News & events
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Sterility Test Failure: Possible Causes and Investigation
Read MoreKerri 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
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Importance of Forced Degradation In Stability-Indicating Methods
Read MoreImportance 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
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Prevent Future Sterility Failures by Identifying Contaminating Microorganisms
Read MoreJames 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