AAMI 13408 2 2018
$75.64
ANSI/AAMI/ISO 13408-2:2018 – Aseptic processing of health care products-Part 2: Sterilizing filtration
| Published By | Publication Date | Number of Pages |
| AAMI | 2018 | 45 |
Specifies requirements for sterilizing filtration as part of aseptic processing of health care products. It also offers guidance to filter users concerning general requirements for selection, set up, validation and routine operation of a sterile-filtration process to be used for aseptic processing of health care products. This document does not apply to removal of mycoplasma or viruses by filtration nor to filtration of whole cell vaccines.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 13408-2:2018; Aseptic processing of health care products—Part 2: Sterilizing filtration |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents Page |
| 6 | Glossary of equivalent standards |
| 7 | Committee representation |
| 9 | Background of AAMI adoption of ISO 13408-2:2018 |
| 10 | Foreword |
| 11 | Introduction |
| 13 | 1 Scope 2 Normative references |
| 14 | 3 Terms and definitions |
| 15 | 4 Quality system elements 4.1 General 4.2 Management responsibility 4.3 Procurement of filters |
| 16 | 5 Sterilizing filter characterization 5.1 General 5.2 Microbial removal effectiveness 5.3 Material effects |
| 17 | 5.4 Environmental considerations 6 Process and equipment characterization 6.1 General 6.2 Risk management |
| 18 | 6.3 Process characterization 6.4 Equipment characterization |
| 19 | 7 Fluid definition 7.1 General |
| 20 | 7.2 Microbiological quality 8 Process definition 8.1 General 8.2 Filter definition and characterization 8.2.1 General |
| 21 | 8.2.2 Compatibility between the filter and fluid 8.2.3 Filter use |
| 22 | 8.3 Filtration process definition |
| 23 | 8.4 Integrity testing process definition 9 Validation 9.1 General |
| 24 | 9.2 Validation of fluid-specific microbial retention by sterilizing filters for liquids 9.2.1 General |
| 25 | 9.2.2 Test organism |
| 26 | 9.3 Validation of the integrity test for sterilizing filters for liquids 9.4 Validation of filter interactions with the process fluid 9.5 Validation of the sterilization of filter system |
| 27 | 9.6 Validation of fluid-specific microbial retention by sterilizing filters for gases 9.6.1 General 9.6.2 Aerosol retention 9.6.3 Validation of physical integrity testing 9.6.4 Compatibility and service life 9.6.5 Validation of the sterilization of the filter system for gases 10 Routine monitoring and control |
| 28 | 11 Product release from sterilizing filtration 12 Maintaining process effectiveness 12.1 General 12.2 Recalibration |
| 29 | 12.3 Maintenance of equipment 12.4 Requalification 12.5 Assessment of change |
| 30 | Annex A (informative) Guidance on the application of this document A.1 General A.2 Note on normative references A.3 Note on terms and definitions |
| 31 | Figure A.1—Pictorial aide to filter terminology A.4 Quality system elements A.4.1 General A.4.2 Management responsibility A.4.3 Procurement of filters |
| 32 | A.5 Sterilizing filter characterization A.5.1 General A.5.2 Microbial removal effectiveness |
| 33 | A.5.3 Material effects A.5.4 Environmental considerations A.6 Process and equipment characterization A.6.1 General A.6.2 Risk management Figure A.2—Process with a single sterilizing filter |
| 34 | Figure A.3—Process with bioburden reduction step and single sterilizing filter Figure A.4—Process with a particulate and/or bioburden reduction filter |
| 35 | Figure A.5—Process with two sterilizing filter in series Figure A.6—Process with a redundant sterilizing filter Figure A.7—Process with serial filtration with a sterile intermediate product hold |
| 36 | Figure A.8—Process with parallel sterilizing filters Figure A.9—Filtration of non-sterile fluid with a bioburden reduction filter followed by an optional bioburden controlled hold tank, bioburden sampling port and then a sterilizing filter |
| 37 | Figure A.10—Multi-filter configuration in series for controlling bioburden and particulates or redundant sterile filtration A.6.3 Process characterization A.6.4 Equipment characterization A.7 Fluid definition A.7.1 General |
| 38 | A.7.2 Microbiological quality A.8 Process definition A.8.1 General A.8.2 Filter definition and characterization A.8.2.1 General |
| 39 | A.8.2.2 Compatibility between the filter and fluid A.8.2.3 Filter use |
| 40 | A.8.3 Filtration process definition A.8.4 Integrity testing process definition Figure A.11—Typical equipment for pre-use integrity test on single 0,2 µm filter in a pre-sterilized single-use system |
| 41 | Figure A.12—Typical equipment for pre-use integrity test on two single 0,2 µm filter in a pre-sterilized single-use system A.9 Validation A.9.1 General A.9.2 Validation of fluid-specific microbial retention by sterilizing filters for liquids |
| 42 | A.9.3 Validation of the integrity test for sterilizing filters for liquids A.9.4 Qualification of filter interactions with the process fluid A.9.5 Validation of the sterilization of filter system |
| 43 | A.9.6 Validation of fluid-specific microbial retention by sterilizing filters for gases A.9.6.1 General A.9.6.2 Aerosol retention A.9.6.3 Validation of physical integrity testing A.9.6.4 Compatibility and service life A.9.6.5 Validation of the sterilization of the filter system for gases A.10 Routine monitoring and control A.11 Product release from sterilizing filtration A.12 Maintaining process effectiveness A.12.1 General A.12.2 Recalibration A.12.3 Maintenance of equipment A.12.4 Requalification A.12.5 Assessment of change |
| 45 | Bibliography |
Related products
-
AAMI 13408 7 2012 RA 2018
ANSI/AAMI/ISO 13408-7:2012/(R)2018 – Aseptic processing of health care products-Part 7: Alternative processes for medical devices…
