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 [...]

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 [...]

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) [...]

Demystifying the Glass Blowback Feature In Pharmaceutical Container Closure Systems

Many folks in the parenteral drug business are confused about the blowback feature in glass and the no-pop ring on the elastomeric closures. Where did they come from? What are their function? What are the do’s and don’ts?  These package features are important to understand in order to select packaging materials and to avoid problems  [...]

An Alternative to Current Sterilized Plungers for Glass Syringes

The use of steam has been the preferred technique to sterilize components for sterile parenteral applications.  Steam is the most common method of sterilization for vial stoppers and related components.  However, in the case of plungers for prefillable applications, gamma irradiation has been the historic standard throughout the industry for sterilization of the elastomeric components, [...]

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 [...]

Drug Product Recalls Linked to Siliceous Flakes from Glass Containers

Glass is not inert and is particularly susceptible to chemical reactions at the surface. The glass formulation and manufacturing processes can influence the potential for leachables and/or glass flakes (delamination). The Na2O and K2O fluxes that are added to glass formulations reduce melting for forming glass but are weakly bonded and can leach into solutions contacting [...]

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 [...]