News & events

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:  

James Zellner, Microbiologist and Technical Sales Representative What Growth Media is Appropriate for Specific Uses? There are dozens of different types of microbial growth media available to Microbiologists, developed for a wide variety of purposes.  The United States Pharmacopeia (USP) references many of these to demonstrate the quality of both compounded drug products and the control of compounding

Andrew Taylor, ARL Bio Pharma Microbiology Supervisor USP <795> Pharmaceutical Compounding – Non-sterile Preparations states compounders are responsible for minimizing patient harm resulting from multiple issues, including excessive microbial contamination in nonsterile drug products. The chapter directs compounders to USP <1163> for recommended quality control tests, including USP <61> Microbial Enumeration Tests and USP <62>