Norman Hodges

CONTENTS

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

References 134

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