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The regulatory environment is moving to a more science-based approach to Container Closure Integrity (CCI). This is driven by the recent publication of United States Pharmacopeia Chapter <1207> Package Integrity Evaluation – Sterile Products. Recently, West gave a webinar (377 registrants) titled Container Closure Integrity: Six Keys to Simplify Your Strategy and Execution, that addressed Chapter <1207> and other topics. The survey questions (over 100 responses) from this webinar are instructive.
It is clear that the market, in general, is still trying to understand how to manage these new expectations, and manage the optimization and qualification of vial containment systems. In particular, “change management” is a challenge – 65% of respondents have not upgraded to the more sensitive and deterministic analytical techniques promoted in Chapter <1207>, but still reply upon probabilistic methylene blue dye ingress.
In order to achieve a better understanding to address these challenges, and others in CCI, see A Holistic Strategy for Container Closure Integrity: Selecting and Evaluating an Integral Packaging System, PDA Journal of Pharmaceutical Science and Technology 72 (1), 15-34 (January-February 2018). Visit the West Knowledge Center, which houses various materials on the subject, or contact a Technical Customer Support representative for more information.
In many instances, injectable pharmaceuticals need to be administered by patients or their caregivers rather than by healthcare professionals. While it is convenient to receive treatment at home without having to travel to a healthcare facility, the notion of administering drug injections, or even the sight of needles, can be intimidating to many individuals. The process can be greatly simplified with the use of auto-injectors. These devices typically contain a drug-filled syringe and make the injection procedure more straightforward by semi-automating the process.
Knowledge generation and risk reduction are goals of combination product testing. A risk-based, and standards-based, testing strategy creates not only a quality product, but ensures continuity between past and future data sets. This enables the long-term, safe and efficient delivery of drug products to patients. And time to market is improved by reducing product launch false starts.<br />
The future is now for parenteral pharmaceutical and biopharmaceutical sterile production. Traditional high-volume automated aseptic filling suites are maintained by contract filling services. But what’s emerging? Parenteral pharmaceutical and biopharmaceutical industries have transitioned to fully enclosed, isolator/restricted access barrier (RAB) systems. These small, efficient systems offer cost savings and can reduce the potential for particulate and microbial ingress during aseptic fill/finish manufacturing by eliminating direct human contact in the filling environment.
USP General Chapter<382> <em>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.
We are excited to share that Annette Favorite, Senior Vice President and Chief Human Resources Officer at West, has been recognized as a 2018 Women of Distinction Winner by the Philadelphia Business Journal. She was recognized at the Women of Distinction Awards Dinner, held at the Sheraton Philadelphia Society Hill Hotel in Philadelphia, Pennsylvania, on November 15, 2018.<br />
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