Automated visual inspection has been created to perform as an alternative to manual visual inspection. This type of inspection is used to lower the cost and speed up the inspection process; pushing more drugs into the market. In USP <1790> it explains that any inspection other than manual inspection has to be “equivalent or better…
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Hospira Issues A Voluntary Nationwide Recall
On May 4th, 2021, Hospira—a Pfizer company, issued a voluntary nationwide recall to lot DN9185 for potential presence of visible particles. This drug product is a sterile water for injectables and is used to dilute or dissolve drugs for injection. Risks to patients are rare, but could potentially conclude anaphylaxis, fever, gastrointestinal disturbances, vein irritation,…
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Testing Container Closures with Dye Ingress Method
The dye ingress test method is a routine test for container closures attached to parenteral drugs and large molecule drugs. Traditionally, this method uses ten test samples and three positive controls. During this testing, the test samples are place in a vacuum chamber and pressurized with dye. Three vials are punctured to allow dye to…
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Particulate Identification
In USP <1790> it focuses on detecting and removing units of visible particles; in addition, it promotes the need of preventing particulate contamination—which only comes from identifying the particle. Most pharmaceuticals require an understanding of particulate matter contamination. The ability to identify and characterize a particle is extremely beneficial with improving products within the development…
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