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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.
<p>In 2015, West Pharmaceutical Services, Inc. (West) announced that two materials of construction of the West STERI<span>LIZABLE</span>BAG™ packaging system will change:</p><ul><li>DuPont announced improvements to the manufacturing of Tyvek® 1073B Medical Packaging Material (using latest flash-spinning technology).</li><li>West’s polyethylene supplier announced discontinuation of current product.</li></ul>
<br />In 2016, the China Federal Drug Administration (CFDA) made two announcements regarding packaging of parenteral drug products. Per these announcements, stability studies of packaging materials should refer to protection, compatibility, safety and functionality properties.
As customer needs rapidly change to meet these new and unprecedented accelerated timelines, West’s steam-sterilized, ready-to-use Westar<sup>®</sup> and Westar<sup>®</sup> Select elastomer components play a critical role. They simplify component preparation and allow customers to focus on other aspects of the drug filling process.
In a product’s development lifecycle, the importance of packaging can sometimes be overlooked until a packaging specialist becomes involved and can elucidate whether the packaging design is suitable and meets the tests for form, fit and function. Some companies that may not understand or emphasize the critical elements of a good package in the design phase may find out too late that the package is unsuitable after sustaining one or more failures during validation testing.
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.
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