AAMI 13408 1 2008 RA 2017 A1 2013
$140.32
ANSI/AAMI/ISO 13408-1:2008/(R)2017 & A1:2013 – Aseptic processing of health care products- Part 1: General requirements (includes Amendment 1).
| Published By | Publication Date | Number of Pages |
| AAMI | 2008 | 79 |
Specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of the manufacturing process for aseptically processed health care products.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 7 | Glossary of equivalent standards |
| 9 | Committee representation |
| 11 | Background of ANSI/AAMI adoption of ISO 13408-1:2008 |
| 12 | Foreword |
| 13 | Introduction |
| 15 | 1 Scope 2 Normative references |
| 16 | 3 Terms and definitions |
| 21 | 4 Quality system elements 4.1 General |
| 22 | 4.2 Assignment of responsibilities 4.3 Calibration 5 Aseptic process definition 5.1 General |
| 23 | 5.2 Risk management 5.2.1 General 5.2.2 Identification of microbiological contamination risks |
| 24 | 5.2.3 Assessment of contamination risks 5.2.4 Monitoring and detection of contamination |
| 25 | 5.2.5 Prevention of contamination 6 Manufacturing environment 6.1 General |
| 26 | 6.2 Manufacturing environment design 6.2.1 General 6.2.2 Construction features |
| 27 | 6.3 Layout 6.3.1 General 6.3.2 Critical processing zone |
| 28 | 6.3.3 Direct support zones 6.3.4 Indirect support zones 6.3.5 Material airlocks, transfer hatches, and product exit openings |
| 29 | 6.3.6 Personnel airlocks 6.3.7 Ancillary areas 6.4 Material and personnel flow 6.4.1 General |
| 30 | 6.4.2 Introduction of materials and components to the APA 6.5 HVAC system 6.5.1 General |
| 31 | 6.5.2 Air handling 6.5.3 Airflow patterns 6.5.4 Temperature and relative humidity 6.5.5 HEPA (including ULPA) filters 6.5.5.1 General 6.5.5.2 HEPA filter certification |
| 32 | 6.5.5.3 Installed filter leakage test 6.5.5.4 HEPA filter failure 6.6 Cleanroom qualification 6.7 Utility services and ancillary equipment 6.7.1 General 6.7.2 Water and wastewater |
| 33 | 6.7.3 Gases 6.7.4 Vacuum utilities 6.8 Environmental and personnel monitoring programs 6.8.1 General |
| 34 | 6.8.2 Sampling for particulate monitoring 6.8.3 Sampling for microbiological environmental monitoring 6.8.4 Monitoring of personnel |
| 35 | 6.8.5 Monitoring procedures 6.8.6 Evaluation of monitoring data 6.8.6.1 Alert and action levels 6.8.6.2 Review of data and trend analysis |
| 36 | 6.8.6.3 Investigations and reports |
| 37 | 7 Equipment 7.1 Qualification 7.1.1 General 7.1.2 User requirements 7.1.3 Design qualification |
| 38 | 7.1.4 Installation qualification 7.1.5 Operational qualification 7.1.6 Performance qualification 7.1.7 Requalification |
| 39 | 7.2 Maintenance of equipment 7.2.1 Scheduled preventive maintenance 7.2.2 Unplanned maintenance |
| 40 | 8 Personnel 8.1 General 8.2 Training for APA qualification |
| 42 | 8.3 Gowning procedures 8.3.1 General 8.3.2 Gowning for entering the APA |
| 43 | 8.4 General employee health 9 Manufacture of the product 9.1 Attainment and maintenance of sterility 9.1.1 Component sterilization |
| 44 | 9.1.2 Depyrogenation 9.1.3 Product sterilization 9.2 Duration of the manufacturing process |
| 45 | 9.3 Aseptic manufacturing procedures 9.4 Cleaning and disinfection of facilities 9.4.1 General 9.4.2 Cleaning |
| 46 | 9.4.3 Disinfection 9.4.4 Equipment used for cleaning/disinfection in APA |
| 47 | 9.4.5 Monitoring of cleaning and disinfection effectiveness 9.4.6 Effectiveness of disinfection procedures 9.5 Cleaning, disinfection and sterilization of equipment 9.5.1 General 9.5.2 Cleaning of equipment |
| 48 | 9.5.3 Disinfection of equipment 9.5.4 Sterilization of critical surfaces 9.5.5 Endotoxin control on critical surfaces |
| 49 | 10 Process simulation 10.1 General 10.2 Media selection and growth support 10.3 Simulation procedures |
| 50 | 10.4 Incubation and inspection of media filled units |
| 51 | 10.5 Initial performance qualification 10.5.1 General 10.5.2 Numbers to be filled 10.5.3 Acceptance criteria |
| 52 | 10.6 Periodic performance requalification 10.6.1 Scheduling requirements 10.6.2 Numbers to be filled 10.6.3 Acceptance criteria 10.7 Repeat of initial performance qualification 10.8 Documentation of process simulations |
| 53 | 10.9 Disposition of filled product |
| 54 | 11 Test for sterility 11.1 General |
| 55 | 11.2 Investigation of positive units from tests for sterility |
| 56 | Annex A Example of a flow chart |
| 57 | Annex B Typical elements of an aseptic process definition |
| 58 | Annex C Examples of specific risks |
| 59 | Annex D Comparison of classification of cleanrooms |
| 60 | Annex E Specification for water used in the process E.1 Source water E.2 Treated source water E.3 Purified water |
| 61 | E.4 Water for injections |
| 62 | Annex F Aseptic processing area |
| 63 | Bibliography |
| 65 | ANSI/AAMI/ISO 13408-1:2008/(R)2017, Aseptic processing of health care products — Part 1: General requirements Amendment 1 |
| 66 | AAMI Standard Copyright information |
| 67 | Contents |
| 68 | Committee representation |
| 70 | Background on AAMI adoption of ISO 13408-1:2008 Amd. 1 |
| 71 | Foreword |
| 73 | Amendment 1 |
