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Pharmaceutical manufacturers are faced with numerous challenges to produce, package, and ship products successfully to the patient or care giver. Common concerns for all pharmaceutical manufactures include meeting targeted timelines, guarding against drug shortages, increasing speed to market, and generating revenue. Maximizing operating speeds and minimizing operating down time are critical factors for all stakeholders.
For manufacturers of sterile liquid, lyophilized, and powder drug products, the filling and finishing (fill/finish) process can be a critical step in ensuring targeted timelines are met. Operating down time associated with fill/finish line stoppages and clearances can impact operating speeds, drug product yields, deviation/investigation resources, and targeted timelines. One of the leading causes for filling line stoppages and clearances involves machinability of the parenteral packaging components (containers, elastomeric components, and caps).
Considerable care must be taken to pair the parenteral packaging components, drug product, processing and fill/finish equipment to optimize and maximize line speeds; as well as to reduce the line stoppages and clearances. Numerous factors can impact the overall performance on the filling line, such as the properties of the parenteral packaging components.
Be sure to check out the November edition of Pharmaceutical Manufacturing to read more of Simon’s “Impact of Sterilization Method on Packaging Component Machinability Performance: Steam vs. Gamma Evaluation of the 1mL Long Plunger.”
West is thrilled to announce that Thaisa Silvestre, Director, Sales, Brazil, was recently named as 2019 HBA Rising Star.
<span>Research has been expanding understanding of biological systems at an exciting pace. In parallel, the biotechnology industry has been rapidly evolving as different biological entities (e.g., cellular and gene-based products) are increasingly harnessed as resources and therapeutics. To maximize the global utilization of biotechnology advances and drive further advancement of the industry, standards are needed.</span>
<p>Amy Miller and Jennifer Riter</p><p>Extractables from elastomeric components become an issue even before a pharmaceutical drug makes contact with the elastomeric component. The suitability of the elastomer and the drug product needs to be taken into consideration at the development stage of the packaging and delivery system for the drug product. The potential for an extractable to leach into the drug product and the impact that leachable will have on the drug’s stability, efficacy and toxicity needs to be scientifically evaluated. </p>
Information is a powerful tool and West&rsquo;s Knowledge Center has been updated to provide our customers with an improved user experience. We&rsquo;ve completed a comprehensive overhaul of the Knowledge Center user interface, including a filter-based search design, more modern look and feel, and easy access to trending articles, new content, and FAQ&rsquo;s answered by West Subject Matter Experts.
<em>Welcome to Tech Talk, our latest feature from blogger Beverly Prohaska, Vice President, Global Information Systems. These features will discuss how West uses information technology internally and externally to help ensure customer satisfaction. Look for Tech Talk to appear regularly on the West blog.</em>
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