AAMI 13408 5 2006 RA 2015
$75.64
ANSI/AAMI/ISO 13408-5-2006/(R)2015 – Aseptic processing of health care products-Part 5: Sterilization in place
| Published By | Publication Date | Number of Pages |
| AAMI | 2006 | 31 |
Specifies the general requirements for sterilization in place (SIP) applied to product contact surfaces of the equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control. This document applies to processes where sterilizing agents are delivered to the internal surfaces of the equipment that can come in contact with the product.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 13408-5:2006(R)2015, Aseptic processing of health care products — Part 5: Sterilization in place |
| 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 13408-5:2006 |
| 13 | Foreword |
| 14 | Introduction |
| 15 | 1 Scope 2 Normative references |
| 16 | 3 Terms and definitions |
| 17 | 4 Quality system elements 4.1 General |
| 18 | 4.2 Management responsibility 4.3 Design control 4.4 Measuring instruments and measuring systems 5 Process and equipment characterization 5.1 General concepts |
| 19 | 5.2 Effectiveness of sterilization in place (SIP) 5.3 Equipment 5.3.1 Equipment to be subjected to SIP |
| 20 | 5.3.2 Equipment to be used for SIP |
| 21 | 5.3.3 Failure detection 6 Sterilizing agent characterization 6.1 Selection of sterilizing agent(s) 6.2 Quality of sterilizing agent(s) 6.3 Safety and the environment |
| 22 | 7 SIP process 7.1 Process parameters 7.2 Cycle development 8 Validation 8.1 Validation protocol |
| 23 | 8.2 Design qualification 8.3 Installation qualification 8.3.1 General 8.3.2 Installation 8.4 Operational qualification |
| 24 | 8.5 Performance qualification 8.5.1 General requirements |
| 25 | 8.5.2 Microbicidal effectiveness 8.6 Review and approval of validation |
| 26 | 8.7 Requalification 9 Routine monitoring and control 9.1 SIP process control 9.2 Procedures 9.3 SIP process records |
| 27 | 9.4 Change control 9.5 Maintenance of equipment 10 Personnel training |
| 28 | Annex A Steam sterilization in place A.1 Introduction A.2 Process and equipment characterization |
| 29 | A.3 Quality of steam A.4 Microbicidal effectiveness |
| 30 | A.5 Routine monitoring and control |
| 31 | Bibliography |
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