ANSI Standards Connect ET ( INTERNATIONAL ISO STANDARD 13408-1 (poweredbyEdaptive Third edition 2023-08 Technol logies) -GuestUser02-10/30/2023 Aseptic processing of health care products - Part 1: General requirements Traitement aseptique des produits de santé - Partie 1: Exigences générales Reference number IS0 13408-1:2023(E) Tso @IS02023 ANSI StandardsConnect ET IS0 13408-1:2023(E) -GuestUser02-10/30/2023 COPYRIGHTPROTECTEDDOCUMENT @IS02023 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may or ISo's member body in the country of the requester. ISO copyright office CP 401 · Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +41 22 749 01 11 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ Is0 2023 - All rights reserved ANSI IS0 13408-1:2023(E) rds Co Contents Page lect ET Foreword .vi Introduction. .vii red 1 Scope. by Edal 2 Normative references pti 3 Terms and definitions. ech 4 General 5 Principles of aseptic processing ..9 5.1 General. ies) .9 5.2 Use of an aseptic process ..9 5.3 Coreelements .10 5.4 Aseptic processing zones ..11 User 5.4.1 General .11 5.4.2 Critical processing zone ..11 02 5.4.3 Direct support zones. .11 10/30/2023 5.4.4 Indirect support zones. ..12 6 Process design, development and risk management ..12 6.1 General ..12 6.2 Process design .13 6.3 Risk assessment. .. 14 6.4 Identification of critical control points and process parameters .14 6.5 Handling and processing ..15 6.6 Environment and air handling .15 6.7 Materials 6.8 Personnel .. 16 6.8.1 General .. 16 6.8.2 Training .16 6.8.3 Health .. 17 6.8.4 Interventions 6.8.5 Service personnel .17 6.8.6 Cleanroom clothing systems .. 17 6.9 Aseptic processing equipment. 18 6.9.1 General ..18 6.9.2 Automated processes and robotics 19 6.9.3 Single use systems and connecting devices ..19 6.9.4 Auxiliary equipment and utilities 19 6.10 Components 20 6.11 Product related safety requirements .20 6.12 Aseptic final packaging process 20 6.13 Flow management 20 6.13.1 Containment 20 6.13.2 Cross contamination. 21 6.13.3 Item introduction. 21 6.13.4 Egress. 21 6.13.5 Waste management 21 6.14 Manufacturing process duration .22 7 Contamination control strategy (cs) .22 7.1 General. .22 7.2 Cleaning and disinfection programs 22 7.2.1 General 22 7.2.2 Cleaning 23 7.2.3 Disinfection .23 7.2.4 Equipment used for cleaning and disinfection in APA 24 @IS02023-All rightsreserved iii ANSI IS0 13408-1:2023(E) rds 7.2.5 Cleaning process validation 24 lect 7.2.6 Disinfection process validation. .25 ET 7.2.7 Cleaning and disinfection of equipment 25 7.2.8 Cleaning and disinfection procedures 25 (po 7.3 Sterilization.. 26 red 7.3.1 General 26 by 7.3.2 Sterilization processes. 26 Edal 7.3.3 Sterilization equipment. 26 pti 7.3.4 Sterilization procedures 26 7.3.5 Post aseptic lethal treatments 27 ech H 7.3.6 Endotoxin control 27 7.3.7 Depyrogenation process. 27 7.4 Maintenance of sterility. 28 ies) 7.5 Maintenance and calibration programs. 30 7.5.1 Service personnel 30 7.5.2 Planned maintenance activities. 30 7.5.3 Unplanned maintenance. 31 User 7.5.4 Calibration of equipment 31 02 7.6 Environmental monitoring. 31 7.6.1 General 31 10/30/2023 7.6.2 Sampling for non-viable particulate monitoring 32 7.6.3 Sampling for microbiological environmental monitoring .32 7.7 Containmentofhighlypotentortoxicsubstances. 33 8 Demonstration of the effectiveness. .33 8.1 Equipment qualification and validation. 33 8.1.1 General 33 8.1.2 User requirements specification. 33 8.1.3 Design qualification. 34 8.1.4 Installation qualification (IQ) 34 8.1.5 Operational qualification (OQ) 34 8.1.6 Performance qualification (PQ) 34 8.1.7 Requalification.. 34 8.2 Aseptic process validation. 35 8.2.1 General 35 8.2.2 Establishment and management of interventions. 35 8.2.3 Process simulation. 35 8.2.4 Initial aseptic qualification. 38 8.2.5 Periodic performance requalification 38 8.2.6 Repeat of initial as