Tag Archives: USP 790

Recall of Sodium Acetate Injection Due to the Presence of Particulate Matter

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…
Read more

Routes of Drug Administration

The route of drug administration is defined as the path by which a drug is taken into the body.  Drugs are administered varied by diagnosis, prevention, cure or treatment needed of diseases and other medical disorders.  A drug must come in contact with the tissues of organs to achieve its desired effects. The route of…
Read more

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…
Read more

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…
Read more