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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No pharmaceutical company wants to sell a non-sterile drug contaminated with objectionable microorganisms, but how does a company know which organisms are objectionable and how do they ensure their drugs do not contain them? An objectionable organism is one which…
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During 2012, an outbreak of Burkholderia cepacia complex spread throughout the intensive care unit of a German hospital. The illness was traced to contaminated alcohol-free mouthwash. Though this event does not mark the first time B. cepacia complex was recovered from…
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Staphylococcus epidermidis colonizes moist body surfaces such as the axillae, nares and toe webs. Normally a harmless species, S. epidermidis can cause clinical disease under the right circumstances. Predisposing factors include immunosuppression and the presence of a medical device such as…
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As a pharmaceutical microbiologist, you are probably no stranger to Micrococcus luteus since it is among the most commonly found organisms in pharmaceutical environmental monitoring. The strain is typically associated with human skin, particularly from the head, arms and legs; consequently,…
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