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Bioburden Testing Market - Global
Industry Analysis, Size, Share,
Growth, Trends And Forecast 2015 2023
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Bioburden is defined as the number in terms of percentage, colony or cell count of bacteria that thrive on a given
unsterilized surface. Bioburden testing, also known as microbial limit testing provides quantification of the bacterial
cell cultures on a given unsterilized surface. The major application of bioburden testing lies in implant fixation
procedures that require testing ofcertain tolerable bioburden limit before implantation in the human body. The
standard for bioburden testing in the US is regulated by the US FDA, whereas global standards are maintained by the
ISO (International Organization for Standardization). The quantification for the standardization process is done in
terms of colony forming unit (CFU).
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Bioburden testing is essential in limiting the presence of infection causing bacteria in an object that is to be
integrated into a human body as an implant. The testing is important to eliminate the presence of bacterial residue
and growth in any object present in natural state. In addition it is almost impossible to remove bacterial residue
permanently in an object that is liable to be exposed to open air. Hence sterilization process is performed on an
implant object or a device post understanding the bioburden limit. This helps to select the appropriate sterilization...