Vial Rubber Stopper

Rubber stoppers are made from bromobutyl, chlorobutyl and silicone materials
A stoppered vial consisting essentially of a vial and a rubber stopper, the rubber stopper comprising a body member of vulcanized rubber having a leg portion inserted into a mouth of the vial and a top portion with an under surface contacting the upper end of the vial, and at least a part of a surface of the body member being laminated with a sheet of polyethylene having a viscosity-average molecular weight of 1, 300, 000 to 8, 000, 000 as measured by viscometry of ASTM-D 2857 wherein unvulcanized rubber is laminated directly with the sheet of polyethylene without surface treatment of the sheet such that the molecular chains of the polyethylene are partially branched by heat and partially cross-linked with the rubber of the body member at the same time that the unvulcanized rubber is vulcanized.

The latest formula Flurotec® Rubber is made from Flurotec® Which is an ETFE fluorocarbon film applied to stoppers to reduce sorption of the drug product, a significant benefit for maintaining the full strength and shelf-life of high potency/low concentration biotech drug products.

Benefits of using a Flurotec® Stopper
Using a stopper with Flurotec® Barrier film can reduce the risk of loss caused when active ingredients, preservatives, stabilisers and buffer systems extract materials from the elastomer, resulting in aggregation and drug degradation that can cause protein unfolding.

Ready to Sterilize (RTS) Final rinse in WFI and packed in a class 100 clean room into a STERIlizableBAG™ .
Cross-linked silicone coating applied to the top surface of the rubber stopper to aid machinability.
The Rubber Stoppers including Injection Stoppers and Freeze Dry (Lyophilisation) Stoppers are to suit 13mm, 20mm and 32mm necked vials and bottles.