AAMI TIR15:2016 R 2024
$99.13
AAMI TIR15:2016/(R)2024 Physical aspects of ethylene oxide sterilization
| Published By | Publication Date | Number of Pages |
| AAMI | 2016 |
This technical information report (TIR) provides additional guidance to augment the ANSI/AAMI/ISO 11135 series. Topics covered in this TIR are sterilization equipment, considerations for preconditioning, calculations for relative humidity, calculations of ethylene oxide concentration, and flammability.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI TIR15:2016/(R)2024; Physical aspects of ethylene oxide sterilization |
| 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 Definitions |
| 12 | 3 EO sterilization processing equipment 3.1 General 3.2 Preconditioning area (outside sterilizer chamber) |
| 13 | 3.3 Sterilizer system |
| 15 | 3.4 Aeration system |
| 16 | 3.5 EO handling, storage, and dispensing 3.6 Calibration and maintenance |
| 18 | 3.7 Safety 4 Determination of minimum product temperature prior to preconditioning 4.1 General 4.2 Simulation of anticipated process conditions |
| 19 | 4.3 Special situations 4.4 Other considerations 5 Calculation of moisture content 5.1 Static humidification 5.1.1 Process definition 5.1.2 Designing a static humidification process 5.1.2.1 Shallow vacuum processes (nitrogen soft cycles) |
| 20 | 5.1.2.2 Deep vacuum processes 5.2 Dynamic conditioning 5.2.1 Process definition |
| 21 | 5.2.2 Design of a dynamic conditioning phase 5.2.2.1 Operational pressure during dynamic conditioning 5.2.2.2 PSI—Process description and setup 5.2.2.3 CSI—Process description and setup |
| 22 | 5.2.3 Equipment concerns—Dynamic conditioning 5.2.3.1 Vacuum system 5.2.3.2 Steam supply 5.2.3.3 Control systems 6 Calculation of EO concentration 6.1 Calculation tables Table 1 — List of constants and molecular weights of some common EO/Diluent combinations |
| 23 | Table 2 — Gas constants (R)* 6.2 Definition of variables 6.3 Ideal Gas Law |
| 24 | 6.4 Calculations 6.5 Method of determining EO gas concentration based on physical laws of perfect gas behavior 6.5.1 100 % EO sterilant 6.5.1.1 Example 1—Partial pressure method 6.5.1.2 Example 2—EO weight method |
| 25 | 6.5.2 EO and diluent molecular blend 6.5.2.1 Example 3—Partial pressure method of a 20 % EO and 80 % CO2 sterilant gas with values of K in Table 1 |
| 26 | 6.5.2.2 Example 4—Sterilant weight method |
| 27 | 6.6 EO absorption 7 Calculations for use of flammability curve |
| 29 | Figure 1 — EO Cycle Flammability Diagram |
| 31 | Table 4 — Flammability review, partial pressures, and volume percentage |
| 32 | 8 Guide for statistical comparison to determine process equivalence 8.1 General 8.2 Equations for Pp, Ppk or for Cp, Cpk 8.2.1 Calculation of Pp |
| 33 | 8.2.2 Calculation of Ppk 8.2.3 Normality test |
| 34 | 8.2.4 Data interpretation 8.2.5 Worked Ppk, Pp example |
| 35 | 8.3 Other statistical methods |
| 36 | Bibliography |
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