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Bioburden is normally defined as the number of bacteria living on a surface that has not been sterilized. [ 1 ] The term is most often used in the context of bioburden testing, also known as microbial limit testing, which is performed on pharmaceutical products and medical products for quality control purposes.
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Microorganisms growing on an agar plate. Sterilization (British English: sterilisation) refers to any process that removes, kills, or deactivates all forms of life (particularly microorganisms such as fungi, bacteria, spores, and unicellular eukaryotic organisms) and other biological agents (such as prions or viruses) present in fluid or on a specific surface or object. [1]
These limits reflect what the process will deliver without fundamental changes. [3]: 43 Points outside of these control limits are signals indicating that the process is not operating as consistently as possible; that some assignable cause has resulted in a change in the process. Similarly, runs of points on one side of the average line should ...