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 [...]

Creating a Verification Process, not an Inspection Process

West’s Peg Frandolig, Technical Customer Support Manager, recently presented “Creating a Verification Process, not an Inspection Process” at the PDA 2011 Visual Inspection Forum, Oct 3-6, 2011. Good pharmaceutical practice requires the individual physical inspection of drug product container closure systems in order to reject those showing evidence of contamination with visible foreign material. Drug products in [...]

West to Present at the PDA 2011 Visual Inspection Forum, Oct 3-6, 2011

Join West’s Peg Frandolig, Technical Customer Support Manager, at the PDA 2011 Visual Inspection Forum, Oct 3-6, 2011, where she will present a poster on the verification process. Good pharmaceutical practice requires the individual physical inspection of drug product container closure systems in order to reject those showing evidence of contamination with visible foreign material. [...]

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 [...]