You’ve identified an organism in your environment. Now what? If you work in a non-sterile pharmaceutical manufacturing laboratory, chances are you’ve encountered this question. You know environmental monitoring doesn’t stop at detection, but what are the correct next steps to…
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Everyone has heard of diphtheria, but this familiar infection caused by a Corynebacterium strain isn’t the only illness laboratories should be concerned about. Sterile manufacturing facilities should also be on the lookout for non-diphtherial Corynebacterium. These strains, commonly found in…
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Cronobacter sakazakii, formerly Enterobacter sakazakii, is a gram-negative bacterium that belongs to the Enterbacteriaceae family. It is found in the environment, commonly on plant and organic materials, and can survive very dry conditions. The bacterium has been isolated from dry…
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Cladosporium cladosporioides, although generally nonpathogenic, can cause illness. This species, along with Exserohilum rostratum and Aspergillus fumigatus, was one of the pathogens isolated during a multistate outbreak of fungal meningitis due to contaminated sterile medication manufactured by the New England Compounding…
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Pluralibacter gergoviae can cause big headaches in cosmetic industry laboratories. It is an opportunistic pathogen that has repeatedly been isolated from personal care products. Most recently, this environmental isolate is the cause of a recall of involving flushable wipes. (6)…
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There are about 20 outbreaks of Legionnaires’ disease each year in the United States. Most outbreaks occur in buildings with large water systems such as hotels and hospitals. The outbreaks are caused by Legionella pneumophila, a harmless microorganism in a…
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In 1950, a United States Navy ship spent six days spraying Serratia marcescens into the air two miles off the coast of San Francisco. The spraying was part of a biological weapon test called Operation Sea Spray. Prior to the…
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Ubiquitous in nature, Listeria monocytogenes can be found in many contamination sources making it difficult to eliminate from food processing facilities. Characteristics, such as the ability to grow at refrigerator temperatures, form biofilms, thrive in moist conditions, and remain viable in high…
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If your manufacturing processes utilize purified water or highly purified water, Ralstonia pickettii should be on your list of microorganisms to control. In fact, it has become a microorganism of concern to sterile drug manufacturers because it is capable of passing through…
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If you have isolated Bacillus cereus in your pharmaceutical manufacturing environment, you are not alone! Bacillus is one of the most common microorganisms cited in U.S. Food and Drug Administration warning letters associated with contamination in pharmaceutical manufacturing. The top…
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