We apologize your item could not be found. Not all items are listed on our website. Please contact your account manager for details regarding your searched item.
Material number (eg: xxxxxxxxxxx) no space or hyphen needed.
No Results Found
In an earlier post, I discussed how the changing market, regulatory expectations and quality issues have an impact on a pharmaceutical manufacturer’s total cost of ownership.
There are a variety of solutions that are currently available to aid with these issues, and thus lower the total cost of ownership. For example, modern polymeric materials can be considered for primary packaging. In addition, the manufacture and processing of such polymers allows for flexibility in molding and forming throughout a drug product’s lifecycle. This means the drug can be contained in the same material from development through commercialization, which may lower evaluation costs.
High-quality components can also make a difference. Primary container closure systems typically consist of a vial, stopper and seal. Selecting a vial made from a cyclic olefin polymer, such as the Daikyo Crystal Zenith® polymer, and a high-quality, ready-to-use component that has been through optimized washing, sterilization and automated vision verification processes can combat issues from particulate and extractables. Administration systems can be developed using the same combination of materials. The key is to develop a delivery system based on the needs of the patient.
West is always working to find new and innovative solutions to our customers’ needs, and in April, we will introduce a new, high-quality line of elastomeric components that have been developed using Quality by Design principles. Check back with us often for more information.
West is pleased to announce the addition of Stevanato Group’s (SG) clean, sterilized, depyrogenated EZ-fill<sup>®</sup> glass vials in 2R, 6R and 10R sizes for 13mm and 20mm stoppers and seals to its Online Store. These ready-to-fill vials are a high-quality option for general pharmaceutical use.
Twelve weeks, 60 days, or 480 hours is all that I have in the summer of 2014 to showcase my talents as the Pharmaceutical Delivery Systems (PDS) Marketing and Innovation Ambassador Intern. To many, that might seem to be a rather extensive amount of time to become familiar with an organization, meet respective colleagues, learn about products and operations, and develop a means to an end for the designated project assignment that all Ambassadors receive every summer.
<em>General chapter USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems</em> is slated to become official on December 1, 2025. This allows five years from the date of publication in December of 2020 for stakeholders to implement the new testing requirements for full compliance. While that date seems to be far off in the future, there has been interest in early adoption of the new chapter and implementation of the various tests it requires.
Particles in an injectable drug product represent a huge risk not only to patient safety – but also to a drug company’s reputation and bottom line. Presence of visible or sub-visible particles has been one of the most common reasons for recalls. According to the <em>FDA Recalls, Market Withdrawals, & Safety Alerts</em> database, 23 of 59 (39%) recalls, market withdrawals, and safety alerts between 2018 and 2020 were due to particulate contamination<sup>1</sup>.
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.
English
Chinese
