Blogs

West and its partner Daikyo have introduced a superior quality elastomeric piston the Daikyo D Sigma^® 1mL long piston, substantially raising the standard for product acceptance. The D Sigma piston combines Daikyo best practices with a known formulation (D21-7H), Daikyo Flurotec^® film, RB2 Coating, RSV^® and RUV^® processing with key innovation improvements of automated dimensional measurements, tight Acceptable Quality Levels (AQLs), particulate testing per ISO 8871-3, and enhanced vision inspection to achieve high levels of performance and consistency.

West is pleased to announce that we’ve recently expanded our Online Store offerings to include a 20mm NovaPure^® Ready Pack™ lyophilization stopper, adaptiQ^® vials from SCHOTT and Ready Pack™ Flip-Off^® CCS (Clean, Certified, Sterilized) seals. West’s Online Store is a one-stop solution for access to small quantities of some of West’s highest quality products, in stock and available ready-to-use in convenient small packs. Depending on their product needs, shoppers can now purchase a complete vial containment system with the option of selecting either Daikyo Crystal Zenith^® or adaptiQ glass vials.

How does West respond to increased demand to produce supplies needed for use with treatments to combat the coronavirus? The answer is – with years of experience, careful planning, and a robust manufacturing program. We are committed to doing our part to speed the successful development and large-scale manufacture of high-quality components required to serve customer needs for the delivery of a safe, effective COVID-19 vaccine, which includes expanding labor and equipment resources.

Fluoropolymer-laminated elastomer stoppers and plungers provide enhanced performance for container and delivery systems for parenteral drug products – especially sensitive biologic drug products. Among the many fluoropolymers available, West uses ETFE [poly(ethylenetetrafluoroethylene)] for its FluroTec^®–laminated products. Selection of ETFE was based upon ease of moldability and the following factors.

The regulatory landscape in China continues to evolve and become more stringent. In December 2018, the Chinese Pharmacopoeia Commission (ChPC) published: Second Draft for Comments on Guideline for Stability Study of Plastic and Rubber Pharmaceutical Packaging Materials. This guideline comprises part of the results of a research project organized by ChPC in 2016 and is one of the actions taken by National Drug Administration of China (formerly the China Food and Drug Administration, CFDA) to support the previously announced Opinions on Reforming the Review and Approval System for Drugs and Medical Devices (No. 44).