AAMI TIR29 2012 RA 2017
$131.66
AAMI TIR29:2012/(R)2017 – Guide for process characterization and control in radiation sterilization of medical devices
| Published By | Publication Date | Number of Pages |
| AAMI | 2012 | 56 |
This technical information report provides additional guidance for characterizing the irradiation process and for establishing requisite process controls to ensure the irradiation system remains in a validated state. This document is intended to complement qualification and routine control activities as defined in ANSI/AAMI/ISO 11137 for gamma, X-ray, and electron beam sterilization.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | Blank Page |
| 3 | Title page |
| 4 | AAMI Technical Information Report Copyright information |
| 5 | Contents |
| 7 | Glossary of equivalent standards |
| 8 | Committee representation |
| 11 | Foreword |
| 13 | 1 Scope 2 Normative reference 3 Terms and definitions |
| 14 | 4 Installation qualification |
| 15 | 4.1 Gamma irradiators 4.2 Electron beam irradiators 4.3 X-ray irradiators |
| 16 | 5 Operational Qualification 5.1 General 5.2 Gamma Irradiators 5.2.1 General 5.2.2 Determination of qualification dosimeter placement grid |
| 17 | 5.2.3 Selection of materials |
| 18 | 5.2.4 Dose mapping 5.2.5 Partially-filled irradiation containers |
| 19 | 5.2.6 Interruption test 5.2.7 Scaling of dose 5.2.8 Non-standard processing |
| 20 | 5.3 Electron Beam Irradiators 5.3.1 General 5.3.2 Determination of the qualification dosimeter placement grid |
| 21 | 5.3.3 Selection of materials 5.3.4 Dose mapping (including 1- and 2-pass) |
| 23 | 5.3.5 Partially-filled irradiation containers 5.3.6 Interruption test 5.3.7 Scaling of dose 5.3.8 Non-standard processing |
| 24 | 5.4 X-ray Irradiators 5.4.2 Determination of the qualification dosimeter placement grid 5.4.3 Selection of materials 5.4.4 Dose mapping 5.4.5 Partially-filled irradiation containers |
| 25 | 5.4.6 Interruption test 5.4.7 Scaling of dose 5.4.8 Non-standard processing 5.5 Review and analysis of Operational Qualification data for all radiation modalities |
| 26 | 6 Performance Qualification 6.1 General 6.2 Gamma irradiators 6.2.1 Product loading pattern 6.2.2 Product dose mapping 6.2.2.6 Dosimeter placement |
| 27 | 6.2.3 Mapping and processing families 6.2.3.2 Mapping families 6.2.3.3 Processing families 6.2.4 Mixed density within the irradiator |
| 28 | 6.2.5 Mixed density within the irradiation container 6.2.6 Heterogeneous products 6.2.7 Partially-filled irradiation containers 6.2.8 Special loading patterns 6.2.9 Off-carrier processing |
| 29 | 6.2.10 Scaling of dose 6.3 Electron beam irradiators 6.3.1 Product loading pattern 6.3.2 Product dose mapping 6.3.2.2 Dosimeter placement |
| 30 | 6.3.3 Mapping and processing families 6.3.3.2 Mapping families 6.3.3.3 Processing families |
| 31 | 6.3.4 Mixed density within the irradiator 6.3.5 Mixed density within the irradiation container 6.3.6 Heterogeneous products 6.3.7 Partially-filled irradiation containers 6.3.8 Special loading patterns 6.3.9 Off-carrier processing 6.3.10 Scaling of dose 6.4 X-Ray irradiators |
| 32 | 6.4.1 Product loading pattern 6.4.2 Product dose mapping 6.4.2.5 Dosimeter placement 6.4.3 Mapping and processing families 6.4.3.3 Mapping families |
| 33 | 6.4.3.4 Processing families 6.4.4 Mixed density within the irradiator 6.4.5 Mixed density within the irradiation container 6.4.6 Heterogeneous products 6.4.7 Partially-filled irradiation containers |
| 34 | 6.4.8 Special loading patterns 6.4.9 Off-carrier processing 6.4.10 Scaling of Dose 6.5 Performance qualification outputs 6.5.1 Review and analysis of data 6.5.2 Selection of routine monitoring positions |
| 35 | 6.5.3 Documentation requirements 7 Product and Process Specifications 7.4 Special handling/processing (e.g., temperature, time-sensitive products) |
| 36 | 8 Routine Monitoring and Control 8.1 General 8.2 Receipt of product 8.3 Scheduling of gamma irradiators 8.3.3 Scheduling product runs 8.3.3.1 Steps in scheduling single product runs |
| 37 | 8.3.3.2 Steps in scheduling multiple product runs 8.3.4 Grouping of products for multiple runs 8.3.5 Separation of product runs 8.3.6 Change in cycle time between product runs 8.4 Scheduling of electron beam irradiators |
| 38 | 8.4.3 Loading of product 8.5 Scheduling of X-ray irradiators 8.5.1 Scheduling of product runs 8.5.2 Loading of product 8.6 Processing of product 8.6.1 Gamma 8.6.1.1 Processing parameters |
| 39 | 8.6.1.2 Location of dosimeters within irradiation container 8.6.1.3 Frequency of dosimeters 8.6.1.4 Partial containers 8.6.1.5 Off-carrier processing 8.6.1.6 Process interruption 8.6.1.7 Analysis 8.6.1.8 Unloading of product 8.6.1.9 Release of product |
| 40 | 8.6.1.10 Shipment of product 8.6.2 Electron beam & X-ray irradiators 8.6.2.1 Processing parameters 8.6.2.2 Location of dosimeters 8.6.2.3 Frequency of dosimeters 8.6.2.4 Partial containers |
| 41 | 8.6.2.5 Off-carrier processing 8.6.2.6 Process interruption 8.6.2.7 Analysis 8.6.2.8 Unloading of product 8.6.2.9 Release of product |
| 42 | 8.6.2.10 Shipment of product 9 Maintaining Process Effectiveness 9.1 General 9.2 Collection and review of data 9.3 Maintenance of process effectiveness 9.3.1 General |
| 43 | 9.4 Calibration 10 Assessment of Change 10.1 Change Control 10.2 Re-sourcing |
| 44 | Annex A, Measurement uncertainty in routine monitoring of dose A.1 Key statistical parameters |
| 45 | A.2 Methods for routine measurement of dose A.3 Production dose monitoring procedure 1–Measurement of minimum and maximum dose in routine processing of product |
| 46 | A.3.1 Calculation of average dose, variance, and standard deviation A.3.2 Estimate of uncertainty in dose measurements A.3.3 Setting process parameters A.3.3.1 Minimum dose |
| 47 | A.3.3.2 Maximum dose A.4 Production dose monitoring procedure 2–Measurement of reference dose and use of adjustment factors to calculate minimum and maximum dose in routine processing of product A.4.1 Calculation of adjustment factors A.4.2 Uncertainty attributable to adjustment factors |
| 48 | A.4.3 Estimate of uncertainty in dose measurements A.4.4 Setting process parameters A.5 Production dose monitoring procedure 3–Measurement of minimum dose and use of adjustment factor for maximum dose in routine processing of product |
| 49 | A.5.1 Calculation of adjustment factor A.5.2 Setting process parameters A.6 Dosing small samples with tight dosing conditions |
| 50 | Annex B, Source distribution equivalency B.1 Equivalent Source Distributions B.2 Planning an equivalent Distribution B.3 Verification requirements to define equivalency |
| 51 | B.4 IQ/OQ Verification Requirements for Equivalent Distributions |
| 52 | Annex C (informative), Bibliography |
