ISO 13408-1:2023
Aseptic processing of health care products — Part 1: General requirements
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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General
5 Principles of aseptic processing
5.1 General
5.2 Use of an aseptic process
5.3 Core elements
5.4 Aseptic processing zones
5.4.1 General
5.4.2 Critical processing zone
5.4.3 Direct support zones
5.4.4 Indirect support zones
6 Process design, development and risk management
6.1 General
6.2 Process design
6.3 Risk assessment
6.4 Identification of critical control points and process parameters
6.5 Handling and processing
6.6 Environment and air handling
6.7 Materials
6.8 Personnel
6.8.1 General
6.8.2 Training
6.8.3 Health
6.8.4 Interventions
6.8.5 Service personnel
6.8.6 Cleanroom clothing systems
6.9 Aseptic processing equipment
6.9.1 General
6.9.2 Automated processes and robotics
6.9.3 Single use systems and connecting devices
6.9.4 Auxiliary equipment and utilities
6.10 Components
6.11 Product related safety requirements
6.12 Aseptic final packaging process
6.13 Flow management
6.13.1 Containment
6.13.2 Cross contamination
6.13.3 Item introduction
6.13.4 Egress
6.13.5 Waste management
6.14 Manufacturing process duration
7 Contamination control strategy (CCS)
7.1 General
7.2 Cleaning and disinfection programs
7.2.1 General
7.2.2 Cleaning
7.2.3 Disinfection
7.2.4 Equipment used for cleaning and disinfection in APA
7.2.5 Cleaning process validation
7.2.6 Disinfection process validation
7.2.7 Cleaning and disinfection of equipment
7.2.8 Cleaning and disinfection procedures
7.3 Sterilization
7.3.1 General
7.3.2 Sterilization processes
7.3.3 Sterilization equipment
7.3.4 Sterilization procedures
7.3.5 Post aseptic lethal treatments
7.3.6 Endotoxin control
7.3.7 Depyrogenation process
7.4 Maintenance of sterility
7.5 Maintenance and calibration programs
7.5.1 Service personnel
7.5.2 Planned maintenance activities
7.5.3 Unplanned maintenance
7.5.4 Calibration of equipment
7.6 Environmental monitoring
7.6.1 General
7.6.2 Sampling for non-viable particulate monitoring
7.6.3 Sampling for microbiological environmental monitoring
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
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
8.2 Aseptic process validation
8.2.1 General
8.2.2 Establishment and management of interventions
8.2.3 Process simulation
8.2.4 Initial aseptic qualification
8.2.5 Periodic performance requalification
8.2.6 Repeat of initial aseptic qualification
8.2.7 Documentation of process simulations
8.2.8 Disposition of filled product
8.2.9 Aseptic process lifecycle considerations
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
9 Product release
9.1 General
9.2 Testing for sterility
9.3 Testing for bacterial endotoxins
9.4 Testing for mycoplasma
9.5 Rapid and alternative microbiological methods
Annex A (informative) Aseptic processing — Typical elements
Annex B (informative) Risk management
Annex C (informative) Typical processing zones
Annex D (informative) Comparison of classification of cleanrooms and filters
Annex E (informative) Example of an aseptic process flow chart
Annex F (informative) Closed systems and robotics
Annex G (informative) Sterile cleanroom clothing system qualification
Annex H (informative) Rapid and alternative microbiological methods
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General
5 Principles of aseptic processing
5.1 General
5.2 Use of an aseptic process
5.3 Core elements
5.4 Aseptic processing zones
5.4.1 General
5.4.2 Critical processing zone
5.4.3 Direct support zones
5.4.4 Indirect support zones
6 Process design, development and risk management
6.1 General
6.2 Process design
6.3 Risk assessment
6.4 Identification of critical control points and process parameters
6.5 Handling and processing
6.6 Environment and air handling
6.7 Materials
6.8 Personnel
6.8.1 General
6.8.2 Training
6.8.3 Health
6.8.4 Interventions
6.8.5 Service personnel
6.8.6 Cleanroom clothing systems
6.9 Aseptic processing equipment
6.9.1 General
6.9.2 Automated processes and robotics
6.9.3 Single use systems and connecting devices
6.9.4 Auxiliary equipment and utilities
6.10 Components
6.11 Product related safety requirements
6.12 Aseptic final packaging process
6.13 Flow management
6.13.1 Containment
6.13.2 Cross contamination
6.13.3 Item introduction
6.13.4 Egress
6.13.5 Waste management
6.14 Manufacturing process duration
7 Contamination control strategy (CCS)
7.1 General
7.2 Cleaning and disinfection programs
7.2.1 General
7.2.2 Cleaning
7.2.3 Disinfection
7.2.4 Equipment used for cleaning and disinfection in APA
7.2.5 Cleaning process validation
7.2.6 Disinfection process validation
7.2.7 Cleaning and disinfection of equipment
7.2.8 Cleaning and disinfection procedures
7.3 Sterilization
7.3.1 General
7.3.2 Sterilization processes
7.3.3 Sterilization equipment
7.3.4 Sterilization procedures
7.3.5 Post aseptic lethal treatments
7.3.6 Endotoxin control
7.3.7 Depyrogenation process
7.4 Maintenance of sterility
7.5 Maintenance and calibration programs
7.5.1 Service personnel
7.5.2 Planned maintenance activities
7.5.3 Unplanned maintenance
7.5.4 Calibration of equipment
7.6 Environmental monitoring
7.6.1 General
7.6.2 Sampling for non-viable particulate monitoring
7.6.3 Sampling for microbiological environmental monitoring
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
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
8.2 Aseptic process validation
8.2.1 General
8.2.2 Establishment and management of interventions
8.2.3 Process simulation
8.2.4 Initial aseptic qualification
8.2.5 Periodic performance requalification
8.2.6 Repeat of initial aseptic qualification
8.2.7 Documentation of process simulations
8.2.8 Disposition of filled product
8.2.9 Aseptic process lifecycle considerations
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
9 Product release
9.1 General
9.2 Testing for sterility
9.3 Testing for bacterial endotoxins
9.4 Testing for mycoplasma
9.5 Rapid and alternative microbiological methods
Annex A (informative) Aseptic processing — Typical elements
Annex B (informative) Risk management
Annex C (informative) Typical processing zones
Annex D (informative) Comparison of classification of cleanrooms and filters
Annex E (informative) Example of an aseptic process flow chart
Annex F (informative) Closed systems and robotics
Annex G (informative) Sterile cleanroom clothing system qualification
Annex H (informative) Rapid and alternative microbiological methods
Bibliography