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AAMI TIR106 2024

AAMI TIR106 2024

$122.42

AAMI TIR106:2024; Microbiological Methods—Understanding And Use Of Product Bioburden Data

Published By Publication Date Number of Pages
AAMI 2024 32
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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.

PDF Catalog

PDF Pages PDF Title
1 AAMI TIR106:2024; Microbiological methods—Understanding and use of product bioburden data
3 Title page
4 AAMI Technical Information Report
5 Copyright information
Contents Page
6 Committee representation
11 Foreword
12 Introduction
13 1 Scope
2 Normative references
3 Terms and definitions
14 4 Bioburden data
4.1 General
4.2 Bioburden variables
4.3 Bioburden test sensitivity
4.4 Bioburden trending
15 5 Use of bioburden data
6 Bioburden resistance to sterilization
16 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
17 8 Analysis
8.1 General
8.2 Characterization of bioburden
8.2.1 General
8.2.2 Use of characterization
18 8.2.3 Characterization of isolates
8.2.4 Selective culturing
8.2.5 Sources of microorganisms
8.2.6 Microbial identification
19 9 Bioburden alert and action levels
10 Bioburden excursions
10.1 General
20 10.2 Investigating bioburden excursions
10.2.1 Laboratory investigation
10.2.2 Trend analysis
10.2.3 Manufacturing investigation
21 10.3 Conclusions of the investigation
10.4 Impact assessment
11 Trending
22 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
23 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
24 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
25 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
26 B.2 Evaluation of the recovery efficiency test method
B.3 Evaluation of the recovery efficiency data
28 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
29 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
30 C.2.6 Laboratory error
C.3 Calculating sample results
31 C.4 Reporting results
32 Bibliography

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AAMI TIR106 2024
$122.42