AAMI 13408 3 2006 RA 2015
$75.64
ANSI/AAMI/ISO 13408-3:2006/(R)2015 – Aseptic processing of health care products-Part 3: Lyophilization
| Published By | Publication Date | Number of Pages |
| AAMI | 2006 | 24 |
Specifies requirements for and offers guidance on equipment, processes, programs and procedures for the control and validation of lyophilization as an aseptic process. It does not address the physical/chemical objectives of a lyophilization process.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 13408-3: 2006/(R)2015, Aseptic processing of health care products — Part 3: Lyophilization |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 8 | Committee representation |
| 10 | Background of ANSI/AAMI adoption of ISO 13408-3:2006 |
| 11 | Foreword |
| 12 | Introduction |
| 13 | 1 Scope 2 Normative references 3 Terms and definitions |
| 14 | 4 Quality system elements 4.1 General 4.2 Management responsibility 4.3 Design control 4.4 Measuring instruments and/or measuring systems 5 Product definition |
| 15 | 6 Process definitions 7 User requirements 7.1 General |
| 16 | 7.2 Equipment characterization 7.3 Product handling 7.3.1 Transport to, and loading of, the lyophilizer |
| 17 | 7.3.2 Unloading the lyophilizer 7.4 Microbiological and particulate environmental monitoring 7.5 Cleaning and sterilization 7.5.1 Cleaning-in-place (CIP) 7.5.2 Manual cleaning 7.5.3 Sterilization in place (SIP) |
| 18 | 7.6 Vent filter system 7.7 Lyophilizer leak test 8 Validation 8.1 General 8.2 Design qualification 8.3 Installation qualification 8.3.1 General |
| 19 | 8.3.2 Installation 8.3.3 Computer and software qualification 8.3.4 Alarm systems 8.4 Operational qualification 8.4.1 General 8.4.2 Leak test 8.4.3 Thermal control system(s) |
| 20 | 8.4.4 Vacuum system 8.4.5 Condenser refrigeration 8.4.6 Defrosting 8.4.7 Lyophilization cycle 8.4.8 CIP cycle 8.4.9 SIP cycle 8.4.10 Stoppering seating system(s) 8.4.11 Shelf temperature distribution |
| 21 | 8.5 Performance qualification 8.5.1 General 8.5.2 Lyophilization 8.5.3 SIP 8.6 Process validation 8.6.1 General 8.6.2 Cleaning validation 8.6.3 Process simulations |
| 22 | 8.6.4 Product validation 8.7 Review and approval of validation 9 Routine monitoring and control 9.1 General 9.2 Operator training |
| 23 | 9.3 Standard operating procedures 9.4 Requalification 9.5 Maintenance of equipment 9.6 Change control |
| 24 | Bibliography |
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