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Andrew Taylor, Microbiology Supervisor Microbial identification is an important component of a quality assurance program; specifically as it relates to environmental monitoring (EM), raw material and final product bioburden assessment, and out-of-specification (OOS) investigations. Environmental Monitoring USP <1116> Microbiological Control and Monitoring of Aseptic Processing Environments states “a successful environmental control program includes an appropriate level of

Andrew Taylor, ARL Bio Pharma Microbiology Supervisor In recent years, there have been instances of endotoxin-caused illness resulting from contaminated compounded sterile preparations. In 2015, an incident occurred where seven cases of endotoxin poisoning were related to contaminated glutathione infusions. In this case, patients were symptomatic within 2 hours of administration. Most cases reported fever, rigor, and headache. An

Kerri Hirst, Microbiologist, ARL Bio Pharma A sterility test detects microbial contamination and provides data to determine if your product is ready for release.  A “Sterile” result indicates no contaminating microorganism is found in the sample. A “Not Sterile” result indicates microbial growth and the product examined does not comply with the test for sterility, unless it

Importance of Forced Degradation in Stability-Indicating Methods Pharmacists often want to assign a beyond-use date (BUD) on a drug product longer than USP guidelines to increase compounding efficiencies and reduce drug waste. For accurate BUD assignment, Stability-indicating methods are recommended as opposed to Potency methods. Stability-indicating methods are specifically designed to separate drug degradants from

James Zellner, Technical Sales Identification of a contaminant in a sterile preparation is vital to determining the origin of the microorganism and its avenue of entry.  The organism’s identity, combined with environmental monitoring data, provides actionable information to improve a pharmacy’s processes and prevent future contamination. Organisms can enter a drug product through: The source