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Foreword 0 Introduction 0 1 Scope 0 2 Normative references 0 3 Terms and definitions 0 4 General requirements 0 4.1 Documentation 0 4.2 Management responsibility 0 4.3 Product realization 0 4.4 Measurement, analysis and improvement 0 5 Selection of products 0 5.1 General 0 5.2 Sample item portion (SIP) 0 6 Methods of determination and microbial characterization of bioburden 0 6.1 Determination of bioburden 0 6.1.1 Selection of an appropriate method 0 6.1.2 Neutralization of inhibitory substances 0 6.1.3 Removal of microorganisms 0 6.1.4 Culturing of microorganisms 0 6.1.5 Enumeration of microorganisms 0 6.2 Microbial characterization of bioburden 0 7 Validation of the method for determining bioburden 0 7.1 General 0 7.2 Validation 0 8 Routine determination of bioburden and interpretation of data 0 8.1 General 0 8.2 Limits of detection and plate counting 0 8.3 Microbial characterization 0 8.4 Bioburden data for extent of treatment 0 8.5 Bioburden spikes 0 8.6 Bioburden levels 0 8.7 Data analysis 0 8.8 Statistical methods 0 9 Maintenance of the method for determining bioburden 0 9.1 Changes to the product and/or manufacturing process 0 9.2 Changes to the method for determining biob

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