1 Definitions and Scope 115
2 Factors Influencing the Bioburden and Testing Requirements 116
3 Sampling 119
4 Preparation of Specimens 121
5 Quantitative Methods 123
5.1 Choice of Method 123
5.2 Diluents, Media and Incubation Conditions 127
6 Qualitative Determinations 128
7 Validation 131
8 Documentation and Data Analysis 134
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