Growth Promotion Test (GPT) – this combination of words might make you wince, but the test is essential for labs following pharmacopeia guidelines. GPT is more challenging than a qualitative or ecometric test. It is deemed successful if a small…
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Last month we outlined the debate for and against requiring B. cepacia testing for all nonsterile pharmaceutical, personal care products and water systems (The Great Debate Over B. cepacia Testing). At the end of the post, we asked our readers…
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To test, or not to test – that is the question. A frequent reason for recalls of nonsterile products is contamination with Burkholderia cepacia, a microorganism capable of causing serious illness in patients with impaired immune systems or chronic lung…
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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. Recently, 15,000 tubes of a popular skin cream product were recalled due to contamination with the…
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“It is what you read when you don’t have to that determines what you will be when you can’t help it.” – Oscar Wilde Microbiologists have an insatiable thirst for knowledge. Keep learning after you leave the lab by reading…
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For years, health organizations including the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) have warned that antibiotic resistance is a major global threat. The Review on Antimicrobial Resistance estimates that at least 700,000 people…
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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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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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