AAMI 13408 4 2005 RA 2014
$75.64
ANSI/AAMI/ISO 13408-4-2005/(R)2014 – Aseptic processing of health care products-Part 4: Clean-in-place technologies
| Published By | Publication Date | Number of Pages |
| AAMI | 2005 | 31 |
Specifies the general requirements for clean-in-place (CIP) processes applied to product contact surfaces of 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 cleaning agents are delivered to the internal surfaces of equipment designed to be compatible with CIP that may come in contact with the product.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 13408-4:2005/(R) 2014, Aseptic processing of health care products — Part 4: Clean-in-place technologies |
| 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 13408-4:2005 |
| 13 | Foreword |
| 14 | Introduction |
| 15 | 1 Scope 2 Normative references 3 Terms and definitions |
| 16 | 4 Quality system elements 4.1 General 4.2 Management responsibility |
| 17 | 4.3 Design control 4.4 Measuring instruments and measuring systems 5 Process and equipment characterization 5.1 General concepts |
| 18 | 5.2 Effectiveness of CIP 5.3 Equipment 5.3.1 Equipment to be subjected to CIP |
| 19 | 5.3.2 Equipment to be used for CIP |
| 20 | 5.3.3 Failure detection 6 Cleaning agent characterization 6.1 Selection of cleaning agent(s) 6.2 Quality of cleaning agent(s) 6.3 Safety and the environment |
| 21 | 7 CIP process 7.1 Process parameters 7.2 Process control 7.2.1 General 7.2.2 Selection of sampling method(s) |
| 22 | 7.2.3 Analytical methods and sample method validation 7.2.4 Acceptance criteria 7.2.5 Visual examination 7.2.6 Chemical examination 7.2.7 Microbiological examination 7.2.8 Endotoxin |
| 23 | 7.2.9 Particulates 7.3 Residues of cleaning agent(s) 8 Validation 8.1 Validation protocol 8.2 Evaluation of the CIP process 8.3 Design qualification 8.4 Installation qualification 8.4.1 General 8.4.2 Installation |
| 24 | 8.5 Operational qualification 8.6 Performance qualification |
| 25 | 8.7 Review and approval of validation 8.8 Requalification 9 Routine monitoring and control 9.1 CIP process control |
| 26 | 9.2 Procedures 9.3 CIP process records 9.4 Change control 9.5 Maintenance and calibration |
| 27 | 10 Personnel training |
| 28 | Annex A Description of sampling methods A.1 Swab samples A.2 Rinse samples A.3 Placebo samples |
| 29 | Annex B Calculation examples for acceptance criteria B.1 Example 1 — 3-log reduction methodology B.2 Example 2 — Analogue methodology |
| 31 | Bibliography |
