FluroTec® Stoppers

FluroTec® is an ETFE fluoropolymer 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.

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), Westar® RS (WRS) and Westar® Select RS (WRS): Final rinse in WFI and packed in a class 100 clean room into a STERIlizableBAG™.

Serum Stoppers: FluroTec® to plug-part and B2-40: Cross-linked silicone coating applied to the top surface of the rubber stopper to aid machinability.

Lyo Stoppers: FluroTec® to product-contact area provides hydrophobic and inert properties. FluroTec® to the top of the stopper aids machinability and prevents sticking to the freeze dryer shelf.