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In the latest installment of our video series, West on the Road, we travel across the Atlantic to our manufacturing facility in Eschweiler, Germany. There we meet Manager of Process Engineering Martin Rothstein, who says he’s impressed at how often he has encountered West products in his private life, whether visiting a family member in the hospital or during a vaccination appointment for one of his two small children.
Rothstein and the teams at the Eschweiler facility produce high-value pharmaceutical packaging products, turning materials into high-quality elastomeric stoppers, plungers and other components for the biotech and pharmaceutical industries. With the biopharmaceutical industry experiencing a shift toward patient-centered, quality care, it is increasingly important to maintain strict manufacturing processes to decrease risk. With this in mind, Rothstein explains that for many customers, it’s important to work with a provider such as West that manufacturers all of the various packaging components for a drug product under one roof, ensuring minimal risk.
The teams at Eschweiler have a long history of providing high-quality components; they possess a deep knowledge of the production process and are able to provide the right support to the customers to help them improve patient care around the world. Check out this new video to learn more about the work being done at West’s Eschweiler facility and visit our Careers page to learn more bout working at West in Germany.
Particulates in injectable drug products continue to be an area of great interest in the industry. The main reason is the potential clinical effects on patients, which can range from emboli to inflammations to infections. There are a series of clinical risk factors that should be considered in evaluating and mitigating these challenges. These factors are route of administration, patient population, and particulate composition (i.e., number, size, and shape). All are critical inputs to understanding risk and determining corrective and preventative actions.
V.P. Technical Customer Service & Scientific Affairs
It’s official – the West Exton Headquarters building has been awarded Leadership in Energy and Environmental Design (LEED) Gold Certification from the US Green Building Council. LEED is an internationally recognized accreditation program that rewards best-in-class strategies and practices for the design, construction, operations and maintenance of environmentally friendly buildings. The Gold certification demonstrates to customers and the community that West is committed to its goals of sustainability.
To improve the consistent evaluation of the quality and efficacy of generic drugs for injections, National Medical Products Administration of China（NMPA）published the draft guidance “<em>Technical Requirement for Quality and Efficacy Consistency Evaluation on Chemical Generic Injections (Exposure Draft)</em>” (15 October 2019). This indicates that the evaluation of the consistency of injections has finally begun. This Exposure Draft clarifies the specific technical requirements on reference-listed drugs, prescription technology, quality control of bulk drugs and excipient packaging, quality studies and control, stability studies, etc.
<p>Integrity of a drug product container/delivery system is essential to guarantee safety and efficacy. USP has recently issued <em>Chapter <1207> “Package Integrity Evaluation – Sterile Products”</em>—a guidance for the pharmaceutical industry in measuring container closure integrity (CCI). In line with this guidance, West has just expanded its capability in measuring CCI by adding<strong> high-voltage leak detection (HVLD)</strong> –a method endorsed in Chapter <1207>.</p><p> </p><br>
What does it mean to have package integrity for your container closure system? It means an absence of breaches that can lead to product loss or ingress. Container closure integrity testing should not be just a “one and done” study. It should be understood throughout the life cycle of the product.