This document provides guidance regarding the understanding and use of product bioburden data including: what bioburden data represent; how to use bioburden data to support a sterilization process; the analysis and characterization of bioburden; establishment and the use of alert and action levels; how to investigate bioburden excursions; trending and maintaining an effective bioburden monitoring program; counting plates and recording results.<\/p>\n
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| 1<\/td>\n | AAMI TIR106:2024; Microbiological methods\u2014Understanding and use of product bioburden data <\/td>\n<\/tr>\n | ||||||
| 3<\/td>\n | Title page <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | AAMI Technical Information Report <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | Copyright information Contents Page <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 4 Bioburden data 4.1 General 4.2 Bioburden variables 4.3 Bioburden test sensitivity 4.4 Bioburden trending <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 5 Use of bioburden data 6 Bioburden resistance to sterilization <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 7 Use of bioburden data in sterility assurance 7.1 Bioburden-based sterilization methods 7.2 Overkill sterilization methods 7.3 Use of bioburden data in product adoptions 7.4 Use of bioburden recovery efficiency data <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 8 Analysis 8.1 General 8.2 Characterization of bioburden 8.2.1 General 8.2.2 Use of characterization <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 8.2.3 Characterization of isolates 8.2.4 Selective culturing 8.2.5 Sources of microorganisms 8.2.6 Microbial identification <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 9 Bioburden alert and action levels 10 Bioburden excursions 10.1 General <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 10.2 Investigating bioburden excursions 10.2.1 Laboratory investigation 10.2.2 Trend analysis 10.2.3 Manufacturing investigation <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 10.3 Conclusions of the investigation 10.4 Impact assessment 11 Trending <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | Annex A (informative) Guidance on laboratory investigations for bioburden excursions A.1 General considerations A.1.1 When it might be meaningful to perform an investigation A.1.2 When it might not be meaningful to perform an investigation A.2 Reproducibility of bioburden result A.3 Contributing factors in determining the root cause in an investigation A.3.1 Shipping (if applicable) and storage conditions A.3.2 Test method compliance and appropriateness <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | A.3.3 Appropriate practices used during the performance of the test A.3.4 Appropriateness of equipment, materials, and media A.3.5 Enumeration practices <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | A.3.6 Training A.3.7 Microorganism characterization A.3.8 Review of lab environmental monitoring data, if applicable A.3.9 Conclusions of the investigation <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | Annex B (informative) Considerations for recovery efficiency data B.1 Determining necessity of recovery efficiency B.1.1 General B.1.2 Conditions under which a recovery efficiency might not be necessary B.1.3 Conditions under which a recovery efficiency might not be possible B.1.4 Conditions under which a recovery efficiency might be necessary <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | B.2 Evaluation of the recovery efficiency test method B.3 Evaluation of the recovery efficiency data <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | Annex C (informative) Guidelines for counting plates and recording results C.1 General C.1.1 Means of counting plates C.1.2 Ideal counts (countable range) C.1.2.1 Lower ideal count C.1.2.2 Upper ideal count C.2 Plate counting guidelines C.2.1 Counts that are below the upper countable range and do not have to be estimated C.2.2 Counts that are above the upper countable range, but countable <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | C.2.3 Counts that are beyond the countable range but can be semi-quantified C.2.4 Counts that are TNTC C.2.5 Spreaders <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | C.2.6 Laboratory error C.3 Calculating sample results <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | C.4 Reporting results <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" AAMI TIR106:2024; Microbiological Methods\u2014Understanding And Use Of Product Bioburden Data<\/b><\/p>\n |