Search results for " bioburden" in Articles / App Notes
Article
Selecting a Comprehensive Bioburden Reduction Plan
By Randi Hernandez
There are multiple variables to consider in the reduction of bioburden, including the evaluation of microbes in a facility, in the manufacturing process, and in the materials us…
Article
Bioburden Control in the Biopharmaceutical Industry
Good Practices in the Biopharmaceutical Industry
Because bio/pharmaceutical products are generally intended for ill populations, bioburden control throughout the whole manufacturing plant should b…
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Bioburden Entry Points in Downstream Processing
If you work in bioprocessing, you are no doubt aware of the need to prevent bioburden entry and proliferation, and reduce the complexity of the equipment and processes involved. Anastasia Lolas, for…
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Sources of Bioburden You Might Have Missed
The open handling introduces many potential bioburden entry points.
In this new blog-article, potential bioburden sources in bioprocessing are discussed and ways to address the risks.
Read m…
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How to Address Bioburden Challenges: Insights and Tips
Learn more about insights and tips to address bioburden challenges here.
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The Extreme Costs of a Bioburden Incident
Read the bioburden article series.
Article
Prepare for an FDA Bioburden Inspection
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Not sure how to best approach a bioburden problem when an FDA inspection is imminent? Anastasia Lolas, former FDA Biologics License Application (BLA) revi…
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Prepare for an FDA Bioburden Inspection
Even with effective prevention, bioburden incidents can occur. A best-practices response will not only help you be prepared for any upcoming FDA inspection, it may also yield valuable insights to help…
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Process Development: What May Lie Ahead in 2018?
Readers were very interested to learn how to prevent bioburden incidents in this article written by a former FDA BLA reviewer and inspector. Also hot was a second piece on protecting against microbiol…
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Current Innovations and Practices To Address Microbial Contamination in Downstream Bioprocessing
A multifaceted, collaborative approach is the key to addressing the multiple challenges of bioburden control. Improved ways of working in the manufacturing facility have been facilitated by supplier d…