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Particles in parenteral drug products continue to be an important concern. At the April-2017 AAPS Workshop Challenges and Patient Impact of Particles in Biologics, Fran DeGrazio, VP of Scientific Affairs and Technical Services, spoke on the topic: Unique Considerations for Testing and Understanding Particle Loads for Primary Packaging Components.
The presentation addressed three major issues: source, control and measurement. Particles represent a very serious risk to patient safety – especially those from external sources, where bioburden is uncontrolled. Sources of particles are many: materials, equipment, processes, people, methods, and release/receipt. The best way to understand the sources, and be in the best position to exercise control over these sources, is through an Ishakawa cause-and-effect analysis – identifying and understanding the influence of all possible factors. Critical as well is the measurement of particles: number, size and composition. However, the challenge is the execution of measurement – which requires considerable insight and laboratory expertise. Identification requires different methods. And like identifying sources of particles, a cause-and-effect analysis must be done to understand factors (e.g., equipment, preparation) that affect limits of uncertainty in measurement.
Particles in parenteral drug products will always pose a risk to patient safety. Better measurement ultimately leads to better understanding of the source, and a better ability to control. West’s aim is to be at the forefront in developing more effective methods to measure particles, with the goal that is always in mind – patient safety. To read Fran DeGrazio's full presentation, visit the Knowledge Center.
West is pleased to announce that it will begin distribution of a new Daikyo offering – the DAIKYO PLASCAP® RUV one-step press-fit vial closure solution for serum applications. DAIKYO PLASCAP RUV features an integrated stopper and plastic cap, offered in nested configuration for small-batch filling. The closure system offers an alternative to aluminum seals.
West is honored to be a recipient of the Philadelphia Business Journal’s 2019 Faces of Philanthropy Award. The honor was presented to West at the Business Journal’s Faces of Philanthropy Awards Breakfast on April 11, 2019 in Philadelphia, PA.
Come one, come all to the 2014 West without Borders campaign! From preliminary planning to the final one-ring circus, the 2014 West without Borders campaign in Kinston, N.C., was a whole lot of clowning around in the name of a good cause. This year, Kinston team members supported three charities: Relay for Life Kids’ Walk, Kid’s Cafe and Shriners’ Hospital for Children’s Transportation Fund.
While you won’t see cats on vacuums, cute dogs doing crazy tricks or any dancing toddlers, the <a href="http://www.youtube.com/user/WestFYI"><span style="color: #0000ff; text-decoration: underline;">WestFYI YouTube Channel</span></a> does offer a variety of product videos to help customers and potential customers learn more about West’s products and our company.
On July 3, 2013, Novartis issued a <span style="color: #0000ff;">voluntary recall</span> of its Menveo<sup>®</sup> vaccine. Menveo is a lyophilized meningococcal vaccine used against <em>Neisseria meningitidis</em>, a bacterium that causes meningitis, meningococcemia and septicemia, and rarely, carditis, septic arthritis or pneumonia.
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