We apologize your item could not be found. Not all items are listed on our website. Please contact your account manager for details regarding your searched item.
Material number (eg: xxxxxxxxxxx) no space or hyphen needed.
No Results Found
Fluoropolymer-laminated elastomer stoppers and plungers provide enhanced performance for container and delivery systems for parenteral drug products – especially sensitive biologic drug products. Among the many fluoropolymers available, West uses ETFE [poly(ethylenetetrafluoroethylene)] for its FluroTec®–laminated products. Selection of ETFE was based upon ease of moldability and the following factors.
There are many benefits of FluroTec®–laminated components. They have high lubricity; by preventing sticking they make processing easier. Further, this lubricity reduces the need for silicone coatings; silicone coatings are known to promote particle formation is protein-based drug products. Because of their chemical inertness, interaction with drug product is minimized. There is reduced risk of particle formation or other unwanted change in drug product resulting from interaction with bare elastomer. Another benefit is restricting movement of leachables from elastomer components into drug products. Leachables likewise can cause particle formation or unwanted changes in drug product. This last point is the focus of a new Technical Report published by West: FluoroTec® Products Protecting Drug Product Quality and Safety, which is available in the West Knowledge Center. This Report shows experimental work demonstrating the value of Flurotec® laminates in restricting leachables.
West’s commitment to patient safety involves developing and supplying components that can meet the requirements of even the most sensitive drug products. For more on how West can help in selection, contact a Technical Customer Service (TCS) representative or Account Manager.
Historically, finding suitable containers for complex protein drug products has been difficult, since interaction with elastomeric closures can result in particle formation. These particles indicate an underlying change within the drug product, undermining integrity and risking patient safety. The correlation of silicone coatings with protein aggregation has made some wary of their use; however, an elastomeric closure with no coating or film can be difficult to process. Another concern is that leachables originating from the elastomeric closure can induce particle formation.
One of the challenges of sharing technical content is making the material engaging and easily digestible to many different types of learners. It must not only be scientifically accurate, but also needs to capture and keep the attention of the intended audience. The Knowledge Center on West’s website is a valuable repository of written and presented materials, created by the experts who develop and test our products. It is also now home to the Learning Center, a section of the Knowledge Center that shares information on a more introductory level, aimed at new employees or companies that are new to packaging. In an effort to continue enhancing our website content, we are now also starting to add new types of media. In the age of podcasts and vlogs (video blogs), we understand that video and audio are just as helpful (maybe more so!) for people trying to grasp a new concept.
<strong>NovaPure® Components Overview</strong><br /><em>By leveraging nearly 100 years of pharmaceutical packaging knowledge and implementing Quality by Design principles, West has developed the continuously improving NovaPure® elastomer portfolio which can be ideal for all drug product phases.</em>
Particles in drug products can come from many sources—extrinsic (from outside the process), intrinsic (from within the process) and even inherent (as part of the drug formulation)<sup>1</sup>.
Patient safety is defined by the Institute of Medicine as: the prevention of harm to patients.<sup>1</sup> The extension of this principle to general safety in healthcare is: the freedom from accidental injury, and it applies not only to patients, but to all professionals and workers in the healthcare field.<sup>2</sup>
English
Chinese
