Quality Solutions Mitigate Total Cost of Ownership

In an earlier post, I discussed how the changing market, regulatory expectations and quality issues have an impact on a pharmaceutical manufacturer’s total cost of ownership. There are a variety of solutions that are currently available to aid with these issues, and thus lower the total cost of ownership. For example, modern polymeric materials can [...]

Quality Performance of Advanced Cyclic Olefin Plastic Prefillable Syringes

Tibor Hlobik, Director, Prefillable Solutions and Technologies Mike Gills, Customer Technical Support Process Engineer Growth in biopharmaceutical therapeutics is leading innovation with prefillable syringe systems. These complex sensitive drug products require highly inert primary packaging materials for improved stability and delivery in perfect quality for reduced safety risk. This poster will provide a quality comparison [...]

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 [...]

Scaleable Pharmaceutical Packaging Systems for Cell Therapy

Daikyo Crystal Zenith Vials: A Sterile System for Cryogenic Applications The development of cell-based therapies for many debilitating diseases including Parkinson’s and Alzheimer’s can make an undeniable impact on a patient’s quality of life. Many current cell-based products are produced, frozen, stored and delivered to the clinical site in intravenous (IV) bags or polypropylene screw-cap [...]

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 [...]

Alternatives to Glass Containers

In May, West participated in the PDA/FDA Glass Conference where West’s Scott Young presented, “Alternative to Glass Containers Daikyo Crystal Zenith® A Unique Plastic Container Solution.” The presentation included a look at how cyclic olefin polymers, such as Daikyo Crystal Zenith, offered a solution to issues with glass container closure and delivery systems, such as: – [...]

Glass Delamination Woes Trigger FDA Advisory

Recent additional product recalls due to glass delamination, including injectables such as dexamethasone, 23.4% concentrated sodium chloride for injection, bacteriostatic water for injection, potassium phosphates, sodium thiosulfate and sodium bicarbonate, have triggered an advisory from the U.S. Food and Drug Administration (FDA). The advisory is designed to help pharmaceutical manufacturers prevent glass flakes from forming [...]

Glass Flakes in Drug Product Trigger Massive Recall

The recently initiated voluntary recall of certain lots of anemia drugs was due to potential contamination of products with glass flakes.  Over 324,000 vials of drug product were recalled. The products are indicated for the treatment of anemia related to HIV therapy, chronic renal failure and chemotherapy.The glass flakes, also known as siliceous flakes, are [...]