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In Part 1 of our West on the Road – Eschweiler series, we learned about the high-value products produced in our Eschweiler, Germany facility and how this dedicated team of manufacturing experts supports customers in their mission to bring critical medicines to patients. In Part 2, we learn from Lukas Buglowski, Team Lead of Engineering, Envision, about how a focus on quality is both a shared mindset and built into every step of the manufacturing process in Eschweiler. Buglowski shares the pride his team feels knowing that they are producing high-quality products that will not only meet customers’ expectations, but more importantly, ensure patient safety, and how this builds trust and makes for a great team dynamic.
We also learn from Manager of Process Engineering Martin Rothstein about another pride-boosting element about working at Eschweiler: the fact that teams are plugged into and collaborating with West’s global network, regularly providing support to other manufacturing plants around the world. Check out this latest video to see the Eschweiler team in action.
Elemental impurities, such as arsenic, cadmium, lead and mercury are ubiquitous in nature. They are also toxic to humans and animals at certain levels. Because these elements are often part of mined minerals used in the manufacture of drug products and/or drug containment systems, they can have an impact on the quality of a drug. <br />
It is essential to consider lifecycle management during the development of new drugs – especially in the evolving area of biologic drugs. The market demand for both ease of use, and patient-centric at-home administration, is driving the need for innovative container systems and delivery devices. Typically, drugs are launched in vials; continuous development often then enables launch in other formats, such as pre-filled syringes and cartridges. West is committed to easing this movement from container systems to delivery devices through its NovaPure<sup>®</sup> component portfolio of elastomer closures. NovaPure stoppers and plungers offer best performance and highest quality. Developed with Quality-by-Design principles, they use FluroTec<sup>®</sup> barrier film and B2 coating technologies.
<p><em>Dr. Heike Kofler, Amy Miller, Jennifer Riter<br /></em><em>West Pharmaceutical Services, Inc.</em></p><p>One of the critical success factors for packaging lyophilized drugs is protection against product degradation caused by moisture. Moisture can be introduced into a lyophilized drug product cake from the elastomeric stopper and from the atmospheric headspace; it can also permeate through the stopper, a process known as moisture transmission.</p>
The Packaging Academy has been organized by West in Asia Pacific for the past 5 years, beginning in 2015, and serves as a valued training platform for our customers in injectable packaging both in the areas of containment and delivery systems.
The coring and fragmentation of elastomer components used in containment of parenteral drug products continues to be a challenge. Many factors influence these phenomena, so it is critical that a pharmaceutical manufacturer understands how a vial system will be used, for example: what is the recommended needle gauge; is it single- or multi-dose; could spikes, vial adapters or closed system transfer devices be used. Cores and fragments can be generated by needle penetration of the elastomer components. Cores are formed by the needle cannula cutting the elastomer – ordinarily they are cylindrical. Fragments are formed via an abrasion phenomenon of the needle penetration – shapes are irregular. <br />