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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.
A way to mitigate this concern is with elastomer stoppers with FluroTec® barrier film. The FluroTec film, which is based on the co-polymer poly(ethylene tetrafluoroethylene), is laminated onto the elastomer stopper. It serves as an effective barrier between the drug product and elastomer, reducing the risk of leachables and volatile organic compounds from contacting the drug product. This has been demonstrated experimentally and was discussed in detail in a recent white paper by West scientists, Elastomer Stoppers with FluroTec® Film: The Right Choice for SARS-CoV-2 Vaccines, which considers the importance of FluroTec barrier films for SARS-CoV-2 vaccines.
For more information 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.
Primary packaging components come in intimate contact with drug products – they can affect both drug product and patient safety. Many elastomer components are offered with a FluroTec<sup>®</sup> film that serves as a chemical barrier to minimize the migration of compounds from the elastomer into the drug product. FluroTec film comprises an ethylene-tetrafluoroethylene co-polymer (ETFE) – selected based upon flexibility, ability to be laminated to an elastomer, and of course, permeability resistance.
Combination products open up new vistas when it comes to delivering innovative therapies to patients in need, but teams bringing these products to the market face a number of significant hurdles. Recent surveys conducted by West at workshops held in PA and AZ have revealed some of our customers’ biggest challenges. This is the first of three blogs focused on these challenges — and how West can help Simplify the Journey™ when it comes to developing a combination product.
“There is no disease so rare that it does not deserve attention.” This statement from Orphanet, a portal for rare diseases and orphan drugs, makes that point very clearly. For patients suffering from a rare disease, orphan drugs and the special attention that they receive during the drug review and approval process can be both life changing and saving.
<span style="color: windowtext;">West</span> is pleased to announce the launch of its 10th annual West without Borders fundraising campaign!
<span>West is pleased to announce that it has joined the Pharmaceutical Supply Chain Initiative (PSCI). PSCI is a group of major pharmaceutical companies, all of which are West customers, that formed to “support pharmaceutical suppliers in efforts to operate in a manner consistent with industry expectations about ethics, labor, health and safety, environment and management systems.” PSCI members believe that through the application of principles for responsible supply chain management, better social, economic and environmental outcomes will result for all involved in the pharmaceutical supply chain. This includes improved conditions for workers, economic development and a cleaner environment for local communities.</span>
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