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The manufacture of polymer containers for parenteral drug products differs from that of glass and elastomers and must combine the common manufacturing methods below to meet the needs of the pharmaceutical market.
Common methods for forming thermoplastic polymer components are:
Conical vials, syringes and cartridges comprising Daikyo Crystal Zenith® cyclic olefin polymer can be produced with a standard injection molding process. But, to allow for release from an injection mold, a component cannot possess features such as an overhang or undercut, thus preventing critical features such as vial shoulder. Therefore, for standard Daikyo Crystal Zenith vials, a hybrid process is needed – one comprising both injection and blow aspects. For the hybrid process, melted polymer is injected into the mold around a core pin, creating a preform with the appropriate neck and flange dimensions. The remaining melted polymer around the core pin is then blown with air to form the complete vial. This hybrid method enables a traditional shape having the very tight tolerances of injection molding, in particular at the flange –minimizing variation at the crucial vial stopper interface and helping to ensure good container closure integrity.
West’s commitment to the safe and efficient delivery of drug products involves not only designing the right components, but also manufacturing them to rigorous standards. To learn more about West products, please visit the Knowledge Center or contact a Technical Account Representative.
Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd. Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
The supply of sterile pharmaceutical closures into a filling line is an essential element of the production of parenteral drug products. In addition to sterilizable bags, West offers closures in aseptic transfer bags – referred to as “port bags” or “ported bags.” Port bags contain a “beta” port that is attached to the actual bag <strong>(Figure 1).</strong>
Some pharmaceutical substances, such as proteins, monoclonal antibodies, enzymes, and vaccines, are unstable in solution. They can degrade, for example by enzymatic or hydrolytic reactions. Lyophilization (also called freeze-drying) is the most common approach to address this.* Lyophilization is the process of dehydrating a material at low temperature and reduced pressure. Absent water, the rates of degradative enzymatic/hydrolytic processes are reduced substantially, and thus drug product stability is improved.
We are delighted to share that West has been honored at the Korea Bioprocessing Excellence Awards (KBEA) for the second year in a row. This year, we were recognized as the grand winner of the Best Bioprocessing Supplier Award: Fill-Finish.
Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission. Defined as extractables and leachables, these assessments continue to evolve and expand due to consistently increasing regulatory agency expectations. Agency expectations require you to act sooner rather than later. Waiting until Phase III in drug development can lead to delays and additional costs due to poor assessments that are questioned by the reviewer, or incomplete submissions that require you to redo or execute additional work. You can start your Extractables and Leachables (E&L) assessment as soon as you have selected your packaging components.
Join West’s Diane Paskiet at the 2013 PDA/FDA Container Closure Components and Systems Workshop:<em>Protecting Parenteral Drugs and Biologics Using Suitable Container Closure Systems,</em> on May 14-15, 2013, at the Hyatt Regency Bethesda in Bethesda, Maryland.
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