Tag Archive: USP

7 Reasons Why Your Lab Should Perform Growth Promotion Testing

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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The Great Debate Over B. cepacia Testing: Your Opinions and FDA Recommendations

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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The Great Debate Over B. cepacia Testing

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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Preservative Testing – Choice of Challenge Isolates

“What you see is that the most outstanding feature of life’s history is a constant domination by bacteria.” ~ Stephen Jay Gould. An effective preservative capability is a central element of drug, cosmetic and household and institutional product microbiological risk assessment…
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Top 10 Tips for Growth Promotion Testing

The Growth Promotion Test can be a hassle, but it is necessary for determining if a new batch of media is acceptable. Use our top 10 tips for achieving Growth Promotion success with Microbiologics products to make your testing process as…
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Objectionable Microorganisms: Keeping Bad Bugs Out of Good Products

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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