AAMI TIR52 2014 R2022
$72.18
AAMI TIR52:2014/(R)2022: Environmental monitoring for terminally sterilized healthcare products
| Published By | Publication Date | Number of Pages |
| AAMI | 2014 | 23 |
This Technical Information Report (TIR) assists in establishing an environmental monitoring program that is meaningful, manageable and defendable, and provides guidance to avoid adverse environmental conditions during the manufacture of terminally sterilized healthcare products. The objective of this TIR is to provide guidance on the routine monitoring for viable and non-viable particulates in controlled environments used to produce healthcare products that are intended to be terminally sterilized.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | Blank Page |
| 3 | Title page |
| 4 | AAMI Technical Information Report Copyright information |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 7 | Committee representation |
| 10 | Foreword |
| 11 | 1 Scope 2 Normative references 3 Terms and definitions |
| 12 | 4 General principles |
| 13 | 5 Factors to consider when establishing an EM program |
| 15 | 6 Sampling plans 7 EM methods 7.1 Airborne particulate monitoring |
| 16 | 7.2 Microbial monitoring 7.2.1 Air microbial monitoring 7.2.2 Surface microbial monitoring |
| 17 | 7.2.3 Water microbial monitoring and compressed gasses monitoring 8 Microbial characterization |
| 18 | 9 Setting alert and action levels 10 Trending results |
| 19 | 11 Investigation of EM excursions 11.1 General 11.2 Concepts of an investigation |
| 20 | 11.3 Actions taken as a result of an investigation 12 Planned and unplanned interruptions 12.1 Characterizing the impact of an interruption |
| 21 | 12.2 Activities prior to resuming manufacturing following an interruption 12.3 Documentation 13 Water monitoring |
| 22 | 14 Compressed gasses |
| 23 | Bibliography |
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