Fresenius Kabi is a global health care company that produces and specializes in medication and infusion/transfusion technology. Fresenius Kabi USA voluntarily recalled seven lots of Sodium Acetate Injection on Monday, March 7th. Various amounts of iron, sodium, silicon, chromium, aluminum and cellulose found in these injections led to seven lots being recalled. The presence of…
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Manual Visual Inspection is Still Critical
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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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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