T/CIET 357-2024 Sterile product production operation technical specifications for BFS (Blow Fill Seal) manufacturing process
T/CIET 357-2024 Sterile product production operation technical specifications for BFS (Blow Fill Seal) manufacturing process
Basic Information
Scope
Scope: This document specifies the terms and definitions, abbreviations, classification, establishment of quality management system, process design requirements, packaging container material requirements, facility and equipment requirements, environmental requirements, operator requirements, packaging processing requirements, and packaging quality requirements for BFS (Blow-Fill-Seal) sterile products. This document is applicable to cosmetic sterile products that adopt BFS technology to achieve a sterile filling process. Main technical content: This document specifies the terms and definitions, abbreviations, classification, establishment of quality management system, process design requirements, packaging container material requirements, facility and equipment requirements, environmental requirements, operator requirements, packaging processing requirements, and packaging quality requirements for BFS (Blow-Fill-Seal) sterile products. This document is applicable to cosmetic sterile products that adopt BFS technology to achieve a sterile filling process.