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
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.
West has developed a solution to address these issues – elastomeric closures laminated with FluroTec® barrier film. Cathy Zhao, Ph.D., Director of Scientific Insights Lab, discussed this in her presentation A Science-Based Recommendation of Elastomer Components for Biologic Drugs at the 2019 PDA Europe – The Universe of Pre-Filled Syringes and Injection Devices conference.
Compared to non-laminated stoppers, laminated stoppers resulted in lower levels of particle formation (under either agitated or non-agitated conditions), and reduced levels of leachables. In addition to the reduction of particle formation and leachables, the FluroTec barrier film offers the lubricity needed for easier processing otherwise provided by silicone coatings.
West’s commitment to patient safety comprises the design, development, and production of high-performing components and delivery devices – of which FluroTec laminated elastomeric closures are an example. For more on West products and services, contact an Account Manager or Technical Customer Service (TCS) representative.
FluroTec® is a registered trademark of West Pharmaceutical Services, Inc. in the United States and other jurisdictions. FluroTec® technology is licensed from Daikyo Seiko, Ltd.
Lyophilization (freeze drying) is the process of dehydrating a material at low temperature and reduced pressure. It is used to extend the shelf life of many biologic drug products. Absent water, degradation processes are greatly reduced. In any primary package system (i.e., vial, elastomer stopper, seal) for a lyophilized drug product, of utmost concern are leachables and volatile organic compounds that may migrate from the elastomer stopper into the lyophilized drug product, creating a risk to patient safety.
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<sup>®</sup>–laminated products. Selection of ETFE was based upon ease of moldability and the following factors.
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.
Beginning in 1998, when an increase in the incidence of pure red cell aplasia (PRCA) was observed in patients with chronic renal failure and associated with the subcutaneous use of Eprex<sup>®</sup> (epoetin alpha), the U.S Food and Drug Administration (FDA) and European regulatory agencies have paid special attention to leachables in drug products especially resulting from uncoated primary elastomer components.
Developing a SARS-CoV-2 vaccine presents numerous and unprecedented challenges; prominent among them are greatly accelerated timelines. Ordinarily for a new drug product, there is sufficient time for selection/evaluation of the vial/stopper packaging system – one that guarantees quality and safety from manufacture through delivery. This is not the case for a SARS-CoV-2 vaccine where the primary packaging system must be chosen quickly, creating a higher risk.
English
Chinese
