We apologize your item could not be found. Not all items are listed on our website. Please contact your account manager for details regarding your searched item.
Material number (eg: xxxxxxxxxxx) no space or hyphen needed.
No Results Found
Extractables and leachables (E&L) remain as one of the hottest topics in China – a topic to which West makes a strong commitment – in order to anticipate and address ever-changing regulatory and technical requirements. As part of this commitment, Lynn Yao, Scientific Affairs Manager at West, presented Challenges of E&L Study Under Changing Regulatory Environment at the second-annual Extractables and Leachables China, hosted by Smithers Rapra, September 2019 in Shanghai. This event assembled local stakeholders and experts for two days of presentations, training, and discussion on the China regulatory landscape, testing methods, and technical advances.
She shared West’s up-to-date knowledge on regulatory requirements and West’s comprehensive experience regarding E&L, specifically on four aspects of elemental impurities:
It was emphasized that to address these aspects careful monitoring and understanding of the regulatory requirements is needed first. Second, a risk-based approach with a holistic understanding of potential sources of elemental impurities regarding, in particular, components and systems is needed.
Selection of the right components is critical. Through Technical Customer Support (TCS) and the Integrated Solutions program, West can not only advise on proper selection, but design and execute the studies needed to support regulatory compliance. For more, contact a TCS representative or Account Manager.
West authors Diane Paskiet, Kim Miller, Laura Stubbs and Diego Zurbriggen contributed to several chapters in the new “Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products” available from Wiley Scientific.
Register today for West’s free educational series <strong>“Supplying Safe Medicines to Patients: Considerations for Container Closure and Delivery Systems”</strong> on March 20, 2014, at the Renaissance Raleigh North Hills Hotel in Raleigh, NC.
In today’s manufacturing processes, defects such as loose and embedded foreign matter may cause end of line rejects of drug products—potentially leading to a loss of product or even market recalls. At the same time, regulatory authorities are becoming increasingly more stringent and continually lowering acceptable levels of particulate matter.
On September 7th, 2023, a long-awaited final guidance was issued by the Food and Drug Administration (FDA) - Application of Human Factors Engineering Principles for Combination Products: Questions and Answers. The document is intended to be used in conjunction with other human factors related guidance and available national and international standards, such as AAMI HE75 and IEC 62366. In this latest guidance, the agency provides its view on best practices for conducting human factors activities for combination products either comprised of a device and a drug or a device and biologic.
In the world of injection molding, experience, expertise, and a passion for sharing knowledge can transform careers and shape the future of the industry. Ron Barr, a seasoned Principal Process Engineer at West, is a testament to this philosophy. With a remarkable journey that began back in 1991 when he joined the workforce at the age of 19, Ron's story is an inspiration to aspiring professionals in the field.
English
Chinese
