Search results for "bioburden"

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…

Article 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…

Poster Infographic: Sources of Bioburden You May Have Missed
This makes bioburden prevention and control in the production facility extremely important. It also underlines the risk that human error will be the cause of a contamination incident. View this inf…

Article 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…

Article Prepare for an FDA Bioburden Inspection
Learn more here how to prepare for an FDA bioburden inspection.

Article How to Address Bioburden Challenges: Insights and Tips
Learn more about insights and tips to address bioburden challenges here.

Article The Extreme Costs of a Bioburden Incident
Read the bioburden article series.

Poster Collaborating to address the bioburden challenge
At a minimum, bioburden contaminations lead to reduced productivity as a result of lost batches and/or deviation investigations. Striving towards a bioburden-free process, biopharmaceutical companies …

Article 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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