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In aseptic pharmaceutical manufacturing, the packaging for parenteral packaging components is essential for ensuring proper sterilization and utilization. The importance cannot be overstated. Ineffective component packaging can potentially affect patient safety, and result in significant financial loss. Acknowledging this, West conducts exhaustive testing on its packaging systems to ensure that quality and functionality requirements are achieved.
The following five points provide a glimpse into the West strategy as it pertains to assessing steam sterilizable packaging, such as the STERILIZABLEBAG™ packaging system commonly used for Westar® and NovaPure® components.
Well-designed, validated, and controlled packaging and processes for parenteral packaging components is one of many factors that is critical to achieving success during aseptic manufacturing of pharmaceutical drug products. Assessing end-use functionality, sterilization capability, packaging integrity, chemical compatibility, and packaging specifications is critical to ensure the suitability of component packaging. West’s strategy and extensive testing assure that the quality and functional requirements of its packaging systems are achieved, and thus meet the demanding needs of the pharmaceutical industry.
For additional details regarding West’s assessment and testing strategy of component packaging, please contact West Technical Services.
In Part I of this two-part series, several of the challenges with USP<789> <em>Particulate Matter in Ophthalmic Solutions</em> were discussed. Namely, the limits were established before routine intravitreal injections existed and the same acceptance criteria are applied to two different particle detection methods with different capabilities. Other challenges include the mismatch between required analysis volume and the very small fill volumes of ophthalmic injections and the lack of translatable limits for the syringe system alone. Regardless of the potential gaps in the pharmacopeial chapter, it is nevertheless clear that for ophthalmic injections, the industry expectations are to strive for the lowest possible visible and subvisible particle levels that are achievable.
West is excited to announce the 2019 recipients of the Herman O. West Scholarship. This year, the Herman O. West Foundation awarded scholarships to eleven children of West team members.
As scientists continue to gain a better understanding of the Corona virus, we are witness to a growing number of novel and repurposed therapeutics in development along with clinical trials designed to attack multiple aspects of the unique clinical pathologies. On the vaccine side, manufacturers are trying a multi-pronged approach to stimulate the immune system by using both traditional approaches (i.e., protein subunits, inactivated viruses, and virus-like particles) and novel platforms that are based on delivery of mRNA, DNA, or non-replicating viral vectors that can trigger the body to make the viral proteins themselves. The typical timelines, not counting the time it takes to demonstrate safety and efficacy of these vaccines, can range from months to years and even up to a decade to successfully design, manufacture and consistently produce high quality vaccines.
<p>It is essential for companies in the pharmaceutical industry to be prepared to comply with compendial changes as soon as they are enacted. USP Chapter <381> (<em>Elastomeric Closure for Injections</em>), which covers West elastomeric components, is scheduled to be reissued on January 1, 2018 as <em>Components Used in Injectable Pharmaceutical Packaging/Delivery Systems</em></p>
<p><strong>Part I</strong></p><p><em>This is a first in a two part series dedicated to the origins and attributes of the Daikyo Crystal Zenith® Polymer </em></p><p>In the early 1990s, Masamichi Sudo, founder and past president of Daikyo Seiko, Ltd., first developed the Daikyo Crystal Zenith polymer. This custom formulated cyclic olefenic polymer, available today in the Daikyo Crystal Zenith (CZ) portfolio of products offered by West, represents his lifelong ambition to improve all aspects of parenteral packaging and commitment to delivering the most precise formulation to the marketplace.</p>
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