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AAMI 13408 1 2023

AAMI 13408 1 2023

$172.79

ANSI/AAMI/ISO 13408-1:2023 Aseptic processing of health care products—Part 1: General requirements

Published By Publication Date Number of Pages
AAMI 2023 89
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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.

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PDF Pages PDF Title
1 ANSI/AAMI/ISO 13408-1:2023; Aseptic processing of health care products—Part 1: General requirements
2 Blank Page
3 Title page
4 AAMI Standard
Copyright information
5 Contents
6 Committee representation
10 Background of ANSI/AAMI adoption of ISO 13408-1:2023
11 Foreword
13 Introduction
15 Figure 1 — Relationship between the ISO 13408 series and ISO 18362
17 1 Scope
2 Normative references
3 Terms and definitions
25 4 General
5 Principles of aseptic processing
5.1 General
26 Figure 2 — Key activities in the development and operation of an aseptic process and their relationships
5.2 Use of an aseptic process
27 5.3 Core elements
28 5.4 Aseptic processing zones
5.4.1 General
5.4.2 Critical processing zone
5.4.3 Direct support zones
29 5.4.4 Indirect support zones
6 Process design, development and risk management
6.1 General
31 6.2 Process design
6.3 Risk assessment
6.4 Identification of critical control points and process parameters
32 6.5 Handling and processing
6.6 Environment and air handling
33 6.7 Materials
6.8 Personnel
6.8.1 General
6.8.2 Training
34 6.8.3 Health
6.8.4 Interventions
35 6.8.5 Service personnel
6.8.6 Cleanroom clothing systems
36 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
37 6.10 Components
6.11 Product related safety requirements
6.12 Aseptic final packaging process
38 6.13 Flow management
6.13.1 Containment
6.13.2 Cross contamination
6.13.3 Item introduction
39 6.13.4 Egress
6.13.5 Waste management
6.14 Manufacturing process duration
7 Contamination control strategy (CCS)
7.1 General
40 7.2 Cleaning and disinfection programs
7.2.1 General
7.2.2 Cleaning
41 7.2.3 Disinfection
7.2.4 Equipment used for cleaning and disinfection in APA
42 7.2.5 Cleaning process validation
7.2.6 Disinfection process validation
7.2.7 Cleaning and disinfection of equipment
43 7.2.8 Cleaning and disinfection procedures
7.3 Sterilization
7.3.1 General
7.3.2 Sterilization processes
7.3.3 Sterilization equipment
44 7.3.4 Sterilization procedures
7.3.5 Post aseptic lethal treatments
7.3.6 Endotoxin control
45 7.3.7 Depyrogenation process
7.4 Maintenance of sterility
47 7.5 Maintenance and calibration programs
7.5.1 Service personnel
48 7.5.2 Planned maintenance activities
7.5.3 Unplanned maintenance
7.5.4 Calibration of equipment
49 7.6 Environmental monitoring
7.6.1 General
7.6.2 Sampling for non-viable particulate monitoring
50 7.6.3 Sampling for microbiological environmental monitoring
7.7 Containment of highly potent or toxic substances
51 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)
52 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
53 8.2.3 Process simulation
8.2.3.1 General
8.2.3.2 Media selection and growth support
54 8.2.3.3 Simulation procedures
55 8.2.3.4 Incubation and inspection of media filled units
8.2.4 Initial aseptic qualification
8.2.5 Periodic performance requalification
8.2.5.1 General
56 8.2.5.2 Numbers to be processed
8.2.5.3 Acceptance criteria
8.2.6 Repeat of initial aseptic qualification
57 8.2.7 Documentation of process simulations
58 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
59 8.3.3 Changes or developments to the manufacturing process
9 Product release
9.1 General
9.2 Testing for sterility
60 9.3 Testing for bacterial endotoxins
9.4 Testing for mycoplasma
9.5 Rapid and alternative microbiological methods
61 Annex A (informative) Aseptic processing — Typical elements
62 Annex B (informative) Risk management
B.1 General
B.2 Quality risk-management process
B.2.1 Risk assessment
B.2.2 Risk control
63 B.2.3 Risk communication
B.2.4 Risk review
Figure B.1 — Overview of a typical quality risk management process (reference ICH Q9)
64 B.3 Risk assessment tools
B.3.1 General
B.3.2 Failure mode and effects analysis (FMEA)
Table B.1 — Sample FMEA for aseptic connection of single-use processing equipment
65 B.3.3 Fault tree analysis (FTA)
66 Figure B.2 — Example FTA diagram
B.3.4 Hazard and operability analysis (HAZOP)
67 B.3.5 Hazard analysis and critical control points (HACCP)
B.3.6 Simplified risk assessment
69 Annex C (informative) Typical processing zones
C.1 General
Figure C.1 — Critical processing zone and support zone
70 Table C.1 — APA system
71 C.2 Aseptic processing area (APA) example set-up
Figure C.2 — Example of an aseptic processing area (APA) configuration using a RABS or biological safety cabinet
72 Figure C.3 — Example of an aseptic processing area (APA) configuration using a closed system
73 Annex D (informative) Comparison of classification of cleanrooms and filters
Table D.1 — Classification systems
75 Table D.2 — Comparison of HEPA and ULPA filters
77 Annex E (informative) Example of an aseptic process flow chart
Figure E.1 — Example of an aseptic process divided into unit operations
78 Annex F (informative) Closed systems and robotics
F.1 General
F.2 Single use systems as closed systems within an aseptic process
Figure F.1 — Overview of a filling system including multiple connections and disconnections
79 Figure F.2 — Example of a single sterile manifold system
F.3 Robotics
81 Annex G (informative) Sterile cleanroom clothing system qualification
G.1 General
G.2 Design qualification
G.2.1 General
G.2.2 Material qualifications
82 G.2.3 Performance testing
G.2.3.1 General
G.2.3.2 Simulated use of cleanroom clothing system
G.2.3.3 Cleanroom clothing system performance supported by historical data from actual use
G.2.4 Stability testing of sterile cleanroom garments and accessories
G.2.4.1 General
G.2.4.2 Sterile disposable garments
G.2.4.3 Reusable garments
G.2.5 Usability evaluation
83 G.3 Installation qualification (IQ)
G.4 Operational qualification (OQ)
84 G.5 Performance qualification (PQ)
85 Annex H (informative) Rapid and alternative microbiological methods
87 Bibliography

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