AAMI 13408 6 2005 RA 2013
$75.64
ANSI/AAMI/ISO 13408-6:2005/(R)2013 & A1:2013 – Aseptic processing of health care products – Part 6: Isolator systems
| Published By | Publication Date | Number of Pages |
| AAMI | 2005 | 44 |
Specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products. The document focuses on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 13408-6:2005/(R)2013, Aseptic processing of health care products — Part 6: Isolator systems |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 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 13408-6:2005 |
| 13 | Foreword |
| 14 | Introduction |
| 15 | 1 Scope 2 Normative references 3 Terms and definitions |
| 17 | 4 Quality system elements 4.1 General 4.2 Management responsibility |
| 18 | 4.3 Design control 4.4 Measuring instruments and measuring systems 5 Design of isolator systems 5.1 General 5.2 Types of isolators 5.2.1 Closed 5.2.2 Open |
| 19 | 5.3 Materials of construction 5.4 Air-handling system 5.4.1 Air change rate 5.4.2 Air flow pattern 5.4.3 Temperature/humidity 5.4.4 Particulate air specifications 5.4.5 Recirculation of air |
| 20 | 5.4.6 Pressure differentials 5.4.7 Filter maintenance 5.5 Operator interface 5.5.1 Isolator gloves/sleeves 5.5.2 Suits/half-suits 5.5.3 Access to the isolator |
| 21 | 5.6 Ancillary equipment 5.6.1 Portable and mobile equipment 5.6.2 Transfer ports 6 Facility requirements 6.1 Surrounding room classification 6.2 Process utilities |
| 22 | 7 User requirements 7.1 Product/process application 7.2 Ergonomics 7.3 Cleaning 7.3.1 General 7.3.2 Clean-in-place 7.3.3 Manual cleaning 7.3.4 Cleaning agent |
| 23 | 7.4 Bio-decontamination 7.4.1 General 7.4.2 Sterilization-in-place 7.4.3 Selection of bio-decontamination agent |
| 24 | 7.4.4 Bio-decontamination agent generation and testing 7.4.5 Bio-decontamination parameters |
| 25 | 7.4.6 Aeration and residue limits 7.4.7 Spore log reduction 7.4.8 Surface bio-decontamination of goods 7.4.9 Surface bio-decontamination of container with sterile product 8 Validation 8.1 General |
| 26 | 8.2 Design qualification 8.3 Installation qualification 8.3.1 General 8.3.2 Installation |
| 27 | 8.4 Operational qualification |
| 28 | 8.5 Performance qualification 8.5.1 General 8.5.2 Cleaning 8.5.3 Bio-decontamination |
| 29 | 8.5.4 Process simulation tests 8.6 Review and approval of validation 8.7 Requalification |
| 30 | 9 Routine monitoring and control 9.1 Procedures 9.2 System integrity 9.3 Bio-decontamination process monitoring 9.4 Environmental monitoring 9.5 Change control |
| 31 | 9.6 Maintenance and calibration 10 Personnel training |
| 32 | Bibliography |
| 33 | ANSI/AAMI/ISO 13408-6:2005, Aseptic processing of health care products — Part 6: Isolator systems Amendment 1 |
| 34 | AAMI Standard Copyright information |
| 35 | Contents |
| 36 | Committee representation |
| 38 | Background on AAMI adoption of ISO 13408-6:2005 Amd. 1 |
| 39 | Foreword |
| 41 | Amendment 1 |
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