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Compendial documents developed by both international and national organizations outline specifications for elastomeric components that are used in packaging of parenteral drug products. These specifications often are not harmonized; not all compendia specify the use of the same tests, and some tests that are used globally have varying specifications. Understanding these specifications and how they influence packaging/delivery of parenteral drug products in global markets is critical.
Monitoring compendia is also critical, since they are updated as needed to meet the ever-changing needs of the industry and regulatory markets. West monitors compendial requirements thoroughly, knowing testing requirements for each characteristic and when changes are forthcoming. An example is the elastomeric requirements in USP <381> Elastomeric Closures for Injections: this document is currently being modernized and three new, related documents are being created to reflect the need for better understanding of component materials and suitability for use. As the pharmaceutical industry evolves, and specifications change, West will remain up-to-date. This level of understanding not only ensures West facilities manufacture and evaluate elastomeric components properly, but also enables West to assist customers world-wide to navigate the very complex regulatory landscape.
For more information about current and upcoming global specifications for elastomers, please visit the Industry Trends/ Regulatory section of West’s Knowledge Center here.
To discuss compliance and certifications for West products, please contact Technical Support using this form.
Modern biopharmaceutical drug molecules are often complex protein structures that need to maintain the molecular structure in order to convey full potency. With biologics, any alteration of the 3-D structure could lead to loss of activity or even to immunogenic reactions in the patient. Proteins can be disrupted by interactions with the container closure or with leachables. West FluroTec® lamination was chosen for NovaPure® plungers to reduce the interaction between the drug product and elastomer material. This includes less adsorption to the plunger surface as well as reduction of the leachables profile of the plunger, helping to maintain the stability of complex molecules.
West authors Diane Paskiet, Kim Miller, Laura Stubbs and Diego Zurbriggen contributed to several chapters in the new “Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products” available from Wiley Scientific.
Nuclear medicine has been extensively used not only to diagnose but also to treat diseases. Radio-labeled proteins and peptides are widely used for this purpose, and glass vials have been traditionally used to store radio-labeled pharmaceutical parenteral dosage forms. One important factor for successful use of the container closure systems (CCS) is how precisely and efficiently the radiopharmaceutical solution is withdrawn from the sealed container. However, due to the generally hydrophobic nature of these compounds, chemical reactions, including product synthesis and purification processes, are often complicated and costly. Overcoming the potential for adsorption of these compounds to the surface of the CCS is key to maximizing the effectiveness of radiopharmaceuticals.
<p>Tibor Hlobik, Director, Prefillable Solutions and Technologies<br />Mike Gills, Customer Technical Support Process Engineer</p><p>Growth in biopharmaceutical therapeutics is leading innovation with prefillable syringe systems. These complex sensitive drug products require highly inert primary packaging materials for improved stability and delivery in perfect quality for reduced safety risk. This <span style="text-decoration: underline; color: #0000ff;"><a href="https://www.westpharma.com/west-login">poster</a></span> will provide a quality comparison of primary prefillable syringe options including glass, coatings/laminates and cyclic olefin polymers, and highlight the findings of a case study comparing 1mL long syringe attributes.</p>
USP General Chapter<382> <em>Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems</em> is slated to become official on December 1, 2025. This allows five years from the date of publication in December of 2020 for stakeholders to implement the new testing requirements for full compliance. While that date seems to be far off in the future, there has been interest in early adoption of the new chapter and implementation of the various tests it requires.
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