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In 2018, CNDA (National Drug Administration of China) issued Technical Guidance of Drug Compatibility with Rubber Elastomer Closures. This clearly demonstrates a focus on administrative guidelines for the safe and effective use of rubber components, which along with plastic and glass, are the most widely used materials in the packaging of parenteral drug products.
This guidance reflects input from over one year of public comment, and incorporates USP guidances on extractables and leachables (E&L) testing. China is the world’s second largest pharmaceutical market. Well known for its highly challenging regulatory environment, this guidance enables easier participation globally by closing gaps with international standards.
To help pharmaceutical companies comply with this guidance in performing E&L studies, West has invested heavily in creation of material characterizations for its most widely used rubber formulations. These characterizations comprise both a best practice for planning an E&L study, and semi-quantitative extractable data from targeted solvents (isopropanol, nitric acid, water) and multiple extraction techniques (reflux, microwave, autoclave). They serve as a very good guide to more focused E&L studies.
For more on how West can help, contact your Account Manager or Technical Customer Support (TCS) representative or visit our Analytical Services section of our website.
<p><span style="background: white;">Recently, interns of West’s global headquarters in Exton, Pennsylvania, hosted a Final Showcase Event where they highlighted various elements of their overall internship experience. The showcase, which included each intern creating a poster to highlight and present their experience, served as a final opportunity for the interns to continue to network with other members of the West team as they finished the ninth week of the ten-week West Ambassador Internship Program. </span></p>
Small is the new big. Growth in specialty treatments that target smaller patient populations means less emphasis on economies of scale and more focus on adaptable and modular manufacturing.
A consequence of the sustained shift of treatment from hospital to home is the evolution of on-body delivery systems (OBDS). OBDS platforms can deliver high volumes of medicines subcutaneously which traditionally would have been administered intravenously via an infusion at a clinic under the supervision of a healthcare professional (HCP).
Our culture is based on supporting the health and well-being of our communities. Now more than ever, it’s important to reach out and help those in need. To support our communities around the world, West is donating to multiple organizations that are making important contributions to society and need support during the COVID-19 pandemic.
I’m coming towards the end of my 19th year at West in May this year. Today, I am the Global Facility Energy Manager, working as part of the Global Facility Engineering team. Previously, I joined the West Dublin site as a Maintenance Technician and after two years I was promoted to Facilities and Maintenance Manager.
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