West Authors Contribute Chapters to New Leachables and Extractables Handbook

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. The Handbook offers a practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated [...]

Glass Delamination and Breakage: New Answers for a Growing Problem

By Graham Reynolds & Diane Paskiet West’s Graham Reynolds and Diane Paskiet recently had their article “Glass Delamination and Breakage: New Answers for a Growing Problem” published by BioProcess International. Although glass is widely considered to be the most traditional and cost-effective option for a parenteral drug container or delivery system, it may not always [...]

The Price of Quality

The FDA initiated a framework to modernize the way pharmaceutical and biopharmaceutical products are developed, manufactured and used through the use of data and science-based decision making.  This was visualized when they published a concept paper on current Good Manufacturing Practices for the 21st century in mid-2002. This was followed by the International Conference on [...]

West and Vetter Collaborate to Offer Customers an Innovative Filling Solution for Biopharmaceutical Drugs

Lionville, Penn.—November 2, 2011—West and Vetter, a leading international independent specialist in the aseptic filling of drug-delivery systems, have collaborated to provide customers with the ability to source filled Daikyo Crystal Zenith® syringes. Providing the best solution to the challenges of packaging and delivering today’s sensitive and complex biopharmaceutical products requires not only a unique [...]

Avoiding Glass Delamination

“Avoiding Glass Delamination, an article by West’s Diane Paskiet, Associate Director – Scientific Affairs, recently appeared in Manufacturing Chemist.  Contamination with glass flakes caused by delamination of the internal finish of container closure systems or prefilled syringes has caused numerous drug recalls. Surface imperfections and aggressive drug components can lead to interaction between product and [...]

Vial Stoppers That Won’t Stop Clumping

West’s Gene Polini, principal technical account specialist, recently contributed to the Troubleshooting column in “Equipment & Processing Report,” a newsletter of Pharmaceutical Technology.  Gene provided a response to a question on how to prevent vial stoppers from clumping in the feeder bowl. “When clumping occurs, manufacturers must first examine the type of stopper they use,” [...]

Rx-360 Launches Audit Sharing Program

West’s Andy Polywacz, Vice President of Quality, Americas, was recently quoted regarding the new Rx-360 Audit Sharing Program. According to a recent Rx-360 press release, the Audit Sharing Program collects and shares audits conducted by member companies on suppliers. Benefits of the program may include a broader “picture” of Quality Culture and performance and the [...]

Prefilled Syringe Technology: Glass versus Plastic

Despite their limitations, glass prefilled syringe systems still dominate the market; with the development of novel polymer materials, however, manufacturers can now offer high-quality, transparent, break-resistant syringes that are less prone to contamination. Read the full article, which appears in the September 2011 edition of Innovations in Pharmaceutical Technology. http://www.iptonline.com/pdf_viewarticle.asp?cat=5&article=797 Tibor Hlobik Associate Director, Marketing (610) [...]

Three tips on packaging selection for parenteral pharmaceutical manufacturers

 Read Fran DeGrazio’s latest article, “Three tips on packaging selection for parenteral pharmaceutical manufacturers,” which recently appeared on Healthcare Packaging’swebsite. The article offers tips that can help drug manufacturers identify potential hazards associated with packaging materials while a product is still in development.  Tips include choosing consistent components, mitigating risk of recalls and differentiating product through unique [...]