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As customer needs rapidly change to meet these new and unprecedented accelerated timelines, West’s steam-sterilized, ready-to-use Westar® and Westar® Select elastomer components play a critical role. They simplify component preparation and allow customers to focus on other aspects of the drug filling process.
Aseptic processing requires sterile components; West’s steam sterilization process assures both sterility and suitability by validating three key elements:
Prior to sterilization, components are washed with the Westar® pharmaceutical wash process, which is validated to reduce bacterial endotoxin by at least 99.9% (3-log reduction). West’s steam sterilization process is based on ISO 17665-1 and ISO 17665-2, Sterilization of Healthcare Products- Moist Heat, Parts 1 and 2. The West process is validated to a minimum sterility assurance level (SAL) of 10-6, which equates to, at most, a one-in-one-million chance of a non-sterile unit.
Packaging system validation is based on both FDA’s Guidance for Industry: Container Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products, and transportation simulation per ASTM D:4169 Standard Practice for Performance Testing of Shipping Containers and Systems verifying integrity through sterilization, transportation, and storage. Components are available in the non-ported STERILIZABLEBAG™ or ported packaging systems.
Components are tested to verify that compendial, physical, and functional specifications are not adversely affected by washing/sterilization processes. West’s modern, and most common, formulations are USP, EP, and JP compliant. Type V DMFs are on file with the FDA and Health Canada, and global submission packages are available to support filings in other regions of the world.
West’s steam-sterilized, Westar and Westar Select ready-to-use elastomer components are an excellent option for aseptic processing; they are validated per accepted guidances and meet world-wide compendial standards. They simplify the process by eliminating time-consuming, on-site, sterilization processes, allowing customers to use product upon acceptance into their facility. For more, contact an account manager or Technical Customer Service (TCS) representative.
Westar® and STERILIZABLEBAG™ are trademarks and registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
Ensuring the sterility of sterile medicinal products has always been one of the key concerns of drug manufacturers, due to the dire health implications it could have on the patients, as well as the potential for costly product recalls. The importance of control strategies to ensure sterile drug products has also been reiterated by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and The European Medicines Agency (EMA) in their respective guidelines: <br /><ul><li>FDA – Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice</li><li>EU GMP Annex 1 Manufacture of Sterile Medicinal Products</li></ul>
Pharmaceutical closures used in aseptic environments must be introduced in a sterile state. The most common methods to sterilize rubber closures (e.g., stoppers) are autoclaving (saturated steam) and gamma irradiation. Both methods can influence chemical (e.g., extractables profile) and physical/functional properties (e.g., break-loose and extrusion forces). Therefore, it is important to choose the right method.
Sterilization processes are fundamental and critical in the manufacturing of sterile pharmaceutical products. According to the US Code of Federal Regulations, “Drug product containers and closures shall be clean and, where indicated by the nature of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use."<sup>1</sup> When considering elastomeric components, common methods for sterilizing include steam and gamma. This is where the sterilized components with Westar™ Ready to use (RU) and Westar™ Select RU quality levels come in. Westar™ RU and Westar™ Select RU quality level products are supplied ready to be used and help simplify and speed up the drug manufacturing process while maintaining high standards of quality and safety.
With the May 21, 2019 meeting to review the FDA draft guidance governing 503B compounding pharmacies, it has become evident that sterility of drugs produced at such facilities is a major focus of the U.S. Food and Drug Administration (FDA).<sup>1</sup> The meeting discussed the importance of qualifying container closure systems and was aimed at providing more context on what compounding pharmacies need to do.
<p><em>A scientific poster by: Clara Goodfield, Eugene Polini, Amy Miller and Wayne Curry</em></p><p><em>The ideal sterilization process destroys all microorganisms rapidly with minimal adverse impact on the chemical and physical properties of the elastomeric closure. Developing and validating an acceptable sterilization process is critical to the drug product quality. This study served to help understand the potential deterioration of physical and chemical properties, the possible impact to functionality and the potential changes to the extractable/leachable profile as a result of sterilization</em></p>
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