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The level of particles in parenteral pharmaceutical formulations is a critical quality attribute. This is no surprise; the clinical consequence of their presence can be very severe, including fatality. In the major pharmacopeia, from the US, Europe, and Japan, there is a specified limit for particles in the final parenteral formulation. Moreover, these pharmacopeia specify two methods for measurement – light obscuration (LO) and microscopic particle count (MPC).
a) robust pre-rinse protocol – to avoid any effects of disturbance
b) appropriate dilution – a solution too concentrated may cause coincidence of particles
c) test solution free of bubbles
d) particle-free test environment
e) sufficient difference in refractive index difference between particles and test solution
The FDA recognizes that compounded drugs serve an important role for patients whose medical needs cannot be met by FDA-approved drugs. However, compounded drugs are not approved by the FDA and therefore, have not been evaluated for safety or efficacy. Poor compounding practices or unsuitable manufacturing conditions can lead to serious adverse effects, or even patient death. Over the past few years, the FDA has taken significant steps to modernize and clarify policies related to the quality of compounding in an effort to ensure continued access to compounded drugs, while also protecting patients from the risks of contaminated or otherwise harmful products<sup>1</sup>. FDA Draft Guidances<sup>2, 3</sup> help to clarify applicable regulatory requirements and specifically address the use and handling of container closure systems.
Competition is increasing in the biopharmaceutical pipeline due to a growing number of new entrants, more players are bringing their drug all the way to market and many companies are utilizing accelerated development pathways, making it an even faster race to market. If you are like many other newly formed biotech companies, you’re doing your best to manage many activities critical to your success with limited resources, all while trying to accelerate your path to market.
In July, the western states of Rhineland-Palatinate and North Rhine-Westphalia in Germany experienced devastating floods caused by days of extreme rainfall. Our Eschweiler and Stolberg production sites and Kiefernweg Campus were not directly impacted; however, the communities were heavily affected. While we are thankful that none of our team members were injured, we empathize with many of them who are dealing with damage to their homes and personal property, as well as trauma caused by such a devastating event.
In the final installment of our blog series on corporate responsibility, we are focusing on quality. This topic is at the forefront of all we do at West. After all, we are ultimately in business to serve the patients who use our products – and those patients are counting on us to deliver those products with the highest level of quality possible. We will not compromise on our commitment to quality. <br />
Put on your mask and suit up as Production Manager, Adam Wrench takes us inside <a href="https://youtu.be/pP7uaialLb0"><span style="text-decoration: underline;">West’s Jersey Shore plant</span></a>. Despite the familiar name, there’s no beach or boardwalk here. Rather, Jersey Shore is a town nestled Pennsylvania’s Allegheny foothills. At this plant, employees create numerous West components, including FluroTec<sup>® </sup>and Teflon<sup>®</sup> laminated 13- and 20mm stoppers. It’s the only West facility that includes two steam sterilizers for Westar<sup>® </sup>RU sterile ready-to-use components.
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