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James Zellner, ARL Bio Pharma Technical Sales and Microbiologist USP <60>, Microbiological Examination of Nonsterile Products – Tests for Burkholderia cepacia Complex, describes a test procedure that evaluates the microbiological quality, specifically the presence of species of the genus Burkholderia, in non-sterile substances and preparations.  This is important, because Burkholderia is a potentially dangerous pathogen, especially for drugs or raw materials that

Evelyn Orona, Associate Microbiology Supervisor Just as crucial as the sterile production of drug products is ensuring those same products are free of dangerous pyrogens – contaminants that induce febrile reactions in patients if introduced at high levels. Relative to patient safety, the most concerning and common pyrogen is bacterial endotoxins. Pyrogens can be removed or

Drug components differ in purity, specifications and quality. According to FDA draft guidance, it’s important for compounding pharmacies and outsourcing facilities to verify drug components purchased from suppliers. Pharmacists verify drug components by: The FDA draft guidance for 503B outsourcing facilities states that “in lieu of testing each shipment of each ingredient, a COA can

Ophthalmic medications must meet particulate matter test requirements. Particulate matter may come from foreign or product-related substances. Clinical exposure to unwanted particulate matter can cause a biological response in patients including blocking capillaries and arteries, introducing microorganisms and causing an infection, or causing an allergic reaction.  Ophthalmic products fall into three route of administration categories: USP

A cleaning validation demonstrates a pharmacy, hospital, or outsourcing facility’s cleaning procedure is effective and consistent in cleaning equipment and compounding surface areas. The Food and Drug Administration (FDA) expects firms to have written procedures (SOP’s) detailing the cleaning processes used for various pieces of equipment.

According to Center for Disease Control and Prevention (CDC), over 8 million US healthcare workers are exposed to hazardous drugs (HDs) every year. Drugs classified as hazardous include cancer therapy, antiviral drugs, hormones, and bioengineered drugs.   More than 12 billion doses of HDs are handled by US providers each year. Anyone handling HDs is at risk