Selecting the Proper Elastomeric Formula

Because your drug product has direct contact with the container closure system (vial and stopper), it is critical to consider compatibility factors of the rubber formula when selecting a stopper for your drug package. It is possible for a drug product to become contaminated if the drug and components react chemically. The substances that may [...]

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 [...]