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In recent years, there has been a shift in the pharmaceutical industry toward a Quality by Design (QbD) philosophy. To maximize a drug product’s safety and efficacy, pharmaceutical companies and their drug packaging and delivery partners are building new quality principles into the entire manufacturing process, from design and development to commercialization and administration. This scientific, risk-based QbD approach is fast becoming an essential strategy for bringing high-quality therapeutics to market quickly and efficiently.
One area where pharmaceutical packaging and device delivery companies are successfully applying QbD principles is the manufacturing of high-quality components for prefillable syringes. The quality, safety and efficacy of a drug product can be linked to the suitability of its container closure system. Understanding how drug container closure systems and their various components impact a drug’s safety and efficacy is fundamental to the QbD approach.
Employing a QbD approach that considers drug packaging and delivery systems in the early stages of drug development can help mitigate risk to quality and position the drug manufacturer to meet regulatory requirements throughout the drug product’s lifecycle. While it is not easy to meet these challenges, pharmaceutical manufacturers can benefit from early investment in high-quality components for drug packaging and delivery systems.
When designing and developing a component using QbD principles, manufacturers must define desired product performance and identify Critical Quality Attributes (CQAs). The component and process are then designed to meet those product attributes, which leads to understanding the impact of material attributes and process parameters on the CQAs and identification and control of sources of variability. As a result of this knowledge, a company can continually monitor, update and improve its manufacturing process to assure consistent product quality.
West has developed NovaPure® components to help ensure the efficacy and purity of a drug product. The NovaPure product offering includes serum and lyophilization stoppers and syringe plungers. For more information, click here.
NovaPure® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions
<p>Demand is increasing for Daikyo’s sterile, ready to use closure components, known as Daikyo RUV® (Ready to Use Validated) components. Against that background, Daikyo has significantly expanded its packaging component sterilization operations to meet the needs of smaller customers as well as large scale pharmaceutical companies. By adopting an approach that replicates its existing footprint, Daikyo has been able to manage validation risks effectively, while meeting an ambitious timeline for bringing on new autoclave capacity. The result of this expansion is a state-of-the-art facility that triples the company’s previous sterilization capacity.</p>
West is committed to delivering safe and efficient drug packaging products to our customers. Part of that commitment involves keeping the industry abreast of the latest regulatory and technology developments/challenges in packaging and delivery. West recently hosted, at its Exton headquarters, an installment of the ongoing Educational Series, titled: <strong>Managing Risk in Injectable Drug Delivery: Regulatory and Technical Challenges and Solutions. <br /></strong><br />
West’s three locations in Germany recently concluded an impressive fundraising campaign as part of West without Borders, West’s employee-led giving program. <br />
I’ve worked at West for 28 years. I lead our Venture Group, Global Labs, and Data Science Team; I’ve spent most of my career in R&D. There’s an expectation from our customers that West will lead the way in developing new products. Ones that are going to be better for patients, easier to use and more cost efficient for the health system. That expectation drives a lot of the R&D work we do.
<p><em>Part 2 of the Good Supply Practices Series</em></p><p><em>West is pleased to welcome guest blogger Dr. Marla Phillips, Director,</em><em> Xavier University. This is the second installment in a four-part series on supply chain management.</em></p><p>In my previous blog, I mentioned the three overarching themes that need to be addressed to help ensure the integrity of the materials supplied throughout the pharmaceutical and medical device supply chains through the development of Good Supply Practices (GSPs).</p>
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