News & events

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

Today, FDA issued updated guidances to provide additional clarification on testing of alcohol used in hand sanitizers manufactured under FDA’s temporary policies to help ensure that harmful levels of methanol are not present in these products. This will help ensure widespread access to alcohol-based hand sanitizers that are free of contamination. FDA has updated their guidances to provide clarification

Evelyn Orona, ARL Bio Pharma Associate Microbiology Laboratory Supervisor Andrew Taylor, ARL Bio Pharma Microbiology Laboratory Supervisor ARL Bio Pharma utilizes the kinetic turbidimetric method described in USP <85> Bacterial Endotoxins Test to provide results. An endotoxin test detects toxins that are released from the cell wall of disrupted gram-negative bacteria. This is a reaction

Contamination of pharmaceuticals with microorganisms may lead to deleterious effects on therapeutic properties of the drug, and may potentially cause injuries to intended recipients. Cases of contaminated nonsterile products have been reported in increasing numbers, and often associated with the presence of objectionable microorganisms. Methods for detection of these organisms are described in three major

Nora Talley, ARL Bio Pharma Analytical Associate Supervisor Jessica Munson, M.S., ARL Bio Pharma Analytical Supervisor This article outlines the importance of sample amounts submitted for potency testing and the impact it can have on potency results. Formulations require different sample amounts to allow for an accurate result representative of the compounded preparation. The table

Growth Promotion demonstrates that media used in environmental monitoring programs, media fills, or personnel qualification are capable of supporting microorganism growth.  Benefits of growth promotion testing: