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.
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)