ISO 13408-7:2012
Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products
ISO 13408-7:2012 specifies requirements and provides guidance on alternative approaches to process simulations for the qualification of the aseptic processing of medical devices and combination products that cannot be terminally sterilized and where the process simulation approach according to ISO 13408-1 cannot be applied.
ISO 13408-7:2012 describes how risk assessment can be used during the development of an aseptic process to design a process simulation study for medical devices and combination products in those cases where a straightforward substitution of media for product during aseptic processing is not feasible or would not simulate the actual aseptic process.
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CVP_Secretariat_Loca
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system elements
5 Aseptic process definition
5.1 General
5.2 Risk management
6 Manufacturing environment
7 Equipment
8 Personnel
9 Manufacture of the product
10 Process simulation
10.1 General
10.2 Media selection and growth support
10.3 Simulation procedures
10.4 Incubation and inspection of process simulation units
10.5 Initial performance qualification
10.6 Periodic performance requalification
10.7 Repeat of initial performance qualification
10.8 Documentation of process simulations
10.9 Disposition of filled product
11 Test for sterility
11.1 General
11.2 Investigation of positive units from tests for sterility
Annex A (informative) Risk assessment for aseptic processing — Quality risk management method
Annex B (informative) Selection of a sample for testing for microbial contamination
Annex C (informative) Testing options for process simulation
Bibliography
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AS/NZS ISO 11137.1:2006
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CVP_Secretariat_Loca
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system elements
5 Aseptic process definition
5.1 General
5.2 Risk management
6 Manufacturing environment
7 Equipment
8 Personnel
9 Manufacture of the product
10 Process simulation
10.1 General
10.2 Media selection and growth support
10.3 Simulation procedures
10.4 Incubation and inspection of process simulation units
10.5 Initial performance qualification
10.6 Periodic performance requalification
10.7 Repeat of initial performance qualification
10.8 Documentation of process simulations
10.9 Disposition of filled product
11 Test for sterility
11.1 General
11.2 Investigation of positive units from tests for sterility
Annex A (informative) Risk assessment for aseptic processing — Quality risk management method
Annex B (informative) Selection of a sample for testing for microbial contamination
Annex C (informative) Testing options for process simulation
Bibliography