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How Certified Reference Materials Help Labs Meet Regulatory Requirements

How Certified Reference Materials Help Labs Meet Regulatory Requirements

by Tina Sobania | Jul 26, 2018 | Clinical, Food, Molecular, Pharmaceutical, Water

As regulatory standards continue to increase, additional responsibility is being placed on laboratories to ensure the quality and safety of finished products. Now more than ever, traceability is a major concern. Laboratories are required to provide evidence that the...
Non-Sterile Pharmaceuticals: Next Steps After Finding an Environmental Isolate

Non-Sterile Pharmaceuticals: Next Steps After Finding an Environmental Isolate

by microbiologics | Apr 12, 2018 | Pharmaceutical

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...
The Scoop on Ready-to-Eat Foods and Listeria monocytogenes

The Scoop on Ready-to-Eat Foods and Listeria monocytogenes

by Ashley Umlauf | Aug 10, 2017 | Food

When summer is in full swing, many of us choose to cool down with sweet frozen dairy treats. However, the thought of ice cream tainted with Listeria monocytogenes may cause anyone, especially those in susceptible populations, to think twice. Listeria monocytogenes is...
The Great Debate Over B. cepacia Testing: Your Opinions and FDA Recommendations

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

by Laurie Kundrat | Jun 8, 2017 | Pharmaceutical, Water

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 what they think – should...

Objectionable Microorganisms: Keeping Bad Bugs Out of Good Products

by Laurie Kundrat | Mar 10, 2016 | Pharmaceutical

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 can...
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