as of 2018 - 12 - 03
13.D Blow-fill-seal technology (BFS technology)
13.D.1 Principles of BFS technology
13.D.1.1 Development of BFS technology
13.D.1.2 Basic system types
13.D.1.3 How BFS technology works – cycle machines
13.D.1.4 How BFS technology works – rotary machines
13.D.2 Application of BFS technology
13.D.2.1 Fields of application
13.D.2.2 Possible products for BFS technology
13.D.2.3 Container forms for BFS technology
13.D.2.4 Materials for BFS technology
13.D.2.5 Limitations of BFS technology
13.D.3 Qualification and validation
13.D.3.1 System qualification
13.D.3.2 Process validation
13.D.3.3 Environmental validation
13.D.4 Operation of a BFS system
13.D.4.1 Required media
13.D.4.2 Ambient conditions
13.D.4.3 Operator training and clothing
13.D.4.4 Carrying out inspections during operation
13.D.4.5 Cleaning a BFS system
13.D.4.6 Sterilising a BFS system
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