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Which one is the most reliable for sterility testing? According to USP <71> Sterility Tests, membrane filtration is the sterility test method of choice for filterable pharmaceutical products. Membrane filtration refers to either an open membrane filtration (OMF) or closed membrane filtration system. Not all sterility test systems are the same. It is important pharmacists

Kerri Hirst, Senior Microbiologist Sterility testing by USP <71> is a test used in tandem with other sterility assurance procedures and tests to ensure that a product is free of microbial contaminants and safe for patients to use.  For a sterility test to perform appropriately, a method suitability validation must be completed on each specific

Kathy Heatherly, MSFS, Technical Sales  As a compounder, protecting yourself and your staff from exposure to hazardous drugs should be important both from a safety and monetary perspective.  USP <800> applies to sterile and non-sterile compounding pharmacies and anywhere that hazardous drugs are received, stored, or administered.   It is also designed to prevent compounders from

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

Cindy Pickens, ARL Bio Pharma Laboratory Supervisor Particulate Matter testing is performed on all parenteral solutions to determine the cleanliness and stability of the solution; and, is listed in USP <797> as a necessary component for quality assurance of compounded sterile preparations under the responsibilities of compounding personnel. It is also specifically outlined as a

Particulate matter contamination in injectable drug products, especially in large numbers, can cause harm to patients. Common particulate sources include: solvent impurities, drug precipitates, dust, glass, rubber, environmental contaminants, fibers and other insoluble materials.  The size of particulate matter is an important factor when considering the potential risk to patients. Particles as small as 2 μm in