maximize extraction of viscous and protein-based content, and the ability to reduce content adherence to the glass surface. The resulting hydrophobic surface can also improve the formation of lyophilization cakes and elastomer closure fit.

Siliconized glass is validated, whiteroom packed in coroplast trays and shrink wrapped for shipment with lot traceability documentation. In addition to siliconization, DWK offers silanization and other surface treatments. Rely on DWK to help you select a surface treatment most appropriate for your drug content, storage conditions, shelf life, and sterilization process.

Advantages

  • Barrier Protection Siliconized glass vials lubricate and protect against alkalization and the potential for content compromising glass interactions.
  • Glass Surface Deactivation Siliconized vials minimize potential for delamination and content adhesion to the glass surface to improve visibility.
  • Product Recovery Siliconization maximizes extraction rates through increased hydrophobicity and restitution rates.
  • The Right Solution DWK offers technical consulting services to optimize surface treatment solutions and can provide samples to aid internal compatibility and surface contact testing.
  • Other Surface Treatments Silanization lubricates the vial and protects against alkalization. Ammonium Sulfate protects against aqueous products that can react with alkali metal ions that are found in glass.

Customization Capabilities

RTS components meeting USP<788>/EP2.9.19

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RTU components meeting USP<85>/EP2.6.1

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RTU components meeting USP<71>/EP2.6.14

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RTU components meeting USP<71>/EP2.6.14

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  • Clear and amber Type I USP <660> tubular glass vials designed for the short and long term storage of parenteral, lyophilized, and vaccine content. Available in ISO 8362-1 and RTU sterile glass vial formats.
  • Clear and amber Type I threaded glass vials with freeze dried bases suitable for lyophilization applications and the packaging of diagnostic assays and reagents. Available in RTU sterile glass vial formats.
  • Clear and amber Type I threaded and crimp finish glass vials designed for maximum retrieval of high value biologic, volatile solvent, corrosive chemical and sensitive content. Available in RTU sterile glass vial formats.
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Roll-neck Vials

  • Type I Borosilicate Clear & Amber and Soda Type III glass vials suitable for use with Snap Caps, Tamper Proof Closures, and Nasal Spray Pump Systems. Available in RTU sterile glass vial formats.