Page Content
Unsurpassed protection for your drug can be achieved with a West FluroTec stopper, available in both serum and lyophilization designs.
FluroTec coated stoppers provide an effective barrier against most organic/inorganic extractable/leachables to minimize interaction between the drug and the stopper. Selecting a stopper with FluroTec barrier film can reduce the risk of loss caused when active ingredients, preservatives, stabilizers and buffer systems extract materials from the elastomer, resulting in aggregation and drug degradation that can cause protein unfolding.
FluroTec is a fluorocarbon film applied to stoppers to reduce sorption of the drug product, a significant benefit for maintaining the full strength and shelf life of drug products. The low surface energy of the fluorocarbon film provides lubricity for proper vial seating without the need for silicone oil.
When considering a stopper coated with a barrier film, it is critical to understand where the protective film is applied. Due to the nature of the film material, it is critical to determine that the film is not present on the underside of the stopper flange at the vial sealing surface. The presence of a barrier coating or film in this area has been proven to be detrimental and has a direct negative impact on the vital container closure integrity of your package. West’s FluroTec stoppers are designed to help protect your drug product against harmful extractables while at the same time, ensuring optimal container closure integrity.
Where there is no film, West utilizes a lubricity coating, B2, which allows for appropriate insertion force and retention of the stopper.
B2 lubricity coating: A cleaner more efficient coating
Elastomeric components used for pharmaceutical primary packaging are naturally sticky. Applying lubricity coatings reduces the coefficient of friction improving break loose extrusion and insertion force, as well as overall machinability.
A clean silicone treatment
B2-Coating is a cross-linkable high molecular weight polydimethylsiloxane applied to the surface of rubber stoppers and syringe components and eliminates the need for conventional siliconization.
  |
The dark color indicates where FluroTec film is applied. The film areas have been darkened for illustration purposes only.
 |
During any phase of drug development, utilization of a FluroTec stopper can reduce the risks associated with failures in screening, compatibility and stability due to the FluroTec reducing the amount of extractables/leachables coming into contact with your drug product.
|
The single-vent stopper with FluroTec barrier film is recommended for lyophilized
drug products.
|
|
As an added benefit for lyophilized drugs, the FluroTec stopper has performance characteristics that prevent it from sticking to lyophilization chamber shelves during processing. Although you may not be concerned with processing today, you or your contract manufacturer will enjoy an efficient lyophilization process in the future, by using West FluroTec stoppers
Click here to contact our West Representatives by phone or by email to discuss the most appropriate vial stopper for your drug product.
|