Datwyler OmniFlex® Serum Stoppers

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OmniFlex® serum stoppers for sensitive drugs in vial applications

Datwyler's OmniFlex® Serum Stoppers are coated with proprietary spray coating technology and ensure advanced packaging stability, compatibility, and container closure integrity for drug products in vial applications.
The total fluoropolymer coating combined with ultra- low extractables bromobutyl formulation FM457, provides excellent barrier properties and eliminates the closure as a source of silicone oil-based subvisible particles addressing the compatibility and performance challenges for sensitive drugs.

OmniFlex® stoppers are produced according to ISO 15378 and using Datwyler’s most advanced manufacturing standard, FirstLine®, which is specially designed to manufacture pharmaceutical rubber components in a fully integrated cleanroom environment conforming to the highest industry standards.

OmniFlex® stoppers in combination with PrimeCaps™ seals and SCHOTT vials, provide a proven system solution to maintain the stability of the drug and preserve container closure integrity.

Properties

Fully coated with a proprietary fluoropolymer spray coating
Best-in-class extractables & leachables (E&L) profile
Surface silicone free
Highest quality standards
100% camera inspected
Pre-sterilized stoppers (Ready-to-use)

Chemical Resistance

OmniFlex® serum stoppers are bromobutyl based medical rubber stoppers covered with a fluorinated polymer coating. The coating is applied via a proprietary spray- coating process. Since products are fully coated on all surfaces, including the trim edge, there is no additional siliconization step during the final washing treatment.

OmniFlex® serum stoppers meet the chemical requirements for Type I closures specified in Ph.Eur. 3.2.9, USP <381> and ISO 8871-1 & chemical requirements specified in Ph.Jap. 7.03.

Possible Applications

• All sensitive drugs with compatibility challenges
• Drug products with silicone oil sensitivity
• Proteins prone to oxidation in the presence of metal ions

Advantages

Barrier effect of the coating contributing to best-in-class Extractables & Leachables profile
Reduced particle contamination due to total coverage of the stopper and absence of surface silicone
Optimized design and reduced rubber stopper clumping to ensure operational efficiency.

Package Information

13mm: 1.000 stoppers per delivery box
20mm: 500 stoppers per delivery box

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Datwyler OmniFlex® Serum Stoppers

OmniFlex® serum stoppers for sensitive drugs in vial applications

Properties

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