eLibrary >
BS EN ISO 13408-7:2015 Aseptic processing of health care products - Alternative processes for medical devices and combination products >
Expand All
TOC Search:
BS EN ISO 13408-7:2015 Aseptic processing of health care products - Alternative processes for medical devices and combination products, 2015
- 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
- 64_e_stf.pdf [Go to Page]
