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BS EN ISO 13408-1:2024

BS EN ISO 13408-1:2024

$215.11

Aseptic processing of health care products – General requirements

Published By Publication Date Number of Pages
BSI 2024 94
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This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products. This document includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series.

PDF Catalog

PDF Pages PDF Title
2 undefined
8 Annex ZA (informative)Relationship between this European Standard and the General Safety and Performance requirements of Regulation (EU) 2017/745 aimed to be covered
12 Annex ZB (informative)Relationship between this European Standard and the General Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered
16 Foreword
18 Introduction
21 1 Scope
2 Normative references
3 Terms and definitions
28 4 General
29 5 Principles of aseptic processing
5.1 General
5.2 Use of an aseptic process
30 5.3 Core elements
31 5.4 Aseptic processing zones
5.4.1 General
5.4.2 Critical processing zone
5.4.3 Direct support zones
32 5.4.4 Indirect support zones
6 Process design, development and risk management
6.1 General
33 6.2 Process design
34 6.3 Risk assessment
6.4 Identification of critical control points and process parameters
35 6.5 Handling and processing
6.6 Environment and air handling
36 6.7 Materials
6.8 Personnel
6.8.1 General
6.8.2 Training
37 6.8.3 Health
6.8.4 Interventions
6.8.5 Service personnel
6.8.6 Cleanroom clothing systems
38 6.9 Aseptic processing equipment
6.9.1 General
39 6.9.2 Automated processes and robotics
6.9.3 Single use systems and connecting devices
6.9.4 Auxiliary equipment and utilities
40 6.10 Components
6.11 Product related safety requirements
6.12 Aseptic final packaging process
6.13 Flow management
6.13.1 Containment
41 6.13.2 Cross contamination
6.13.3 Item introduction
6.13.4 Egress
6.13.5 Waste management
42 6.14 Manufacturing process duration
7 Contamination control strategy (CCS)
7.1 General
7.2 Cleaning and disinfection programs
7.2.1 General
43 7.2.2 Cleaning
7.2.3 Disinfection
44 7.2.4 Equipment used for cleaning and disinfection in APA
7.2.5 Cleaning process validation
45 7.2.6 Disinfection process validation
7.2.7 Cleaning and disinfection of equipment
7.2.8 Cleaning and disinfection procedures
46 7.3 Sterilization
7.3.1 General
7.3.2 Sterilization processes
7.3.3 Sterilization equipment
7.3.4 Sterilization procedures
47 7.3.5 Post aseptic lethal treatments
7.3.6 Endotoxin control
7.3.7 Depyrogenation process
48 7.4 Maintenance of sterility
50 7.5 Maintenance and calibration programs
7.5.1 Service personnel
7.5.2 Planned maintenance activities
51 7.5.3 Unplanned maintenance
7.5.4 Calibration of equipment
7.6 Environmental monitoring
7.6.1 General
52 7.6.2 Sampling for non-viable particulate monitoring
7.6.3 Sampling for microbiological environmental monitoring
53 7.7 Containment of highly potent or toxic substances
8 Demonstration of the effectiveness
8.1 Equipment qualification and validation
8.1.1 General
8.1.2 User requirements specification
54 8.1.3 Design qualification
8.1.4 Installation qualification (IQ)
8.1.5 Operational qualification (OQ)
8.1.6 Performance qualification (PQ)
8.1.7 Requalification
55 8.2 Aseptic process validation
8.2.1 General
8.2.2 Establishment and management of interventions
8.2.3 Process simulation
58 8.2.4 Initial aseptic qualification
8.2.5 Periodic performance requalification
59 8.2.6 Repeat of initial aseptic qualification
8.2.7 Documentation of process simulations
60 8.2.8 Disposition of filled product
8.2.9 Aseptic process lifecycle considerations
61 8.3 Maintenance of process
8.3.1 General
8.3.2 Review of the manufacturing process
8.3.3 Changes or developments to the manufacturing process
62 9 Product release
9.1 General
9.2 Testing for sterility
9.3 Testing for bacterial endotoxins
63 9.4 Testing for mycoplasma
9.5 Rapid and alternative microbiological methods
64 Annex A (informative) Aseptic processing — Typical elements
65 Annex B (informative) Risk management
72 Annex C (informative) Typical processing zones
77 Annex D (informative) Comparison of classification of cleanrooms and filters
80 Annex E (informative) Example of an aseptic process flow chart
81 Annex F (informative) Closed systems and robotics
84 Annex G (informative) Sterile cleanroom clothing system qualification
88 Annex H (informative) Rapid and alternative microbiological methods
90 Bibliography

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BS EN ISO 13408-1:2024
$215.11